Chula Vista City Council
September 27, 2022

From: Rima Khoury <
Sent: Monday, September 12, 2022 10: 29 AM
To: CityClerk < CityClerk@chulavistaca. gov>
Subject: Chula Vista Flavored Tobacco Ban Agenda # 8. 2 - Hookah Exemption Dear Mayor and City Councilmembers,
My name is Rima S. Khoury and I am General Counsel for Fumari, a premium hookah tobacco manufacturer located in San Diego City and one of the founding members of the National Hookah Community Association which was established to protect and preserve the cultural tradition of hookah. https:// www. nationalhookah. com/
Thank you for exempting the nearly thousand year cultural tradition of hookah at in the City of Chula Vista.

Please see presentation link below for your consideration. https:// docs. google. com/ presentation/ d/ 1SvmoLKgKKm81TDzBv0P3cQdDovhJj5srvHis2JpzccA/ present? usp= sharing
There is no teen hookah epidemic. The FDA and CDC reports have made it clear that hookah is not the problem with youth. According to the CDC 2021 survey, current hookah use among high school students is less than 1% at 0. 8%, and this number has been going down over the last decade.

The FDA recently stated in their Guidance for the Industry dated April 2020 that although data shows that flavored tobacco entice youth, that such data does NOT appear to raise comparably urgent public health concerns with youth usage of hookah products because the lower prevalence of youth use of these products suggests that they do NOT appear to be as appealing to youth at this time. Emphasis added. See page 30 in attached.

If the goal is to protect kids, this would not be achieved by banning hookah as kids are not using hookah according to these reliable sources. If hookah is banned, there will be a disproportionate impact on Middle Eastern, Persian, Turkish, Indian, Armenian, and North African minority communities and minority owned businesses who are still struggling due to COVID- 19. https:// www. cdc. gov/ tobacco/ data_ statistics/ fact_ sheets/ youth_ data/ tobacco_ use/ index. htm#:~: text= In% 202021% 2C%20about% 201% 20of% 20every% 20100% 20middle% 20school% 20students, in% 20the% 20 past% 2030% 20days.& text= In% 202021% 2C%20nearly% 202% 20of, in% 20the% 20past% 2030% 20days.

Warning:

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Hookahs are not being confiscated in schools. Hookahs are 3 feet tall and cannot be easily concealed in your pocket or backpack like vape. Hookahs take 25 – 30 minutes to set up and need hot coals, therefore it cannot be smoked during recess in the bathroom at school. Hookah’ s cost over $ 200 for all the ten parts and accessories, making it out of reach for most kids.

Hookah is not the problem.

Yet hookah has become collateral damage in the war against vape. Hookah is not vape. Hookah has been practiced for nearly a thousand years by Persians, Arabs, Armenians, Turks, Indians, North Africans, and other minority groups many of which have immigrated to America and still practice their cultural traditions. Hookah is the center piece of social gatherings and is often offered to guests as a sign of hospitality and respect.

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Many immigrant small business owners have built their business doing what they know from their home country. Often times they work 20 hour days, seven days a week to support multiple generations of their family. Banning hookah has crippled these immigrant small business owners who are already struggling due to COVID- 19. Thank you for proposing a reasonable regulation that addresses youth usage and access to flavored vape. Many of these business owners that have been operating legally for years are happy to work with law makers to address youth access issues verses losing their livelihood as hookah lounges and retailer owners often have several years remaining on their leases and have personally guaranteed their leases. If hookah were banned they would not only lose their business, but their homes and no longer be able to support their family and extended family.

A tobacco flavor ban is a ban on hookah because it only comes in flavors. Even hundreds of years ago hookah was made with molasses and honey which is still the case today.

The federal government is doing a lot to address youth access and usage of flavored tobacco products. At the end of 2019 the federal government passed a 21 and over minimum for tobacco products across all fifty states, called Tobacco- 21. In addition, in February 2020 the FDA passed an e- cigg ban on flavored e- cartridges. September 9, 2020 was the FDA deadline for all vape and hookah products to be accepted for FDA review through PMTA or SE applications, after which any products without FDA authorization will be unlawfully on the market and their products seized and injunctions restricting sales will be issued along with fines and penalties. Currently, FDA has issued approximately six million refusals or Marketing Denial Orders for these applications. Furthermore, the FDA announced that they will be banning menthol and flavored cigars. The federal government is addressing the youth access issue and also providing legislation across the board, eliminating the patchwork of laws from city to city and closing loop holes for bad actors to skirt the law.

Moreover, Hookah has been exempted from the California State flavored tobacco ban, SB793, because of its cultural significance and that it is fundamentally different from vape. Please see attached video of Senator Hill, author of the bill, explaining why hookah was exempted from SB793 at the Senate Appropriations hearing on June 25th, 2020. Senator Hill learned the difference between vape and hookah and understood that hookah was not the problem and took steps to exempt it due to its cultural significance.

SB793, which, as amended and revised, prohibits the sale of all flavored tobacco products and flavored tobacco product enhancers, exempting hookah tobacco, cigars with a wholesale price of $ 12. 00 or more, loose leaf pipe tobacco was signed by Governor Gavin Newsom on August 28, 2020. SB793 was referendized and is on the November 2022 general election ballot as Prop 31.

Please see the hookah exemption language from SB793 below:
c) Subdivision ( b) does not apply to the sale of flavored shisha tobacco products by a hookah tobacco retailer if all of the following conditions are met:
1) The hookah tobacco retailer has a valid license to sell tobacco products issued pursuant to Chapter 2 commencing with Section 22971. 7) of Division 8. 6 of the Business and Professions Code. 2) The hookah tobacco retailer does not permit any person under 21 years of age to be present or enter the premises at any time.
3) The hookah tobacco retailer shall operate in accordance with all relevant state and local laws relating to the sale of tobacco products.

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4) If consumption of tobacco products is allowed on the premises of the hookah tobacco retailer, the hookah tobacco retailer shall operate in accordance with all state and local laws relating to the consumption of tobacco products on the premises of a tobacco retailer, including, but not limited to, Section 6404. 5 of the Labor Code.

SB793 balances the interests of law makers by addressing youth access and usage of flavored tobacco products, while protecting the cultural tradition of hookah. The SB793 hookah exemption limits sales to 21 and over establishments, meaning you have to be 21 and over to enter a retail establishment or lounge in order to purchase hookah and requires these establishments to comply with local and state laws. This shows that law makers can reach their regulatory goals without creating unintended consequences like eliminating the rich cultural tradition of hookah.

We thank the City of Chula Vista for proposing a flavor ban that exempts hookah just as the State of Massachusetts and soon California, Denver, CO; and the following California Cities: Los Angeles City, San Jose, Elk Grove, Walnut Creek, West Hollywood, Burbank, Glendale, Irvine, Long Beach, Encinitas, San Diego City and County, El Cajon, Ventura, Pleasant Hill, Redwood City and Culver City have done. Please feel free to contact me with any questions or to discuss further. https:// www. youtube. com/ watch? v= 9qlUH3hmvUc
The Culture of Hookah | An Exploration of History and Tradition RIMA KHOURY, ESQ.

GENERAL COUNSEL
619) 331- 3535 EXT. 723
FUMARI INC.

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SB 793 Hookah Exemption Senator Hill Video:

https://cvapps.chulavistaca.gov/WebLink/Browse.aspx?id=246066&dbid=0&repo=CityClerk&dbid=0&re po=CityClerk&mediaid=246214
EnforcementPrioritiesfor
ElectronicNicotineDelivery
Systems (ENDS) andOther
DeemedProductsontheMarket
Without Premarket
Authorization (Revised)*
Thisis arevisionto thefirst editionof thisguidance, whichissuedin January2020.

Guidancefor Industry
Commentsmaybesubmittedatanytimefor Agencyconsideration. Electroniccommentsmaybe submittedtohttps://www.regulations.gov. Alternatively, submitwrittencommentsto the DocketsManagementStaff (HFA-305), FoodandDrugAdministration, 5630FishersLane, Room1061, Rockville, MD 20852. All commentsshouldbeidentifiedwithdocketnumber FDA-2019-D-0661.

Forquestionsregardingthisguidance, contacttheCenterfor TobaccoProductsat (Tel) 1-877- CTP-1373 (1-877-287-1373) Monday-Friday, 9 a.m. – 4 p.m. ET.

Additionalcopiesareavailableonlineathttps://www.fda.gov/tobacco-products/products- guidance-regulations/rules-regulations-and-guidance. Youmaysendane-mailrequestto [email protected] thisguidance. Youmaysenda requestfor hardcopiesto U.S. FoodandDrugAdministration, Centerfor TobaccoProducts, Attn: Officeof SmallBusinessAssistance, DocumentControlCenter, Bldg. 71, Rm. G335, 10903NewHampshireAve., SilverSpring, MD 20993-2000.

U.S. Departmentof HealthandHumanServices
FoodandDrug Administration
Centerfor TobaccoProducts
April 2020
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i
Tableof Contents
I. INTRODUCTION............................................................................................................. 2 II. BACKGROUND ............................................................................................................... 3 A. StatutoryandRegulatoryHistory ................................................................................................ 3 B. FDA Responseto Evidenceof IncreasingYouthUseof ENDSProducts ................................. 6 III. DEFINITIONS .................................................................................................................. 9 IV. ENFORCEMENTPRIORITIESREGARDINGCERTAINENDSPRODUCTS ONTHE MARKET WITHOUT PREMARKETAUTHORIZATION .................... 10 A. Overview ........................................................................................................................................ 10 B. DataShowSubstantialIncreasein YouthUseof ENDSProducts, ParticularlyCertain Flavored, Cartridge-BasedENDSProducts .............................................................................. 11 C. AdditionalRelevantConsiderations .......................................................................................... 17 D. EnforcementPrioritiesfor ENDSProducts ............................................................................... 18

1. Any flavored, cartridge-basedENDSproduct (otherthanatobacco- ormenthol- flavoredproduct) ....................................................................................................... 19

2. All otherENDSproductswithoutadequatemeasuresto preventminors’ access .... 21

3. Any ENDSproductthatis targetedtominorsorwhosemarketingis likely to promoteuseof ENDSbyminors .............................................................................. 24

4. Any ENDSproductthatis offeredfor salein theUnitedStatesafter September9, 2020 ..................................................................................................... 27 E. Avoidinga “BlackMarket” ........................................................................................................ 28 V. PREMARKETREVIEW FOROTHERDEEMEDNEWTOBACCO
PRODUCTS .................................................................................................................... 29 APPENDIXA – SIGNIFICANTCOMMENTSRECEIVEDIN RESPONSETO
MARCH 2019DRAFTGUIDANCEANDFDA RESPONSES ..............................................30 WrittenCommunications
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2 EnforcementPrioritiesfor
ElectronicNicotineDelivery
Systems (ENDS) andOther
DeemedProductsontheMarket
Without Premarket
Authorization (Revised)
Guidancefor Industry1
1 ThisguidancewaspreparedbytheOfficeof ComplianceandEnforcement, Officeof HealthCommunicationand Education, Officeof Regulations, andOfficeof Sciencein theCenterfor TobaccoProductsatFDA.

Thisguidancerepresentsthecurrentthinkingof theFoodandDrugAdministration (FDA or Agency) on thistopic. It doesnotestablishanyrightsfor anypersonandis notbindingonFDAor thepublic. You canuseanalternativeapproachif it satisfiestherequirementsof theapplicablestatutesandregulations.

Todiscussanalternativeapproach, contacttheFDAstaffresponsiblefor thisguidanceaslistedonthe titlepage.

I. INTRODUCTION
Thisguidancedocumentdescribeshowweintendtoprioritizeourenforcementresourceswith regardtothemarketingof certaindeemedtobaccoproductsthatdonothavepremarket authorization.2
2 AswithFDA’spriorcompliancepoliciesondeemednewtobaccoproductsthatdonothavepremarket authorization, thisguidancedocumentdoesnotapplytoanydeemedproductthatwasnotonthemarketonAugust 8, 2016.

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3 ForENDSproductsmarketedwithoutFDAauthorization, FDAintendsto prioritizeenforcement against:

Any flavored, cartridge-basedENDSproduct (otherthanatobacco- ormenthol-flavored ENDSproduct);
All otherENDSproductsfor whichthemanufacturerhasfailedtotake (oris failingto take) adequatemeasuresto preventminors’ access; and
Any ENDSproductthatis targetedtominorsorwhosemarketingis likely topromoteuse of ENDSbyminors.3
3 Forpurposesof thisFinalGuidance, FDA’suseof theterm “minor” refersto individualsundertheageof 21. This is consistentwith theFurtherConsolidatedAppropriationsAct, 2020 (H.R. 1865), signedintolawonDecember20, 2019, whichincludedaprovisionamendingsection906(d) of theFederalFood, Drug, andCosmeticAct toincrease thefederalminimumageto purchasetobaccoproductsfrom18to21, andaddingaprovisionthatit is unlawfulfor anyretailertosellatobaccoproducttoanypersonyoungerthan21yearsof age. In addition, FDAisworkingto updateourregulationswithin180days, consistentwiththetimelinesetforthin thelaw.

Further, FDAintendsto prioritizeenforcementof anyENDSproductthatis offeredfor saleafter September9, 2020, andfor whichthemanufacturerhasnotsubmittedapremarketapplication orafteranegativeactionbyFDAonatimelysubmittedapplication).

Thisguidancedoesnotin anywayalterthefactthatit is illegalto marketanynewtobacco productwithoutpremarketauthorization. FDAis continuouslyevaluatingnewinformationand adjustingitsenforcementprioritiesin lightof thebestavailabledata, andit will continueto doso withrespecttotheseproducts. FDAwill takeappropriateactionregardingtobaccoproductsthat aremarketedwithoutpremarketauthorization, includingaswarrantedbasedonchanged circumstances, newinformation, orto betteraddressminors’ useof thoseproducts.

FDA’sguidancedocuments, includingthisguidance, donotestablishlegallyenforceable responsibilities. Instead, guidancesdescribetheAgency’scurrentthinkingonatopicandshould beviewedonlyasrecommendations, unlessspecificregulatoryorstatutoryrequirementsare cited. Theuseof thewordshouldin Agencyguidancesmeansthatsomethingis suggestedor recommended, butnotrequired.

II. BACKGROUND
A. StatutoryandRegulatoryHistory
TheFamilySmokingPreventionandTobaccoControlAct (TobaccoControlAct) (Public Law111-31) grantedFDAtheauthorityto regulatethemanufacture, marketing, and distributionof cigarettes, cigarettetobacco, roll-your-own (RYO) tobacco, andsmokeless tobaccoproductsto protectthepublichealthandto reducetobaccousebyminors. The TobaccoControlAct alsogaveFDAtheauthoritytoissueregulationsdeemingother productsthatmeetthestatutorydefinitionof atobaccoproduct4 4 21U.S.C 321(rr) (section201(rr) of theFD&C Act).
to besubjectto chapterIX of
theFederalFood, Drug, andCosmeticAct (FD&C Act) (21U.S.C. 387through387u) section901(b) of theFD&C Act).

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4 In accordancewith thatauthority, onMay10, 2016, FDAissuedafinalruledeemingall productsthatmeetthestatutorydefinitionof atobaccoproduct, exceptaccessoriesof deemed tobaccoproducts, to besubjectto FDA’stobaccoproductauthority. Thisincludedelectronic nicotinedeliverysystems (ENDS), cigars, waterpipe (hookah) tobacco, pipetobacco, nicotinegels, anddissolvablesthatwerenotalreadysubjectto theFD&C Act (81FR28974 at28976 (May10, 2016)).

Therequirementsin ChapterIX of theFD&C Act nowapplyto deemedproducts.

Particularlyrelevanttothisguidanceis section910, whichimposescertainpremarket-review requirementsfor “newtobaccoproducts”—i.e., thosethatwerenotcommerciallymarketedin theUnitedStatesasof February15, 2007. Accordingly, aftertherule’seffectivedate, deemednewtobaccoproductswererequiredto obtainpremarketauthorizationunderSection 910. Deemednewtobaccoproductsthatremainonthemarketwithoutmarketing authorizationaremarketedunlawfullyin contraventionof theTobaccoControlAct. Through thepremarketreviewprocess, FDAconductsascience-basedevaluationto determine whetheranewtobaccoproductmeetstheapplicablestatutorystandardfor marketing authorization—for example, whethertheproductis appropriatefor theprotectionof public healthwithrespectto therisksandbenefitsto thepopulationasawhole, includingusersand nonusers, andtakingintoaccount, amongotherthings, thelikelihoodthatthosewhodonot usetobaccoproductswill startusingthem.

ThepreambletotheMay10, 2016, finaldeemingruleexplainedthatFDAintendedtodefer enforcementfor failureto havepremarketauthorizationduringtwocomplianceperiods relatedtopremarketreview: onefor submissionandFDAreceiptof applicationsandonefor obtainingpremarketauthorization. Thefirst complianceperioddependedonthetypeof application. Thecompliancedatewas12monthsfromtheeffectivedateof therulefor substantialequivalenceexemptionrequests (EX REQs), 18monthsfor substantial equivalencereports (SEReports), and24monthsfor premarkettobaccoapplications PMTAs). In addition, thepreambleexplainedthatunderthesecondcomplianceperiod:

UnlessFDAhasissuedanorderdenyingor refusingto acceptthesubmission, productsfor whichtimelypremarketsubmissionshavebeensubmittedwill besubject toacontinuedcomplianceperiodfor 12monthsaftertheinitial complianceperiod describedpreviously. Forsuchproducts, FDAdoesnotintendto initiateenforcement for failureto havepremarketauthorizationduringthiscontinuedcomplianceperiod.5 5 81FRat29011.

Thepreamblefurtherexplainedthatthiscompliancepolicydidnotapplyto anynewtobacco productthatwasnotonthemarketonAugust8, 2016. Significantly, thispolicydidnot conferlawfulmarketingstatusonnewtobaccoproductsbeingmarketedwithoutthe necessarypremarketauthorization.

In May2017, FDApublishedaguidancedocument, Three-MonthExtensionof CertainTobacco ProductComplianceDeadlinesRelatedto theFinal DeemingRule, underwhichtheAgency, as WrittenCommunications
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5 amatterof enforcementdiscretion, stateditsintentionto deferenforcementfor anadditional threemonthsfor all futurecompliancedatesfor requirementsunderthefinaldeemingrule.

In July2017, FDAannouncedanewcomprehensiveplanfor tobaccoandnicotineregulationthat wouldserveasamulti-yearroadmapin aneffortto significantlyreducetobacco-relateddisease anddeath. Priorto thisannouncement, nationallyrepresentativedatasuggestedthatyouthuseof e-cigaretteshaddeclinedbeginningin 2016.6
6 Jamal, A., A. Gentzke, S.S. Hu, etal., “TobaccoUseAmongMiddleandHighSchoolStudents — UnitedStates, 2011–2016,” MorbidityandMortalityWeeklyReport, 66:597–603, 2017, availableat:
https://www.cdc.gov/mmwr/volumes/66/wr/mm6623a1.htm.

Thecomprehensiveplanwasannouncedin partto
affordtheAgencytimeto exploreclearandmeaningfulmeasuresto makecombustibletobacco productslesstoxic, lessappealing, andlessaddictive. Oneaspectof theplaninvolvedstrikinga balancebetweenregulationandencouragingdevelopmentof innovativetobaccoproductsthat maybelessharmfulthancigarettes. TheAgencyannouncedthatit plannedto issueanupdated compliancepolicyfurtherdeferringsomeenforcementtimelinesdescribedin thefinaldeeming rule.

In accordancewiththiscomprehensiveplan, in August2017, FDAannouncedanextension of theperiodduringwhichit didnotintendtoinitiateenforcementactionfor premarket reviewrequirementsunderthefinaldeemingrule (“August2017CompliancePolicy”) for deemedtobaccoproductsthatwereonthemarketonAugust8, 2016. Thisrevisedpolicy statedthat, for theseproducts, FDAdidnotintendtoinitiateenforcementregarding submittingEX REQs, SEReports, andPMTAsfor newlyregulatedcombustedtobacco products (suchasmostcigars) until August8, 2021, andFDAdidnotintendto initiate enforcementregardingEX REQs, SEReports, andPMTAsfor newlyregulated noncombustedtobaccoproducts (suchasmostENDSproducts) until August8, 2022. In addition, FDArevisedthecompliancepolicyrelatingto theperiodafterFDAreceiptof EX REQs, SEReports, andPMTAsfor deemedtobaccoproductsthatwereonthemarketon August8, 2016. FDAstatedthat, underthispolicy, it intendedto continuedeferring enforcementuntiltheAgencyrenderedadecisiononanapplication (i.e., issuanceof: a MarketingOrder; aNoMarketingOrder; aRefusetoFile; oraRefuseto Accept) or the applicationwaswithdrawn.

In March2018, theAugust2017CompliancePolicywaschallengedin theU.S. DistrictCourt for theDistrictof Maryland, andonMay15, 2019, thecourtissuedanorderthatvacatedthe guidance.7
7 AmericanAcademyofPediatrics, etal. v. FoodandDrugAdministration, etal., 379F. Supp. 3d461, 496 (D. Md. 2019).

OnJuly12, 2019, thecourtissuedafurtherorderdirectingFDAtorequirethat premarketauthorizationapplicationsfor all new—i.e., not “grandfathered”8 8 A “grandfathered” productisonethatwasonthemarketasof February15, 2007. Guidance, EstablishingThata TobaccoProductWasCommerciallyMarketedin theUnitedStatesasof February15, 2007, datedSeptember2014, availableat: https://www.fda.gov/media/123544/download. deemedtobacco
productsbesubmittedto theAgencywithin10months, byMay12, 2020, andprovidingfor a one-yearperiodduringwhichproductswith timelyfiledapplicationsmightremainonthemarket WrittenCommunications
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6 pendingFDAreview.9
9 AmericanAcademyof Pediatrics, etal. v. FoodandDrugAdministration, etal., No. 8:18-cv-883 (PWG), 2019 WL 3067492, at *7 (D. Md. July12, 2019) (Dkt. No. 127). Thecourthasgrantedinterventiontovaporindustry tradeassociationsfor purposesof appealingthecourt’sdecisionandremediesorder. SeeAmericanAcademyof Pediatrics, etal. v. FoodandDrugAdministration, etal., No. 8:18-cv-883 (PWG), Dkt. No. 154 (Oct. 2, 2019). An appealis pending. SeeAmericanAcademyof Pediatricsv. CigarAss’n of America, Nos. 19-2130, -2132, -2198, - 2242 (4thCir.).

ThecourtsubsequentlyclarifiedthatitsorderdidnotrestrictFDA’s authorityto enforcethepremarketreviewprovisionsagainstdeemedproducts, orcategoriesof deemedproducts, priorto thesubmissiondateorduringtheone-yearreviewperiod.10 10 AmericanAcademyof Pediatrics, etal. v. FoodandDrugAdministration, etal., CaseNo. 8:18-cv-883 (PWG), D. Md. Aug. 12, 2019), Dkt. No. 132.

OnApril
22, 2020, thecourtgrantedamotionfor a120-dayextension (until September9, 2020) in light of theglobaloutbreakof respiratoryillnesscausedbyanewcoronavirus.11 11 AmericanAcademyof Pediatrics, etal. v. FoodandDrugAdministration, etal., CaseNo. 8:18-cv-883 (PWG), D. Md. Apr. 22, 2020), Dkt. No. 182.

Asrequiredbythe
court’sorder, deemednewtobaccoproductsonthemarketasof August8, 2016, for which premarketauthorizationapplicationsarenotfiled bySeptember9, 2020, aresubjecttoFDA enforcementactions, in theAgency’sdiscretion.12
12 AmericanAcademyofPediatrics, etal. v. FoodandDrugAdministration, etal., No. 8:18-cv-883 (PWG), 2019 WL 3067492, at *7 (D. Md. July12, 2019) (Dkt. No. 127).

B. FDAResponseto Evidenceof IncreasingYouthUseof ENDSProducts In late2017, FDAstartedtoseeamarkedincreasein complaintsaboutENDSproducts. FDA initiatedaninvestigationof thesecomplaints, themajorityof whichpertainedtominors’ access toanduseof theseproducts. Thisnewinformationindicatedanalarmingincreasein theuseof ENDSproductsbymiddleandhighschoolstudents. In April 2018, FDAconducteda nationwideundercoverenforcementeffortthatresultedin FDAissuing56warninglettersto onlineretailersand6 civil moneypenalty (CMP) complaintsto retailestablishmentsrelatedto theillegalsalesof certainENDSproductstominors. In addition, FDAsentanofficialrequest for informationtomanufacturersof certainENDSproductscommonlyusedbyminorsrequiring themto submitdocumentsto facilitatetheAgency’sunderstandingof thereportedhighratesof youthuseandtheparticularyouthappealof theseproducts. FDAalsotookmeasurestoaddress thesaleof ENDSproductstominorsonlinebycontactingeBaytoraiseconcernsoverseveral listingsonitswebsite. Thisresultedin listingsfor theseENDSproductsbeingremovedfrom eBay.

In May2018, FDAissued17warninglettersto manufacturers, distributors, andretailersfor sellinge-liquidswith labelingand/oradvertisingthatresemblekid-friendlyfoodproducts, such asjuiceboxes, candy, or cookies. Thewarninglettersstatedthatfailuretocorrectviolations mayresultin FDAinitiatingfurtheractionsuchasseizureorinjunctiverelief. Of thesewarning letters, 13wereissuedaspartof ajoint actionwith theFederalTradeCommission (FTC).

OnSeptember12, 2018, FDAannouncedaseriesof enforcementandotherregulatoryactions relatedtothelabelingandadvertisingof ENDSproducts, includingthatit hadconducted WrittenCommunications
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7 nationwide, undercoverinvestigationsof brick-and-mortarandonlinestoresoverthesummerof 2018andissuedmorethan1,300warninglettersandCMPcomplaintstoretailerswhoillegally soldENDSproductstominors. FDAalsoissued12warningletterstoonlineretailersthatwere sellingmisleadinglylabeledand/oradvertisede-liquidsresemblingkid-friendlyfoodproducts suchascandyandcookies.

In addition, onSeptember12, 2018, FDAissuedlettersto five ENDSproductmanufacturers, requestingeachcompanytosubmitaplandescribinghowit wouldaddressminors’ accesstoand useof itsproducts.

In responseto theSeptember12thlettersto industry, manufacturersdescribedsafeguardsthat theycouldimplementtohelptorestrictminors’ accessto ENDSproductssoldatbrickand mortarretailersandonline. Examplesof potentialsafeguardsincluded:

Establishingorenhancingprograms, suchasmysteryshopperprograms, to monitor retailercompliancewith age-verificationandsalesrestrictions; Establishingandenforcingcontractualpenaltiesfor contractedretailersthatsell tobaccoproductstoyouth;
Usingage-verificationtechnologytobetterrestrictaccesstothemanufacturer’s website, suchasthroughindependent, third-partyage- andidentity-verification servicesthatcomparecustomerinformationagainstthird-partydatasources; and Limitingthequantityof ENDSproductsthatacustomermaypurchasewithinagiven periodof time.

In conjunctionwithissuingtheSeptember2018letters, FDAannouncedin September2018that theAgencywasconsideringwhether, in light of currentinformation, it wouldbeappropriateto revisittheAugust2017CompliancePolicy, whichcouldresultin withdrawingorrevisingthe policywith respectto certainflavoredproductsthatmaybecontributingto therisein youthuse andhavingfirms “removesomeorall of [these] products . . . until theyreceivepremarket authorizationandotherwisemeetall of theirobligationsunderthelaw.”13 13 FDAtakesnewstepsto addressepidemicof youthe-cigaretteuse, includingahistoricactionagainstmorethan 1,300retailersand5 majormanufacturersfor theirrolesperpetuatingyouthaccess (Sept. 11, 2018), availableat:
https://www.fda.gov/news-events/press-announcements/fda-takes-new-steps-address-epidemic-youth-e-cigarette- use-including-historic-action-against-more.

Followingthe
September12thlettersandannouncement, FDArepeatedlypubliclydiscussed14 14 See, e.g., StatementfromFDACommissionerScottGottlieb, M.D., onproposednewstepstoprotectyouthby preventingaccesstoflavoredtobaccoproductsandbanningmentholin cigarettes, availableat:
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm625884.htm; Scudder, L., “VapingandE- Cigarettesin Kids: An UnprecedentedEpidemic,” Medscape, January28, 2019, availableat:
https://www.medscape.com/viewarticle/908077?faf=1.
thefactthatthese
compliancetimelineswereunderreconsiderationandsolicitedtheviewof stakeholders— includingmanufacturers, retailassociations, andpublicinterestorganizations.15 15 See, e.g., FDAPublicCalendar – MeetingWithFDAOfficials, availableat: https://www.fda.gov/news- events/fda-meetings-conferences-and-workshops/public-calendar-meetings-fda-officials (notingmeetingsheldon October11, 16, 18, 29and30of 2018; November13, 2018; andDecember19, 2018); February6, 2019Letterssent WrittenCommunications
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8 Sincetheeffectivedateof theDeemingRulein August2016, FDAhasissuedmorethan10,000 warninglettersandmorethan1,400CMPcomplaintsto retailersfor thesaleof ENDSproducts to minors. Specifically, fromApril 2018throughAugust2019, FDAissuedover6,000warning lettersandmorethan1,000CMPcomplaintstoretailersfor thesaleof ENDSproductsto minors. SinceMay2018, FDAhasalsoissuedover40warninglettersto manufacturers, distributors, andretailersfor sellinge-liquidswith falseormisleadinglabelingand/oradvertising thatresemblekid-friendlyproducts. In June2019, theAgencyissuedjoint FDA/FTCwarning lettersto foure-liquidmanufacturersfor violationsrelatedtoonlinepostsbysocialmedia influencersonthecompanies’ behalf. In September2019, FDAissuedawarninglettertoan ENDSmanufacturerfor marketingunauthorizedmodifiedrisktobaccoproducts, includingin outreachtoyouth.16
16 Formoreinformation, pleaseseehttps://www.fda.gov/news-events/press-announcements/fda-warns-juul-labs- marketing-unauthorized-modified-risk-tobacco-products-including-outreach-youth.

FDAwill continueto useall availabletoolstopreventyouthuseof all tobaccoproducts, includingENDSproducts.

In 2018, FDAcontinuedtoreceiveinformationunderscoringtheproblemof youthuseof ENDS products. Currente-cigaretteusehadincreasedconsiderablyamongU.S. middleandhighschool studentsduring2017–2018, reversingadeclinein e-cigaretteusethathadbeenobservedin recentyearsandincreasingoveralltobaccoproductusein 2018. Specifically, amonghigh schoolstudents, currente-cigaretteusehadincreasedby78percentin thepastyear (from11.7 percentin 2017to20.8 percentin 2018, p<0.001), whileamongmiddleschoolstudents, current e-cigaretteusehadincreasedby48percent (from3.3 percentin 2017to4.9 percentin 2018, p =

0.001).17
17 Cullen, K.A., B.K. Ambrose, A.S. Gentzke, etal., “NotesfromtheField: Increasein e-cigaretteuseandany tobaccoproductuseamongmiddleandhighschoolstudents – UnitedStates, 2011-2018,” MorbidityandMortality WeeklyReport, 67(45);1276-1277, 2018.

Frequentuseamonghighschoolstudents (definedasuseon 20of thepast30days) alsohadincreased, from20.0 percentin 2017to 27.7 percentin 2018 (p = 0.008).18 18 Id.

Datafrom
thisstudy, aswell astheconcernsdescribedabove, promptedFDA to issueadraftguidance, Modificationsto CompliancePolicyfor CertainDeemedTobaccoProducts” (“March2019 DraftGuidance”), regardingthecontinuedmarketingof deemedtobaccoproductsthathavenot obtainedpremarketauthorization, andto callonindustrytodomoretokeeptheirproductsoutof thehandsof minors.

In 2019, twoof thelargestsurveysof tobaccouseamongyouthfoundthate-cigaretteusehashit thehighestlevelseverrecorded. Asdetailedin SectionIV below, datafromboththeNational YouthTobaccoSurvey (NYTS) andtheMonitoringtheFuture (MTF) Studyhavedocumenteda continuedincreasein youthuseof ENDSproductsandfurtherunderscoredthemagnitudeof the problem. Thesedata, informationconveyedto FDAin commentstotheMarch2019Draft Guidance, andconcernabouthealthandsafetyissuesconnectedtotheseproducts—e.g., the toJUULLabs, Inc. andAltriaGroupInc., requestingmeetingstodiscussconcernsrelatedyouthaddictionto tobaccoproducts, availableat: https://www.fda.gov/tobacco-products/rules-regulations-and-guidance/ctp-letters- industry.

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9 harmfuleffectsof nicotineonadolescentbraindevelopment, aswellasbatteryexplosionswith ENDSproducts—continueto informFDA’sseriouspublichealthconcernsregardingthesaleof theseproductswithoutpremarketauthorization. Repeatedexposuretonicotineduring adolescenceinduceslong-lastingchangesin brainregionsinvolvedin addiction, attention, learning, andmemory.

Furthermore, asof December17, 2019, therehavebeenapproximately2,506reportedcasesof hospitalizationsfor lunginjuriesassociatedwithuseof vapingproducts (“hospitalizedEVALI patients”), including54confirmeddeaths.19
19 SeeCentersfor DiseaseControlandPrevention, “Outbreakof LungInjuryAssociatedwithE-cigaretteUse, or Vaping,” availableathttps://www.cdc.gov/tobacco/basic_information/e-cigarettes/severe-lung-disease.html#latest- outbreak-information.

Workingcloselywith otherfederalandstate
agencies, FDAhasnotbeenableto determinethecauseof thisoutbreak. It appearsthatmostof thepatientsimpactedbytheseillnessesreportedusingTHC-containingproducts, withevidence suggestingthatadditiveagents, specificallyVitaminE, mayplayacausativerole. In manyof thecases, individualsreportedusingmultipleproducts, includingsomewithnicotine. Many differentsubstancesandproductsourcesarestill underinvestigation.

Althoughthisguidancedoesnotaddressproductsthatarenottobaccoproducts, theoutbreakof lunginjuriesassociatedwith useof vapingproductsillustratespublichealthandsafetyconcerns thatmayarisefor productsfor whichinformationrelatedtoproductsafetyandhealthimpactare lackingandaffirmstheimportanceof thepremarketreviewprocess, ascontemplatedbythe TobaccoControlAct, to scientificallyevaluateproductsbasedonapublichealthstandard.

Accordingly, FDAis issuingthisFinalGuidanceto communicateitsenforcementprioritieswith respecttoENDSproducts. FDA’sdecisionto exerciseitsenforcementauthoritieswithrespect to particularproductswill bedeterminedonacase-by-casebasis, informedbytheenforcement prioritiesdescribedin thisFinalGuidanceandanyotherrelevantfactors.20 20 SeeHecklerv. Chaney, 470U.S. 821, 835 (1985) (providingthattheFD&C Act’senforcementprovisionscommit broaddiscretionto theSecretaryto decidehowandwhentheyshouldbeexercised).

III. DEFINITIONS
Forpurposesof thisguidance, FDAintendstousethefollowingdefinitions:

Cartridge-basedENDSproductsareatypeof ENDSproductthatconsistsof, includes, or involvesacartridgeorpodthatholdsliquidthatis tobeaerosolizedthroughproductuse. For purposesof thisdefinition, acartridgeorpodis anysmall, enclosedunit (sealedorunsealed) designedto fit withinoroperateaspartof anelectronicnicotinedeliverysystem.21 21 Anexampleof productsthatwouldnotbecapturedbythisdefinitionincludecompletelyself-contained, disposableproducts.

Electronicnicotinedeliverysystems (or ENDS) includedevices, components, and/orpartsthat deliveraerosolizede-liquidwheninhaled. Forexample, FDAconsidersvapesorvapepens, personalvaporizers, e-cigarettes, cigalikes, e-pens, e-hookahs, e-cigars, ande-pipesto beENDS.

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10 E-liquidsareatypeof ENDSproductandgenerallyrefertoliquidnicotineandnicotine- containinge-liquids (i.e., liquidnicotinecombinedwithcolorings, flavorings, and/orother ingredients). Liquidsthatdonotcontainnicotineorothermaterialmadeorderivedfromtobacco, butthatareintendedorreasonablyexpectedto beusedwithorfor thehumanconsumptionof a tobaccoproduct, maybecomponentsorpartsand, therefore, subjectto FDA’stobaccocontrol authorities.

Labelmeansadisplayof written, printed, orgraphicmatterupontheimmediatecontainerof any article. Section201(k) of theFD&C Act.

Labelingmeansall labelsandotherwritten, printed, orgraphicmatter (1) uponanyarticleorany of itscontainersorwrappers, or (2) accompanyingsucharticle. Section201(m) of theFD&C Act.

Newtobaccoproductmeans (1) anytobaccoproduct (includingthoseproductsin testmarkets) thatwasnotcommerciallymarketedin theUnitedStatesasof February15, 2007; or (2) any modification (includingachangein design, anycomponent, anypart, oranyconstituent, includingasmokeconstituent, orin thecontent, deliveryorformof nicotine, oranyother additiveoringredient) of atobaccoproductwherethemodifiedproductwascommercially marketedin theUnitedStatesafterFebruary15, 2007. Section910(a) of theFD&C Act.

Tobaccoproductmeansanyproductmadeor derivedfromtobaccothatis intendedfor human consumption, includinganycomponent, part, or accessoryof atobaccoproduct (exceptfor raw materialsotherthantobaccousedin manufacturingacomponent, part, or accessoryof atobacco product). Theterm “tobaccoproduct” doesnotmeananarticlethatundertheFD&C Act is a drug (section201(g)(1) (21U.S.C 321(g)(1))), adevice (section201(h)), or acombination product (section503(g) (21U.S.C 353(g))). Section201(rr) of theFD&C Act.

IV. ENFORCEMENTPRIORITIESREGARDINGCERTAINENDSPRODUCTSON

THE MARKET WITHOUT PREMARKETAUTHORIZATION
A. Overview
TheTobaccoControlAct providesthatnewtobaccoproducts (i.e., non-grandfatheredproducts) maynotlegallybemarketedwithoutpremarketauthorization. Accordingly, all deemednew tobaccoproductsonthemarketwithoutauthorizationareillegallymarketedproducts.

BeginningFebruary6, 2020, FDAintendsto prioritizeenforcementof thepremarketreview requirementsfor certainENDSproducts, includingagainstretailerssellingsuchproducts.

Specifically, FDAintendsto prioritizeenforcementagainst:
1) Flavored, cartridge-basedENDSproducts (exceptfor tobacco- ormenthol-flavored products);
2) All otherENDSproductsfor whichthemanufacturerhasfailedto take (oris failingto take) adequatemeasuresto preventminors’ access; and
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11 3)AnyENDSproductstargetedto, or whosemarketingis likely topromoteuseby, minors.

In addition, FDAintendstoprioritizeenforcementof anyENDSproductthatis offeredfor sale in theUnitedStatesafterSeptember9, 2020, andfor whichthemanufacturerhasnotsubmitteda premarketapplication (or afteranegativeactionbyFDAonatimelysubmittedapplication).22 22 WenotethatFDAwouldbeenforcingtheprioritiesdiscussedin SectionIV of thisguidanceregardlessof the court’sdecisionin theAAPcase. Asdiscussedin thisFinalGuidance, FDAis implementingthispolicytoaddress thealarmingincreasein youthuseof ENDSproductsaswellasotherrecenthealthandsafetyissuesregardingsuch products.

FDAwill makeenforcementdecisionsonacase-by-casebasis, recognizingthatit is unable, asa practicalmatter, to takeenforcementactionagainsteveryillegallymarketedtobaccoproduct, andthatit needstomakethebestuseof Agencyresources. Thisguidancedoesnotin anyway alterthefactthatit is illegaltomarketanynewtobaccoproductwithoutpremarketauthorization, orto sellanytobaccoproducttominors. TheAgencyalsoretainsdiscretionto pursue enforcementactionatanytimeagainstanydeemednewtobaccoproductmarketedwithout premarketauthorization, regardlessof whetherit fallswithinoneof thesecategoriesof enforcementpriorities.

B. DataShowSubstantialIncreasein YouthUseof ENDSProducts, ParticularlyCertain Flavored, Cartridge-BasedENDSProducts
At thetimeFDAissuedtheAugust2017CompliancePolicyto announcechangesin itsapproach to enforcementregardingpremarketauthorization (asdescribedin thepreambleto thefinal deemingrule), datafromthe2016NYTSshowedadecreasein prevalenceof currente-cigarette use (i.e., past30-dayuse) amonghighschoolstudents, from16percentin 2015to11.3 percentin 2016.23
23 Jamal, A., A. Gentzke, S.S. Hu, etal., “TobaccoUseAmongMiddleandHighSchoolStudents — UnitedStates, 2011–2016,” MorbidityandMortalityWeeklyReport, 66:597–603, 2017, availableat:
https://www.cdc.gov/mmwr/volumes/66/wr/mm6623a1.htm.

Resultsfromthe2017NYTSlaterconfirmedthatin regardstoyouthusetherewasno statisticallysignificantriseatthetime, withdatasuggestingthathighschoolstudentusehad leveledoff between2016 (11.3 percent)24
24 Id.
and2017 (11.7 percent).25
25 Wang, T.W., A. Gentzke, S. Sharapova, etal., “TobaccoProductUseAmongMiddleandHighSchoolStudents – UnitedStates, 2011-2017,” MorbidityandMortalityWeeklyReport, 67:629-633, 2018, availableat:
http://dx.doi.org/10.15585/mmwr.mm6722a3.

However, multiplesurveyresultsoverthepastseveralyearsdemonstratethatthereis significant initiationbyyouth. Therecentsurgein youthuseof ENDSproductshascausedusto reevaluate ourJuly2017assessmentandto modifyourenforcementprioritiesfor ENDSproducts. Recent datashowanalarmingincreasein youthuseof ENDSproductsin thepasttwoyears. Theyalso showyoutharemorelikely tousecertainflavored, cartridge-basedENDSproducts.

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12 Overall, datashowedthatENDSproductusemorethandoubledamongmiddleschoolandhigh schoolstudentsfrom2017to2019.26
26 MiechR, L. Johnston, P.M. O’Malley, etal., “Trendsin adolescentvaping, 2017–2019,” NewEnglandJournalof Medicine, 381:1490-1491, 2019; DOI:10.1056/NEJMc1910739.

DatafromMTFshowedthatfrom2017to2018, current
past30-day) e-cigaretteusesignificantlyincreasedfrom6.6 percentto 10.4 percentamong8th graders (a58percentincrease), 13.1 percentto21.7 percentamong10thgraders (a66percent increase), and16.6 percentto 26.7 percentamong12thgraders (a61percentincrease).27 27 Miech, R. A., Johnston, L. D., O’Malley, P. M., etal., “MonitoringtheFuturenationalsurveyresultsondruguse, 1975–2018: VolumeI, Secondaryschoolstudents,” AnnArbor: Institutefor SocialResearch, TheUniversityof Michigan (2019), availableathttp://monitoringthefuture.org/pubs.html#monographs. Foreachagegroup, the increasefrom2017to2018wasstatisticallysignificant (p<.001).

This
trendcontinuedin the2019MTFdata. Thenumberof studentswhohadusedENDSproducts duringtheprevious12monthsandthosewhohadeverusedENDSproductssignificantly increasedin 8th, 10th, and12thgradefrom2018to 2019.28
28 MiechR, L. Johnston, P.M. O’Malley, etal., “Trendsin adolescentvaping, 2017–2019,” NewEnglandJournalof Medicine; 381:1490-1491, 2019; DOI:10.1056/NEJMc1910739.

DatafromtheNYTSfor thesame
timeperiodshowthat, between2017and2018, currente-cigaretteuseamonghighschool studentsincreasedfrom11.7 percentto 20.8 percent (a78percentincrease, p<0.001).29 29 Cullen, K.A., B.K. Ambrose, A.S. Gentzke, etal., “NotesfromtheField: Increasein e-cigaretteuseandany tobaccoproductuseamongmiddleandhighschoolstudents – UnitedStates, 2011-2018,” MorbidityandMortality WeeklyReport, 67(45);1276-1277, 2018. TheNYTSdefinese-cigarettesas “battery-powereddevicesthatprovide nicotineandotheradditivesto theuserin theformof anaerosol.” Current
e-cigaretteuseamongmiddleschoolstudentsalsoincreasedfrom3.3 percentto4.9 percentover thesametimeperiod (a48percentincrease, p=0.001), whichwecalculatedasanincreaseof an estimated180,000middleschoolstudentsreportingpast30-daye-cigaretteusein oneyear.30 30 Id.

Thedatafrom2019NYTShavealsodocumentedthatthisis thesecondyearin arowwhere current (past30-day) e-cigaretteusereachednewhighsamongyouth.31 31 Cullen, K.A., A.S. Gentzke, M.D. Sawdey, “E-cigaretteuseamongyouthin theUnitedStates, 2019,” JAMA, 322(21);2095-2103, 2019. Severalimprovementsweremadeto theNYTSin 2019, includingswitchingfrompaper- and-pencilto electronicsurveyadministration, addingskippatternsandexampleproductimages, andupdating brandexamplestoreflectthecurrenttobaccomarketplace (e.g., addingJUUL), whichmayaffectthecomparability of tobaccoproductusebehaviors, includinge-cigaretteusebehaviors, withpreviousyears. Althoughtrendanalyses, whichusemoredatapointsandarenotsolelydependentonchangesduringasingleyear, maybeconductedwithout majorshiftsin patternsorfindings, theexactmagnitudeof theeffectof thesesurveyimprovementsin 2019cannot befully quantified. Thus, directstatisticalcomparisonsbetweenestimatesof tobaccoproductusebetween2018and 2019werenotconducted.

Theprevalenceof
currente-cigaretteuseamonghighschoolstudentswas27.5 percentandmiddleschoolstudents was10.5 percent.32
32 Cullen, K.A., A.S. Gentzke, M.D. Sawdey, “E-cigaretteuseamongyouthin theUnitedStates, 2019,” JAMA, 322(21);2095-2103, 2019.

Amonghighschoolstudents, 4.11million reportedhavingusedane- cigarettein thepastmonthin 2019with 1.24millionmiddleschoolstudentsreportingthesame.

Forthefirst timeever, thetotalnumberof middleandhighschoolstudentsreportingcurrentuse of e-cigarettessurpassed5 millionin 2019.33
33 Id.

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13 Disturbingly, thesedataalsoindicatethatagrowingpercentageof America’syouthwhousee- cigaretteshavebecomefrequente-cigaretteusers (definedasreportinguseon20daysormoreof theprior30-dayperiod). An increasingnumberof youtharethusatgreaterriskof nicotine addictionatatimewhenthedevelopingbrainis particularlysusceptibleto permanentchanges fromnicotineuseandwhenalmostall nicotineaddictionis established.34 34 MiechR., JohnstonL, O’MalleyPM, etal., “Adolescentvapingandnicotineusein 2017–2018 — U.S. National Estimates,” NewEnglandJournalof Medicine; 380:192-3, 2019.

Datafromthe2019
NYTShavedocumentedcontinuedfrequentyouthENDSuse.35
35 Cullen, K.A., A.S. Gentzke, M.D. Sawdey, “E-cigaretteuseamongyouthin theUnitedStates, 2019,” JAMA, 322(21);2095-2103, 2019.

Theproportionof currenthigh
schoole-cigaretteuserswhoreporteduseon20daysormore (of theprior30-dayperiod), and thuswerefrequentusers, was34.2 percentin 2019.36
36 Id.

Theproportionof currentmiddleschoole-
cigaretteuserswhoreporteduseon20daysormore (of theprior30-dayperiod) was18.0 percentin 2019.

Thisbuildsuponanincreasein frequentENDSuseamongyouthwhoreportusingENDS productsobservedin 2018. Forexample, datafromthe2018NYTSshowedthattheproportion of currenthighschoole-cigaretteuserswhoreporteduseon20daysormore (of theprior30-day period) increasedby38.5 percent, from20.0 percentin 2017to 27.7 percentin 2018.37 37 Cullen, K.A., B.K. Ambrose, A.S. Gentzke, etal., “NotesfromtheField: Increasein e-cigaretteuseandany tobaccoproductuseamongmiddleandhighschoolstudents – UnitedStates, 2011-2018,” MorbidityandMortality WeeklyReport, 67(45);1276-1277, 2018.

In a
studythatcollecteddatafromFebruaryto May2018andfocusedspecificallyon15-to-17-year- oldcurrentusersof JUULproducts (themostcommonlyusedbrand, includingamongyouth),

55.8 percentreportedusingsuchENDSproductson3 ormoreof theprevious30days, andover aquarter (25.3 percent) reporteduseon10to30daysof thepriormonth.38 38 Vallone, D.M., M. Bennett, H. Xiao, etal., “Prevalenceandcorrelatesof JUULuseamonganationalsampleof youthandyoungadults,” TobaccoControl,0:1-7, 2017, doi: 10.1136/tobaccocontrol-2018-05463.

Theconcernscausedbythesharpincreasein thenumberof youthusingENDSproductsare compoundedbyevidenceindicatingthatyouthwhosefirst tobaccoproductis anENDSproduct areatanincreasedriskof becomingcigarettesmokersascomparedtonon-ENDSusers. A 2018 reportbytheNationalAcademyof Sciences, Engineering, andMedicineentitled “PublicHealth Consequencesof E-Cigarettes,” whichtookintoaccountmultiplelinesof evidenceacross differentstudiesandstudydesigns, concludedthat “thereis substantialevidencethate-cigarette useincreasesriskof everusingcombustibletobaccocigarettesamongyouthandyoungadults.”39 39 NationalAcademiesof Sciences, Engineering, andMedicine, “Publichealthconsequencesof e-cigarette,”.

Washington, DC: TheNationalAcademiesPress, 2018, doi: https://doi.org/10.17226/24952.

FDAis alsoconcernedabouttheextraordinarypopularityof flavoredENDSproductswith youth. Researchhaslongshownthatflavorsincreaseyouthappealof tobaccoproducts, WrittenCommunications
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14 includingENDS.40
40 E.g., Carpenter, C.M., etal., “NewCigaretteBrandswithFlavorsthatAppealtoYouth: TobaccoMarketing Strategies,” HealthAffairs, 24(6):1601-1610, 2005; Pepper, J. K., K.M. Ribisl, N.T. Brewer, “Adolescents’ interest in tryingflavouredecigarettes,” TobaccoControl, 25:ii62-ii66, 2016; Camenga, D. R., M. Morean, G. Kong, etal., Appealanduseof customizablee-cigaretteproductfeaturesin adolescents,” TobaccoRegulatoryScience, 4(2):51- 60, 2018; Harrell, M.B., S.R. Weaver, A. Loukas, etal., “Flavorede-cigaretteuse: characterizingyouth, young adult, andadultusers,” PreventiveMedicineReports, 5:33-40, 2017.

Evidencecontinuestoaccumulate, furtherconfirmingthatyouthare particularlyattractedto flavoredENDSproducts. Datafromthe2018NYTSshowedthatpast 30-dayuseof anyflavorede-cigaretteincreasedfrom2017amonghighschoolstudentswho reportedcurrente-cigaretteuse (60.9 percentto67.8 percent, p<0.05).41 41 Cullen, K.A., B.K. Ambrose, A.S. Gentzke, etal., “NotesfromtheField: Increasein e-cigaretteuseandany tobaccoproductuseamongmiddleandhighschoolstudents – UnitedStates, 2011-2018,” MorbidityandMortality WeeklyReport, 67(45);1276-1277, 2018.

In the2016-2017
Wave4)42
42 PopulationAssessmentof TobaccoandHealth (PATH) Study [UnitedStates] RestrictedUseFiles (ICPSR 36231), availableat: https://www.icpsr.umich.edu/icpsrweb/NAHDAP/studies/36231.

PopulationAssessmentof TobaccoandHealth (PATH) Study,43 43 ThePATHstudyisaresearchstudythatassesseswithin-personchangesandbetween-persondifferencesin a largenationalcohortof participantsaged12yearsandolderovertime. Eachwaveis afollow-upwherethePATH studycanexamineitsobjectives, iterativelyandcumulatively, to generateabroadbodyof knowledgeabouttobacco productusein theUSA. Datacollectionfor eachwaveoccurredduringthefollowingtimeframes: Wave1 September2013-December2014), Wave2 (October2014-2015), Wave3 (October2015-2016), andWave4 (2016- 2017).
amongyouthage12
to17whoreportedusinganENDSproduct, 93.2 percentreportedthattheirfirst ENDSusewas withaflavoredENDSproduct.44
44 RostronB etal. “PrevalenceandReasonsfor Useof FlavoredCigarsandENDSamongUSYouthandAdults:

EstimatesfromWave4 of thePATHStudy, 2016-2017,” AmericanJournalof HealthBehavior, 44(1);76-81, 2020.

DatafromWave4 alsoshowedthat71percentof current
youthENDSuserssaidtheyusedENDSproducts “becausetheycomein flavorsI like.” 45 Id.
45 TheNYTSsurveyinstrumentgroupsmint- andmenthol-flavoredproductstogether, soit is not possibleto differentiateyouthuseof mintandmentholflavorsseparatelybasedontheNYTS data. The2018NYTSdataindicatethat, amonghighschoolstudentswhoseonlytobacco productuseis e-cigarettes, knownasexclusivee-cigaretteusers, theproportionwhoreported fruit-flavoredENDSusewas75.5 percentin 201846
46 Cullen, K.A., A.S. Gentzke, M.D. Sawdey, etal., “E-cigaretteuseamongyouthin theUnitedStates, 2019,” JAMA, 322(21);2095-2103, 2019.
andtheproportionwhoreportedmint-and
menthol-flavoredENDSusewas38.1 percent.47
47 Cullen, K.A., B.K. Ambrose, A.S. Gentzke, etal., “NotesfromtheField: Increasein e-cigaretteuseandany tobaccoproductuseamongmiddleandhighschoolstudents – UnitedStates, 2011-2018,” MorbidityandMortality WeeklyReport, 67(45);1276-1277, 2018.

In 2019, in thesamepopulation, fruit-flavored
ENDSusewas66.1 percentandmint- andmenthol-flavoredENDSusewas57.3 percent.48 48 Cullen, K.A., A.S. Gentzke, M.D. Sawdey, “E-cigaretteuseamongyouthin theUnitedStates, 2019,” JAMA, 322(21);2095-2103, 2019.

Amongmiddleschoolexclusivee-cigaretteusers, the2018NYTSdataindicatethatuseof fruit- flavoredENDSusewas58.1 percentandmint-andmenthol-flavoredENDSusewas20.6 WrittenCommunications
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15 percent.49
49 Id.

In 2019, in thesamepopulation, fruit-flavoredENDSusewas67.7 percentandmint- andmenthol-flavoredENDSusewas31.1 percent.50
50 Id.

Between2016and2019, highschool
exclusivee-cigaretteuserswhoreportedmint- andmenthol-flavoredENDSuseincreasedfrom

16.0 percentto 57.3 percent, p<0.05.51
51 Id.

Datafor middleschoole-cigaretteuserswasinconclusive
onthispointduetoalimitednumberof middle-schoolstudentsin theNYTSsamplewhonot onlyusede-cigaretteswithinthepast30days, butwhoseexclusivetobaccoproductusein the past30dayswase-cigarettes.52
52 Id.

In 2019, thedataindicatethatmorethanonemillionmiddleand highschoolexclusivee-cigaretteusersusedmint- ormenthol-flavoredENDSin thepast30 days.53
53 Id.

However, datafromtheMTFsurveyexaminemintandmentholJUULuseseparatelyand indicatethatyouthuseof menthol-flavoredproductsis notashighasthatfor mint- andfruit- flavoredproducts. Specifically, arandomly-selectedthirdof 2019MTFrespondentswereasked abouttheirflavoredJUULuse.54
54 LeventhalA., etal., “Flavorsof e-CigarettesUsedbyYouthsin theUnitedStates,” JAMA, 322(21):2132-2134, 2019.

Theanalyticsampleincludedpast30-dayJUULuserswho
answeredthequestion, “WhichJUULflavordoyouusemostoften?” with responseoptionsof ClassicTobacco, Crème, Cucumber, Fruit, Mango, Menthol, Mint, VirginiaTobacco, andOther.

Amongpast30-dayJUULusersin eachgradestudied (8th, 10th, and12th), useof mangoandmint rankedhighest, followedbyfruit. Reporteduseof mentholandtobaccoflavorswereamongthe lowestrankedoptions. Specifically, anumberof 8thgradepast30-dayJUULusersreporteduse of mango (33.5 percent), whiletheothersreporteduseof mint (29.3 percent), fruit (16.0 percent), andother (14.8 percent).55
55 Theremainingflavors, includingtobaccoandmentholflavors, eachhadestimatesof 2.3%.

A largepercentageof 10thgradepast30-dayJUULusers
reporteduseof mint (43.5 percent), whiletheothersreporteduseof mango (27.3 percent), fruit

10.8 percent), andother (8.4 percent).56
56 Theremainingflavors, includingtobaccoandmentholflavors, eachhadestimatesof 3.0%.

Closeto halfof 12thgradepast30-dayJUULusers
reporteduseof mint (47.1 percent), whiletheothersreporteduseof mango (23.8 percent), fruit

8.6 percent), other (6.0 percent), menthol (5.9 percent), andcucumber (4.4 percent).57 57 Theremainingflavors, includingtobaccoflavors, eachhadestimatesof 1.5%.

Datafromthe2019NYTSalsoindicatethatyouthoverwhelminglyprefercartridge-basedENDS products,58
58 Cullen, K.A., A.S. Gentzke, M.D. Sawdey, “E-cigaretteuseamongyouthin theUnitedStates, 2019,” JAMA, 322(21);2095-2103, 2019.
andwehavefoundthattheseproductsareeasyto conceal, canbeuseddiscreetly, mayhaveahighnicotinecontent, andaremanufacturedonalargescale. The2019survey instrumentincludedameasurefor the “usualbrand” of e-cigaretteusedin thepast30days.

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16 Mostyouthwhowerecurrente-cigaretteusersreportedacartridge-basede-cigaretteastheir usualbrand.59
59 Id. Unpublisheddatafromthe2019surveylist otherbrandsthatareusedbyyouth, someof whichareavailable in bothcartridge-basedandnon-cartridge-basedforms.

In fact, theleadingbrandis acartridge-basedproductthatcommands approximately70percentof themarket.60
60 NielsenTotalUSxAOC/ConvenienceDatabase & WellsFargoSecurities, LLC, in WellsFargoSecurities, Nielsen: TobaccoAll ChannelDataThru10/4 – CigVol DeclinesModerate, October15, 2019.

Of particularconcernarethedesignfeaturesthatappeartomakethecartridge-basedproductsso popularwith youngpeople. Attributestypicallypresentin cartridge-basedproductsincludea relativelysmallsizethatallowsfor easyconcealability, andintuitiveandconvenientfeaturesthat facilitateeaseof use, includingdrawactivation, prefilledcartridgesorpods, andUSB rechargeability.

Smallproductsmayallowyouthto usetheproductin circumstanceswhereuseof tobacco productsis prohibited, suchasaschool.61
61 See, e.g., SchilloB., etal., “JUULin School: TeacherandAdministratorAwarenessandPoliciesof E-Cigarettes andJUULin U.S. MiddleandHighSchools,” HealthPromotPract., 21(1):20-24, 2020; “Why 'juuling' hasbecome anightmarefor schooladministrators,” KaiserHealthNews (March26, 2018), availableat:
https://www.nbcnews.com/health/kids-health/why-juuling-has-become-nightmare-school-administrators-n860106/; JuulIsSuedbySchoolDistrictsThatSayVapingIsaDangerousDrainonTheirResources,” TheNewYorkTimes October7, 2019), availableat: https://www.nytimes.com/2019/10/07/us/juul-vaping-schools.html.

Smallsizemayalsoallowtheuserto quicklyconceal
theproductin thepalmof one’shandorin apocket.62
62 http://pittsburgh.cbslocal.com/2017/12/13/new-ecigarette-popular-among-kids-easy-to-conceal-from-parents/ Smallsizemayallowfor productusein a
socialsettingwithoutothers’ awareness,63
63 https://www.npr.org/sections/health-shots/2017/12/04/568273801/teenagers-embrace-juul-saying-its-discreet- enough-to-vape-in-class
particularlyin conjunctionwithvapingtechniques
thatmaybeusedto preventorhidethevaporcloud. Additionally, dependingonthesizeand shapeof theproduct, it mayalsoblendin with otherequipmentthatisexpectedin thatsetting e.g., if theENDSis shapedlike aflashdrive, for example, nexttoacomputer, whereanactual flashdrivewouldbeused), orit mayotherwisegoundetectedbecauseparents, teachers, or coachesdonotrecognizetheproductasanENDS.64
64 “Newvapingdevicesmaygoundetectedbyparents,” TheExcelsiorSpringsStandard, April 16, 2018, available at: http://excelsior225.rssing.com/chan-47020297/all_p70.html#item1400.

Productsreadyfor useimmediatelyafterpurchasehavecharacteristicsthatfacilitateeaseof use amongyoungpeople. Withcartridge-basedproducts, therearenosettingsto changeandvery little assemblyis required. Researchonothertobaccoproductssuggeststhateaseof useis associatedwith susceptibilitytotobaccoproductuptakeamongyouth.65 65 ChaffeeB.W., J. Urata, E.T. Couch, S. Gansky, “Perceivedflavoredsmokelesstobaccoease-of-useandyouth susceptibility,” TobaccoRegulatoryScience, 3(3):367-373, 2017.

Additionalresearch
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17 productsthanolderadolescents.66
66 PepperJ.K., A.J. MacMonegle, J.M. Nonnemaker, “Adolescents’ useof basic, intermediate, andadvanceddevice typesfor vaping,” Nicotine & TobaccoResearch, 21(1):55–62, 2019.

Thus, particularlyeasy-to-useproducts, suchascartridge- basedproducts, mayhavelowerbarrierstoinitiation.

Otherproductfeaturesthatfacilitateeaseof useincludepre-filled cartridges, whichare convenientbecausetheydonotrequirefilling priortouseandareeasytodisposeof andreplace; adraw-activatedbatterythatmakesthedevicesmucheasierto usethanotherdevices; and rechargeability, animportantcharacteristicfor useamongyouthwhorechargeviaaUSBport whenconnectedtoacomputerorchargingadapterfromotherelectronicdevices, suchasa cellphone.

In thenoticeof proposedrulemakingfor theDeemingRule, FDAnotedthattheoverallpublic- healthimpactof ENDSproductswoulddependcruciallyupon “whousestheproductsandhow theyareused. If suchproductsresultin minimalinitiationbychildrenandadolescentswhile significantnumbersof smokersquit, thenthereis apotentialfor thenetpublichealthimpactat thepopulationleveltobepositive. If, ontheotherhand, thereis significantinitiationbyyouth, minimalquitting, orsignificantdualuseof combust[ed] andnon-combust[ed] products, thenthe publichealthimpactcouldbenegative.”67
67 79Fed. Reg. 23141, 23147 (2016).

Thedatadiscussedabovedemonstratesubstantialand
increasinginitiationof ENDSproductsbyyouth, particularlycertainflavored, cartridge-based products.

C. AdditionalRelevantConsiderations
In issuingtheMarch2019DraftGuidance, FDAsolicitedpubliccommentgenerallyonthe proposedapproachandspecificallysoughtinformationthatcouldhelpinformitsdecision- makingfor eachkeyissue. In developingthisFinalGuidance, FDAconsideredinformation providedin thepubliccommentssubmittedontheMarch2019DraftGuidance. Overall, outof theover15,000publiccommentsFDAreceivedin responseto theDraftGuidance, manywere relatedtoformlettercampaigns, whileapproximately294publiccommentsprovideduniqueand substantiveinformation. In additiontothecommentsthatprovideduniqueandsubstantive information, FDAreceivedthousandsof generalcommentsexpressingsupportoroppositionto theguidanceandseparateprovisionswithintheguidance. Thesecommentsexpressbroadpolicy viewsanddonotaddressspecificpointsrelatedto theMarch2019DraftGuidance. Additional informationregardingsignificantcommentsreceivedin responsetotheMarch2019Draft GuidanceandFDA’sresponsesis describedin AppendixA.68
68 FDAgenerallydoesnotrespondtocommentsin guidancedocumentsand, asnotedin thepreambletothe deemingrule, generally “[a]gencycompliance/enforcementpoliciesarenotsubjecttotherequirementsthatgovern notice-and-commentrulemaking.” 81Fed. Reg. at28,977, 29,010 (citingProf’ls & Patientsfor CustomizedCarev.

Shalala, 56F.3d592 (5thCir. 1995) (acompliancepolicyguideisnotasubstantiveruleandnotsubjecttoAPA’s notice-and-commentrulemaking); Takharv. Kessler, 76F.3d995, 1002 (9thCir. 1996) (FDAcompliancepolicy guideswerenotrequiredto gothroughnotice-and-commentprocedures)). AlthoughFDAis addressingcomments here, it doessovoluntarilyandgiventhecircumstances. By respondingto commentshere, FDAin noway WrittenCommunications
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18 FDAalsoremainsconcernedabouthealthandsafetyissuesconnectedtoENDSproducts—e.g., casesof lunginjuriesassociatedwithuseof vapingproducts69 69 See, e.g., Centersfor DiseaseControlandPrevention, “Outbreakof LungInjuryAssociatedwith E-cigaretteUse, or Vaping,” availableat: https://www.cdc.gov/tobacco/basic_information/e-cigarettes/severe-lung- disease.html#latest-outbreak-information; Layden, J. E., I. Ghinai, I. Pray, etal., “PulmonaryIllnessRelatedto E- CigaretteUsein IllinoisandWisconsin – PreliminaryReport,” NewEnglandJournalof Medicine, Sept. 2019; DOI:

10.1056/NEJMoa1911614.
aswellasbatteryexplosionswith
ENDSproducts70
70 See, e.g., Rossheim, M.E., M.D. Livingston, E.K. Soule, etal., “ElectronicCigaretteExplosionandBurnInjuries, USEmergencyDepartments2015-2017,” TobaccoControl, 2019; 28:472-474, availableat:
http://dx.doi.org/10.1136/tobaccocontrol-2018-054518.
particularlygiventhattheseproductshavebeenmarketedwithoutpremarket evaluation. Thesecurrentpublichealthissuesaffirmtheimportanceof thepremarketreview process, ascontemplatedbytheTobaccoControlAct, to scientificallyevaluateproductsbased onapublichealthstandard. Forexample, FDAreviewof premarkettobaccoproduct applicationsconsiderstherisksandbenefitsof theproducttothepopulationasawhole, includingtobaccoproductusersandnon-users. In reviewingpremarkettobaccoproduct applications, FDAwill consider, amongotherthings: theproduct’scomponents, ingredients, additives, andproperties; manufacturingpractices; andanystudiesorinvestigationsintothe healthrisksof thetobaccoproduct.

D. EnforcementPrioritiesfor ENDSProducts
In thediscussionthatfollows, wedescribeourcurrentintentregardingprioritizingour enforcementresourceswith respecttocertainillegallymarketedENDSproducts.

FDAwill prioritizeenforcementof flavored, cartridge-basedENDSproducts (otherthan tobacco- andmenthol-flavoredproducts), whichareproducedprimarilybylargemanufacturers.

Thispolicyshouldhaveminimalimpactonsmallmanufacturers (e.g., vapeshops) thatprimarily sellnon-cartridge-basedENDSproducts, unlesstheymarketto youthorfail to takeadequate measurestopreventyouthaccess. Specifically, FDAintendstoprioritizeenforcementregarding thelackof marketingauthorizationagainst:

Any flavored, cartridge-basedENDSproduct (otherthanatobacco- ormenthol-flavored ENDSproduct);
All otherENDSproductsfor whichthemanufacturerhasfailedtotake (oris failingto take) adequatemeasurestopreventminors’ access; and
AnyENDSproductthatis targetedto minorsorwhosemarketingis likely to promoteuse of ENDSbyminors.

FDAintendstoprioritizeenforcementbeginningFebruary6, 2020. establishesapolicy, practice, orprecedentrequiringtheAgencytodosowithrespecttofutureiterationsof this documentoranyotherguidancedocument.

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19 Further, FDAintendsto prioritizeenforcementof anyENDSproductthatis offeredfor saleafter September9, 2020, andfor whichthemanufacturerhasnotsubmittedapremarketapplication orafteranegativeactionbyFDAonatimelysubmittedapplication).

In additiontoviolationsrelatedto lackof marketingauthorization, FDAwill continueto take legalactionregardingsalesof tobaccoproductsto minorsandotherviolationsandwill closely monitorall salesof ENDSproducts.

1. Any flavored, cartridge-basedENDSproduct (otherthanatobacco- ormenthol-flavored product)
FDAintendsto prioritizeenforcementfor lackof marketingauthorizationagainstanyflavored, cartridge-basedENDSproduct (otherthanatobacco- ormenthol-flavoredENDSproduct) thatis offeredfor salein theUnitedStateswithoutregardto whetherorwhenpremarketapplicationfor suchproducthasbeensubmitted.

In itsbalancingof thedifferentpublichealthconsiderationsregardingENDSproducts, the March2019DraftGuidancedidnotincludetobacco-, mint- andmenthol-flavoredENDS productsin itsproposedenforcementpriorities, basedonthedataatthattimeindicatingthat theseflavorswerepreferredmorebyadultsthanyouth. Theintentwas, totheextentpossible consistentwithprotectingpopulationhealth, toavoidforeclosingonepotentialmeansbywhich someadultsmokersmightseekto transitioncompletelyawayfromcombustedtobaccoproducts to potentiallylessharmfultobaccoproducts. Moreover, theMarch2019draftdidnotdistinguish betweencartridge-basedproductsandotherproducts, andinsteadfocusedonhowproductsare soldratherthanproductcharacteristics.

Asdiscussedabove, evidenceshowsthatyouthareparticularlyattractedto flavored, cartridge- basedENDSproducts. Datashowthat, amongyouthwhoreportedeverusinganENDSproduct, alargemajorityreportedtheirfirst ENDSusewaswithaflavoredENDSproduct.71 71 RostronB etal. “PrevalenceandReasonsfor Useof FlavoredCigarsandENDSamongUSYouthandAdults:

EstimatesfromWave4 of thePATHStudy, 2016-2017,” AmericanJournalof HealthBehavior, 44(1);76-81, 2020.

Dataalso
showthatamongcurrentyouthENDSusers, amajorityof youthrespondentsstatedthatthey usedENDSproducts “becausetheycomein flavorsI like.”72
72 Id.

In addition, recentdataindicate
thatflavorspreferredbyyouthincludemint. Datafromthe2019MTFsurveyindicatethatyouth useof mint- andfruit-flavoredJUULproductsis higherthanthatof menthol- andtobacco- flavoredJUULproducts.73
73 LeventhalA., etal., “Flavorsof e-CigarettesUsedbyYouthsin theUnitedStates,” JAMA, 322(21):2132-2134, 2019.

Finally, datafromthe2019NYTSindicatethatyouth
overwhelminglyprefercartridge-basedENDSproducts.74
74 Cullen, K.A., A.S. Gentzke, M.D. Sawdey, “E-cigaretteuseamongyouthin theUnitedStates, 2019,” JAMA, 322(21);2095-2103, 2019.

Theseproductsareeasytoconceal,
canbeuseddiscreetly, mayhaveahighnicotinecontent, andaremanufacturedonalargescale.

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20 FDAreceivedanumberof commentsthatfocusedonthepopularityof mint- andmenthol- flavoredENDSamongyouthandadultpopulations. Somecommenterssuggestedthatsuch productswouldbecomeevenmorepopularif othersbecamelessavailable. Theyarguedthatnot prioritizingenforcementagainstmint- andmenthol-flavoredENDSproductswouldrisktheshift of youthfromoneflavorof ENDSproductstoanotherbasedonapotentialbutindeterminate impactonadultconsumers. Severalcommentsarguedthatdatasuggestthatevenif youth currentlyprefer “fruit” and “sweets” to mintandmenthol, thisdoesnotmeanthatyouthdonot still find mintandmentholto beappealingflavors. FDAalsoreceivedpubliccomments claimingthatmint- andmenthol-flavoredENDSproductshelpsmokingcessation. Forexample, somecommentersfocusedonthepotentialrolethatmint- andmenthol-flavoredENDSproducts couldplayin helpingsomeadultsceasetheuseof combustedtobaccoproducts.

It is possiblethatprioritizingenforcementagainstmint-flavoredENDSproductscouldatleastin theshorttermmakefewerproductsavailablefor someaddictedadultsmokersseekingto use ENDSproductstotransitioncompletelyawayfromcigarettes. However, thecomments, aswell astherecentsurgein youthuseof ENDSproducts, andespeciallythepreferencesindicatedin the2019NYTSand2019MTFdata, haveledFDAto reconsideritsapproachwithregardto prioritizingenforcementof mint-flavoredENDSproducts.

FDAalsoreceivedmultiplecommentsurgingtheAgencyto furtherrefineits enforcement prioritiesin considerationof howthedesignfeaturesof certainENDSproductsmaymakethem sopopularamongyouth. Somecommentersfocusedonthefeaturesof cartridge-basedsystems, particularlythattheymaycontainhighnicotinecontentandthattheyareeasytoconceal.

Similarly, somecommentersfocusedonthepotentialimpactof nicotinesalts, whichareusedin somebrandsof cartridge-basedENDSproducts. In contrast, FDAreceivedacommentarguing thattheriseof youthuseshouldnotbeattributedtoall cartridge-basedproductsbutratherto a single, uniquelyprevalentcartridge-basedproduct, andthatFDA’sregulatoryactionsshouldbe tailoredaccordingly.

Asdiscussedabove, datashowthatflavorsareastrongdriverfor youthuse, andthatyouth overwhelminglyusecartridge-basedENDSproducts. Moreover, preliminaryresearchindicates thatcertaineffectsof nicotinesaltsin ENDSproducts (e.g., highernicotineexposureandfaster rateof absorption) mayincreasetheabuseliability of ENDSwith nicotinesalts, whichraises concernsof addictionin youth, particularlydueto thevulnerabilityof thedevelopingadolescent brain. However, for manyindividualaddictedcigarettesmokers, thepotentialfor ENDSto act asasubstitutefor cigarettes, therebyencouragingsmokersto seektoswitchcompletelyaway fromcombustiblecigarettes, maybedependent, in part, upontheproducthavingacceptability andabuseliability morecomparableto acigarette.

FDAhasrefineditsenforcementprioritiesin theFinalGuidanceto focusonflavored, cartridge- basedENDSproducts (otherthantobacco- andmenthol-flavored). Thisapproachstrikesan appropriatebalancebetweenrestrictingyouthaccessto suchproducts, whilemaintaining availabilityof potentiallylessharmfuloptionsfor currentandformeradultsmokerswhohave transitionedorwishto transitioncompletelyawayfromcombustedtobaccoproducts. FDAwill, however, continueto evaluatenewinformationandadjusttheseenforcementpriorities, as warranted, in light of thebestavailabledataabouttheseproducts.

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21 WealsonotethattheMarch2019DraftGuidanceproposedto prioritizeenforcementfor flavoredENDSproductsthatareofferedfor salein waysthatposeagreaterriskfor minorsto accesssuchproducts. Severalcommentsdiscussedthewideavailabilityof theseproductsand themeansbywhichyouthgainaccess. Theseincludedcommentsthatexpressedconcern regardingtheavailabilityof flavoredENDSproductsontheInternetandin vapeshops. Other commentersfocusedonhowtheenforcementprioritieswereunclearanddifficult for retailersto understand, andhowthatmaynegativelyaffect “potentiallycompliant” retaillocationsthat attempttopreventminoraccess. Othersexpressedconcernthattheenforcementprioritieswere altogetherimpracticalandcostlyfor retailers. WhiletheMarch2019DraftGuidanceproposed to focusitsenforcementprioritiesof flavoredENDSproductsonhowtheproductwassold, after consideringthecomments, thepublichealththreats, andthenewevidencedescribedabove, FDA determinedthatfocusingonhowtheproductwassoldwouldnotappropriatelyaddressyouthuse of theproductsthatarethemostpopularamongyouth—i.e., flavored, cartridge-basedproducts.

Therealityis thatyouthhavecontinuedaccesstotheseproductsin thefaceof legalprohibitions andevenaftervoluntaryactionsbysomemanufacturers. Moreover, asdiscussedabove, thedata showthatyouthoverwhelminglyprefercertainflavorsof cartridge-basedENDSproducts.75 75 Cullen, K.A., A.S. Gentzke, M.D. Sawdey, “E-cigaretteuseamongyouthin theUnitedStates, 2019,” JAMA, 322(21);2095-2103, 2019.

Theseproductsareproducedonalargescale, areeasyto conceal, canbeuseddiscreetly, andare nottheproductstypicallyproducedin vapeshopsthatmix nicotinewithe-liquidflavors. Given theurgentneedto addressthedramaticrisein youthuse, thisFinalGuidanceprioritizes enforcementwith respectto anyflavored, cartridge-basedENDSproducts (otherthanatobacco- andmenthol-flavoredENDSproduct) withoutregardtothelocationormethodof sale. FDA believesthatfocusingenforcementontheseproductsis importantin addressingtheincreasing ratesof youthuseof theseflavored, cartridge-basedproductsbecausethisis aprimarydriverin youthexperimentationwith, andcontinueduseof, ENDSproducts.

Accordingly, FDAhasrecalibrateditsbalancingof publichealthconsiderationsin light of the publichealththreatsandthesignificantnewevidencedescribedabove. Thispolicyreflects FDA’sbalancingof concernsregardingtheappealof certainflavored, cartridge-basedENDS productstoyouth; thepotentialpublichealthbenefitof noncombustedoptionsbywhichsome adultsmokersmightseekto transitioncompletelyawayfromcombustedtobaccoproducts; and thepotentialriskscreatedbyextendedavailabilityof thesenewtobaccoproductswithout scientificreviewandevaluationundertheapplicablepublichealthstandard.

2. All otherENDSproductswithoutadequatemeasuresto preventminors’ access FDAintendsto prioritizeenforcementfor lackof amarketingauthorizationfor anyotherENDS products (i.e., anytobacco-, menthol-, ornon-flavoredENDSproductsandanynon-cartridge- based, flavoredENDSproducts) whenthemanufacturerhasnottakenoris nottakingadequate measuresto preventminors’ accessto theseproducts, withoutregardtowhetherornot, orwhen, apremarketapplicationfor suchproducthasbeensubmitted.

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22 In assessingwhetheramanufactureris taking (or hastaken) adequatemeasurestoprevent minors’ accessto theseENDSproducts, factorstheAgencyintendstoconsiderinclude, butare notlimitedto:

Whetherthemanufacturerhasimplementedadequateprogramstomonitorretailer compliancewithage-verificationandsalesrestrictions. Suchprogramsmightinclude, for instance: screeningretailers, in advanceof establishingorrenewingdistribution agreements, basedonthestrengthof theretailers’ ageverificationpolicies; establishing andpublicizingahotlinefor anonymousreportingof noncompliantsales; implementinga mysteryshopperprogram; requiringuseof technologythattracksage-verification practices; orothermechanisms.

Whetherthemanufacturerhasestablishedandenforcespenaltiesagainstretailersthatfail to complywith age-verificationandsalesrestrictions. Forinstance, in responseto the September12thletters, respondentmanufacturersstatedthattheyhadmechanisms, such asthroughdistributionagreements, toenforcefinancialpenaltiesandstopsalesto retailersin responseto noncompliance. In additiontosuchmechanisms, FDAmay considerwhetheramanufacturerhasimplementedapolicyof notifyingFDAof retailer violations.

If themanufactureris alsoaretailer, factorsto adequatelypreventunderageaccessmight include: whetherthemanufacturer/retailerhasimplementedprogramstoensure compliancewithage-verificationandsalesrestrictions; establishingandpublicizinga hotlinefor anonymousreportingof noncompliantsales; checkingidentificationatthe door; orothermechanisms.

If themanufactureris alsoaretailer, whetherthemanufacturerusesadequateage- verificationtechnology (orrequiresthatretailerswhosellitsproductsusesuch technology) to preventunderageaccesstoitswebsiteandto preventunderagesales throughtheInternet. Forinstance, adequateage-verificationcouldincludeuseof an independent, third-partyage- andidentity-verificationservicethatcomparescustomer informationagainstthird-partydatasources, suchaspublicrecords; and Whetherthemanufacturerlimits (orrequiresthatretailerswhosellitsproductsto limit) thequantityof ENDSproductsthatacustomermaypurchasewithinagivenperiodof time.

FDA’sdecisiontoexerciseitsenforcementauthoritieswith respectto particularproductswill be fact-specificanddeterminedonacase-by-casebasis.

Thisprioritizationtakesintoaccountinformationthatwasprovidedbymanufacturersin responseto theAgency’sSeptember2018letters, includingmeasuresto addressyouthusethat manufacturerscanorhavealreadytakento addressyouthaccesstoENDSproducts, aswellas informationprovidedin commentsto theMarch2019DraftGuidance.

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23 Asnoted, FDAconsideredcommentsaboutthepracticalconcernsof implementingan enforcementpolicybasedonhowproductsaresold. ThefactorsabovereflectinformationFDA receivedfromindustry, includinginformationmanufacturerssharedduringmeetingswith FDA leadership, in responseto theSeptember2018letters, andpubliccommentssubmittedin responseto theMarch2019DraftGuidance. Fromthisinformation, FDAunderstandsthat manufacturershavethemeansto monitorand/orcontrolhowtheirproductsaresoldatretailby, for example, includingorrequiringterms, conditions, orcontrolsin theircontractswith downstreamdistributors (wholesalers, distributors, importers, and/orretailers) topreventyouth access.

TheMarch2019DraftGuidancedidnotproposeto prioritizeenforcementfor tobacco- or menthol-flavoredENDSproductsanddidnotproposetodistinguishbetweencartridge-based andotherENDSproducts. Thecontinuedsignificantincreasein youthuseof ENDS, as demonstratedin the2019NYTSandMTFdata, aswell asthedatashowingthatyouth overwhelminglyuseflavored, cartridge-basedENDSproducts, supportareconsiderationof the Agency’sapproach. Asnotedin thedraftguidance, FDAis continuouslyevaluatingnew informationandadjustingitsenforcementprioritiesin lightof thebestavailabledata, andit will continuetodosowithrespectto theseunauthorizedENDSproducts.

Asnotedabove, FDAreceivedanumberof commentsarguingthatthepopularityof menthol- flavoredENDS (aswell asmint-flavoredENDS, whicharediscussedabove) hadincreased amongyouthandadultpopulations, andsuggestingthatsuchproductswouldbecomeevenmore popularif otherflavoredENDSproductsbecamelessavailable. Theyarguedthatexcluding menthol-flavoredENDSproductsfromprioritizationwouldrisktheshiftof youthfromone flavorof ENDSproductstoanotherbasedonapotentialbutindeterminateimpactonadult consumers. FDAalsoreceivedcommentsstatingthatit shouldimmediatelybeginenforcing premarketreviewof all ENDSproducts, includingtobacco-flavoredENDSproducts.

Othercommentersemphasizedaneedfor ENDSproductsto remainavailablefor former smokerswhohavetransitionedorcurrentsmokerswhowanttotransitioncompletelyawayfrom combustibleproducts. Mentholis uniquecomparedtootheravailableENDSproductflavorsas it is theonlycharacterizingflavoravailablein cigarettes, andit mayreducetheirritationand harshnessof smoking.76
76 See, e.g., Harris, B., “Menthol: A reviewof itsthermoreceptorinteractionsandtheirtherapeuticapplications,” InternationalJournalof Aromatherapy, 16(3-4):117-131, 2006; Galeotti, N., L.D. Mannelli, G. Mazzanti, etal., Menthol: anaturalanalgesiccompound,” NeuroscienceLetters, 322(3):145-148, 2002; Nishino, T., Y. Tagaito, Y.

Sakurai, “Nasalinhalationof l-mentholreducesrespiratorydiscomfortassociatedwith loadedbreathing,” American Journalof RespiratoryandCriticalCareMedicine, 156(1):309-313, 1997; Lawrence, D., B. Cadman, A.C. Hoffman, Sensorypropertiesof mentholandsmokingtopography,” TobaccoInducedDiseases, 9Suppl1(Suppl1):S3, 2011; Garten, S. & R.V. Falkner, “Continualsmokingof mentholatedcigarettesmaymasktheearlywarningsymptomsof respiratorydisease,” PreventiveMedicine, 37(4):291-296, 2003.

Mentholcigarettesarealsousedbyasubstantialportionof theU.S. population, whoareaddictedtonicotineandmaybelookingfor analternativeproductto seekto transitioncompletelyawayfromcombustedproducts.77
77 See, e.g., UnitedStatesDepartmentof HealthandHumanServices. SubstanceAbuseandMentalHealthServices Administration (SAMHSA). Centerfor BehavioralHealthStatisticsandQuality. NationalSurveyonDrugUseand FDAis compelledto actbydatathat
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24 showyouthoverwhelminglyprefercertainflavorsof cartridge-basedENDSproductssuchas fruit, mint, andcandy.78
78 Cullen, K.A., A.S. Gentzke, M.D. Sawdey, “E-cigaretteuseamongyouthin theUnitedStates, 2019,” JAMA, 322(21);2095-2103, 2019.

At thesametime, FDAis awarethatapproximately9 million adults currentlyusee-cigarettes.79
79 Creamer, M.R., “TobaccoProductUseandCessationIndicatorsAmongAdults- UnitedStates2018,” Morbidity andMortalityWeeklyReport, 68:1013-1019, 2019, availableat:
https://www.cdc.gov/mmwr/volumes/68/wr/pdfs/mm6845a2-H.pdf.

Studieshaveshownthatthemajorityof adulte-cigaretteusersuse flavorede-cigarettesandthereis someevidenceto suggestthatflavorede-cigarettesmay improveswitchingfromcigarettesmokingto usinge-cigarettes, comparedtonon-flavorede- cigarettes.80
80 Russell, C. etal. “ChangingPatternsof FirstE-CigaretteFlavorUsedandCurrentFlavorsUsedby20,836Adult FrequentE-CigaretteUsersin theUSA,” HarmReductionJournal, 15(1):33-47, 2018; Bonhomme, M.G. etal.

FlavouredNon-CigaretteTobaccoProductUseAmongUSAdults: 2013–2014,” TobaccoControl, 25(Suppl2):4– 13, 2016.

FDAseeksboth (1) to avoidforeclosing, evenif temporarily, onepotentialmeansbywhich someadultsmokersmightseekto transitioncompletelyawayfromcombustedtobaccoproducts to potentiallylessharmfultobaccoproducts; and (2) to preventminors’ accessto ENDS products. FDAbelievesthatthispolicystrikesanappropriatebalancebetweenrestrictingyouth accessto ENDSproductsandmaintainingavailabilityof potentiallylessharmfuloptionsfor currentandformeradultsmokerswhohavetransitionedor wishto transitioncompletelyaway fromcombustedtobaccoproducts.81
81 FDAnotesthatnoENDSproducthasbeenapprovedbyFDAasadrugfor smokingcessation. However, the premarketreviewprocessfor ENDSproductswill provideanopportunityfor FDAtofurtherexaminethepotential of anENDSproducttomeetthetobaccoproductpremarketauthorizationstandardof “appropriatefor theprotection of publichealth,” includingadultdecisionsto completelytransitionawayfromuseof combustibleproductsto potentiallylessharmfulENDSproductsorothernon-combustibleformsof nicotinedelivery.

Moreover, theprioritizationof flavored, cartridge-basedproductsarticulatedin SectionD.1 above, andtheprioritizationof all otherflavoredENDSproductsoldwithoutadequatemeasures to preventyouthaccess, shouldhaveminimalimpactonthosevapeshopsthatprimarilysellnon- cartridge-basedENDSproductsandthatensurepurchasersareof therequisiteageandnot purchasingfor resale (e.g., arenotpurchasingin largequantities). Shouldevidenceindicateto thecontrary, theAgencywill takeappropriateaction.

3. Any ENDSproductthatis targetedtominorsorwhosemarketingis likely topromoteuse of ENDSbyminors
ManyENDSproductshavebeenandcontinueto bemarketedto minorsthroughawidevariety of mediaandtechnology, andtheirlabelsandlabeling, printadvertising, and/oronline advertisingareappealingto minors. Unlikecombustedcigarettesandsmokelesstobacco products, for whichadvertisingthroughtelevisionandradio (andanyothermediumof electronic Health, 2016. AnalysisrunonOctober12, 2018. SAMHSA’spubliconlinedataanalysissystem (PDAS). (Original DataSource: NSDUH2016)
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25 communicationsubjecttoregulationbytheFederalCommunicationsCommission) hasbeen prohibitedsince1971and1986respectively,82
82 15U.S.C. § 1335 (“It shallbeunlawfulto advertisecigarettesor little cigarsonanymediumof electronic communicationsubjectto thejurisdictionof theFederalCommunicationsCommission”); 15U.S.C. § 4402(c) same, for smokelesstobacco).

ENDSproductsareadvertisedthroughtelevision,
radio, andonline.83
83 U.S. Departmentof HealthandHumanServices, “E-CigaretteUseAmongYouthandYoungAdults. A Reportof theSurgeonGeneral,” 2016.

Socialmediaaccountsarefrequentlyusedto electronicallysharetobacco- product-relatedcontentwith otherminors.84
84 SeeChu, K.-H., J.B. Colditz, B.A. Primack, etal., “JUUL: SpreadingOnlineandOffline,” Journalof Adolescent Health, 63(5), 582-586, 2018.

Salesof suchproductsto minorsareprohibited, and
FDAis concernedwith actionslikely topromoteunlawfulsalesandmaintainorincreaseyouth use. FDAhasissuedjoint warningletterswith theFTCtofourfirmsthatmanufacture, advertise andofferfor saleordistributionseveralflavorede-liquidproductsfor violationsrelatedtoonline postsbysocialmediainfluencersoneachcompany’sbehalf.85
85 FDANewsRelease, “FDA, FTCtakeactionto protectkidsby citingfourfirmsthatmake, sellflavorede-liquids for violationsrelatedtoonlinepostsbysocialmediainfluencersontheirbehalf,” June7, 2019, availableat:
https://www.fda.gov/news-events/press-announcements/fda-ftc-take-action-protect-kids-citing-four-firms-make-sell- flavored-e-liquids-violations-related.

Thistypeof marketingis
especiallyconcerningbecauselongitudinaldatafromWaves1 (2013-2014) and2 (2014-2015) of thePATHStudyshowthatengagementwith onlinetobaccomarketingis ariskfactorfor adolescenttobaccouse, asadolescentswhoengagedwith onlinetobaccomarketinghadgreater incidencesof initiatingtobaccouse, increasedfrequencyof useandprogressionto poly-product use, andlowerincidencesof cessationcomparedto thosewhodonotengage.86 86 Soneji, S., J. Yang, K.E. Knutzen, etal., “OnlineTobaccoMarketingandSubsequentTobaccoUse,” Pediatrics, 141(2):e20172927, 2018; doi:10.1542/peds.2017-2927.

Researchershavefoundthatcertainmarketingstrategiescanincreaseyouthappeal, bothin generalandwith respectto tobaccoproductsin particular. FDAhaspreviouslyissuedwarning lettersfor productsthatresemblekid-friendlyfoodsanddrinksorthatresembleothernon-ENDS productsthatareoftenconsumedbyyouth.87
87 E.g., “E-LiquidsMisleadinglyLabeledorAdvertisedasFoodProducts,” availableat:
https://www.fda.gov/tobaccoproducts/newsevents/ucm605729.htm; “FDAIn Brief: FDAwarnscompaniestostop making, sellingordistributinge-liquidsmarketedtoresembleprescriptioncoughsyrups,” availableat:
https://www.fda.gov/news-events/fda-brief/fda-brief-fda-warns-companies-stop-making-selling-or-distributing-e- liquids-marketed-resemble.

Thisincludeslabelingand/or advertisingthat
resultsin theproductresemblingjuiceboxes, candy, orkid-friendlycereal. Actionsby manufacturerstopresenttheirENDSproductsin thiswayarelikely to promoteyouthuse, and alsopresentariskof confusionthatcouldbeharmfulto children, includingtheriskof accidental poisoning.88
88 See, e.g., Kamboj, A., H.A. Spiller, M.J. Casavant, etal., “PediatricExposuretoE-Cigarettes, Nicotine, and TobaccoProductsin theUnitedStates,” Pediatrics, 2016;137(6):e2016004.

Othermarketingconductlikely topromoteyouthuseincludestheuseof cartoons aspartof e-cigarettemanufacturers’ andretailers’ logos, marketingmaterials, promotions,89 89 Allem, J.-P., T. B. Cruz, J.B. Unger, etal., “Returnof cartoonto markete-cigarette-relatedproducts,” Tobacco Control, 0, 1-3, 2018; doi:10.1136/tobaccocontrol-2018-054437 (2018); Jackler, R. K., & Ramamurthi, D., WrittenCommunications
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26 Instagramposts,90
90 Allem, J.-P., T.B. Cruz, J.B. Unger, etal., “Returnof cartoonto markete-cigarette-relatedproducts,” Tobacco Control, 0, 1-3, 2018; doi:10.1136/tobaccocontrol-2018-054437. andvideoadvertisements.91
91 Padon, A. A., Maloney, E. K., & Cappella, J. N., “Youth-targetede-cigarettemarketingin theUS,” Tobacco RegulatoryScience, 3(1):95-101, 2017; doi:10.18001/TRS.3.1.9.

Cartoonfiguresarefrequentlyusedonproduct
packagingandin televisionadvertisingtopromoteyouthconsumptionof consumergoods.92 92 Ethan, D., C.H. Basch, L. Samuel, etal., “An examinationof productpackagingmarketingstrategiesusedto promotepediatricmultivitamins,” Journalof CommunityHealth, 40(3), 564-568, 2015; doi:10.1007/s10900-014- 9972-1; Kraak, V. I., & Story, M., “Influenceof foodcompanies' brandmascotsandentertainmentcompanies' cartoonmediacharactersonchildren'sdietandhealth: asystematicreviewandresearchneeds,” ObesityReviews, 16(2), 107-126, 2015.

A
commonthemediscussedin foodandbeverageindustrypublicationshasbeenusingcartoonsin marketingandpackagingconsumerproductstotargetchildrenandteenagers.93 93 Barrey, S., M. Baudrin, & F. Cochoy, “Fromfunfoodstofunstores,” YoungConsumers, 11(2);138-147, 2010; Cioletti, J., “Cerealthrillers,” SupermarketBusinessMagazine, 56(10):30, 2001; Cioletti, J., “Futureof... youth marketing,” BeverageWorld, 122(8), 10 (2003); Cvetan, D., “Activemarketfor activecultures,” DairyField, 183(4):18, 2000; Fry, J., “Mookidsontheblocksaythey'vegotmorethanthewhitestuff,” BeverageWorld, 114(1596):1, 1995; Landi, H., “HighTea,” BeverageWorld, 130(7):18-22, 2011; Steinriede, K., “Theyear'sbest packaging,” BeverageIndustry, 91(12): 34, 2000; White, L., “A licensefor profits,” ProfessionalCandyBuyer, 19(6):19-21, 2011.

Another
marketingstrategythathasbeenrecentlyemployedbymanufacturersis labeling, advertising, and/orproductdesignthatresultsin theENDSproductresemblingordinaryitemsthatmaynot drawtheattentionof adults.94
94 See, e.g., Ramamurthi, D., C. Chau,, R.K. Jackler, “JUULandOtherStealthVaporisers: HidingtheHabitFrom ParentsandTeachers,” TobaccoControl, Sept. 2018, doi: 10.1136/tobaccocontrol-2018-054455.

Similarmarketingconductlikely to promoteyouthuseincludes labelingand/oradvertisinghighlightinghowtheproductis ‘stealth’ or ‘secret’ andin theformof ordinaryobjectsthatmaynotbereadilyrecognizedbyparentsorteachers.95 95 Id.

Any effortstoenticeminorsto usetobaccoproductsareof concerntoFDA. FDAintendsto prioritizeitsenforcementto focusonproductsthataretargetedtominorsorlikely topromote useof ENDSbyminors. Someexamplesof suchproductsinclude:

Productsmarketedwithlabelingand/oradvertisingthatresemblekid-friendlyfoodsand drinksorresembleothernon-ENDSproductsthatareoftenmarketedand/or appealingto youth. Thisincludes, for example, labelingand/oradvertisingthatresultsin theproduct resemblingjuiceboxes, candy, orkid-friendlycereal; and/or Productsmarketeddirectlytominorsbypromotingeaseof concealingtheproductorthe natureof theproductasatobaccoproductfromparents, teachers, orotheradults; and/or Productsmarketedwith youth-appealingcartoonoranimatedcharacters, suchasthose thatdepictorresemblepopularchildren’scharacters; and/or Unicornscartoons: marketingsweetandcreamye-juiceto youth,” TobaccoControl, 26(4), 471-475, 2017; doi:10.1136/tobaccocontrol-2016-053206; Kirkpatrick, M. G., T.B. Cruz, N.L. Goldenson, etal., “Electronic cigaretteretailersusePokémonGoto marketproducts,” TobaccoControl, 26(e2), e145, 2017; doi:10.1136/tobaccocontrol-2016-053369 (2017); Padon, A. A., E.K. Maloney & J.N. Cappella, “Youth-targetede- cigarettemarketingin theUS,” TobaccoRegulatoryScience, 3(1), 95-101, 2017; doi:10.18001/TRS.3.1.9.

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27 Productsmarketed, includingthroughpaidsocialmediainfluencers, with popular children’scharactersandtitles (e.g., popularchildren’sYouTubechannels, television shows, orcharacters). Thisincludes, for example, theuseof minorsorpeoplewho portrayminorsonsuchshowsandtheirassociatedshowtitles.

4. Any ENDSproductthatis offeredfor salein theUnitedStatesafterSeptember9, 2020.

TheU.S. DistrictCourtfor theDistrictof Marylandhasorderedthatpremarketapplicationsfor all deemednewtobaccoproductsonthemarketasof August8, 2016, besubmittedby September9, 2020. Evenin theabsenceof thiscourtorder, FDAwouldprioritizeenforcement of anyENDSproductthatlacksapremarketapplicationafterSeptember9, 2020, for thereasons describedin thisguidance. ForENDSproductsotherthanthosedescribedin D.1 – D.3 above, if premarketapplicationsaresubmittedbySeptember9, 2020, FDAintendsto continueto exercise enforcementdiscretionfor uptooneyearpendingFDAreview, unlessthereis anegativeaction byFDAonsuchapplication. A negativeactionwouldconsistof theissuanceof aRefuseto Accept (RTA), Refuseto File (RTF), and/orNoMarketingOrder (NMO); orof aletter administrativelyclosingtheapplication, orcancellingtheapplicationif FDAfindsthatit mistakenlyacceptedtheapplicationorthattheapplicationwassubmittedin error. In addition, theotherenforcementprioritiesdiscussedin thisguidancewouldapplyto suchproducts, regardlessof whetheror notapremarketapplicationhasbeensubmittedfor theproduct.

WenotethattheMarch2019DraftGuidancehadincludedAugust8, 2021, asthedatefor which FDAwouldprioritizeenforcementfor flavoredENDSproductsthathadnotsubmittedpremarket applications. A numberof commentsexpressedconcernabouttheimpactof theAugust2021 dateonbusinesses. Forexample, severalcommentersarguedthatanyrestrictiononthesaleor distributionof ENDSproductscouldresultin companiesgoingoutof business. Ontheother hand, FDAreceivedmanycommentssuggestingthatin light of theproblemof increasingyouth accessanduseof ENDSproducts, FDAshouldbeginenforcingthepremarketauthoritiesas appliedto deemednewtobaccoproductsearlierthanAugust8, 2021. Severalcomments remarkedthatFDAshouldhavebegunenforcingthepremarketreviewrequirementsagainst ENDSproductsalready, thatFDA’spreviouspremarketreviewcompliancedateextensions enabledsomecompaniesto “delayorcircumventareasof regulatorycompliance,” andthat furtherdelayswerecontrarytopublichealth.

AlthoughFDAconsideredthepotentialimpactof thedraftcompliancepolicyonbusinesses largeandsmall, wenotethat, pursuantto theTobaccoControlAct, asof theeffectivedateof the finaldeemingrule, ENDSproductswererequiredto havepremarketauthorizationpriorto marketing. Whilesomedeemednewtobaccoproductsremainedonthemarketin light of FDA’s deferredenforcementpolicy, suchpoliciesaresubjectto change. Manufacturerscannothave settledexpectationstomarketunlawfulproducts, especiallyin thefaceof evolvingpublichealth concerns. Therefore, FDAbelievesthatmanufacturersshouldhavebeguncontemplatingand/or preparingpremarketapplicationsnolaterthanthetimeof thefinaldeemingrule. Asdiscussed in SectionII.B of thisFinalGuidance, FDAhasrepeatedlypubliclydiscussedthefactthat enforcementdiscretiontimelinesfor deemedtobaccoproductswereunderreconsiderationand solicitedviewsfromstakeholders. Manufacturersmayobtaininformationabouttheapplication WrittenCommunications
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28 processfromthestatutorycriteria, aswellaspublishedguidances, webinars, andmarketing ordersandtheiraccompanyingdocumentationprovidedbyFDA.96 96 FormoreinformationonpremarkettobaccoproductapplicationspleaseseePremarketTobaccoProduct Applicationsfor [ENDS], Guidancefor Industry (June2019), availableathttps://www.fda.gov/regulatory- information/search-fda-guidance-documents/premarket-tobacco-product-applications-electronic-nicotine-delivery- systems-ends; Applicationsfor PremarketReviewof NewTobaccoProducts (updatedJune2019) availableat https://www.fda.gov/regulatory-information/search-fda-guidance-documents/applications-premarket-review-new- tobacco-products. FormoreinformationonCTP’sotherpublishedregulationsandguidances, pleasesee https://www.fda.gov/tobacco-products/products-guidance-regulations/rules-regulations-and-guidance; for more informationonFDACTPwebinars, pleaseseehttps://www.fda.gov/tobacco-products/compliance-enforcement- training/fda-tobacco-compliance-webinars; for informationonmarketingordersandaccompanyingdocumentation, pleaseseehttps://www.fda.gov/tobacco-products/compliance-enforcement-training.

Underthecircumstances, FDAbelievesthatearlierenforcementof thepremarketreview provisionsis appropriatefor ENDSproducts. Thispolicyshouldresultin earliersubmissionof applicationsandallowFDAtobetterevaluatewhethertheseproductsmeettheapplicable premarketstandard, suchaswhethertheproductsareappropriatefor theprotectionof thepublic health, consideringtherisksandbenefitstothepopulationasawhole, includingusersand nonusersof thetobaccoproduct. Becauseof FDA’sconcernsregardingyouthuseof ENDS products, aswell asotherongoinghealthconcernsregardingvapingmoregenerally, all describedatlengthabove, FDAis prioritizingenforcementof premarketreviewrequirementsfor ENDSproducts, asdescribedin thissection, andis doingsoindependentlyof thecourtorder.

Thiswill ensurethatFDAhasthenecessaryinformationto exerciseadequate, timelyoversight overtheserelativelynovelandpotentiallyharmfulproducts. Enforcingpremarketauthorization requirementswill, consistentwith theprocesssetforthin theTobaccoControlAct, ensurethat theburdenfallsonmanufacturersof ENDSproductstodemonstratethatthemanufactureand saleof theirproductsis appropriatefor theprotectionof thepublichealth.

E. Avoidinga “BlackMarket”
FDAis awareof concernsthat, giventherisein popularityof ENDS, removalof someof the mostpopularproductsfromthemarketmaybeaccompaniedbyanincreasein blackmarket versionsof theseproductsthatmayposeadditionalhealthandsafetyriskstoconsumersbeyond thoseof theauthenticproducts. Althoughall newlydeemedproductscurrentlyonthemarket withoutpremarketauthorizationarebeingsoldin violationof theTobaccoControlAct, in this section, weusetheterm “blackmarket” toreferto, for example, productsintendedtolooklike anotherENDSproductsthatis currentlybeingmarketed, productsintendedtotaketheplaceof anENDSproductthatamanufacturerhasstoppeddistributingbecausetheproductlacks premarketauthorization, andENDSproductsintendedfor anothercountry’smarketbutdiverted to theU.S. market. Additionalrisksposedbytheseproductsincludethepotentialthatthey containharmfulchemicalsorconstituentsthatarenotpresentin otherproducts, thattheyare manufacturedusingcomparativelypoorqualitycontrols, andthattheyaredesignedin waysthat facilitatemodificationsbydistributorsorusers—all of whichincreasetheriskof adverse events.97
97 E.g., “AmidVapingDeaths, CaliforniaTargetsCounterfeitProducts,” TheNewYorkTimes (Sept. 17, 2019), availableathttps://www.nytimes.com/2019/09/16/us/california-vaping.html; “‘Juul-alikes’ AreFilling ShelvesWith Moreover, to theextentthatsuchproductsaresoldthroughnontraditionalretail WrittenCommunications
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29 channels, suchassocialsourcesoronlinecommercialmarketplacesthatdonotincludeage- verificationrequirements, theyposeanincreasedriskof beingaccessedbyminors.

FDAhasregulatorytoolsandenforcementauthoritiesto addressENDSandothertobacco productsthataremarketedwithoutauthorization, thatarecounterfeit, and/or thatareotherwise involvedin illicit trade.98
98 See, e.g., sections301, 902, 903, 905, 910, and920of theFD&CAct.

FDAhaspreviouslyissuedletterstocompaniessuspectedof
marketingcounterfeitor otherwiseunauthorizedproducts.99 99 E.g., “StatementfromFDACommissionerScottGottlieb, M.D., onforcefulnewactionsfocusedonretailers, manufacturersto combatyouthaccessto e-cigarettesaspartof FDA’sYouthTobaccoPreventionPlan,” available at: https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-forceful- new-actions-focused-retailers-manufacturers.

Additionalpotentialactionsagainst
adulteratedor misbrandedillicit tobaccocouldinclude: (1) issuingaWarningLetter; (2) issuing animportalertandrefusingadmissionof tobaccoproductsimportedorofferedfor importinto theUnitedStates; and (3) initiatingseizureorinjunctioncourtactions. Personsengagingin illicit tradein tobaccoproductsmayalsobecriminallyprosecutedunderthelaw.

Asaresultof thispolicy, FDAwill bebettersituatedtocombatblackmarketproducts, including thosethatareparticularlytroublingfromapublichealthorsafetyperspective, suchascounterfeit podsenteringthecountryattheborderorbeingsoldthroughillicit, onlinechannels. By prioritizingourfocusasoutlinedin SectionIV.D, theAgencycantargetoursupplychain surveillanceandinvestigationresourcesonthetypesof ENDSproductsthatarelikely to be subjectto counterfeitingand/orsaleontheblackmarket. Asaresult, wewill beabletomore efficientlyandeffectivelydeployourenforcementtoolsto getcounterfeitandblackmarket productsoff themarket. Moreover, FDAbelievesthattherearesignificantpublichealthbenefits of thepolicysetforthin thisguidance, whichis aimedatcurbingthedramaticrisein youthuse of ENDSproductsandwill helpaddresssafetyissuesconnectedtoENDSproductsthatarenot fully understood—e.g., thedevelopmentof acuteorchroniclunginjuriesassociatedwithuseof vapingproductsaswell asbatteryexplosionswithENDSproducts—particularlygiventhatthese productshavebeenmarketedwithoutpremarketevaluation. Thesecurrentpublichealthissues affirmtheimportanceof thepremarketreviewprocess, ascontemplatedbytheTobaccoControl Act, to scientificallyevaluateproductsbasedonapublichealthstandard.

V. PREMARKETREVIEW FOROTHERDEEMEDNEWTOBACCOPRODUCTS
FDAremainsconcernedwithminors’ accesstoanduseof all tobaccoproducts, particularly flavoredtobaccoproducts, whichappealto minorsandpromoteinitiation.100 100U.S. Departmentof HealthandHumanServices, “E-cigaretteUseAmongYouthandYoungAdults: A Reportof theSurgeonGeneral,” 2016; Villanti, A.C., A.L. Johnson, B.K. Ambrose, etal., “FlavoredTobaccoProductUsein YouthandAdults: FindingsFromtheFirstWaveof thePATHStudy (2013-2014),” AmericanJournalof PreventiveMedicine, 53(2); 139-151, 2017.

In additiontothe
Sweet, Teen-FriendlyNicotineFlavors” TheNewYorkTimes (Aug. 13, 2019), availableat https://www.nytimes.com/2019/08/13/health/juul-flavors-nicotine.html; Omaiye, E.E., I. Cordova, B. Davis, et. al., CounterfeitElectronicCigaretteProductswithMislabeledNicotineConcentrations,” TobaccoRegulatoryScience, 3(3): 347–357, 2017.

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30 tobaccoproductscoveredearlierin thisguidancedocument, FDAhasconsideredrevisingits enforcementprioritieswith respectto premarketauthorizationfor otherdeemednewtobacco products. WenotethatseveralcommentsontheMarch2019DraftGuidancesuggestedthat FDAbeginimmediatelyenforcingthepremarketrequirementsfor flavoreddeemedtobacco productssuchascigarsandotherdeemedtobaccoproducts.

FDAreceivednumerouscommentsrelatingtotheproposedpolicyfor flavoredcigarsin the March2019DraftGuidance. Someof thecommentsweresupportiveof thatproposedpolicy, althoughsomewantedtheAgencyto takeevenmoreaggressiveaction. Othercomments opposedinclusionof flavoredcigarsasanenforcementpriorityanddisagreedwith thebasesfor theproposedpolicy. Forexample, somecommentersarguedthatflavoredcigarsareusedmost commonlybyadultusersandthattheinclusionof flavoredcigarsasanenforcementpriority limitsadults’ freedomtochoosetheirpreferredproduct. OthercommentersarguedthatFDAdid nothavethedatanecessaryto supporttheneedfor “adrasticandunprecedentedchangein enforcementpriorities.” SomecommentersalsostatedthattheevidencecitedbyFDA discussinginitiationof youthusageof flavoredcigarswasinconsistentandinconclusive. After considerationof thedataregardingyouthuseof cigarsgenerallyandcommentsreceivedonthis issue, wehavedecidedtonotprioritizeenforcementof flavoredcigarsbeforeSeptember9, 2020. Whilethereis nopublichealthbenefitassociatedwith flavoredcigarsandFDAremains concernedwith youthuseof flavoredcigars, currentdataindicatethatyouthareusingflavored cigarsatalowerratethantheyareusingflavoredENDSproducts.

CommentsregardingdeemedtobaccoproductsotherthanENDSproductsandcigars, suchas waterpipetobacco (hookah) products, alsoprovideddatashowingtheuseof suchtobacco productsamonghighschoolstudentsandstatingthatevidencereflectsthatflavorsfor these tobaccoproductsenticeyouth. However, suchdatadonotappeartoraisecomparablyurgent publichealthconcerns, asthelowerprevalenceof youthuseof theseproductssuggeststhatthey donotappeartobeasappealingto youthatthistime.

Accordingly, atthistime, FDAhasdecidedto prioritizeuseof itslimitedenforcementresources toaddressthesuddenanddramaticincreasein youthuseof ENDSproducts, aswellasto focus onhealthandsafetyconcernsconnectedto ENDSproductssuchasvaping-associatedlung injuries. Whileacknowledgingthatall newtobaccoproductsonthemarketwithouttherequired authorizationaremarketedunlawfullyandarepotentiallysubjectto enforcementaction, atany time, in FDA’sdiscretion, FDA’sprimaryfocuswill beto addressthesuddenanddramatic increasein youthuseof ENDSproducts, andtheproductscoveredbythissectionof the guidancewill thereforebealowerpriority.

Wehavedecidednotto prioritizeenforcementof thetobaccoproductscoveredbythissection beforeSeptember9, 2020. Manufacturersof flavoredcigars, however, justlike manufacturersof all otherdeemednewtobaccoproducts, will berequiredtosubmitmarketingapplicationsfor thoseproductsbySeptember9, 2020, consistentwith theU.S. DistrictCourtfor theDistrictof Maryland’sorderdirectingFDAtorequirethatapplicationsbesubmittedto theAgencyby September9, 2020, for deemednewtobaccoproductsonthemarketasof August8, 2016, orbe subjecttoFDAenforcementactions, in FDA’sdiscretion. Aspartof thepremarketreview process, FDAmayevaluate, amongotherthings, theproduct’sconstituents, ingredients, WrittenCommunications
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31 additives, andproperties; manufacturingpractices; andanystudiesorinvestigationsintothe healthrisksof thetobaccoproduct. FDAalsohasstateditsintentionto issuearegulationthat wouldbantheuseof characterizingflavorsin cigars, andFDAis activelyworkingtowardsthat proposedrule.

AfterSeptember9, 2020, FDAwill makeenforcementdecisionsonacase-by-casebasis, recognizingthatit is unable, asapracticalmatter, to takeenforcementactionagainstevery illegallymarketedtobaccoproduct, andthatit needstomakethebestuseof Agency resources. FDAintendsto prioritizeenforcementbasedonthelikelihoodof youthuseor initiationtomakethemostefficientuseof itsresources. In assessingthis, factorstheAgency intendsto considerinclude, butarenotlimitedto:

WhatFDAunderstandsaboutthenumberof youthcurrentlyusingtheproductor categoryof product;
Thetrendsin thosenumbers, particularlysince2016;
Whethertheproductcontainsaddedflavors;
WhatFDAunderstandsabouthowtheproductorcategoryof productis typicallysold andhowthatis likely to impactaccessandusebyminors; and
WhatFDAunderstandsaboutthefrequencyandotherdemographicsof usebyminors.

Toillustrate, basedonthesefactors, FDA’slowestpriorityamongtheseproductswill include relativelyexpensive, largehand-rolledcigarsthatdonothaveflavors (e.g., fruit, candy, ormint), givenwhatFDAunderstandsto betheircomparativelyloweryouthusagerates.

FDAis continuouslyevaluatingnewinformationandadjustingitsenforcementprioritiesin light of thebestavailabledata, andit will continueto dosowith respectto theseproducts. FDAwill takeappropriateactionregardingtobaccoproductsthataremarketedwithoutpremarket authorization, includingaswarrantedbasedonchangedcircumstances, newinformation, orto betteraddressminors’ useof thoseproducts.

VI. DOCUMENTHISTORY
January2020 – Firsteditionof guidanceissued.

April 2020 – Guidanceis revisedto reflectthecourt’sorderin AmericanAcademyof Pediatrics, etal. v. FoodandDrugAdministration, etal., CaseNo. 8:18-cv-883 (PWG), (D. Md. Apr. 22, 2020), Dkt. No. 182, grantingamotionfor a120-dayextension (until September9, 2020) in light of theglobaloutbreakof respiratoryillnesscausedbyanewcoronavirus. Specific revisionsincludethefollowing:

SectionII.A – Addedreferenceto ordergranting120-dayextension.

SectionIV.A (andthroughout) – ChangedlanguagestatingthatFDA’snewenforcement prioritieswouldbegin “30daysafterissuanceof thisFinalGuidance” to “February6, WrittenCommunications
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32 2020,” whichis 30daysaftertheNoticeof AvailabilityannouncingtheFinalGuidance waspublished.

SectionIV.A (andthroughoutdocument) – Changed “May12, 2020” to “September9, 2020.”
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33 APPENDIXA – SIGNIFICANTCOMMENTSRECEIVEDIN RESPONSETO MARCH 2019DRAFTGUIDANCEANDFDARESPONSES
Legalandstatutoryframeworkissues
Comment Response
FDAshouldengagein legislativerulemaking
process
Thedraftguidanceconstitutedamajor
ruleandFDAhasnot followedprocedures
establishedbytheAdministrative
ProcedureAct (APA) governingthe
promulgationof rules
TheRegulatoryFlexibilityActrequiresan
analysisof aproposedrule’simpacton
smallbusinessandFDAhasnot conducted
suchananalysis
FDAisbypassingtherequirementto
conductacostbenefitanalysisbyissuinga
guidanceinsteadof formalrule
FDAhasnot consideredregulatory
alternativesto theapproachoutlinedin
thedraftguidance
Thisactionwouldimposecostsand
adverseeffectsonindustrywhich
constitutesamajorrulewhichshouldbe
subjectto therequirementsunderthe
CongressionalReviewAct
Thoughguidancedocumentsarenon-
binding, thewaytheguidanceiswritten,
retailoutletswouldneedto complywith
standardssuggestedbythedraftguidance
asthoughtheywerelaw
Engagingin rulemakingwouldoffermore
substantialopportunityfor stakeholdersto
providepubliccommentsandwould
provideclarityonwhatstakeholders
throughthesupplyandretailchain)
neededto doto comeintocompliance
TheFinalGuidanceisastatementof policythat
discussestheenforcementof premarketauthorities
alreadyexistinginthestatute. It doesnot establish
anyrightsfor anyperson, isnot bindingonFDAor the
public, andisnot subjectto requirementsof the
RegulatoryFlexibilityActor thenotice-and-comment
provisionsof theAPA. Historically, FDAhasnot
analyzedtheeconomiceffectsof enforcement
guidance, includingfor reasonssuchasdifficultyin
predictingsucheffects. Alternativessuchasissuing
warninglettersandotherenforcementtechniques
havebeenconsideredandusedbytheAgency.

Despitethis, asshownbythedatahighlightedin the
FinalGuidance, therateof youthuseof tobacco
products (particularlyfruit- andcandy-flavoredand
mint-flavoredENDSproducts) hasdramatically
increased. FDAretainsdiscretionto enforce
premarketauthorities.

Therelevantsubstantiverequirementsarethose
governingpremarketauthorizationassetforth in
Section910. TheFinalGuidancedoesnot imposenew
restrictions, for retailersor manufacturers, but rather discussesFDA’senforcementprioritiesfor existing
statutoryrequirements. InSection910, Congress
placedtheonusonmanufacturersto demonstrate
that themarketingof atobaccoproductisappropriate
for theprotectionof thepublichealth, takinginto
account, amongotherthings, thelikelihoodthat those
whodonot usetobaccoproductswill startusing
them.

FDAprovidedfor a45-dayperiodfor commentonthe
draftguidance, andinterestedpartiesmaycontinueto
submitcommentsafterpublicationof thefinal
guidance, providingasubstantialopportunityfor
publicinput.

FDAisbypassingstatutoryrestrictionsonits
discretionaryenforcementauthorityand
obligationsrelatedto rulemaking, bythreatening
selectiveenforcementof itspremarket
authorizationauthority.

FDAhasdiscretionto decidehowwhento enforceits
premarketauthorizationauthoritiesundertheFD&C
Act. SeeHecklerv. Chaney, 470U.S. 821, 835 (1985).

TheFinalGuidanceisastatementof policythat
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34 outlinesFDA’senforcementprioritieswith respectto
suchrequirements.

Guidanceshouldconformto Section907.

Actionsin thisguidanceshouldconformto
Section907, whichobligatesFDAto
considerfactorsnot addressedbythe
guidance, includingtechnicalachievability
andcountervailingeffects.

FDAshouldnot adoptmodificationsto
compliancepolicybut shouldinstead
followthroughwith arulethat considers
thecommentsfromFDA’sANPRMon
Flavorsin TobaccoProducts.

Section907refersto tobaccoproductstandards. This
FinalGuidanceisnot settingtobaccoproduct
standards, suchasatobaccoproductstandard
restrictingor eliminatingtheuseof flavorsin ENDS.

Instead, it isexplainingFDA’senforcementpriorities
for premarketreviewrequirementsalreadyincludedin
theTobaccoControlAct. Aflavoredproductcouldbe
marketedconsistentwith thisguidanceif it meetsthe
statutorystandardsfor authorization. Forexample, in
April2019, FDAauthorizedthemarketingof a
menthol-flavoredIQOSheat-not-burncigarette
productthroughthePMTApathway.101
101Formoreinformationpleaseseehttps://www.fda.gov/news-events/press-announcements/fda-permits-sale-iqos- tobacco-heating-system-through-premarket-tobacco-product-application-pathway.

FDAissupposedto beanadvisoryagency, not a
regulatoryagency, anditsactionsarean
overreach.

TheTobaccoControlActprovidesFDAwith regulatory
authorityovertobaccoproducts.

FDA’sproposedactionsarearbitraryand
capriciousbecauseit hasfailedto provide
adequatereasoning/scientificreasoning/used
incompleteor incorrectdata.

Theenforcementprioritiesexplainedin theFinal
Guidancearebaseduponandsupportedby, among
otherthings, multiplehigh-qualityscientificdata
sources (e.g., NYTS, PATH, MTF).

FDAhasfailedto connecttheproposedpolicyto
anofficialfindingthat theactionswere
appropriatefor theprotectionof publichealth.”
TheFinalGuidancediscussestheenforcementof
premarketauthoritiesalreadyexistingin statute.

Section910placestheonusonmanufacturersto show
that themarketingof atobaccoproductwouldbe
appropriatefor theprotectionof thepublichealth, not
ontheFDAto showotherwise. TheTobaccoControl
Actusestheterm “appropriatefor theprotectionof
thepublichealth,” in section910andseveralother
provisions. Theconsiderationsidentifiedin the
statutetypicallyincludeanalysisof whethertheaction
wouldincreaseor decreasethelikelihoodthat existing
usersof tobaccoproductswouldstopusingsuch
products, andwhetherit wouldincreaseor decrease
thelikelihoodthat thosewhodonot usetobacco
productswill startusingtheproducts. TheGuidance
reflectstheseconsiderations.

FDAhasbeenunresponsive/lackof clarity.

Manufacturershavebeenrelyingon
guidanceandinformationsincethe
deemingrule; thisisadrasticdeparture
FDAhascommunicateditsconcernsregardingthe
increasein youthaccessinpublicstatements, the
March2019draftguidance, andrequestsfor
informationto manufacturers. FDAhasconsistently
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35 fromdeemingandguidancesissuedsince
deeming.

Difficultto keeptrackof FDA’spoliciesand
compliancerequirements.
informedindustrythat itscompliancepolicieswill be
responsiveto changedcircumstances. Therecouldbe
noreasonablerelianceonadeferredenforcement
policysubjectto changeat anytime. Theguidance
explainswhythechangedcircumstanceswarrantthis
prioritization; i.e., thesubstantialincreasein youthuse of ENDSin additionto otherhealthandsafety
considerations. FDAhasalwaysstated (andthe
TobaccoControlActitselfisclear) that deemednew
tobaccoproductsarerequiredto obtainpremarket
authorizationandthat suchproductsthat remainon
themarketwithoutmarketingauthorizationare
marketedunlawfully.

FDAhasstatedit will providefurtherguidanceand
issuerulesto maketheproductreviewprocess
moretransparentandpredictablebut hasnot
doneso.

FDAhasprovidedguidanceandinformationto
industryonthepremarketpathwaysthrough
publishingguidancesandmarketingorders, aswellas
postinginformationviawebinarsandpublic
workshops.102
102FormoreinformationonpremarkettobaccoproductapplicationspleaseseePremarketTobaccoProduct Applicationsfor [ENDS], Guidancefor Industry (June2019), availableathttps://www.fda.gov/regulatory- information/search-fda-guidance-documents/premarket-tobacco-product-applications-electronic-nicotine-delivery- systems-ends; Applicationsfor PremarketReviewof NewTobaccoProducts (updatedJune2019) availableat https://www.fda.gov/regulatory-information/search-fda-guidance-documents/applications-premarket-review-new- tobacco-products. FormoreinformationonCTP’sotherpublishedregulationsandguidances, pleasesee https://www.fda.gov/tobacco-products/products-guidance-regulations/rules-regulations-and-guidance; for more informationonFDACTPwebinars, pleaseseehttps://www.fda.gov/tobacco-products/compliance-enforcement- training/fda-tobacco-compliance-webinars; for informationonmarketingordersandaccompanyingdocumentation, pleaseseehttps://www.fda.gov/tobacco-products/compliance-enforcement-training.

Thestatutealsoinformsthepublicof
theinformationneededinapremarkettobacco
productapplication. Industrymembershave
successfullyobtainedmarketingauthorizationorders
with informationcurrentlyavailable.

Draftguidancewouldhaveunjustifiable
retroactiveeffectsonindustryactorswhowere “in
compliance” with FDA’spreviouspolicy.

ThisFinalGuidancewouldonlyaffectthoseproducts
that areillegallyonthemarket; noneof theproducts
affectedbytheguidancewereeverin compliancewith
thepremarketauthorizationrequirementsof thelaw.

FDAhasconsistentlyinformedindustrythat its
compliancepolicieswill beresponsiveto changed
circumstances. Asdiscussedin theguidance, FDA
statedin thenoticeof proposedrulemakingfor the
DeemingRule, that theoverallpublichealthimpactof
ENDSproductswoulddependcruciallyupon “who
usestheproductsandhowtheyareused. If such
productsresultinminimalinitiationbychildrenand
adolescentswhilesignificantnumbersof smokersquit,
thenthereisapotentialfor thenetimpactat the
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36 populationlevelto bepositive. If, ontheotherhand,
thereissignificantinitiationbyyouth, minimal
quitting, or significantdualuseof combust[ed] and
non-combust[ed] products, thenthepublichealth
impactcouldbenegative.” Assuchpoliciesare
subjectto change, manufacturerscannothavesettled
expectationsto marketunlawfulproducts, especially
in thefaceof evolvingpublichealthconcerns.

Therefore, FDAbelievesthat manufacturersshould
havebeguncontemplatingand/or preparing
premarketapplicationsat nolaterthanthetimeof the
finaldeemingrule.

Draftguidancewill kill innovationandforce
industryout of work.

FDAdisagreesthat theFinalGuidancewill causethese
results. TheFinalGuidanceexplainsFDA’s
enforcementprioritiesfor certaindeemednew
productsthat arebeingmarketedwithoutrequired
premarkettobaccoproductauthorization. TheFinal
Guidancewouldonlyaffectthoseproductsthat are
illegallyonthemarket; noneof theproductsaffected
bytheguidancewereeverin compliancewith the
premarketauthorizationrequirementsof thelaw. In
anyevent, FDAbelievesthat theuseof premarket
pathwayswill incentivizedevelopmentof innovative
tobaccoproductsthat meettheapplicablestatutory
standards.

Draftguidancepolicyonmarketingpractices
wouldviolatetheFirstAmendmentasit
representsanimpermissiblybroadcommercial
speechrestriction.

FDAdisagreesthat theFinalGuidanceviolatesthe
FirstAmendment. Speechregardinganillegalactivity
includingdistributionof aproductthat requires
premarketreviewundertheFDCA – isnotprotected
undertheFirstAmendment. SeeUnitedStatesv.

Caputo, 517F.3d935, 941 (7thCir. 2008) (unapproved
device); UnitedStatesv. LeBeau, 654Fed. App’x826,
831 (7thCir. 2016) (unapproveddrug); UnitedStatesv.

Cole, 84F. Supp. 3d1159, 11-66-67 (D. Or. 2015)
unapproveddrug). Evenif theFirstAmendmentwere
applicable, thegovernmenthasasubstantialinterest
in protectingyouthfromtobaccoproducts, and
prioritizingenforcementactionswith respectto ENDS
productstargetedto, or likelyto promoteuseby,
minorsisareasonablemeasureto directlyadvance
that interest. See, e.g., DiscountTobaccoCity &
Lottery, Inc. v. UnitedStates, 674F.3d509, 536 (6th
Cir. 2012). Wehaveprovidedadditionalexamplesfor
clarityin theFinalGuidance.

Modificationsto ENDSCompliancePolicy – FlavoredENDSexceptTobacco, Mint, Menthol Comment Response
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37 Thereisnoevidence/limitedevidenceto connect
liquidnicotineusewith harmfulhealtheffectsin
youth.

Asdiscussedin theFinalGuidancethestudiesof the
effectsof nicotineexposurein thenaïveadolescent
brainfindthat theadolescentbrainisuniquely
vulnerableto nicotinecomparedto theadultbrain.

Repeatedexposureto nicotineduringadolescence
induceslong-lastingstructuralandfunctionalchanges
in brainregionsinvolvedinaddiction, attention,
learning, andmemory.103
103McDonald, C.G., A.K. Eppolito, J.M. Brielmaier, et. al., “Evidencefor elevatednicotine-inducedstructural plasticityin nucleusaccumbensof adolescentrats,” BrainResearch, 1151, 211-218, 2007; doi:

10.1016/j.brainres.2007.03.019; Bergstrom, H.C., R.F. Smith,, N.S. Mollinedo, etal., “Chronicnicotineexposure produceslateralized, age-dependentdendriticremodelingin therodentbasolateralamygdala,” Synapse, 64(10), 754- 764, 2010; doi:10.1002/syn.20783; England, L.J., K. Aagaard, M. Bloch, etal., “Developmentaltoxicityof nicotine: atransdisciplinarysynthesisandimplicationsfor emergingtobaccoproducts,” Neuroscienceand BiobehavioralReviews, 72:176-189, 2017.

Studiesfurthersuggestthat nicotine-inducedchanges
in theadolescentbraincanleadto long-lastingeffects
oncognitivefunction, suchascognitivedeficits
followingnicotineabstinence, andmaycontributeto
theriskfor moodandanxietydisorders. Nicotineisthe
primaryaddictivesubstancein tobaccoproducts,
includinge-cigarettesandcombustiblecigarettes. The
rateandextentof nicotinedeliverysignificantly
impactproductabuseliability. Highernicotinecontent
andfasterratesof nicotinedeliveryincreaseproducts’
abuseliabilitydueto therapidabsorptionof nicotine
into thebrain. Somee-cigarettesarecapableof
achievingsimilaror greaternicotinedeliveryas
cigarettes.104
104Hiler, M., A. Breland, T. Spindle, etal., “Electroniccigaretteuserplasmanicotineconcentration, puff topography, heartrate, andsubjectiveeffects: Influenceof liquidnicotineconcentrationanduserexperience,” ExperimentalandClinicalPharmacology, 25(5), 380-392, 2017; doi:10.1037/pha0000140; Lopez, A.A., M.M.

Hiler, E.K. Soule, etal., “Effectsof ElectronicCigaretteLiquidNicotineConcentrationonPlasmaNicotineandPuff Topographyin TobaccoCigaretteSmokers: A PreliminaryReport,” Nicotine & TobaccoResearch, 18(5):720-723, 2016; doi:10.1093/ntr/ntv182; Maloney, S. F., A. Breland, E.K. Soule, etal. “Abuseliabilityassessmentof an electroniccigarettein combustiblecigarettesmokers,” ExperimentalandClinicalPsychopharmacology, 27(5):443- 454, 2019; doi:10.1037/pha0000261; O’Connell, G., J.D. Pritchard, C. Prue, etal, “A randomised, open-label, cross- overclinicalstudyto evaluatethepharmacokineticprofilesof cigarettesande-cigaretteswithnicotinesalt formulationsin USadultsmokers,” InternalandEmergencyMedicine, 14(6):853-861, 2019; doi:10.1007/s11739- 019-02025-3; Ramoa, C. P., M.M. Hiler, T.R. Spindle, etal. “Electroniccigarettenicotinedeliverycanexceedthat of combustiblecigarettes: apreliminaryreport,” TobaccoControl, 25(e1): e6-9, 2016; doi:10.1136/tobaccocontrol- 2015-052447; Yan, X. S., & C. D’Ruiz, “Effectsof usingelectroniccigarettesonnicotinedeliveryand cardiovascularfunctionin comparisonwithregularcigarettes,” RegulatoryToxicologyandPharmacology, 71(1):24- 34, 2015; doi:10.1016/j.yrtph.2014.11.004.

Banning” flavorsoutsideof tobacco, mint, and
mentholwoulddetercigarettesmokersfrom
TheFinalGuidancedoesnot bananyproductsbut
ratheridentifiesFDA’sprioritiesin connectionwith the
enforcementof thestatutorypremarketreview
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38 quittingor forcesmokersto restartsmokingif they
havealreadyquit.

Smokerstryingto quitsmokingavoid
tobacco-, mint-, andmenthol-flavored
productsbecausetheyaretoo similarto
flavorsof atraditionalcigarette.

Stricterpoliciesfor ENDSproductsfor
youthshouldnot comeatexpenseof adult
users.
requirements. Moreover, thepolicyannouncedin the
FinalGuidancedoesnot prioritizeanymenthol-
flavored, tobacco-flavored, or non-flavoredENDS
productsor anynon-cartridge-basedflavoredENDS
productsfor enforcementwherethemanufactureris
takingadequatemeasuresto preventminors’ access
to theseproducts. Additionally, consumerswill be
ableto accessENDSproducts (includingflavoredENDS
products) that receivemarketauthorization. Nicotine
replacementtherapyproductsalsoremainavailable
for tobaccoproductuserswhomayneedassistance
with withdrawalsymptomsandarealsoavailablein
severalflavors.

Availableresearchdoesnot supporttheargumentthat
smokerstryingto quit smokingandtransitionto ENDS
productsavoidtobaccoandmenthol-flavoredENDS
productsbecausetheyaretoo similarto traditional
cigaretteflavors.

FDAhasrepeatedlyemphasizedthat theavailabilityof
non-combustibleoptionsshouldnot comeat the
expenseof addictingagenerationof childrento
nicotinethroughthesesamedeliveryvehicles. FDA
believesthat thispolicystrikesanappropriatebalance
betweenpreventingyouthaccessto ENDSproducts
andmaintainingavailabilityof potentiallylessharmful
optionsfor currentadultsmokerswhohave
transitionedor wishto transitioncompletelyaway
fromcombustedtobaccoproducts.

Nobasisfor prioritizingflavoredENDSproducts.

Thepolicywill not besuccessfulat keeping
kidsfromusingtheseproducts; kidsuse
anythingthat istabooandillegal.

Youtharemoreattractedto these
productsdueto peerusethanflavors.

YouthuseENDSproductsfor nicotine
deliverynot for flavors.

Onlyacorrelative, notcausal, relationship
betweenyouthpreferencefor flavorsand
increasedENDSusage.

Asdiscussedin theFinalGuidance, datafrom2018
NYTSaswellasfrom2019MonitoringtheFuture
studyand2019NYTSshowasignificantincreasein
youthuseof theseproducts. Dataalsoclearlyshow
that flavorsareaprimarydriverin youth
experimentationwith, andcontinueduseof, ENDS
products, andthat theflavoredENDSproducts
overwhelminglyusedbyyoutharecartridge-based
products. Thepolicyoutlinedin theFinalGuidance
prioritizesenforcementof ENDSproductsthat are
targetedto minorsor likelyto promoteuseof ENDSby
minors. FDAexpectsthat thispolicyandothersstated
in theguidancewill makefewerproductsavailableand
moredifficultfor youthto obtain.

Nobasisfor excludingtobacco, mint, andmenthol
fromprioritization.

TheFinalGuidanceexplainsthat FDAintendsto
prioritizemint-flavored, cartridge-basedENDS
products (andanyotherflavored, cartridge-based
WrittenCommunications
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39 Generalincreasingpopularityof mintand
mentholENDSproductsamongstyouth
populations.

Mint- andmenthol-flavoredproductsdrive
youthENDSusage.

Flavorsclearlyincreaseappealof ENDS
productsandsomeflavorshavetoxic
effectsanddocumentedrespiratory
toxicity.

ENDSproduct, otherthantobacco- or menthol-
flavoredENDSproducts) for enforcementfor lackof a
marketingauthorization. Theguidancealsoexplains
that FDAintendsto prioritizeenforcementfor lackof a
marketingauthorizationfor anytobacco- or menthol-
flavoredENDSproductsandnon-cartridge-based
flavoredENDSproductswhenthemanufacturerisnot
takingadequatemeasuresto preventminors’ access
to theseproducts. Datashowsthat tobacco- and
menthol-flavoredENDSproductsarenot asappealing
to minorsasotherflavoredENDSproducts. Whilethe
NYTSgroupsmint- andmenthol-flavoredproducts
together, arandomly-selectedthirdof respondentsto
theMonitoringtheFuture (MTF) studywereasked
specificallyabouttheirpreferredflavorsof JUULand
reporteduseof menthol- andtobacco-flavored
productswereamongthelowestrankedoptions.

BasedontheavailabledataandFDA’sinterestin
balancingbetweenpreventingyouthusageand
preservingoptionsfor adultstryingto transitionaway
fromcombustibleproducts, FDAisnotprioritizing
enforcementagainsttobacco-, menthol-, andnon-
flavoredENDSproductsornon-cartridge-based
flavoredENDSproductsexceptwhenthe
manufacturerisnottakingadequatemeasuresto
preventminors’ accessto theseproducts.

Prioritizingflavorsfor enforcementwill createa
significantblackmarketfor “banned” flavors
outsidethosethatareexempted.

Byblackmarketflavoredproducts, weassumethis
couldreferto, for example, flavoredENDSproducts,
includinge-liquids, putonthemarketafterthe
guidance, flavoredENDSproductsdivertedfrom
anothercountry’smarketto theU.Smarket, and/or
flavoredENDSproductsmadeto looklikeanother
ENDSproductthat iscurrentlybeingmarketed. FDA
hasregulatorytoolsandenforcementauthoritiesto
addressdeemedtobaccoproductsthat aremarketed
withoutauthorization, counterfeit, and/or otherwise
involvedin illicit trade. See, e.g., sections301, 902, 903, 905, 910, and920of theFD&CAct.

ThisFinalGuidancedescribestheAgency’s
enforcementprioritiesfor productsthat areonthe
marketwithouttherequiredpremarket
authorization—it doesnot bananytobaccoproduct—
andillicit ENDSproductsarenecessarilysubjectto the
enforcementprioritiesidentifiedin theguidanceas
theydonot havepremarketauthorization. Thus, FDA
believesthat thispolicywill not significantlyincrease
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40 illicit practicesor createnewillicitmarkets, andit
couldhelpFDAbetteraddresssuchpractices. Once
productsreceivepremarketauthorization, theycan
legallyenterthemarket.

FDAbelievesthat therearesignificantpublichealth
benefitsof thepolicysetforth in theguidance, which
isaimedat curbingthedramaticriseinyouthuseof
ENDSproductsandwill helpaddresssafetyissues
connectedto ENDSproductsthat arenot fully
understood—e.g., lunginjuriesassociatedwith useof
vapingproductsaswellasbatteryexplosionswith
ENDSproducts—particularlygiventhat theseproducts
havebeenmarketedwithoutpremarketevaluation.

Thesecurrentpublichealthissuesaffirmthe
importanceof thepremarketreviewprocess, as
contemplatedbytheTobaccoControlAct, to
scientificallyevaluateproductsbasedonapublic
healthstandard. FDAbelievesthat bypursuingthis
policytheAgencywill bebetterableto monitorand
identifyillicitcartridge-basedproductsthat arethreats
to publichealthandsafety. Asflavored, cartridge-
basedproductsexitthemarketuntil theyareableto
demonstratethat theymeettheapplicablepublic
healthstandardandreceiveauthorization, thenumber
of potentialflavored, cartridge-basedproductsthat
couldcausethesethreatswill shrinkto amore
manageablenumberfor FDAto monitor. Thus, FDA
expectsthat to theextentanyillicit marketswereto
developwith respectto cartridge-basedproductsin an
attemptto evadepremarketreviewrequirements, this
guidancewill helpFDAbetteraddressthepublic
healththreatscausedbysuchmarketsandtheoverall
publichealthbenefitsthat will likelyaccrueasaresult
of theguidancewill begreaterthananynegative
effectsof increasedillicit markets. Moreover, FDA
doesnotbelievethattheAgencyshouldrefrainfrom
enforcingexistingstatutoryauthoritiesmerely
becauseregulatedentitiescouldfindotherwaysto
violatesuchauthorities. TheAgencycan, andwill,
continueto monitorthemarketinganduseof ENDS
andothertobaccoproducts, andadjustitspoliciesand
approachesaswarranted.

Manyotherharmfulproducts (e.g., alcohol) are
availablein variousflavorsattractiveto youth; it is
inconsistentto onlyprioritizefor enforcement
flavoredENDSproducts.

Thepolicyexpressedin thisFinalGuidanceislimited
solelyto tobaccoproductsoverwhichFDAhas
statutoryauthority. Thefocusof thisguidanceandthe
Agency’senforcementprioritiesistobaccoproducts,
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41 specificallycertainENDSproducts. Moreover, this
commentisaboutflavoredalcoholproductsthat are
lawfullyonthemarket, whereasthisguidance
concernsproductsbeingsoldin violationof the
requirementto havepremarketauthorization, where
theproduct’singredientsandadditivesareamongthe
considerationsin thepremarketreview.

FDAshouldfocusitsenforcementprioritieson
productsthat containnicotinesaltsand/or should
specifydifferencesbetweennicotineandnicotine
salts.

FDAbelievesthatENDSproductscontainingnicotine
saltswill beadequatelyaddressedbytheenforcement
prioritiessetin thisFinalGuidance.

Researchisongoingto betterunderstandtheabuse
liabilityassociatedwith nicotine-saltbasede-liquids
andnewcartridge-styleENDSproducts, thepotential
for initiationin youthandnonusers, andthepotential
for switchingfromcombustedcigarettesin current
smokersfromuseof theseproducts. Preliminary
researchindicatesthat nicotinesaltsin ENDSproducts
candrivenicotineexposuresin usershigherthanENDS
containingfreebasenicotine; theseexposurescanalso
becomparableto or potentiallyhigherthan
cigarettes.105
105Goniewicz, M. L., R. Boykan, C.R. Messina, etal., “HighexposuretonicotineamongadolescentswhouseJuul andothervapepodsystems (‘pods’),” TobaccoControl, 28(6), 2019; doi:10.1136/tobaccocontrol-2018-054565; Talih, S., R. Salman, R. El-Hage, etal, “Characteristicsandtoxicantemissionsof JUULelectroniccigarettes,” TobaccoControl, 28(6):678-680, 2019; doi:10.1136/tobaccocontrol-2018-054616; Teichert, A., P. Brossard, L.F.

Medlin, etal, “Evaluationof NicotinePharmacokineticsandSubjectiveEffectsfollowingUseof aNovelNicotine DeliverySystem,” NicotineTobaccoResearch, 20(4):458-465, 458-465; doi:10.1093/ntr/ntx093.

Inadditionto greaternicotine
exposures, ENDSwith nicotinesaltscanhavefaster
absorption106
106O’Connell, G., J.D. Pritchard, C. Prue, etal., “A randomised, open-label, cross-overclinicalstudyto evaluatethe pharmacokineticprofilesof cigarettesande-cigaretteswith nicotinesaltformulationsin USadultsmokers,” Internal andEmergencyMedicine, 14:853-861, 2019; doi:10.1007/s11739-019-02025-3. andpotentiallyfastereliminationfrom
theblood.107
107Bowen, A., & C. Xing, “NicotineSaltFormulationsfor AerosolDevicesandMethodsThereof,” UnitedStates Patent, Pub. No. US2015/0020824, 2015,
https://patentimages.storage.googleapis.com/57/f8/7e/2db69f396801d5/US20150020824A1.pdf (visitedOct8 2019).

Thesefactorscanincreasetheabuse
liabilityof ENDSwith nicotinesaltscomparedto
freebasenicotine, andpotentiallycigarettes.

Thehigherabuseliabilityof ENDSwith nicotinesalts
comparedto freebasenicotineraisesconcernsof
addictioninyouth, particularlydueto thevulnerability
of thedevelopingadolescentbrain. However, for
manyindividualaddictedcigarettesmokers, the
potentialfor ENDSto actasasubstitutefor cigarettes,
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42 therebyencouragingsmokersto seekto switch
completelyawayfromcombustiblecigarettes, maybe
dependent, in part, upontheproducthaving
acceptabilityandabuseliabilitymorecomparableto a
cigarette.

TheFinalGuidancefocusesFDA’sprioritieson
flavored, cartridge-basedENDSproductsbecausedata
showthatflavorsareastrongdriverfor youthuse,
andthat youthoverwhelminglyprefercartridge-based
ENDSproducts. However, FDAiscontinuously
evaluatingnewinformationandadjustingits
enforcementprioritiesin lightof thebestavailable
data, includinganydataonENDSproductscontaining
nicotinesalts, andit will continueto dosowith
respectto theseproducts.

FDAshouldfocusitsenforcementprioritieson
cartridge-basedENDSproducts.

FDAisconcernedabouttherisingyouthappealand
useof ENDSproducts. Thedatashowthat flavorsare
astrongdriverfor youthuse, andthat youth
overwhelminglyusecartridge-basedENDSproducts.

Accordingly, suchproductsareakeyfocusof theFinal
Guidance. FDAwill, however, takeappropriateaction
regardingENDSthat aremarketedwithoutpremarket
authorization, includingaswarrantedbasedon
changedcircumstances, newinformation, or to better
addressminors’ useof thoseproducts.

Modificationsto ENDSCompliancePolicy – Offeredfor salein waysthat poseagreaterriskfor minorsto accesssuchproducts
Comment Response
TheTobaccoControlActprohibitsFDAfrom
restrictingtobaccosalesto aspecificcategoryof
retailoutlets.

FDAisnot restrictingor evenprioritizingenforcement
againstENDSproductssoldin aspecificcategoryof
retailoutlets. AlthoughtheMarch2019Draft
Guidanceproposedto focusitsenforcementpriorities
for flavoredENDSproductsonhowtheproductwas
sold (regardlessof thetypeof retailestablishment),
afterconsideringthecomments, thepublichealth
threats, andnewevidence, FDAdeterminedthat
focusingonhowtheproductwassoldwouldnot be
sufficientto addressyouthuseof theseproducts.

Giventheurgentneedto addressthedramaticrisein
youthuse, thisFinalGuidanceprioritizesenforcement
with respectto anyflavored, cartridge-basedENDS
products (otherthanatobacco- andmenthol-flavored
ENDSproduct) withoutregardto thelocationor
methodof sale.

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43 Withrespectto tobacco-, menthol-, andnon-flavored
ENDSproductsaswellasflavoredcartridge-based
ENDSproducts, theFinalGuidancestatesthat FDA
doesnot intendto prioritizeenforcementwhere
manufacturershavetakenadequatemeasuresto
preventyouthaccess. Thesetypesof measures
generallyareamongthosethat manufacturershave
informedFDAthat theyarecapableof implementing
for ENDSproductsandnoneinvolveaspecific
categoryof retailoutlet.

Lackof clarityfor retaillocations
Shouldretaillocationshaveage
verificationat theirdooror aseparate
roomfor thesaleof anyENDSproducts?
Canretaillocationsemployless
burdensomealternatives?
Concernthatthepolicycouldmake
traditionalcigaretteproductsmoreeasily
accessiblethanENDSproducts.

Needclarityonhowmanufacturersor
wholesalerscandocumentadequate
measuresto preventyouthaccess.

Howareretailoutletssupposedto balance
spaceconstraintswith youthaccess
concerns?
FDAshouldgiveexistingenforcement
mechanismsthechanceto succeedor
focusonenforcingexistingmechanisms
beforeinstitutingnewpolicy.

FDAhasprovidedadditionaldetailsregardingfactors
that it intendsto considerin assessingwhethera
manufactureristakingadequatemeasuresto prevent
youthaccess. Forexample, theFinalGuidancelists
severaldifferenttypesof programsto monitor
compliancewith age-verificationandsalesrestrictions,
allof whichareprogramsthat somemanufacturers
havestatedtheyarecapableof implementingfor
ENDSproducts. UnliketheDraftGuidance, it doesnot
include, asafactorfor prioritization, whetherthe
productissoldbyretailersin alocationwhereminors
areableto enterat anytime.

TheMarch2019DraftGuidanceproposedto focusits
enforcementprioritiesof flavoredENDSproductson
howtheproductwassold (regardlessof thetypeof
retailestablishment). Afterconsideringthe
comments, thepublichealththreats, andnew
evidence, FDAdeterminedthat, to addressyouthuse
of theseproducts, thisFinalGuidanceshouldprioritize
enforcementwith respectto anyflavored, cartridge-
basedENDSproducts (otherthanatobacco- and
menthol-flavoredENDSproduct) withoutregardto the
locationor methodof sale. Thealarmingdataonthe
increasein youthuseof ENDSproductsshowsthat the
FDA’senforcementeffortsto datedidnot adequately
addressthisproblem.

Enforcementprioritieswouldeffectivelybanmany
retailersfromsellingENDSproductswhileallowing
salesfromvapeshopsandonlineretailers.

Concernsthat manyretailerswill beforced
to close.

Concernsthat thiswill justcauseretailers
to shiftunauthorizedproductsto vape
shopsandotherstores.

ThisFinalGuidanceprioritizesenforcementwith
respectto anyflavored, cartridge-basedENDS
products (otherthanatobacco- andmenthol-flavored
product) withoutregardto thelocationor methodof
sale.

Inaddition, theFinalGuidanceexplainsthat FDA
intendsto prioritizeenforcementfor lackof a
marketingauthorizationfor tobacco-, menthol-, and
non-flavoredENDSproductsandfor non-cartridge-
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44 Concernsabouttheriseinyouthuseof
opentanksystemsandsourcingof e-vapor
productsat vapeshops, asindicatedbyan
analysisof Wave2 (2014-2015) to Wave3
2015-2016) of resultsfromthePATH
study.
basedflavoredENDSproductswherethe
manufacturerisnot takingadequatemeasuresto
preventyouthaccessto ENDSproducts. Forexample,
theFinalGuidancelistsseveraldifferenttypesof
programsto fostercompliancewith age-verification
andsalesrestrictions, allof whichareprogramsthat
somemanufacturershavestatedtheyarecapableof
implementingfor ENDSproducts.

Finally, FDAnotesthat therehasbeenadramaticrise
in youthuseof cartridge-basedENDSproductssince
Wave3of thePATHstudywascompletedin 2016, as
demonstratedbyresultsfromtheNYTSin 2018and
2019. TheserecentdatainformFDA’sseriouspublic
healthconcernsregardingthesaleof certainflavored,
cartridge-basedproductswithoutpremarket
authorization. Moreover, althoughthisFinalGuidance
shouldhaveminimalimpactonthosevapeshopsthat
primarilysellnon-cartridgeENDSproductsandensure
that purchasersareof therequisiteageandarenot
purchasingfor resale (e.g., arenot purchasingin large
quantities), shouldevidenceindicateto thecontrary,
theAgencywill takeappropriateaction.

Stricterenforcementof currentageverifications
ruleswouldbeaneffectiveenforcementstrategy.

Laxenforcementisaprimarydriverof
youthENDSuse.

FDAshouldincreasepenaltiesto retailers
whoviolatecurrentregulationsandsellto
minors.

Ageverificationshouldbeasstrongasit is
for alcohol.

Thereisaneedfor stricterageverification
for onlinesalesof ENDSproducts.

Asdescribedin theFinalGuidance, FDAvigorously
enforcestheageverificationrequirementsin its
compliancecheckprogram. FDAhasbeenfocusing
enforcementeffortsonageverificationasastrategy
to addressyouthuseof tobaccoproducts, andFDA
continuesto enforceagerestrictions. However, FDA
believesthat ageverificationaloneisnotsufficientto
addressthisissue, giventhemostrecentdatathat
youthuseof ENDSproductscontinuesto increase.

FDAdeterminedthat focusingonhowtheproductwas
soldwouldnot besufficientto addressyouthuseof
theseproductsgiventhemanysourcesof products
availablefor youthaccess. Therealityisthat youth
havecontinuedaccessto ENDSproductsin thefaceof
legalprohibitionsandevenaftervoluntaryactionsby
somemanufacturers. FDAbelievesthat thepolicy
expressedin theFinalGuidanceisamoreappropriate
meansto combatyouthuseof, andaccessto, these
products.

Manycompaniesalreadycomplywith age
verificationrequirements.

Policiesthat encourageadditional
measureswouldharmlaw-abiding
retailers.

TheFinalGuidancedoesnot requireadditionalage
verificationmeasures. Instead, it statesthat FDA
intendsto prioritizeenforcementfor lackof a
marketingauthorizationfor tobacco-, menthol-, and
non-flavoredENDSproductsaswellasnon-cartridge-
WrittenCommunications
Item8.2 - Khoury - Received9/12/2022
ContainsNonbindingRecommendations
45 basedflavoredENDSproductswherethe
manufacturerisnot takingadequatemeasuresto
preventyouthaccessto ENDSproducts.

Onlinesalesof ENDSproductsshouldbebanned. Thissuggestedsalesrestrictionisoutsideof thescope of thisguidance, whichconcernsenforcementof the
premarketauthorizationrequirements.

At thistime, FDAisfinalizingthisGuidanceto address
itsconcernsregardingyouthuseof ENDSproducts.

Theguidanceprioritizesenforcementwith respectto
flavored, cartridge-basedENDSproductsbecausedata
showsthat flavorsaretheprimarydriverin youth
experimentationwith, andcontinueduseof, ENDS
products, andthat youthoverwhelminglyuse
cartridge-basedENDSproducts. Theseprioritiesapply
whethertheproductsaresoldonlineor in brick-and-
mortarstores. However, theAgencywill continueto
monitorthisissue.

Lackof clarityonwhatquantitylimitsfor online
saleswouldentail.

GiventhedatathatmanyyouthobtaintheirENDS
productsfromfriendsor sourcesin theirsocial
networks, FDAbelievesthat quantitylimitsareone
measurethat amanufacturercouldadoptto prevent
individualsfrompurchasinglargequantitiesof ENDS
productsto thendistributeto minorsonasecondary
market. FDA’senforcementdecisionswill bemadeon
acase-by-casebasisanddependonmanyfactors, but
FDAintendsto considerwhetheramanufacturerlimits
thequantityof ENDSproductsthat acustomermay
purchasewithinagivenperiodof timeasafactorin
assessingwhetheramanufactureristakingadequate
measuresto preventyouthaccess. Thereiswide
variationin thesetypesof ENDSproductsand, based
onsomeof thecommentsFDAreceivedandthe
responsesto theAgency’sSeptember12, 2018letters,
FDAbelievesindividualmanufacturersarebest
positionedto knowhowto setpurchaselimitsfor their
specificproducts. Therefore, FDAdoesnot believe
that furtherdetailiswarrantedregardingthisissue.

Ageto purchaseENDSproductsshouldbe
increasedto 21.

OnDecember20, 2019, thePresidentsignedintolaw
legislationthat raisedthefederalminimumageof sale
of tobaccoproductsfrom18to 21years. FDAviews
thisasamajorstepin protectingthenextgeneration
of youthfrombecomingaddictedto ENDSandother
tobaccoproducts. FDAbelieves, however, that this
changealoneisnot sufficientto addresstheepidemic
useof ENDSbyyouth, especiallyuseof flavored,
WrittenCommunications
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ContainsNonbindingRecommendations
46 cartridge-basedproducts (exceptfor tobacco- or
menthol-flavoredproducts) that areeasilyconcealed,
producedonalargescale, and (in somecases) soldin
bulkquantitiesthat hashelpedenableresalethrough
socialor blackmarketsources. Aspartof the
premarketreviewprocessfor theseproducts, FDA
intendsto considermeasurestakenbymanufacturers
to controlyouthaccessto theseproducts.

Purchasingfromotheradolescentsisamajor
factordrivingENDSusagein youthpopulations.

FDAshouldincreasepenaltiesfor
individualswhoprovideproductsto youth.

Thistypeof behaviorshouldbethe
responsibilityof parents, not the
government.

Onlyspecialtyvapestoresshouldbe
permittedto sellENDS.

DatafromCDC’s2017YouthRiskBehavior
SurveillanceSystem (YRBSS) foundthat

86.4% of youthwhousedENDSdidnot
purchasethemat aretailstore.

Youthwill findwaysto purchaserestricted
flavoredproductsandincreased
regulationswill beineffective.

FDAagreesthatsocialsourcesremainaconcernfor
ENDSandothertobaccoproducts. Giventhe
popularityof socialsources, FDAbelievesthat quantity
limitscouldbeeffectiveinpreventingindividualsfrom
purchasinglargequantitiesof ENDSproductsto then
distributeto minorsonasecondarymarket.

Accordingly, FDAintendsto considerwhethera
manufacturerlimitsthequantityof ENDSproducts
that acustomermaypurchasewithinagivenperiodof
timeasafactorin assessingwhetheramanufactureris
takingadequatemeasuresto preventyouthaccess.

Limitsonretailor onlinesaleswouldremovetwo
of thetop purchaseoptionsfor adultENDS
productusers.

Theprioritiesin theFinalGuidanceareaddressedto
particularproducts, notretailers. FDAbelievesthat
theFinalGuidancestrikesanappropriatebalance
betweenpreventingyouthaccessto ENDSproducts
andmaintainingavailabilityof potentiallylessharmful
optionsfor currentadultsmokerswhohave
transitionedor wishto transitioncompletelyaway
fromcombustedtobaccoproducts. FDAwould
considermeasurestakenbymanufacturersto control
youthaccess, not adultaccess, whendetermining
whetherto enforcethepremarketauthoritieswith
respectto theseproducts.

Doesnotprovideadequatereasoningor specificity
for manufacturersto understandwhatmarketing
actionswouldpromptenforcementactions.

FDA’sdecisionto exerciseitsenforcementauthorities
with respectto particularproductswill bedetermined
onacase-by-casebasis, informedbytheenforcement
prioritiesdescribedinthisFinalGuidanceandany
otherrelevantfactors. TheFinalGuidanceprovidesa
numberof examplesof measuresmanufacturescan
taketo helppreventyouthaccessto theirtobacco
products. Suchexamplesreflectinformationprovided
bymanufacturersin responseto theAgency’s
September12, 2018letters, includingmeasuresto
WrittenCommunications
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ContainsNonbindingRecommendations
47 addressyouthusethat manufacturerscanor have
alreadytakento addressyouthaccessto ENDS
products, aswellasinformationprovidedin
commentsto theMarch2019DraftGuidance.

Modificationsto ENDSCompliancePolicy – flavoredENDSofferedfor saleafterAugust8, 2021, without themanufacturersubmitting (andFDAreceiving) apremarketapplication Comment Response
Movingupthecompliancereviewdatewouldbe
harmful.

Hasthepotentialto impactadultsusing
ENDSproductsfor smokingcessation
purposes.

Willharmbusinessesthat havealready
plannedfor theinitialdate.

Willexacerbateanalreadyburdensome
premarketreviewprocess.

Willbedifficultfor smallbusinessesto
submitcompleteapplicationsbyAugust8,
2021.

TheTobaccoControlActprovidesthatnewtobacco
productsmaynot belegallymarketedwithout
premarketauthorization. Accordingly, alldeemed
newtobaccoproductsonthemarketwithout
authorizationareillegallymarketedproducts. As
discussedin theFinalGuidance, industryhadnotice
that FDAwouldrevisititscompliancepolicyif
necessary. TheFinalGuidanceannouncesthat FDA
intendsto prioritizefor enforcementENDSproducts
for whichapremarketapplicationhasnot been
submittedbySeptember9, 2020. FDAunderstands
theconcernsexpressedbythesecommentersbut
believesthat it isappropriatefor ENDSproductsto
undergopremarketreviewonashortertimeframe
giventherisein youthuse, in additionto othernew
andcontinuingpublichealthandsafetyconcerns, such
astheoutbreakof pulmonaryinjuriesandbattery
hazards.

Leavingproductsonthemarketfor thislongis
problematic.

Dateisstilltoo far awayandwill allow
harmfulproductsto remainonthemarket.

Deadlinemeanslongertimefor products
onthemarketto continueto make
unsubstantiatedclaimswithoutscientific
review.

Leavingproductsonthemarketis
problematicdueto lackof evidence
justifyinglaterpremarketreview.

FDAagreeswiththesecommentersthattheproposed
August8, 2021, datewouldallowproductsthat may
beharmfulto remainonthemarkettoo long, would
allowproductsto marketunsubstantiatedclaims
withoutscientificreview, andthat thedatabeforethe
agencydoesnotjustifylaterpremarketreview. The
FinalGuidancediscussesthedatefor premarket
applicationsubmissionandtheimportanceof earlier
submissionof applicationsto allowfor FDAto better
evaluatewhethertheseproductsmeetapplicable
premarketstandards, suchaswhethertheproducts
areappropriatefor theprotectionof thepublichealth,
consideringtherisksandbenefitsto thepopulationas
awhole, includingusersandnonusersof thetobacco
product.

Lackof clarityarounddatefor submissionof
premarketreviewapplications
FDAshouldarticulatethestatusof
submittedpremarketapplicationsand
providemanufacturersopportunityto
TheFinalGuidancediscussesdatesfor submissionof
applicationsfor premarketreviewandprovideslinks
to applicationsubmissioninformation, including
whereto viewmarketingordersandaccompanying
documentation, availableat FDA.gov. FDAhas
WrittenCommunications
Item8.2 - Khoury - Received9/12/2022
ContainsNonbindingRecommendations
48 amendapplicationsin lightof changing
deadlines.

Stillunclearwhatinformationmustbe
includedin aPMTAand/or SEreport
providedguidanceandinformationto industryonthe
premarketpathwaysthroughpublishingguidances
andmarketingorders, aswellaspostinginformation
viawebinarsandpublicworkshops.108
108FormoreinformationonpremarkettobaccoproductapplicationspleaseseePremarketTobaccoProduct Applicationsfor [ENDS], Guidancefor Industry (June2019), availableathttps://www.fda.gov/regulatory- information/search-fda-guidance-documents/premarket-tobacco-product-applications-electronic-nicotine-delivery- systems-ends; Applicationsfor PremarketReviewof NewTobaccoProducts (updatedJune2019) availableat https://www.fda.gov/regulatory-information/search-fda-guidance-documents/applications-premarket-review-new- tobacco-products. FormoreinformationonCTP’sotherpublishedregulationsandguidances, pleasesee https://www.fda.gov/tobacco-products/products-guidance-regulations/rules-regulations-and-guidance; for more informationonFDACTPwebinars, pleaseseehttps://www.fda.gov/tobacco-products/compliance-enforcement- training/fda-tobacco-compliance-webinars; for informationonmarketingordersandaccompanyingdocumentation, pleaseseehttps://www.fda.gov/tobacco-products/compliance-enforcement-training.

Modificationsto ENDSCompliancePolicy – targetedto minorsor likelyto promoteuseof ENDSproduct byminors
Comment Response
FDAshoulduseitsauthorityto requireENDS
manufacturersto stoprunningadswith
unsubstantiatedclaimsaboutsmokingcessation
andmodifiedriskclaims.

Thisisoutsideof thescopeof theFinalENDS
guidance, whichaddressespremarketreview
requirementsfor ENDSproducts. FDAclosely
monitorsretailer, manufacturer, importer, and
distributorcompliancewith Federaltobaccolawsand
regulationsandtakescorrectiveactionwhen
violationsoccur. WhenenforcingFDA’stobacco
productauthorities, theAgencygenerallyissuesa
warningletter thefirsttimeacompliancecheck
revealsaviolationof federaltobaccolawsand
regulations, includingwhenamanufacturersellsor
distributesaproductasamodifiedrisktobacco
productwithoutanFDAorderin effect. Failureto
promptlyandadequatelycorrectallviolationsand
ensurecompliancewith allapplicablelawsand
regulationsmayleadto enforcementactions,
includingcivilmoneypenalties, seizure, and/or
injunction. Totheextentthat manufacturersare
marketingtheirproductsfor therapeuticpurposes,
theyaresubjectto FDA’smedicalproductauthorities.

Lackof clarity – it isunclearwhatENDSproducts
manufacturers (andotherpartiesthat engagein
ENDSmarketingactivities) andretailerscandoto
avoidconcerningmarketingactivities.

Wouldliketo knowwhatspecificsteps
theycantaketo ensuretheirmarketing
reachesadultsratherthanminors.

FDAbelievesthelevelof detailandexamplesinthe
FinalGuidanceprovidesufficientclarity.

WrittenCommunications
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ContainsNonbindingRecommendations
49 Needclarityonwhattheagencyconsiders
targetingor promotingto minors.

FDAshouldensuresocialmediaplatformsarenot
usedasadvertisingplatformsfor ENDSproducts,
includingmonitoringvideosthat promoteENDS
productsandlimitingthereachof socialmedia
influencerswhopromoteproducts.

Totheextentthiscommentisabouttheadvertisingof
ENDSproductsgenerally, it isoutsidethescopeof the
policy. Totheextentthiscommentisabout
advertisingof ENDSproductsthat aretargetedto
minorsor likelyto promoteuseof ENDSbyminors,
FDAbelievestheFinalGuidanceaddressesthisby
indicatingthat suchproductswill beanenforcement
priority.

Anumberof ENDSproductsaredesignedto be
smallanddiscreet, thuspromotingENDSusein
minors.

TheFinalGuidancediscussestheAgency’sintentto
prioritizeitsenforcementfor productsthat are
targetedto minorsor likelyto promoteuseof ENDSby
minors. Oneexampleof suchproductsincludes
productsmarketeddirectlyto minorsbypromoting
easeof concealment.

FDAshouldsupportstakeholderpartnershipsto
developcommonapproachandstandardsin
preventingyouthaccess.

FDACTP’sOfficeof StakeholderRelationsregularly
connectswith stakeholders. Stakeholdersalsohave
accessto theombudsmanaswell.

FlavoredCigars
Comment Response
Enforcingthepremarketrequirementsagainst
flavoredcigarswouldlimit adults’ freedomto
choosetheirpreferredproducts.

TheFinalGuidancedoesnotincludeapolicyto
prioritizeflavoredcigarsfor enforcement. Instead, as
describedin theFinalGuidance, flavoredcigarsare
treatedlikeallotherdeemedproductsthat arenot
ENDS. Flavoredcigarsmayseekpremarket
authorizationfromFDA. Manufacturersof flavored
cigars, andof otherdeemednewtobaccoproducts,
will berequiredto submitmarketingapplicationsfor
thoseproductsbySeptember9, 2020, consistentwith
theU.S. DistrictCourtfor theDistrictof Maryland’s
order, asdescribedin theGuidance.

Eliminatingflavoredcigarswouldresultin the
creationof ablackmarket.

TheFinalGuidancedoesnot includeapolicyto
prioritizeflavoredcigarsfor enforcement. Inaddition,
wedonot thinkdevelopmentof ablackmarketis
likelygiventhat thereareanumberof
grandfathered” flavoredcigarsthat arelawfully
marketedandwouldremainavailableto consumers
regardlessof FDA’senforcementof premarket
authorities.

FDA’sassertionof productmigrationof youthisan
unfoundedhypothesis.

Concernsthat FDAmischaracterizes
researchanddoesnot citecontrary
TheFinalGuidancedoesnot includeapolicyto
prioritizeflavoredcigarsfor enforcement.

WrittenCommunications
Item8.2 - Khoury - Received9/12/2022
ContainsNonbindingRecommendations
50 governmentfindings (citingto CDCreports
andPATHdata)
FDA’sdataonthistopiclimitedto two
studiesthat onlyrecentlybecame
availableandhasnot beenvetted
Therearelimitationsto theWave1-3
PATHdatathat FDAcitesin support
FDArelieson2018NYTSdataand
incorrectlyspeculatesthatyouthcould
migrateto flavoredcigars
CDCMMWRdataandPATHdata
contradictsuggestionsthat youthusageof
cigarsisontherise
Datashowdecreasingimportanceof
flavorsto firsttimecigarusers
Onlyallowing30daysafterguidanceisfinalized
wouldresultin adefactobanonflavoredcigars.

Notenoughtimefor manufacturersto
submitSEreports.

Maynotbeenoughtimefor retailersto
selloff inventory/FDAshouldincludean
additionalselloff periodof timeto the
complianceguidance.

Shouldbeableto remainonthemarket
untilFDAhasreviewedandmadea
determinationonthepremarketreview
application.

TheFinalGuidancedoesnotincludeapolicyto
prioritizeflavoredcigarsfor enforcement. Inaddition,
wenotethat thereareanumberof “grandfathered”
flavoredcigarsthat arelawfullymarketedthat would
remainavailableto consumersregardlessof FDA’s
enforcementof premarketauthorities.

Guidanceshouldaddressgrandfatheredflavored
cigarproductsaswell.

TheDraftandFinalGuidanceareaboutenforcement
againstproductsthat lackrequiredpremarket
authorization. Grandfatheredtobaccoproducts,
whichdonot requirepremarketauthorization, are
outsidethescopeof thepolicy.

Lackof clarity
Lackof adefinitionof flavoredcigarswill
leadto confusionandleaveretailers
misinformedaboutwhatconstitutesa
flavoredcigar.

Lackof definitionof characterizingflavor.

TheFinalGuidancenolongerdiscussesprioritizing
enforcementfor flavoredcigars.

FDAshouldpursuetheflavoredcigarenforcement
policyaddressedintheDraftGuidance.

At thistime, FDAhasdecidedto focusthisFinal
GuidanceonENDSproducts, giventherecentsurgein
youthuseandadditionalconsiderationssuchas
batteryexplosionsandvaping-relatedillnesses.

Nevertheless, FDAiscontinuouslyevaluatingnew
informationandadjustingitsenforcementprioritiesin
lightof thebestavailabledata. FDAwill take
WrittenCommunications
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ContainsNonbindingRecommendations
51 appropriateactionregardingtobaccoproductsthat
aremarketedwithoutpremarketauthorization,
includingcigars, in accordancewith thecourt’sorder
in AmericanAcademyof Pediatrics. FDAalsohas
stateditsintentionto issueaflavoredcigarrule.

CompliancePolicyfor OtherDeemedProducts
Comment Response
FDAshouldmodifycompliancepolicyfor other
deemedproducts.

Dataonwaterpipetobaccouse
demonstratesincreasein youthuse.

Asdiscussedin theFinalGuidance, consistentwith the
U.S. DistrictCourtfor theDistrictof Maryland’sorder,
FDAintendsto enforcepremarketrequirementsfor
theseproductsafterSeptember9, 2020.

FDAshouldnotmodifycompliancepolicyfor other
deemedproducts.

Asdiscussedin theFinalGuidance, consistentwith the
U.S. DistrictCourtfor theDistrictof Maryland’sorder,
FDAintendsto enforcepremarketrequirementsfor
theseproductsafterSeptember9, 2020.

FDAshouldfocusitseffortsonmentholcigarettes. TheFinalGuidancedescribesFDA’spolicyonenforcing premarketrequirementsfor productssubjectto the
deemingrule. Mentholcigarettesareoutsidethe
scopeof thispolicy.

WrittenCommunications
Item8.2 - Khoury - Received9/12/2022