THE PUBLIC HEALTH LAW CENTER · • Flavored e-cigarettes (except tobacco, mint, and menthol)...

13/20/2019

TOO LITTLE, TOO LATE?THE FDA’S NEW ENFORCEMENTGUIDANCE

THE PUBLIC HEALTH LAW CENTER

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LEGAL TECHNICAL ASSISTANCE

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Legal Research

Policy Development, Implementation, Defense

Publications

Trainings

Direct Representation

Lobby

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Photo credit: Sam Bradd https://drawingchange.com/gathering-wisdom-visuals-for-a-healthy-future/

AGENDA

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• Background: premarket review & the deeming rule

• Effect of the new guidance• Gaps in the proposal• Process & next steps

THE DEEMING RULEPREMARKET REVIEW

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• No “new tobacco product” can be sold without marketing authorization from the FDA.– “new tobacco product” first sold after 2/15/07– “grandfathered product” available for sale on 2/15/07

• All currently marketed e-cigarettes are “new tobacco products.” (not sold on 2/15/07)

• All e-cigarettes require marketing authorization from the FDA in order to be sold.


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• In 2009, FDA was given authority to regulate cigarettes, smokeless tobacco, RYO & cigarette tobacco.

• For all other tobacco products, FDA must “deem” them (with a rulemaking).

• The FDA cannot accept marketing applications for e-cigarettes until they have been deemed.


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• Once the FDA has regulatory authority, all e-cigarettes require affirmative marketing authorization from the FDA before they can be sold.

• The FDA cannot accept marketing applications for e-cigarettes until they have regulatory authority.

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DEEMING RULEPREMARKET REVIEW

10

8/8/20198/8/2016 8/8/2018 8/8/2022

Continued marketing without application Continued marketing with application

Marketing with affirmative order

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2016 Final Deeming Rule (Deadlines for E-cigarettes)

Today

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Nielsen All-Channel Data

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$350.00

Nov-13 May-14 Nov-14 May-15 Nov-15 May-16 Nov-16 May-17 Nov-17 May-18 Nov-18

Monthly E-Cigarette Sales (in millions)

Market Total JUUL


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Deeming RuleEffective Date

Regulatory Plan


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FDA TOBACCO & NICOTINE REGULATORY PLAN

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2017 Regulatory Plan (Deadlines for E-cigarettes)

8/8/2016 8/8/20228/8/20198/8/2018

8/8/20198/8/2016 8/8/2018 8/8/2022



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2016 Final Deeming Rule (Deadlines for E-cigarettes)

Today

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Nielsen All-Channel Data

$-

$50.00

$100.00

$150.00

$200.00

$250.00

$300.00

$350.00

Nov-13 May-14 Nov-14 May-15 Nov-15 May-16 Nov-16 May-17 Nov-17 May-18 Nov-18

Monthly E-Cigarette Sales (in millions)

Market Total JUUL


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Deeming RuleEffective Date

Regulatory Plan

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NEW GUIDANCE

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THE NEW GUIDANCEE-CIGARETTE ENFORCEMENT

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• Flavored e-cigarettes (except tobacco, mint, and menthol) “that are offered for sale in ways that pose a greater risk for minors to access such products”


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• Flavored e-cigarettes (except tobacco, mint, and menthol) “that are offered for sale in ways that pose a greater risk for minors to access such products”– Products sold in locations where minors can enter

– Products sold to minors in an FDA undercover buy inspection

– Products sold online with no quantity limit

– Products sold online without independent, third-party age- and identity-verification


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• Flavored e-cigarettes (except tobacco, mint, and menthol) that are offered for sale in the United States after August 8, 2021, without the manufacturer submitting (and FDA receiving) a premarket application (or after action by FDA on that application)

8/8/2016 8/8/20228/8/20198/8/2018

8/8/2016 8/8/20228/8/20198/8/2018


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Deadlines for All Other Flavored E-cigarettes



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Deadlines for Tobacco, Mint, & Menthol Flavored E-cigarettes

8/8/2021

8/8/2021


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• All e-cigarette that are targeted to minors or likely to promote use of e-cigarettes by youth.


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• All e-cigarettes that are targeted to minors or likely to promote use of e-cigarettes by youth.


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• All e-cigarettes that are targeted to minors or likely to promote use of e-cigarettes by youth.

THE NEW GUIDANCECIGAR ENFORCEMENT

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• All flavored cigars (other than tobacco flavored) that were on the market on August 8, 2016, and that meet the definition of a new tobacco product.

• Only “New Tobacco Products” are subject to Premarket Review.– “new tobacco product” first sold after 2/15/07

– “grandfathered product” available for sale on 2/15/07


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8/8/2016 8/8/20228/8/20198/8/2018

2017 Regulatory Plan (Deadlines for Cigars)



8/8/2021


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8/8/2016 8/8/20228/8/20198/8/2018

2017 Regulatory Plan (Deadlines for Tobacco-Flavored Cigars)



8/8/2021

THE NEW GUIDANCEOTHER PRODUCTS

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8/8/2016 8/8/20228/8/20198/8/2018

2017 Regulatory Plan (Deadlines for All Flavors of Pipe and Waterpipe Tobacco)



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THE NEW GUIDANCEPRODUCTS INTRODUCED POST-DEEMING

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8/8/20162/15/2007 6/22/2009

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“Grandfathered products”

exempt from premarket

review

E-cigarettes and cigars introduced pre-deeming stay on market but must file

marketing applications

E-cigarettes and cigars introduced post-deeming

must receive authorization from the FDA before being

sold

Grandfather Date

Tobacco Control ActDeeming

THE NEW GUIDANCEAMBIGUITIES

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• What does prioritization look like?– Products removed from the market immediately and only

reintroduced with a marketing order?

– Products placed first in the review queue after applications are submitted in 2021/2022?

– Something in between?


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THE NEW GUIDANCEGAPS

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• Mint and menthol flavored e-cigarettes• Online sales of e-cigarettes• 2021 application deadlines for e-cigarettes• Tobacco flavored cigars• Waterpipe & pipe tobacco


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• Mint and menthol flavored e-cigarettes


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• Mint and menthol flavored e-cigarettes– Allowed in all stores

– Allowed online without restrictions on quantity and without independent, third-party age- and identity-verification (age verification is still required)

8/8/2016 8/8/20228/8/20198/8/2018


Today


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• Mint and menthol flavored e-cigarettes• Online sales of e-cigarettes• Application deadlines for e-cigarettes• Tobacco flavored cigars• Waterpipe & pipe tobacco


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8/8/2016 8/8/20228/8/20198/8/2018

8/8/2016 8/8/20228/8/20198/8/2018

Deadlines for All Other Flavored E-cigarettes


8/8/2021

8/8/2021

Today

• Application deadlines for e-cigarettes


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• Tobacco Flavored Cigars– Allowed in all stores


8/8/2016 8/8/20228/8/20198/8/2018

Deadlines for Tobacco-Flavored Cigars

8/8/2021

Today


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• Waterpipe & pipe tobacco– All flavors allowed

– Allowed in all stores


8/8/2016 8/8/20228/8/20198/8/2018

Deadlines for All Flavors of Pipe and Waterpipe Tobacco

8/8/2021

Today


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• Grandfathered flavored cigars (rulemaking)• Menthol cigarettes (rulemaking)

THE NEW GUIDANCEPROCESS

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• Draft guidance issued March 13, 2019• Comments are due April 15, 2019

– Visit our FDA Action Center for a link to the docket and materials about the guidance

• FDA will review comments and finalize guidance• Final guidance has no due date• Final guidance is effective 30 days after it is issued

THE NEW GUIDANCESTATE & LOCAL ACTION

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CONTACT THE FDA TEAM

651.290.7612

[email protected]

www.publichealthlawcenter.org

@DesmondJenson

facebook.com/publichealthlawcenter

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651.290.7666

[email protected]

www.publichealthlawcenter.org

@publichealthlawcenter

facebook.com/publichealthlawcenter

THE PUBLIC HEALTH LAW CENTER · • Flavored e-cigarettes (except tobacco, mint, and menthol)...

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