13/20/2019
TOO LITTLE, TOO LATE?THE FDA’S NEW ENFORCEMENTGUIDANCE
THE PUBLIC HEALTH LAW CENTER
3/20/2019 2
LEGAL TECHNICAL ASSISTANCE
3/20/2019 3
Legal Research
Policy Development, Implementation, Defense
Publications
Trainings
Direct Representation
Lobby
3/20/2019 4
Photo credit: Sam Bradd https://drawingchange.com/gathering-wisdom-visuals-for-a-healthy-future/
AGENDA
3/20/2019 5
• Background: premarket review & the deeming rule
• Effect of the new guidance• Gaps in the proposal• Process & next steps
THE DEEMING RULEPREMARKET REVIEW
63/20/2019
• 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.
THE DEEMING RULEPREMARKET REVIEW
73/20/2019
• 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.
THE DEEMING RULEPREMARKET REVIEW
83/20/2019
• 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.
93/20/2019
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
3/20/2019
2016 Final Deeming Rule (Deadlines for E-cigarettes)
Today
11
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
DEEMING RULEPREMARKET REVIEW
3/20/2019
Deeming RuleEffective Date
Regulatory Plan
THE DEEMING RULEPREMARKET REVIEW
123/20/2019
FDA TOBACCO & NICOTINE REGULATORY PLAN
13
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
Continued marketing without application Continued marketing with application
Marketing with affirmative order
3/20/2019
2016 Final Deeming Rule (Deadlines for E-cigarettes)
Today
14
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
DEEMING RULEPREMARKET REVIEW
3/20/2019
Deeming RuleEffective Date
Regulatory Plan
15
NEW GUIDANCE
3/20/2019
THE NEW GUIDANCEE-CIGARETTE ENFORCEMENT
163/20/2019
• 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”
THE NEW GUIDANCEE-CIGARETTE ENFORCEMENT
173/20/2019
• 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
THE NEW GUIDANCEE-CIGARETTE ENFORCEMENT
183/20/2019
• 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
THE NEW GUIDANCEE-CIGARETTE ENFORCEMENT
19
Deadlines for All Other Flavored E-cigarettes
Continued marketing without application Continued marketing with application
Marketing with affirmative order
3/20/2019
Deadlines for Tobacco, Mint, & Menthol Flavored E-cigarettes
8/8/2021
8/8/2021
THE NEW GUIDANCEE-CIGARETTE ENFORCEMENT
203/20/2019
• All e-cigarette that are targeted to minors or likely to promote use of e-cigarettes by youth.
THE NEW GUIDANCEE-CIGARETTE ENFORCEMENT
213/20/2019
• All e-cigarettes that are targeted to minors or likely to promote use of e-cigarettes by youth.
THE NEW GUIDANCEE-CIGARETTE ENFORCEMENT
223/20/2019
• All e-cigarettes that are targeted to minors or likely to promote use of e-cigarettes by youth.
THE NEW GUIDANCECIGAR ENFORCEMENT
233/20/2019
• 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
THE NEW GUIDANCECIGAR ENFORCEMENT
243/20/2019
8/8/2016 8/8/20228/8/20198/8/2018
2017 Regulatory Plan (Deadlines for Cigars)
Continued marketing without application Continued marketing with application
Marketing with affirmative order
8/8/2021
THE NEW GUIDANCECIGAR ENFORCEMENT
253/20/2019
8/8/2016 8/8/20228/8/20198/8/2018
2017 Regulatory Plan (Deadlines for Tobacco-Flavored Cigars)
Continued marketing without application Continued marketing with application
Marketing with affirmative order
8/8/2021
THE NEW GUIDANCEOTHER PRODUCTS
263/20/2019
8/8/2016 8/8/20228/8/20198/8/2018
2017 Regulatory Plan (Deadlines for All Flavors of Pipe and Waterpipe Tobacco)
Continued marketing without application Continued marketing with application
Marketing with affirmative order
8/8/2021
THE NEW GUIDANCEPRODUCTS INTRODUCED POST-DEEMING
273/20/2019 27
8/8/20162/15/2007 6/22/2009
3/20/2019
“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
283/20/2019
• 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?
THE NEW GUIDANCEAMBIGUITIES
293/20/2019
THE NEW GUIDANCEAMBIGUITIES
303/20/2019
THE NEW GUIDANCEGAPS
313/20/2019
• Mint and menthol flavored e-cigarettes• Online sales of e-cigarettes• 2021 application deadlines for e-cigarettes• Tobacco flavored cigars• Waterpipe & pipe tobacco
THE NEW GUIDANCEGAPS
323/20/2019
• Mint and menthol flavored e-cigarettes• Online sales of e-cigarettes• 2021 application deadlines for e-cigarettes• Tobacco flavored cigars• Waterpipe & pipe tobacco
THE NEW GUIDANCEGAPS
333/20/2019
• Mint and menthol flavored e-cigarettes
THE NEW GUIDANCEGAPS
343/20/2019
• 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
Deadlines for Tobacco, Mint, & Menthol Flavored E-cigarettes
Today
THE NEW GUIDANCEGAPS
353/20/2019
• Mint and menthol flavored e-cigarettes• Online sales of e-cigarettes• 2021 application deadlines for e-cigarettes• Tobacco flavored cigars• Waterpipe & pipe tobacco
THE NEW GUIDANCEGAPS
363/20/2019
• Mint and menthol flavored e-cigarettes• Online sales of e-cigarettes• Application deadlines for e-cigarettes• Tobacco flavored cigars• Waterpipe & pipe tobacco
THE NEW GUIDANCEGAPS
373/20/2019
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
Deadlines for Tobacco, Mint, & Menthol Flavored E-cigarettes
8/8/2021
8/8/2021
Today
• Application deadlines for e-cigarettes
THE NEW GUIDANCEGAPS
383/20/2019
• Mint and menthol flavored e-cigarettes• Online sales of e-cigarettes• Application deadlines for e-cigarettes• Tobacco flavored cigars• Waterpipe & pipe tobacco
THE NEW GUIDANCEGAPS
393/20/2019
• Tobacco Flavored Cigars– 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
Deadlines for Tobacco-Flavored Cigars
8/8/2021
Today
THE NEW GUIDANCEGAPS
403/20/2019
• Mint and menthol flavored e-cigarettes• Online sales of e-cigarettes• Application deadlines for e-cigarettes• Tobacco flavored cigars• Waterpipe & pipe tobacco
THE NEW GUIDANCEGAPS
413/20/2019
• Waterpipe & pipe tobacco– All flavors allowed
– 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
Deadlines for All Flavors of Pipe and Waterpipe Tobacco
8/8/2021
Today
THE NEW GUIDANCEGAPS
423/20/2019
• Grandfathered flavored cigars (rulemaking)• Menthol cigarettes (rulemaking)
THE NEW GUIDANCEPROCESS
433/20/2019
• 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
443/20/2019
CONTACT THE FDA TEAM
651.290.7612
www.publichealthlawcenter.org
@DesmondJenson
facebook.com/publichealthlawcenter
453/20/2019
651.290.7666
www.publichealthlawcenter.org
@publichealthlawcenter
facebook.com/publichealthlawcenter