After years of delays and deadline extensions that allowed thousands of e-cigarettes to remain on the market without any FDA premarket review and millions of kids to become nicotine addicts, health groups successfully sued FDA to force action. As a result, on July 11, 2019 Judge Paul Grimm ordered FDA to require premarket tobacco product applications (PMTAs) for e-cigarettes be filed within 10 months of the order, but due to the COVID pandemic, the deadline to submit PMTAs was extended to September 9, 2020. The order provided that any product that did not submit a PMTA by that deadline, or that had not obtained a permissive marketing order from FDA by September 9, 2021, was being marketed illegally and was subject to enforcement action by FDA.
In today’s (September 9, 2021) statement by Acting FDA Commissioner Janet Woodcock and Center for Tobacco Products Director Mitch Zeller, FDA patted itself on the back for making “significant progress” in taking action “on about 93% of the timely-submitted applications,” including issuing Marketing Denial Orders for more than 946,000 flavored e-cigarette products. However, while FDA’s announcement acknowledged that it still needed to work on the remaining applications that were timely filed, it failed to mention that the incomplete reviews include those of the PMTAs submitted by the three largest US e-cigarette manufacturers – Juul (part owned by Altria), Reynolds American and NJOY.
Although FDA’s announcement correctly and unambiguously stated that “all new tobacco products on the market without the statutorily required premarket authorization are marketed unlawfully,” it added the modifying language that these illegally marketed products are “subject to enforcement action at the FDA’s discretion,” and that its “highest enforcement priorities” would be against products for which no application was submitted and products that have already received a Marketing Denial Order.
Judge Grimm’s July 2019 order says:
“New Products for which applications have been timely filed may remain on the market without being subject to FDA enforcement actions for a period not to exceed one year from the date of application while FDA considers the application.”
Although this order did not discuss how FDA should exercise its discretion or how it should prioritize enforcement, it was consistent with federal law (Tobacco Control Act section 902) which deems tobacco products to be “adulterated” and subject to enforcement if they are being sold without the premarket review required by Tobacco Control Act section 910.
Juul Labs, always ahead of the curve, submitted its PMTA application on July 30, 2020, 41 days ahead of the September 9, 2020 deadline. So like a bad house guest, Juul has already overstayed its welcome and for more than a month has been unlawfully marketing its highly addictive products, including menthol-flavored Juul that’s especially appealing to youth.
Moreover, at this point by delaying enforcement FDA is de facto prioritizing Juul’s (and Atria’s, Reynolds’ and the other major e-cigarette companies’) ongoing sales over the health of youth who are starting their nicotine addiction every day with e-cigarettes. The FDA’s delay is also hurting adults who are using e-cigarettes in futile efforts to quit smoking rather than using effective FDA-approved therapies.
Federal law and Judge Grimm’s order give FDA the clear authority to enforce against the marketing of any new tobacco product, including Juul, that has is being sold without a required marketing order based on FDA’s completed premarket review.
The time has come for FDA to direct Juul to suspend sales unless and until FDA issues a permissive marking order.
It’s hard to understand why FDA is having such a hard time deciding what to do with Juul (and the other major e-cig brands it is still thinking about).
Reading the tea leaves in FDA’s August 26, 2021 press release announcing its initial decisions denying marketing orders to several minor e-cigarette brands raises three concerns about FDA’s thinking that may indicate it intends to allow Juul and other major tobacco company e-cigarettes, including with menthol:
- By focusing on clinical trials of e-cigarettes for smoking cessation, the FDA Center for Tobacco Products is applying the wrong standard. Randomized clinical trials (RCTs) are how you evaluate medicines, not consumer products. Population studies on e-cigarettes as consumer products – which show no cessation benefit – is the correct standard.
- The FDA seems to be willing to trade off actual damage to youth for potential benefits to adults. And evidence for cancer is even starting to appear. The fact is that e-cigarettes have been on the market for around 15 years (since 2006) and if e-cigarettes were having substantial actual health benefits for adults, it would have been obvious by now and it is not. Moreover, a well-done analysis of the tradeoff between adult quitting and youth starting that uses the RCT effect for e-cigarettes on cessation (and so is over-optimistic) shows that for every adult that quits, 80 kids start. And even making favorable assumptions about the health risks of e-cigarettes, there is a net loss of about 1.5 million life years. It’s not even close.
- Menthol does not raise “unique considerations.” As 31 state attorneys general wrote the FDA on June 28, 2021, there is no question that menthol e-cigarettes contributes to youth use. Menthol needs to be banned together with all the other flavors.
Lauren Lempert coauthored this blog post.