FDA prejudged e-cigs as good before it evaluated a single application

An August 31, 2020 memo detailing FDA’s plan for dealing with the expected flood of Premarket Tobacco Applications (PMTAs), clearly prejudges e-cigarettes as a good thing before looking at a single application.

In particular, the FDA describes its “public heath goals” as including

Ensure a variety of ENDS [electronic nicotine delivery systems] have an opportunity to remain on the market to facilitate adult smokers switching to less harmful tobacco products.

In other words, before considering the specific evidence on any specific products FDA made a policy decision to “ensure” that “a variety” of these products would be authorized for sale. Another goal is that FDA would “minimize” youth initiation, but that was in the context of ensuring availability. There is no mention of how many kids FDA is willing to sacrifice to ensure that e-cigarettes are available for adults.

The memo seriously misstates FDA’s mission. FDA’s job is not to ensure that a variety of e-cigarettes remain on the market for adult smokers; it is to determine whether any e-cigarettes as they will actually be marketed and used — including by kids — are “appropriate for the protection of public health.”

In particular, FDA’s protocol is inconsistent with the Family Smoking Prevention and Tobacco Control Act, which requires FDA to evaluate the likelihood “that existing users of tobacco products will stop using such products.”

The key scientific decision about whether a given e-cigarette (or other ENDS) is “appropriate for the protection of public health” requires, first and foremost, that current cigarette users switch to the new product, something that is not the case for e-cigarettes as consumer products. It also requires consideration of the fact that e-cigarettes promote relapse among former smokers. Only after passing those thresholds — something e-cigarettes fail — does the potential toxicity of the product even become an issue.

The fact that FDA prejudged the evidence as a matter of policy helps explain the actions to approve several e-cigarettes so far based on incomplete shallow analyses that has consistently ignored the substantial evidence base that does not support the FDA’s policy bias.

The memo provides details on the products it plans to prioritize in Table 2 of the memo, reproduced below with links to my comments on the FDA’s decisions added:

ManufacturerBrandReceipt dateAuthorized
Japan Tobacco International (Logic Technology Development)Vapeleaf, Power, Pro19 Aug 2019Yes
British American Tobacco (RJ Reynolds)Vuse Solo10 Oct 2019Yes (also Vibe)
NJOYNJOY ACE10 Mar 2020Yes
Imperial Tobacco (Fontem Ventures)myBlu24 Apr 2020Pending
JUUL Labs (Altria)Juul29 Jul 2020Pending

The thinking in the memo also explains FDA’s flawed authorization of Philip Morris’ IQOS heated tobacco product as well as some snus products.

FDA says it wants decisions that are “Defendable: Decisions are not arbitrary and capricious.” FDA has a long way to go the meet that goal.

The question is: Who can hold FDA’s feet to the fire?

This article on filtermag.org, a pro-e-cig website, provides an industry perspective on the memo. Interestingly, they seem to think FDA will also give menthol a pass and may even leave the door open to other flavors. Worth reading.

August 18, 2022 update: An earlier August 2020 memo on how to process the large number of anticipated flavors also establishes procedures to “increase the likelihood that FDA can issue more marketing orders on a greater number of tobacco products which would produce public health benefit.”

Published by Stanton Glantz

Stanton Glantz is a retired Professor of Medicine who served on the University of California San Francisco faculty for 45 years. He conducts research on tobacco and cannabis control and cardiovascular disease/

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