In the past, when FDA announced that it was authorizing the sale of new products through the Premarket Tobacco Authorization process (PMTA), they released a detailed scientific summary of the rationale behind their decision known as the Technical Project Lead (TPL) report. These documents were released on the FDA web page announcing the positive decisions.
One March 24, 2022, when FDA announced that it was approving (technically, “authorizing”) the sale of 8 Logic electronic nicotine delivery systems (a mix of e-cigarettes and heated tobacco products), they broke with this precedent and only released 4 pages of the 56 page long TPL with the scientific arguments justifying its decisions for each product.
We know that the TPL is 56 pages long because the 4 released pages are identified as pages 4-7 from the 56 page TPL.
Moreover, most of the material in the 4 pages that FDA did release is boilerplate summarizing the legal process rather than the scientific justification for the FDA’s decision. The science is summarized in about a page and a half in very general terms, with few specifics and no specific citations to the scientific literature.
Why did the FDA withhold most of these documents?
If certainly cannot be because they were not available, since what they did release was a few pages extracted from each TPL summary.
The only thing I can think of is because the FDA was trying to avoid outside scientific scrutiny of its decision. We did detailed analyses of FDA’s decision to authorize the sale of Philip Morris’ IOQS HTP (peer reviewed papers on problems with IQOS PMTA: paper 1; paper 2) and RJR Vuse e-cigs and found many deficiencies.
We even wrote Acting FDA Commissioner Janet Woodcock detailing the problems with the Vuse decision (and I privately emailed Dr. Robert Califf a copy while he was being considered for confirmation as commissioner) in the hope that doing so would lead FDA to be more careful in doing these PMTA reviews.
Key issues in the Vuse approval included:
- FDA did not adequately consider Vuse’s popularity with kids and unacceptably trades off youth addiction for unproven adult benefit.
- FDA misstates the evidence showing that youth e-cigarette use stimulates cigarette smoking, including making the false statement, “Overall, the available evidence to date does not adequately address whether new product use in youth and young adults leads to regular smoking,” which ignores more than 17 scientific studies.
- FDA failed to address the evidence that huge numbers of kids are being recruited to nicotine addiction through e-cigarettes.
- FDA places heavy weight on the assumption that prohibiting flavors (other than menthol) will deter kids from using Vuse.
- FDA ignored the consistent evidence that e-cigarettes in use as consumer products do not help smokers quit and that they promote relapse in former smokers.
- FDA did not address the finding that about a quarter of adult non-tobacco users could be interested in using the product despite the fact that there is no public health benefit of recreational e-cigarette use or for non-tobacco users.
- FDA ignored the evidence that dual use (when smokers add e-cigs rather than “switching completely”) is more dangerous than smoking.
- FDA’s discussion of health effects was shallow, focusing on the fact that e-cigs deliver lower levels of some toxins while ignoring or downplaying the large body of evidence of substantial specific harms.
- The FDA mentions but does not act on its own study showing no all-cause mortality benefit of smoking reduction.
- FDA considers e-cigarettes having high addictive potential to be a good thing; high abuse liability can enhance youth addiction and can undermine tobacco cessation.
We had hoped that FDA would engage with these detailed criticisms and either present good substantive answers or change its permissive stance on e-cigarettes.
Rather than FDA responding by doing a better job of justifying its actions FDA just cut off the details, making it harder to raise criticisms about their scientific arguments in the latest set of PMTAs.
This attempt to avoid confronting the growing evidence that ENDS are no “appropriate for the protection of public health” represents the same kind of behavior FDA exhibited when they left menthol out of their discussion of the importance of flavored e-cigarettes.
This continuing behavior reinforces the fact that the public can’t really rely on FDA to regulate ENDS products, making it even more important that states and localities fill the vacuum FDA continues to leave by passing bans on flavored tobacco products, taxes and other sales restrictions on new tobacco products.