Colleagues at UCSF and Stanford and I wrote FDA Acting Commissioner Janet Woodcock raising concerns that FDA’s October 12, 2021 Marketing Granted Orders for Vuse Solo failed to substantiate its determination that authorizing the marketing of Vuse Solo will provide a net improvement to public health. In particular, FDA failed to quantify the benefits vs. the risks. The letter presents scientific evidence showing why the continued marketing of these products is not appropriate for the protection of the public health, and therefore FDA must withdraw its Marketing Granted Orders for Vuse Solo products.
The letter also expresses concern that future authorizations for e-cigarettes will suffer from the same limitations and urges that the Vuse Solo authorization not become a template for further decisions on e-cigarettes.
- 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.
Here is the letter, which includes full details and citations to the literature:
Copies were sent to Health and Human Services Secretary Xavier Becerra and Center for Tobacco Products Director Mitch Zeller.