FDA’s Menthol Vape Ban Shows It Is Not Science-Based

 On October 26, the Food and Drug Administration (FDA) issued its first market denial orders for menthol vaping products. Its justification for the decision was “the application does not demonstrate that these menthol-flavored e-cigarettes are more effective in promoting complete switching or significant cigarette use reduction relative to tobacco-flavored e-cigarettes among adult smokers.”

This is yet another surprise sprung on manufacturers who believed that the FDA would make decisions based on science rather than moral panic and political disquiet. When businesses applied for authorization for their products, there was no indication that the FDA required non-tobacco flavors to be more efficacious than tobacco flavor for helping adult smokers quit. Moreover, it is arguably not even possible to prove this with any science-based process. Each individual vaper has their own subjective taste when it comes to flavors, meaning that each flavor could be the most useful for switching depending on the individual.

Tobacco is also a flavor and works the same way any other flavors work. There is no evidence that any flavor is superior to another for smoking cessation, and most certainly no evidence that tobacco flavor is superior to all others. The FDA’s justification is about as scientific as feeling in one’s bones that it is about to rain.

In effect, the FDA has abandoned adhering to scientific method and reviewing products in an objective fashion, and instead created an arbitrary measure which can satisfy a political goal rather than one which would improve public health. Comparing menthol and other vape flavors with tobacco flavor products has no health merit whatsoever. The real comparison should be with combustible tobacco smoke which kills around 480,000 Americans every year.

It is baffling how the FDA considers it appropriate for the protection of public health to prohibit products which are at least 95 percent less harmful than combustible tobacco, while not subjecting incumbent cigarettes to any authorization process whatsoever. To add to the absurdity, in December, the FDA not only authorized a brand new menthol cigarette brand, but also allowed the manufacturer to make beneficial health claims despite it containing the same 7,000 toxic chemicals as other cigarettes. There is not a scintilla of doubt that the menthol vaping products which have just been denied authorization are orders of magnitude less harmful, yet the safer product is banned and the one that can kill is not.

In 2017, the FDA announced a plan which envisioned “a world where cigarettes would no longer create or sustain addiction, and where adults who still need or want nicotine could get it from alternative and less harmful sources.” Yet five years on, with the Biden government proposing banning conventional menthol cigarettes and its primary regulatory agency now prohibiting the obvious escape route of non-combustible menthol alternatives.

This is not consistent, or even competent, regulation. It is haphazard policy-led continual shifting of the playing field to get to an ideological pre-conceived result based on voodoo assumptions and fantasy about real world consequences.

It is indicative of something going badly wrong with the FDA’s Center for Tobacco Products (CTP). The current Reagan-Udall Foundation inquiry to review how the agency operates has been taking testimony from stakeholders. The testimony has revealed systematic failures and has attracted damning comments highlighting deep dissatisfaction on how vaping product applications are handled from FDA staff whistle-blowers, citing corrupt practices, political interference and intimidation of those who attempt to conduct application reviews in a scientific manner.

An outsider looking in would surely wonder why an agency which claims to be scientific and exists to act in the best public health interests of the American people is so determined to protect the deadly cigarette trade from competition from products which are saving millions of lives around the world.

The FDA appears to be on a mission to crash its scientific credibility into the side of a mountain. It is shameful that in doing so it is sacrificing many thousands of lives which could be saved by safer nicotine products which the agency is arbitrarily denying to Americans who smoke. 

Martin Cullip is International Fellow at The Taxpayers Protection Alliance's Consumer Center and is based in South London, UK.

https://www.realclearscience.com/articles/2022/10/29/the_fdas_menthol_vape_ban_shows_it_is_not_a_science-based_agency_861877.html