FDA Denies PMTAs for 300,000 More Flavored E-Liquids
Today the FDA Center for Tobacco Products announced it has issued MDOs as of yesterday (Sept. 2) to 31 additional companies for approximately 300,000 products. However, the agency’s published list of MDOs—updated today, Sept. 3—only lists 23 new manufacturers, not 31, and the newest ones are from Sept. 1.
The updated list includes some notable names. Ohio-based NicQuid is one of the oldest American e-liquid manufacturers, and Big Time Vapes unsuccessfully sued the FDA in 2019, going as far as petitioning the Supreme Court to review its appeal.
Products receiving an MDO must be immediately removed from the market, or manufacturers can face additional enforcement steps from the FDA.
That standard was not explained in advance of last year’s PMTA deadline. The FDA further says that such evidence “would likely be in the form of a randomized controlled trial or longitudinal cohort study, although the agency does not foreclose the possibility that other types of evidence could be adequate if sufficiently robust and reliable.”
Small e-liquid manufacturers don’t have the financial resources to do the kinds of studies the FDA is retroactively demanding as proof that a product is “appropriate for the protection of public health.” Randomized controlled trials and longitudinal cohort studies would cost millions of dollars for each product tested.
If the FDA eliminates all bottled e-liquid in non-tobacco flavors—as it appears the agency intends to do—a large part of the e-liquid industry is likely to convert to using synthetic nicotine or simply selling illegally. The open-system market, including vape shops and online sales, will become a true “wild west” almost overnight because of the FDA’s poorly calculated decisions.
Jim McDonald
Vaping for: 13 years
Favorite products:
Favorite flavors: RY4-style tobaccos, fruits
Expertise in: Political and legal challenges, tobacco control haters, moral panics
Jim McDonald
Smokers created vaping without help from the tobacco industry or anti-smoking crusaders, and I believe vapers have the right to continue innovating to help themselves. My goal is to provide clear, honest information about the challenges vaping faces from lawmakers, regulators, and brokers of disinformation. I’m a member of the CASAA board, but my opinions aren’t necessarily CASAA’s, and vice versa. You can find me on Twitter @whycherrywhy