Thursday, May 30, 2024

FDA Denies PMTAs for 300,000 More Flavored E-Liquids


Since issuing the first Marketing Denial Orders (MDOs) on Aug. 26—rejecting Premarket Tobacco Applications (PMTAs) from three companies for 55,000 of their flavored products—the agency has been busy denying additional applications.

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.

The FDA said that the products on the new list were all flavored (meaning flavors other than tobacco). In its Aug. 26 announcement, the agency said for the first time that manufacturers of e-liquid in non-tobacco flavors must show “product-specific scientific evidence to demonstrate enough of a benefit to adult smokers that would overcome the risk posed to youth.”

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.

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