FDA denied over 1 million e-cig flavored products but not a single one with menthol

Despite the fact that menthol and mint are wildly popular with kids (and contribute to keeping adults addicted), the FDA Center for Tobacco Products has yet to prohibit the sale of a single menthol e-cigarette flavor.

The CTP News sent out today reported:

FDA Denies Marketing Applications for Over 1 Million Flavored E-Cigarette Products
In August, FDA issued the first marketing denial orders (MDOs) for electronic nicotine delivery system (ENDS) products.  As of now, the agency has issued a total of 295 MDOs for more than 1,089,000 flavored ENDS products.  Products subject to an MDO for a premarket application may not be introduced or delivered for introduction into interstate commerce. If the product is already on the market, the product must be removed from the market or risk enforcement.  Companies receiving these MDOs may have submitted premarket applications for other products (such as ENDS devices, tobacco-flavored ENDS, or menthol-flavored ENDS), and those products, if still pending, remain under review at FDA.  The aggregate information on these actions will be provided within our regular updates on the Tobacco Product Applications: Metrics and Reporting page.  [emphasis added]

As I discussed before, FDA’s August 26, 2021 press release singled out menthol for speciial consideration: ““The scientific review of menthol ENDS, as compared to other non-tobacco-flavored ENDS products, raises unique considerations. … the FDA notes that its reviews will similarly examine whether the evidence in the application demonstrates a benefit to existing adult users that outweighs the known youth use of such products.” As I said in an earlier blog post on that press release,

While the FDA did not spell out what the “unique considerations” are, the FDA has exempted menthol flavor from its enforcement decision about pod-based flavored e-cigarettes on the grounds that many adult smokers smoke menthol cigarettes, something the FDA has yet to eliminate.  This decision is implicitly based on the assumption that e-cigarettes as consumer products would help adults quit cigarettes and FDA wanted to keep that door open.

As noted above [in the earlier blog post], that is an incorrect assumption for e-cigarettes as consumer products.

As 31 state attorneys general wrote the FDA on June 28, 2021, there is no question that menthol e-cigarettes contributes to youth use.  Menthol needs to be banned together with all the other flavors.

The fact that FDA continues to defer action on menthol is very concerning.

Published by Stanton Glantz

Stanton Glantz is a retired Professor of Medicine who served on the University of California San Francisco faculty for 45 years. He conducts research on tobacco and cannabis control and cardiovascular disease/

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