Updates
Oct. 26, 2022 The FDA today issued its first MDOs for menthol-flavored vaping products—specifically, menthol refill cartridges for two Logic devices that had been authorized for sale previously with tobacco-flavored refills.
Nov. 1, 2021 We have noted MDOs rescinded by the FDA.
September 23, 2021
The FDA announced today that 28 additional companies have been added to its list of manufacturers that have received marketing denials since its last update on Sept. 17. All the products receiving Marketing Denial Orders (MDOs) were flavored vaping products.
The total number of companies receiving MDOs for flavored product Premarket Tobacco Applications (PMTAs) is now 323. (An alphabetical list can be found at the end of this article.) The FDA says the denials cover nearly 1.2 million flavored products.
All of the new listings are small manufacturers. Since the FDA began issuing MDOs on Aug. 26, the vast majority have gone to small companies, with just a few issued to larger open-system manufacturers like Turning Point Brands and AVAIL Vapor. One publicly traded company that makes closed-system prefilled devices, Bidi Vapor, has also received MDOs for flavored products.
With the first MDO’s issued in August, the FDA also announced a new standard that requires PMTAs for flavored products other than tobacco and menthol to show “sufficient product-specific scientific evidence to demonstrate enough of a benefit to adult smokers that would overcome the risk posed to youth.” All of the marketing denials issued so far have been based on that previously unwritten standard.
Since the Sept. 9, 2020 submission deadline for PMTAs, the FDA has issued no marketing authorizations for any vapor products. [EDITOR'S NOTE: On Oct. 12, the FDA issued marketing authorizations for the Vuse Solo and two tobacco-flavored cartridges.] The agency has also not made decisions on mass-market products from Juul Labs, Reynolds American, NJOY, Logic, or Blu, which FDA Center for Tobacco Products Director Mitch Zeller said would be prioritized in the review process because of their popularity.
The FDA was expected to announce some decisions on the large manufacturers’ products by Sept. 9, 2021—the deadline for unauthorized products to be removed from the market. All vaping products made with tobacco-derived nicotine are now technically illegal to sell, and only exist on the market through FDA enforcement discretion. That includes tobacco- and menthol-flavored vaping products and flavored products like nicotine pouches.
Some small manufacturers have begun reformulating their products with synthetic nicotine, which could skirt current FDA tobacco product authority. It isn’t known if the agency will attempt to regulate synthetic nicotine as a drug.
List of FDA Marketing Denial Orders (MDOs)
Although the FDA says it has issued 323 MDOs, the agency's published list contains just 260 names. The FDA says manufacturers that were issued denials for products not currently being marketed are not named.
We are updating the list by adding companies that receive MDOs after the first round—for example, Fontem US and Juul Labs. We are also adding notes explaining MDOs that have been rescinded or vacated by court rulings.