The FDA recently added 28 companies to its list of manufacturers receiving Marketing Denial Orders (MDOs) for flavored vaping products since the last update on September 17. This brings the total to 323 companies, affecting nearly 1.2 million flavored products. Most MDOs target small manufacturers, with some larger firms like Turning Point Brands and AVAIL Vapor also affected. The new FDA standard requires extensive scientific evidence to justify the benefits of flavored products for adults over the risks to youth.

FDA Status on PMTAs and Vaping Product Authorizations

Since the September 9, 2020 deadline for PMTAs, the FDA hasn't authorized any vapor products, except for the Vuse Solo and two tobacco-flavored cartridges on October 12. Decisions on major brands like Juul, Reynolds American, NJOY, Logic, and Blu are still pending. The FDA missed the September 9, 2021 deadline for decisions on large manufacturers' products. All tobacco-derived nicotine products are technically illegal without FDA approval but remain on the market through enforcement discretion. Some small manufacturers are now using synthetic nicotine to potentially bypass FDA regulations.

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.