• May 23, 2024

FDA to List PMTA Applicants

 FDA to List PMTA Applicants
Mitch Zeller

The U.S. Food and Drug Administration (FDA) plans to publicly list all e-cigarette manufacturers that want permission to sell their products in the U.S., reports Bloomberg, citing a blog post published on Monday by Mitch Zeller, director of the FDA’s Center for Tobacco Products.

The move could help consumers and retailers spot illegal products.

Vapor product manufacturers who want to keep their products on the U.S. market will have to file requests for marketing authorization with the FDA by Sept. 9.

The FDA has received applications for about 2,000 e-cigarettes and other newly regulated tobacco products already. There are more than 400 million eligible items that would need to apply to stay on the market, according to Zeller.

Products whose applications were filed on time will have a one-year grace period to stay on the market while the FDA reviews them, unless the agency rejects the request. Large manufacturers, retailers who could be liable for selling illegal products and public-health groups had pushed the FDA to make the process more transparent.

In a letter to the FDA, several retail associations had asked the agency to release a list of manufacturers that have PMTAs on file so retailers can know what electronic nicotine delivery system (ENDS) brands can remain on store shelves.