FDA's Oversight of Synthetic Nicotine Takes Effect

Manufacturers have 30 days to file premarket tobacco applications.

SILVER SPRING, Md. — The Food and Drug Administration (FDA) has officially added synthetic nicotine under its regulatory umbrella.

The federal appropriations bill, signed by President Joe Biden on March 15, included a section granting the FDA authority to regulate tobacco products that contain nicotine not made or derived from tobacco (e.g., synthetic nicotine). The new rule went into effect on Thursday, April 14.

"As I've said before, this law closes the 'loophole' some tobacco product manufacturers have exploited to bypass FDA's regulatory authority. We'll hold e-cigarette companies using synthetic nicotine to the same public health standards we’ve implemented for other tobacco products," FDA Commissioner Robert Califf tweeted.

With law now in effect, manufacturers, distributors, importers and retailers of tobacco products containing non-tobacco nicotine — nicotine not made or derived from tobacco, such as synthetic nicotine — must ensure compliance with applicable requirements under the Federal Food, Drug, and Cosmetic Act (FD&C Act), according to the agency. The requirements include:

  • Not selling these products to persons under 21 years of age (both in-person and online);
  • Not marketing these products as modified risk tobacco products without FDA's authorization; and,
  • Not distributing free samples of these products. 

The owners and operators of establishments engaged in the manufacture, preparation, compounding or processing of these products must register with the FDA and list all these tobacco products that they manufacture, prepare, compound or process for commercial distribution, the agency added.

Manufacturers of synthetic nicotine products are also now required to submit a premarket tobacco application (PMTA) for those products and obtain FDA authorization to market them. The PMTA deadline for synthetic nicotine products is May 14, 2022.

As Convenience Store News reported, last month's appropriation bill amends the definition of the term "tobacco product" under the Family Smoking Prevention and Tobacco Control Act to define a tobacco product as "any product made or derived from tobacco or containing nicotine from any source, that is intended for human consumption."

The new authority closes a loophole that allowed some vapor companies to remain on the market despite the FDA's focus on removing flavored electronic cigarettes and vapor cartridges in early 2020.

Earlier this month, Thomas Briant, executive director of the National Association of Tobacco Outlets (NATO), detailed what retailers and wholesalers need to do now in order to avoid selling tobacco products that contain synthetic nicotine and are not authorized by the FDA to be sold in the marketplace. 

Notably, if a manufacturer files a PMTA by May 14, but the FDA does not issue an order authorizing the sale of that product by July 13, 2022, then the manufacturer must immediately remove the product from the market unless the FDA states differently.

The law also prohibits companies that previously received a PMTA denial order for an equivalent tobacco-derived nicotine vapor product from keeping their synthetic nicotine version of that product on the market after May 14 while the FDA reviews any applicable PMTA, he told Convenience Store News.