NATO Offers Its Take on FDA Regulation of Synthetic Nicotine Products

WASHINGTON, D.C. — Thomas Briant, executive director of the National Association of Tobacco Outlets (NATO), issued the association’s response to the recently passed federal spending bill that gives the Food and Drug Administration (FDA) the authority to regulate synthetic nicotine. 

The bill, signed by President Joe Biden on March 15, 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 move 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.

In an email to Convenience Store News, Briant provided details about the recently enacted federal law. Specifically, he laid out 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. 

Synthetic nicotine products significantly expanded their presence in the U.S. market over just the past year or two. Products that may incorporate synthetic nicotine include not only electronic vaping products, but also some modern oral nicotine products such as pouches, gum, mints, lozenges, and other nicotine delivery systems.

With the new law going into effect, what happens now? 

According to Briant, the new law empowers the FDA to regulate the entire nicotine category, and will create parity by requiring synthetic nicotine product manufacturers to submit Premarket Tobacco Product Applications (PMTAs) or remove their products from the market. 

Specifically, manufacturers must submit a PMTA for each synthetic nicotine product SKU by May 14, 2022, or take the product off the market by this date. In FDA terms, these illegal products become “misbranded and adulterated” if a PMTA is not submitted, Briant explained.

If a PMTA is filed 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. 

“As a result of this new law, the regulatory status of synthetic nicotine products is now clear, as are the next steps for the product manufacturers and the FDA,” Briant stated. “The focus now turns to U.S. tobacco and nicotine retailers and distributors, who will have a responsibility for ensuring that illicit synthetic nicotine products are not offered for sale to U.S. consumers.” 

This means that retailers and wholesalers need to contact their manufacturers very soon to determine whether they will submit a PMTA to the FDA by the May 14th deadline. 

Retailers and wholesalers place themselves at risk of FDA enforcement actions and penalties if they continue to sell a synthetic nicotine product that does not have a PMTA filed by May 14, or if they continue to sell a synthetic nicotine product that the FDA does not issue a PMTA authorization order for by July 13, according to Briant.

Generally, the FDA does not grant a “sell-through” period if a manufacturer does not file a PMTA by the filing deadline, or if the agency issues a PMTA marketing denial order disapproving the PMTA application. This means retailers and wholesalers would not have additional time to sell tobacco products with synthetic nicotine from their inventories.

NATO, the National Association of Tobacco Outlets, is a national trade association organized to enhance the common business interests of all tobacco retailers and to monitor and assist members in responding to tobacco-related legislation on the local, state and federal levels.