During his nomination hearing before the U.S. Senate Health, Education, Labor and Pensions Committee on Dec. 14, 2021, Robert Califf stated that he would work to close the so-called “synthetic nicotine loophole” if he was appointed to be the next U.S. Food and Drug Administration (FDA) commissioner.
The day after the hearing, a bill was introduced in Congress that would extend the FDA’s regulatory authority over tobacco products that contain synthetic nicotine. Then, on successive days in early March, both the U.S. House and U.S. Senate passed the Consolidated Appropriations Act that contained unambiguous language amending the Family Smoking Prevention and Tobacco Control Act’s definition of a “tobacco product” to mean “any product made or derived from tobacco or containing nicotine from any source, that is intended for human consumption.”
With President Biden signing the legislation on March 15 (with an effective date of April 14, 2022), tobacco products with synthetic nicotine will now be under the FDA’s regulatory control.
Synthetic nicotine products significantly expanded their presence in the U.S. market in just the past year or two. Those products that may incorporate synthetic nicotine include not only electronic vaping products, but could also include some modern oral nicotine products such as pouches, gum, mints, lozenges and other nicotine delivery systems.
What Happens Now?
With the new law going into effect, what happens now? In general, the new law empowers the FDA to regulate the entire nicotine category and will create parity by requiring synthetic nicotine product manufacturers to submit 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 products off the market by this date. In FDA terms, these illegal products become “misbranded and adulterated” if a PMTA is not submitted.
Moreover, if a PMTA is filed by May 14, and the FDA does not issue an order authorizing the sale of the synthetic nicotine product by July 13, 2022, then, unless the FDA states differently, the manufacturer must immediately remove the product from the market. 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 the product on the market after May 14, while 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. 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 14, deadline. Retailers and wholesalers place themselves at risk of FDA enforcement actions and penalties if they continue to sell a synthetic nicotine product which does not have a PMTA filed by May 14 or sell a synthetic nicotine product if the FDA does not issue a PMTA authorization order by July 13.
Generally, the FDA does not grant a “sell-through” period if a manufacturer does not file a PMTA by a filing deadline or if the agency issues a PMTA marketing denial order disapproving the PMTA application. This means that retailers and wholesalers would not have additional time to sell tobacco products with synthetic nicotine from their inventories: (1) after May 14, 2022, if a PMTA is not submitted to the FDA, or (2) after July 13, 2022, if the FDA does not issue a PMTA marketing authorization order for the product that contains synthetic nicotine.
Thomas Briant is the executive director for the National Association of Tobacco Outlets (NATO). NATO’s mission is to enhance the business interests of retailers that sell tobacco products, support the legislative and regulatory interests of members, and encourage the expansion of the retail tobacco segment in a responsible manner.
