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 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, which 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, 2022, (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.
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 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 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, 2022, 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, 2022, while the FDA reviews any applicable PMTAs.