On March 15, President Joe Biden signed a $1.5 trillion omnibus spending bill to fund the federal government through September. The bill, as passed, includes a provision amending the definition of “tobacco product” in section 201(rr) of the Federal Food, Drug, and Cosmetic Act (“FDCA”) as ” any product made or derived from tobacco, or containing nicotine from any source, intended for human consumption. 21 USC 321(rr). Now that it has the force of law, this provision closes the synthetic nicotine “loophole” and brings synthetic nicotine products under the tobacco regulatory authority of the United States Food and Drug Administration (FDA) .
The law will enter into force 30 days after the promulgation of the bill, that is to sayto April 14, 2022 (“Effective date”). Any synthetic nicotine product currently on the US market as of April 14, 2022 may remain on the market for an additional 30 days until May 14, 2022 (the “PMTA Submission Deadline for Synthetic Nicotine”). Manufacturers of synthetic nicotine products who wish to take advantage of the FDA’s compliance policy and discretion after this date must submit a Premarket Tobacco Product Application (PMTA) to the FDA through the execution date. If a PMTA is submitted in a timely manner, the product(s) may remain on the market for an additional 90 days after the effective date, that is to sayuntil July 13, 2022. After July 13, 2022, any synthetic nicotine product not cleared by the FDA must be removed from the market.
|Passage of the bill||March 15, 2022|
|Effective date||April 14, 2022||
Deadline for everything New* synthetic nicotine products to enter the market
Deadline for modified synthetic nicotine products to remain on the market
|PMTA Submission Deadline for Synthetic Nicotine||May 14, 2022 (Saturday)||Deadline for submitting PMTAs for all synthetic nicotine products in the U.S. market as of the effective date|
|Deadline||July 13, 2022 (Wednesday)||Deadline for unauthorized synthetic nicotine products to remain on the US market|
Notably, under the provision, a synthetic version of an existing nicotine product that has gone through the PMTA process and is now subject to a Refuse-to-Accept (RTA), Refuse-to-File (RTF) , Marketing Denial Order (MDO), or withdrawal of a marketing order cannot be marketed beyond the effective date, that is to say, April 14, 2022. In other words, products originally formulated with tobacco-derived nicotine that were denied or denied clearance by the FDA and then modified to use synthetic nicotine instead (and this is the only modification ), will be effectively banned on April 13, 2022. Manufacturers of these products will not have the opportunity to submit a new PMTA. This appears to be Congress’s way of doubling down on products that Congress says switched to synthetic nicotine to circumvent the PMTA process.
Beyond the PMTA submission requirement, manufacturers of synthetic nicotine products will be subject to all Tobacco Product Regulation requirements. This likely includes all other Tobacco Control Act requirements, including tobacco product establishment registration and product listing; list of ingredients ; label compliance; and health document submissions, among others. We anticipate that the FDA will provide guidance on timelines for these requirements in the near future.