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, that is intended for human consumption.” 21 U.S.C. 321(rr). Now that it is law, this provision closes the synthetic nicotine “loophole” and puts synthetic nicotine products under the U.S. Food and Drug Administration’s (FDA) tobacco regulatory authority.
The law will become effective 30 days after the bill’s enactment, i.e., on April 14, 2022 (“Effective Date”). Any synthetic nicotine product currently on the U.S. market as of April 14, 2022, can remain on the market for an additional 30 days until May 14, 2022 (the “Synthetic Nicotine PMTA Submission Deadline”). Manufacturers of synthetic nicotine products wishing to take advantage of FDA’s compliance policy and enforcement discretion after that date must submit a premarket tobacco product application (PMTA) to FDA by that date (i.e., May 14, 2022). Since that date is a Saturday, companies that are not planning to use the CTP Portal, but are planning to physically deliver PMTAs to FDA, should do so by 4:00 pm ET on Friday, May 13, 2022 (but note that any non-electronic PMTA submissions require a waiver from FDA). 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, i.e., until July 13, 2022. After July 13, 2022, any synthetic nicotine product not authorized by FDA must come off the market.
|Bill Enactment||March 15, 2022||Bill signed into law by President Biden.|
|Effective Date||April 14, 2022||
Deadline for synthetic nicotine products to enter the market without PMTA authorization. PMTAs for such newly introduced products are due by May 14, 2022.
However, a synthetic nicotine version of a previously marketed tobacco-derived nicotine product whose PMTA was refused or denied may not be marketed beyond this date, and is not permitted to submit a new PMTA.
|Synthetic Nicotine PMTA Submission Deadline||May 14, 2022 (Saturday)||Deadline for submitting PMTAs for all synthetic nicotine products on the U.S. market as of the Effective Date. Since the deadline falls on a Saturday, companies that are not planning to use the CTP Portal, but are planning to physically deliver PMTAs to FDA, should do so by 4:00 pm ET on Friday, May 13, 2022 (but note that any non-electronic PMTA submissions require an advance waiver from FDA).|
|Final date||July 13, 2022 (Wednesday)||
Any synthetic nicotine product whose PMTA has not been authorized by FDA will be in violation of the premarket authorization requirements (Section 910) of the Tobacco Control Act after this date. While FDA maintains enforcement discretion, it will be illegal to continue to market and distribute synthetic nicotine products after this date (there is no sell-through period for existing inventory).
We do not anticipate that any synthetic nicotine PMTAs will be authorized by this date (or even accepted/filed), and expect that all of these PMTAs will be placed at the “back of the line” behind the thousands of PMTAs for tobacco-derived products still pending.
Notably, under the provision, a synthetic version of an existing nicotine product that went 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 may not be marketed beyond the effective date, i.e., April 14, 2022. In other words, products originally formulated with tobacco-derived nicotine that were refused or denied authorization by FDA, then modified to use synthetic nicotine instead (and that is the only modification), will effectively be banned on April 13, 2022. Manufacturers of these products will not be given an opportunity to submit a new PMTA. This appears to be Congress’s way of doubling down on products that, in Congress’ view, switched to synthetic nicotine to get around the PMTA process.
Beyond the PMTA submission requirement, manufacturers of synthetic nicotine products will be subject to all requirements of regulations for tobacco products. This likely includes all other Tobacco Control Act requirements, including tobacco product establishment registration and product listing; ingredient listing; label compliance; and health document submissions, among others. We anticipate that FDA will provide guidance on deadlines for these requirements in the near future.