May 25, 2022

Volume XII, Number 145

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FDA Receives Authorization to Regulate Synthetic Nicotine

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 the enforcement 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, i.e., until July 13, 2022. After July 13, 2022, any synthetic nicotine product not authorized by FDA must come off the market.

EVENT DATE NOTES
Bill Enactment March 15, 2022  
Effective Date April 14, 2022

Deadline for any new* synthetic nicotine products to enter the market

Deadline for modified synthetic nicotine products to remain on the market

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
Final date July 13, 2022 (Wednesday) Deadline for unauthorized synthetic nicotine products to remain on the U.S. market

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.

© 2022 Keller and Heckman LLPNational Law Review, Volume XII, Number 75
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About this Author

Azim Chowdhury, Keller Heckman, ECigarette Research lawyer, FDA Regulatory Compliance Attorney
Partner

Azim Chowdhury joined Keller and Heckman in 2010 and practices in the area of food, drug, and tobacco law. 

Mr. Chowdhury advises domestic and foreign corporations in matters of FDA and international regulatory compliance. In particular, he assists corporations in establishing clearances for food and drug additives in the U.S., Canada, and the European Union, with an emphasis on indirect additives used in food-contact materials.  Mr. Chowdhury has also developed expertise in tobacco and e-vapor product regulation relating to the implementation...

202.434.4230
Associate

Neelam Gill advises clients and supports Keller and Heckman Partners in the areas of food and drug law and tobacco and e-vapor law, counseling both domestic and international corporations on product and regulatory compliance issues involving the U.S. Food and Drug Administration (FDA). 

In her tobacco and e-vapor practice, Neelam advises tobacco, e-cigarette, and e-liquid manufacturers, distributors, retailers, suppliers, and trade associations on FDA, state, and global regulatory compliance issues. In the food and drug arena, she assists...

202-434-4292
Josephine Hsu Associate Keller and Heckman LLP
Associate

Josephine Hsu counsels domestic and foreign clients on regulatory and compliance matters as a member of the firm’s food and drug practice group, with an emphasis on food additives, food contact materials, and cannabidiol (CBD) and related cannabinoids. She assists clients in obtaining regulatory clearances for packaging materials in jurisdictions around the world.
 
Prior to joining Keller and Heckman, Josephine was a Law Clerk to the Senior Judges at the Superior Court of the District of Columbia. She has also served as a Legal Assistant at the International...

202-434-4353
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