On March 15th, US President Joe Biden signed a comprehensive spending bill worth $1.5 trillion to provide funding for the federal government until September, according to international media reports. The bill includes a provision that modifies the definition of "tobacco products" in section 201(rr) of the Federal Food, Drug and Cosmetic Act ("FDCA") to include "any product made or derived from tobacco or containing nicotine derived from any source, intended for human consumption." This provision, now law, closes a loophole for synthetic nicotine and places synthetic nicotine products under the jurisdiction of the US Food and Drug Administration's (FDA) tobacco regulatory authority.
The law will go into effect 30 days after it is passed, on April 14, 2022 ("effective date"). As of April 14, 2022, any synthetic nicotine product currently on the US market can remain on the market for an additional 30 days, until May 14, 2022 ("synthetic nicotine PMTA submission deadline"). Synthetic nicotine product manufacturers hope to take advantage of the FDA's compliance policies and enforcement discretion after that date and must submit pre-market tobacco product applications (PMTAs) to the FDA prior to the enforcement date. If PMTAs are submitted in a timely manner, products may be allowed to remain on the market for an additional 90 days after the effective date, until July 13, 2022. After July 13, 2022, any synthetic nicotine product not authorized by the FDA must be removed from the market.
It is noteworthy that under this provision, synthetic versions of existing nicotine products that have gone through the PMTA process are now subject to Refusal to Accept (RTA), Refusal to File (RTF), Marketing Denial Orders (MDO), or withdrawal of marketing orders and cannot be sold after the effective date of April 14, 2022. In other words, products originally formulated with tobacco-derived nicotine, which were rejected or not authorized by the FDA, and then modified to use synthetic nicotine instead (the only change made), will be effectively banned as of 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 cracking down on companies trying to circumvent the PMTA process by switching to synthetic nicotine products.
In addition to PMTA submissions, makers of synthetic nicotine products will also be subject to all requirements of tobacco product regulations. This may include all other requirements of the Tobacco Control Act, including tobacco product establishment registration and product listing; ingredient disclosure; labeling compliance; and health document submissions, among others. It is expected that the FDA will provide guidance on the deadlines for these requirements in the near future.
(Source: National Law Review)
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