Synthetic Nicotine: Drug or Tobacco Product? Bill H.R. 6286 approval closes the loophole

by: Gurhan Coban – External Opinion Leader

While having the same chemical structure, synthetic nicotine does not come from tobacco (leaf, stem etc…), it is instead developed through patented manufacturing processes in laboratory.
There are several forms of synthetic nicotine, varying from ones that are identical to the tobacco derived one (TDN), formed by a 99% of (S)-nicotine, to others that have a different percentage of (S)-nicotine and (R)- nicotine. In addition, given its production process, producers claim that synthetic nicotine lacks impurities found in the TDN.

Until few weeks ago, there was a huge debate around this products and the lack of regulation for them. In fact, synthetic nicotine products fell outside the Tobacco Products regulation of the FDA that regulates, as per definition, products “made or derived from tobacco.” This loophole brought some producers to switch to synthetic nicotine to avoid the Pre Market Authorization and be free to put their products in commerce, without any control from regulatory authorities.

With the approval of the the bill H.R. 6286, proposed by the Democrat Congresswoman Mikie Sherrill, there has been an amendment to the definition of “tobacco product” in the Federal Food, Drug, and Cosmetic Act as “any product made or derived from tobacco, or containing nicotine from any source, that is intended for human consumption.” Under this definition, synthetic nicotine products, including flavored e-cigarettes, are included under the FDA’s tobacco regulatory authority.
The FDA’s new tool to regulate e-cigarettes is the latest in a series of efforts in recent years to curtail vaping. In January 2020, the FDA announced a ban on refillable cartridge- or pod-based e-cigarettes featuring mint or fruit flavors popular among young people—excluding menthol or tobacco flavors and disposable e-cigarettes of any flavor that cannot be refilled and are designed to be discarded. Under a federal court order, the agency ordered all US manufacturers of e-cigarettes and related products to remove banned flavored products from the market or apply to have the agency review them, a process that is still ongoing.

The agency noted in September 2021 that it had rejected applications from more than 500 companies affecting more than 6 million e-cigarettes, e-liquids, and related products. However, in a statement announcing the action, acting FDA commissioner Janet Woodcock, MD, noted that the agency would miss the September 9 court-ordered deadline in deciding whether to ban products from the largest manufacturers of e-cigarettes, including Juul, Vuse, and NJOY.

Banned Products: July 13th marks the end?

With the new definition, after July 13, 2022, any synthetic nicotine product not authorized by FDA must come off the 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.

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