Before legislation enacted by Congress on March 15, 2022 expanded FDA’s authority, the Agency’s Center for Tobacco Products had authority over products such as ENDS containing nicotine derived from tobacco, and required manufacturers to submit a premarket tobacco product application (PMTA) by September 2020 in order to stay on the market. Instead of submitting PMTAs—or following the denial of their applications—many manufacturers decided to switch from tobacco-derived nicotine to synthetic nicotine, taking advantage of what many describe as a “loophole” in the FDA’s attempts to regulate ENDS.

Now that the FDA has authority over synthetic nicotine, manufacturers of those products had only until May 14, 2022 to submit formal PMTAs. If they failed, then their products would need to come off the market or face FDA enforcement. But even for companies that did submit timely applications, the outcome wasn’t much better, as their synthetic nicotine products would remain marketable only for an additional 60 days until July 13, 2022. Come July 14 of this year, all synthetic nicotine products on the market will be in violation of the statute, regardless of PMTA status, and will be subject to FDA enforcement. Retailers who keep these products on their store shelves could also face enforcement and penalties for selling “adulterated” tobacco products. The only exception will be for synthetic nicotine products that receive a marketing authorization by July 13—a virtual impossibility.

With PMTAs being difficult to develop, many industry observers expect most products with synthetic nicotine—including the bulk of flavored ENDS currently on the market—will fall out of FDA compliance.

“C-store retailers should pay close attention to what products are permitted for sale and are compliant with the requirements of the FDA, the Prevent All Cigarette Trafficking or PACT Act and numerous state and local licensing and tax laws,” said Niraj Patel, president and CEO of Bidi Vapor, LLC, Melbourne, Fla. “We anticipate that as the FDA begins enforcement against illegally marketed and synthetic-nicotine vaping products, there may be an increased demand for the few remaining ENDS products made with tobacco-derived nicotine that are not currently subject to marketing denial orders, such as the BIDI^® Stick.”