After July 13, 2022 only FDA-authorized synthetic nicotine products may be marketed—none are expected
MELBOURNE, Fla. – With Congress granting the U.S. Food and Drug Administration (FDA) authority over synthetic nicotine earlier this spring, most products, including electronic nicotine delivery systems (ENDS) using nicotine derived from synthetic sources, are no longer in compliance with FDA rules, experts say.
More specifically, after July 13, 2022, only synthetic nicotine products subject to timely submitted Premarket Tobacco Product Applications (PMTAs) that have received a Marketing Granted Order (MGO) from the FDA is permitted to remain on the U.S. market. As of mid-July, the FDA did not issue notice of any such product authorizations.
The development will largely hit retailers who sell e-cigarettes and ENDS that contain nicotine derived from non-tobacco sources and produced through the synthesization of chemicals—essentially “synthetic” nicotine. Prior to synthetic nicotine becoming prevalent, most ENDS products contained nicotine derived from tobacco leaves. While not many of these products are still on the market after the FDA’s marketing denial orders (MDOs), the BIDI® Stick remains, and continues to be the No. 1 selling disposable ENDS in the United States.
- 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 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. After July 13 of this year, all synthetic nicotine products on the market will be in violation of the statute and will be subject to FDA enforcement, unless they have received an MGO. 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.”
Bidi Vapor Can Help
Companies selling flavored vaping products have struggled to remain compliant with the FDA, Patel said. But Bidi Vapor remains one of the few independent vaping companies left on the market. Here are key points about the BIDI® Stick:
- 11 Flavors, with nicotine derived from tobacco.
- Judicial Stay of MDO.
- Bidi Vapor received a court-ordered suspension of the MDO it received from the FDA for its non-tobacco flavored ENDS. The decision suspends the FDA’s MDO and allows the sale of Bidi’s non-tobacco flavored ENDS, subject to FDA’s enforcement discretion, until the resolution of its case challenging the legality of the MDO.
- Top-selling Disposable, according to a 52-week Nielsen survey ending April 23, 2022.
- Inventory Promise. If the BIDI® Stick MDO is reinstated or if the PMTA is ultimately denied, Bidi Vapor will purchase inventory back from all current and potential retailers and wholesalers.
“We hope retailers take a serious look at who their partners are,” Patel said. “You want to partner with companies that comply with regulations and produce high-quality products. That’s the only way the industry will survive and thrive in the future and continue to benefit adult smokers.”