FDA sends more than 100 warning letters to firms over new synthetic nicotine law

Date:

The FDA said it has issued warnings to two manufacturers for marketing synthetic vaping products without authorization and sent 107 other warning letters to retailers for illegally selling such products to underage buyers in recent days.

Driving the news: The Food and Drug Administration has moved to crack down on vaping companies that use non-tobacco nicotine products since a law designed to close a loophole that companies had exploited to avoid oversight of devices like e-cigarettes took effect in April.

  • The law means synthetic nicotine products must comply with the FDA’s regulations for nicotine, including not selling the products to buyers under 21 and not marketing the products without the agency’s authorization.

What they’re saying: Brian King, director of the FDA’s Center for Tobacco Products, said in a statement the agency would continue to investigate companies that may be marketing, selling, or distributing non-tobacco nicotine products illegally and will pursue action, as appropriate,” in the coming weeks.

The big picture: The FDA has faced pressure from both lawmakers and vaping industry groups over the enforcement of the new law, per health news outlet Stat News.

  • The agency agreed this month to suspend its court case while it conducts a review of Juul’s e-cigarettes, temporarily pausing its order banning the company from marketing and selling its popular electronic cigarettes.
  • The American Vapor Manufacturers group has expressed concern that small vape shops won’t have time to comply with the new requirements.

Zoom in: Sens. Dick Durbin (D-Ill.) and Susan Collins (R-Maine), who helped push for the FDA’s new regulatory authority in Congress, said in a letter to FDA commissioner Robert Califf on Tuesday that recent reporting from Stat News suggested that the FDA “has failed to take enforcement action against e-cigarette manufacturers that are on the market illegally.”

  • The FDA can “rectify these mistakes” as from Wednesday the new law enables the agency to “clear the market of all unauthorized e-cigarettes that use synthetic nicotine,” giving the “FDA the clear authority and duty to remove all unauthorized synthetic nicotine e-cigarettes from the market,” the senators said.
  • They asked the FDA to respond by July 20 to a set of questions concerning regulatory compliance, such as how many synthetic nicotine firms “failed to submit timely applications” under the new law and requesting the agency list how many warning letters it has issued.

Meanwhile, the American Vapor Manufacturers group has filed a petition urging the FDA to allow affected synthetic e-liquid manufacturers required to submit a Premarket Tobacco Product Application by July 13 to stay on the market beyond this deadline.

Read full article here.

Julia Shapero & Rebecca Falconer – Axios – 2022-07-14.

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