Must-pass spending bill will let FDA regulate synthetic nicotine, which electronic cigarette makers adopted to avoid regulation

The Puff Bar e-cigarette (Photo by Marshall Ritzel, AP)

The spending bill Congress is passing to keep the federal government going until the fall will let the Food and Drug Administration regulate synthetic nicotine, “which is used in e-cigarettes popular with young people,” reports Laurie McGinley of The Washington Post.

“The FDA already has authority over nicotine extracted from tobacco plants. The new legislation would provide the agency with explicit jurisdiction over nicotine made in labs. In the last few years, as the agency has cracked down on e-cigarette makers to curb youth use, some companies, including the popular Puff Bar brand, have switched to synthetic nicotine to avoid regulation.”
The FDA gave Puff Bar a big boost in 2020, when it temporarily banned “sweet and fruity e-cigarettes featuring refillable cartridges,” McGinley notes. “The restrictions did not apply to Puff Bar’s products because they are not refillable,” so “young people flocked to the brand.” It was the most popular among high- and middle-school students in a 2021 survey by the FDA and the Centers for Disease Control and Prevention.
The FDA ordered Puff Bars off the market in July 2020, “saying they did not have the needed authorization,” McGinley reports. “Last year, Puff Bar reemerged, using a new synthetic nicotine formula that put it beyond the reach of the FDA tobacco regulators. Some other vaping companies took similar steps and still others are considering it, including ones whose marketing applications for tobacco-derived products were rejected by the FDA.”

Matthew L. Myers, president of the Campaign for Tobacco-Free Kids, told McGinley, “There has never been a more blatant attempt to circumvent regulation. Some companies announced they were using synthetic nicotine for exactly that purpose.”

Amanda Wheeler, president of American Vapor Manufacturers, which represents companies that make electronic cigarettes and e-liquids, told McGinley, “Like nearly the whole of our industry, we believe synthetic nicotine is a positive innovation that enhances consumer choice and provides a crucial pathway for cigarette smokers to switch to vaping.”

The bill passed the House Wednesday and the Senate is expected to pass it soon. “I’ll be encouraging my colleagues to support this bill,” Senate Republican Leader Mitch McConnell said in a press release. “This compromise is not the bill that Republicans would have written on our own. But I am proud of the major concessions we have extracted from this all-Democrat government.”
Sixty days after the bill becomes law, the manufacturers would have to apply for FDA authorization, and “Any product not authorized by the agency within 120 days of enactment would become illegal,” McGinley reports. “Industry officials said they doubted that the synthetic-nicotine companies would apply to the FDA for permission to sell their products, given that some acknowledged they were striving to avoid FDA regulation. And they questioned whether the firms would have the scientific data necessary to meet the FDA’s standard for granting marketing clearance — that the product be ‘appropriate for the protection of public health’.”

McGinley notes, “For more than a year, the FDA has been going through the time-consuming task of deciding which vaping products can remain on the market. (Products introduced before August 2016 were given until September 2020 to apply for FDA authorization.) The agency has ordered a halt in sales for a multitude of products but has not acted on the applications of some big players, including Juul. And some of the companies that have been denied marketing authorization are suing the agency.”

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