The Food and Drug Administration would get new authority over synthetic nicotine — which is used in e-cigarettes popular with young people — under a massive government spending bill expected to win congressional approval in coming days.
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.
In 2020, sales of Puff Bar’s flavored disposable e-cigarettes boomed after the FDA temporarily barred sweet and fruity e-cigarettes featuring refillable cartridges. The restrictions did not apply to Puff Bar’s products because they are not refillable. Anti-tobacco advocates decried what they called the “Puff Bar loophole” as young people flocked to the brand. In July 2020, the FDA ordered the company’s products off the market, saying they did not have the needed authorization. Under the agency’s regulations, tobacco products introduced after August 2016 are required to get clearance from the FDA before going on sale.
But 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.
“There has never been a more blatant attempt to circumvent regulation,” said Matthew L. Myers, president of the Campaign for Tobacco-Free Kids. “Some companies announced they were using synthetic nicotine for exactly that purpose.”
Health groups say nicotine, which is highly addictive whether it comes from nature or is made in the lab, gets young people hooked on vaping and can lead to cigarette smoking. Pro-vaping groups argue that e-cigarettes can help adults stop the dangerous habit of smoking.
A 2021 survey by the FDA and the Centers for Disease Control and Prevention showed that Puff Bar — disposable vapes that come in an array of flavors such as Banana Ice and Blue Razz — was the most popular choice among high school and middle school students who identified themselves as current e-cigarette users, with 26.8 percent saying Puff Bar was their “usual brand.” Juul, which is restricted in what vapes it can sell, was in fourth place, at 6.8 percent.
The survey also showed that teen vaping plunged last year, the second big decline in a row.
Under the legislation under consideration, makers of synthetic nicotine products would be required to file an application seeking authorization from the FDA within 60 days of enactment of the law. Any product not authorized by the agency within 120 days of enactment would become illegal.
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.”
House Energy and Commerce Committee Chairman Frank Pallone Jr. (D-N.J.) said in a statement that “some bad actors have attempted to avoid FDA regulation by pivoting to using synthetic nicotine in their products. That ends with passage of this bill, which will close this loophole and clarify FDA’s authority to regulate all tobacco products, including those containing synthetic nicotine.”
Closing the “ ‘Puff Bar loophole’ will hopefully end the whack-a-mole” that has bedeviled the FDA’s effort to regulate e-cigarettes, said Erika Sward, assistant vice president of national advocacy for the American Lung Association.
Vaping advocates sharply criticized the congressional move.
“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,” said Amanda Wheeler, president of the American Vapor Manufacturers, which is based in Prescott, Ariz., and represents companies that make vaping devices and e-liquids.
Gregory Conley, president of the American Vaping Association, a nonprofit advocacy group, said the change would hurt efforts by thousands of small vape shops that offer synthetic nicotine e-liquids to serve their customers. The result, he said, would be an increase in smoking.
Puff Bar did not respond immediately to an email request for comment. The company’s website, in addition to touting its products, warns that “this product contains tobacco-free nicotine. Nicotine is an addictive chemical.”
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.
In recent months, the House Subcommittee on Economic and Consumer Policy and the attorney general of North Carolina launched investigations involving Puff Bar and other companies using synthetic nicotine, saying the firms were undermining FDA efforts to end youth vaping.
Rachel Roubein contributed to this report.