Congress is on the verge of giving the Food and Drug Administration (FDA) the authority to regulate synthetic nicotine, which would close a loophole some lawmakers and anti-tobacco advocates said allows vaping companies to evade agency oversight and keep selling to teenagers.
A bipartisan provision in long-term government funding legislation agreed to this week would allow the FDA to regulate synthetic nicotine products, which are made in a lab and not from tobacco plants, the same way it regulates tobacco products.
The FDA in recent years has stepped up enforcement of e-cigarette rules, and has removed from the market disposable vape products, refillable pods and flavored liquids. But just as the agency has cracked down, companies such as Puff Bar have exploited the loophole by selling products containing only synthetic nicotine not sourced from tobacco.
According to a government survey, 26 percent of high school students who vaped reported that their usual brand was Puff Bar.
The massive legislation, which is still being debated, provides FDA with authority over tobacco products containing nicotine from any source.
“Dangerous nicotine products shouldn’t be on the market totally unregulated just because of an outdated legal loophole — and now they won’t be,” Sen. Patty Murray (D-Wash.), the Senate Health Committee chairwoman, said in a statement. “This bipartisan legislative fix will help protect our kids from highly addictive products like flavored e-cigarettes containing synthetic nicotine — which have fueled the youth vaping crisis — by ensuring there’s FDA oversight of all synthetic nicotine products.”
Robert Califf, who was approved as FDA commissioner just last month, said he recognized the concern over synthetic nicotine products during his confirmation hearing in December.
“We’ve got to close this loophole so that we make sure that we understand the risks and benefits and particularly deal with the issues in children,” Califf said.
FDA ordered Puff Bar off the market in 2020 because the agency said it lacked the authorization to sell tobacco products. The company then pivoted to synthetic nicotine and re-emerged last year, selling many of the fruity flavors advocates have decried as being aimed at kids, such as Banana Ice, Blue Razz Lemonade and Cheesecake.
Advocates said the provision is needed to stop more companies from making the same moves.
“If left unaddressed, manufacturers of thousands of e-cigarettes — as well as other tobacco products — are likely to switch to synthetic nicotine to evade critical public health protections, including premarket review requirements for new tobacco products, the nationwide tobacco sale age of 21, and health warnings,” said Matt Myers, president of the Campaign for Tobacco-Free Kids.
Rep. Frank Pallone Jr., (D-N.J.), chairman of the House Energy and Commerce Committee, said the provision would be a public health victory over “bad actors” who circumvented the FDA’s authority.
“This is an enormous win for public health and American consumers. I’m grateful to members on both sides of the aisle for working with me to close this loophole in the omnibus. This provision will help ensure that decades of progress to address youth tobacco usage will not be undermined by bad actors attempting to evade FDA regulation and hook a new generation of young people into a lifetime of nicotine addiction,” Pallone said in a statement.
The provision would require manufacturers of synthetic nicotine products to obtain FDA authorization to keep a product on the market, a process that requires demonstrating that the product is appropriate for the protection of public health.
But the vaping industry is pushing back against the measure, arguing it is a gift to traditional cigarette manufacturers.
Industry groups said synthetic nicotine provides a pathway for adult smokers to switch from cigarettes, and banning it will only drive more people to cigarettes.
“It’s already lunatic that FDA is prohibiting adult American smokers from switching to vaping but this legislation is so absurd that it will extend FDA’s reach to products that have no actual, physical connection to tobacco whatsoever,” said Amanda Wheeler, president of the American Vapor Manufacturers Association.