Congress Seems Poised To Let the FDA Ban E-Cigarettes Containing Synthetic Nicotine
The Food and Drug Administration (FDA) seems intent on banning nearly all of the nicotine vaping products currently available in the United States, even though it acknowledges their harm-reducing potential as an alternative to combustible cigarettes. But under current law, the FDA’s e-cigarette authority is limited to nicotine derived from tobacco, which means the synthetic nicotine in products made by companies such as Puff Bar is beyond its purview. A fast-tracked spending bill that Congress is expected to pass by Friday includes a provision that would close that escape hatch by redefining “tobacco products” to include products that have nothing to do with tobacco.
“At a time when FDA is under scrutiny from multiple federal courts for unlawful regulatory overreach on nicotine, handing the agency even more powers to prevent Americans from switching to vaping is like handing car keys and a bottle opener to the town drunk,” says Amanda Wheeler, president of the American Vapor Manufacturers Association, in a press release. “This legislation is so absurd that it will extend FDA’s reach to products that have no actual, physical connection to tobacco whatsoever. This bill ought to be called the Cigarette Protection Act, because the indisputable outcome will be countless more Americans pushed away from nicotine vaping and back into combustible smoking.”
Rep. Frank Pallone (D–N.J.), who helped lead the effort to include this redefinition in the omnibus spending package, sees it differently. “This is an enormous win for public health and American consumers,” he says. “I’m grateful to members on both sides of the aisle for working with me to close this loophole.”
What Pallone calls “this loophole” is the language that Congress included in the Family Smoking Prevention and Tobacco Control Act, the 2009 law that allowed the FDA to regulate tobacco products. It defines that category as “any product made
or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product.” While the law said nothing about e-cigarettes, which were barely available in the United States at the time, the FDA later interpreted that definition to include vaping products, which do not contain tobacco but typically contain nicotine derived from it.
The FDA recognizes that reading “tobacco products” to include synthetic nicotine is legally problematic. “The FDA is aware of a number of companies, such as Puff Bar, claiming their products contain only synthetic nicotine not sourced from tobacco, which may raise separate regulatory and legal issues that the agency is considering how best to address,” it says. Here is how the FDA describes those “regulatory and legal issues”:
The definition of “tobacco product” includes any product made or derived from tobacco, including any component, part, or accessory of a tobacco product. E-liquids that do not contain nicotine or other substances made or derived from tobacco may still be components or parts and, therefore, subject to FDA’s tobacco control authorities.
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