Congress Seems Poised To Let the FDA Ban E-Cigarettes Containing Synthetic Nicotine
A spending bill provision would redefine "tobacco products" to include products that have nothing to do with tobacco.
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.
However, it's possible that a disposable, closed system device that contains an e-liquid with truly zero nicotine (or synthetic nicotine) would not be regulated by the FDA as a tobacco product, if it is not intended or reasonably be expected to be used in such a fashion. FDA intends to make these determinations on a case-by-case basis, based on a totality of the circumstances.
In the FDA's view, even nicotine-free e-liquids qualify as tobacco products because they are used in systems that can also deliver tobacco-derived nicotine. Any vaping device that can deliver tobacco-derived nicotine (even if it is not actually used for that purpose) and any parts for that device would be covered too. But even that strained logic does not encompass disposable, closed-system devices like Puff Bar's, which the company says contain nicotine "crafted from a patented manufacturing process, not from tobacco."
For smokers who have switched to vaping and like a wide variety of flavors (which is most of them), "this loophole" is a godsend. But as far as Pallone is concerned, it is part of a sinister plot to "hook a new generation of young people into a lifetime of nicotine addiction." According to this way of thinking, nicotine liquids in flavors other than tobacco, no matter how popular they are among adults, are obviously aimed at minors (who are not legally allowed to buy e-cigarettes) and therefore cannot be tolerated.
The FDA seems to take a similar view. The agency has received about 6 million applications for "premarket" approval of vaping products, which it was supposed to act on by last September. It has rejected millions of applications but so far has approved just three products: R.J. Reynolds Vapor Company's Vuse Solo and two tobacco-flavored cartridges used in that device. The FDA is still considering whether menthol-flavored Vuse cartridges should be allowed, and it has repeatedly expressed skepticism that nicotine liquids in other flavors (the ones that adult vapers overwhelmingly prefer) can be "appropriate for the protection of the public health," as the Tobacco Control Act requires.
In the meantime, the FDA says, nearly all vaping products are "marketed unlawfully" and "subject to enforcement action at the FDA's discretion." Vuse Solo is one exception. Products that exclusively deliver synthetic nicotine are another—but not for long, assuming that the spending bill, the full text of which is not yet available, passes in its current form.*
After the FDA ordered Puff Bar to stop selling flavored vaping products in 2020, the company started making them with synthetic nicotine. "People always say, like, 'You guys are trying to sidestep…laws,'" Puff Bar Co-CEO Patrick Beltran told CBS News in December. "And we're not…If there's a law that would order us off the market tomorrow, we would pull our products off the market tomorrow."
Beltran noted that the FDA is perversely making it harder to sell vaping products than it is to sell cigarettes, which are far more dangerous. "Traditional cigarettes on the market right now…are not safe," he said. Why should people "trust the FDA to be stamping approvals for the safety of products," he wondered, when the federal government "knowingly is allowing cigarettes to be on the market," even though they "are killing 480,000 people a year"?
Anti-vaping legislators never seem to seriously consider that question. How can they claim to be promoting "public health" by supporting policies that deter smokers from switching to a much safer habit? Even when it comes to teenagers, politicians like Pallone seem to prefer that they smoke rather than vape, which makes no medical sense. Recent trends suggest that the availability of e-cigarettes has accelerated the downward trend in adolescent smoking.
Rep. Raja Krishnamoorthi (D–Ill.) is reflexively outraged by the fact that Puff Bar offers a variety of flavors. "When I go to their website and I see strawberry banana and raspberry ice and banana ice flavors being sold," he told CBS News, "I know exactly who they're appealing to. It's mainly kids."
Since Krishnamoorthi falsely claims "there's simply no evidence" that e-cigarettes help smokers quit, it is not surprising that he is similarly oblivious to research showing that adults also like the supposedly juvenile flavors that offend him. Their interests count for nothing in the mindless crusade against products that have the potential to reduce smoking-related deaths on a massive scale.
*Update: The text of the 2,741-page omnibus spending bill, dubbed the Consolidated Appropriations Act of 2022, was released on Wednesday. The redefinition of "tobacco products" begins on page 1,861.