Congress appears ready to let the FDA ban e-cigarettes containing synthetic nicotine

The Food and Drug Administration (FDA) seems determined to ban nearly all nicotine vaping products currently available in the United States, even as it recognizes their harm reduction potential as an alternative to combustible cigarettes. But under current law, the FDA’s authority over e-cigarettes is limited to tobacco-derived nicotine, which means synthetic nicotine in products made by companies like Puff Bar falls outside its jurisdiction. . A fast-track spending bill Congress is expected to pass by Friday includes a provision that would close that escape route by redefining “tobacco products” to include products that have nothing to do with tobacco.

“At a time when the FDA is under scrutiny in multiple federal courts for illegal over-regulation of nicotine, giving the agency even more powers to stop Americans from switching to vaping is like handing car keys and a bottle opener to the drunk town,” Amanda Wheeler, president of the American Vapor Manufacturers Association, said in a press release. “This legislation is so absurd that it will extend the FDA’s reach to products that have no real physical connection to tobacco. This bill should be called the Cigarette Protection Act, because the indisputable result will be countless other Americans moved away from vaping nicotine and back to combustible smoking.”

Representative Frank Pallone (D – NJ), who helped lead efforts to include this redefinition in the omnibus spending package, sees it differently. “This is a huge win for public health and American consumers,” he said. “I am 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 Congress included in the Family Smoking Prevention and Tobacco Control Act, the 2009 law that allowed the FDA to regulate tobacco products. It defines this category as “any product manufactured
or derivative of tobacco intended for human consumption, including any component, part or accessory of a tobacco product.” While the law is silent on electronic cigarettes, which were barely available in the United States at the At the time, the FDA interpreted this definition to include vaping products, which do not contain tobacco but generally contain nicotine derived from it.

The FDA acknowledges that reading “tobacco products” to include synthetic nicotine is legally problematic. “The FDA is aware that a number of companies, such as Puff Bar, claim that their products contain only synthetic nicotine not derived from tobacco, which may raise distinct regulatory and legal issues that the FDA agency plans to resolve as best as possible,” he said. Here’s how the FDA describes these “regulatory and legal issues”:

The definition of “tobacco product” includes any product manufactured 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 tobacco control authorities.

However, a closed-system disposable device containing e-liquid with truly zero nicotine (or synthetic nicotine) may not be regulated by the FDA as a tobacco product, if it is not intended or reasonably likely to be used. in such a way. The FDA intends to make these decisions on a case-by-case basis, based on all of the circumstances.

According to the FDA, even nicotine-free e-liquids are considered 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 not actually used for that purpose) and all parts of that device would also be covered. But even that strained logic doesn’t encompass closed-system disposable devices like those at Puff Bar, which the company says contain nicotine “made from a patented manufacturing process, not from tobacco.” .

For smokers who have transitioned to vaping and love a wide variety of flavors (most of them), “this loophole” is a godsend. But as far as Pallone is concerned, it’s part of a sinister plot to “hook a new generation of young people to a life of nicotine addiction”. By this logic, non-tobacco flavored nicotine liquids, popular as they are with adults, are obviously aimed at minors (who are not legally allowed to purchase e-cigarettes) and therefore cannot be tolerated.

The FDA seems to take a similar view. The agency has received about 6 million “pre-market” approval applications for vaping products, which it was supposed to act on last September. It has rejected millions of claims, but so far it has only approved three products: the RJ 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 (those that adult vapers overwhelmingly prefer) may be ” appropriate for the protection of public health”, as required by the Tobacco Control Act.

In the meantime, according to the FDA, nearly all vaping products are “illegally marketed” and “subject to enforcement action at the discretion of the FDA.” Vuse Solo is an exception. Products that exclusively deliver synthetic nicotine are another, but not for long, assuming 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 began manufacturing them with synthetic nicotine. “People always say, like, ‘You’re trying to get around…the laws,’” Puff Bar co-CEO Patrick Beltran told CBS News in December. “And we are not… If there was a law ordering us to leave the market tomorrow, we would withdraw our products from the market tomorrow.”

Beltran noted that the FDA perversely makes it harder to sell vaping products than it does 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 approve products for safety,” he wondered, when the federal government “knowingly allows cigarettes to be marketed” even though they “kill 480,000 people per year”?

Anti-vaping lawmakers never seem to seriously consider this issue. How can they claim to promote “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 them to smoke rather than vape, which doesn’t make medical sense. Recent trends suggest that the availability of e-cigarettes has accelerated the downward trend in teenage smoking.

Representative Raja Krishnamoorthi (D–Ill.) is reflexively outraged that Puff Bar offers a variety of flavors. “When I go to their website and see strawberry banana and raspberry ice cream and banana ice cream flavors being sold,” he told CBS News, “I know exactly who they’re selling to. address. They are mainly children.”

Since Krishnamoorthi falsely claims “there’s simply no evidence” that e-cigarettes help smokers quit, it’s no surprise that he’s also oblivious to research showing that adults like e-cigarettes too. supposedly juvenile flavors that offend him. Their interests count for nothing in the blind crusade against products that have the potential to massively reduce smoking-related deaths.

About Margaret Shaw

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