The FDA Uses Its New Authority To Close Off the Last Remaining Legal Option for Vapers Who Like Flavor Variety
In a move that is likely to undermine public health, the agency warns that products containing synthetic nicotine "will be subject to FDA enforcement."
The Food and Drug Administration (FDA) is moving fast to close off what seems to be the last remaining legal option for vaping companies that want to provide the e-liquid flavors that former smokers overwhelmingly prefer. Exercising regulatory authority that Congress recently gave it, the FDA has set a May 14 deadline for seeking "premarket" approval of vaping products that deliver nicotine derived from sources other than tobacco. Companies that fail to submit applications by then, the agency warns, "will be subject to FDA enforcement."
The Consolidated Appropriations Act of 2022, which President Joe Biden signed into law on March 15, included a provision that expanded the FDA's authority over "tobacco products" to include products that do not contain tobacco or tobacco derivatives. Congress achieved that counterintuitive result by amending the Family Smoking Prevention and Tobacco Control Act, the 2009 law that first authorized the FDA to regulate tobacco.
The FDA says that amendment, which took effect on April 14, "makes clear that FDA can regulate tobacco products containing nicotine from any source." The agency describes the change as a response to manufacturers "who saw a loophole in the current law" and used it to "skirt federal regulation" so they could sell products "packed with nicotine and sold in a myriad of kid-appealing flavors." According to the FDA, that situation was intolerable, because the agency "has made it one of our top priorities to reduce youth use of these products." That gloss is misleading for several reasons.
First, the Tobacco Control Act defined "tobacco product" as "any product made
or derived from tobacco that is intended for human consumption," including "any component, part, or accessory of a tobacco product." Although the law did not mention vaping or e-cigarettes, the FDA successfully argued that products delivering nicotine derived from tobacco were covered by that definition. The amendment did not clarify the definition; it expanded the definition in a way that rendered the term tobacco product a misnomer.
Second, the insinuation that vaping companies were doing something shady by "skirt[ing] federal regulation" is based on the idea that it was clearly illegitimate to frustrate the FDA's goals, regardless of whether those goals were consistent with the agency's statutory authority. Companies that claimed an exemption from FDA regulation based on the legal definition of "tobacco product" were not skirting the law; they were following the law as Congress wrote it.
Third, the Tobacco Control Act described "the use of tobacco products by the Nation's children" as "a pediatric disease" with potentially lethal consequences, since "a consensus exists within the scientific and medical communities that tobacco products are inherently dangerous and cause cancer, heart disease, and other serious adverse health effects." That is not true of vaping products, which are far less hazardous than cigarettes and offer a harm-reducing alternative that promises to drive down tobacco-related morbidity and mortality, as even the FDA concedes.
Fourth, the "kid-appealing flavors" that the FDA sees as a threat to the nation's youth are also highly popular among adults. A 2019 analysis of data from the Population Assessment of Tobacco and Health Study found that three quarters of past-month adult vapers, 93 percent of whom were current or former smokers, preferred flavors other than tobacco. Furthermore, "former smokers who [had] completely switched to an e-cigarette" were especially likely to have "transitioned from a tobacco flavored product to a non-tobacco flavored product."
Given this pattern of preferences, it is reasonable to ask what impact restricting flavors can be expected to have on smokers who have switched to vaping or might be interested in doing so. If limiting flavor variety makes vaping less appealing as an alternative source of nicotine, it could drive some people back to smoking and deter others from switching. The upshot would be more smoking-related deaths than would otherwise occur.
The same analysis applies to teenagers, some of whom smoke or vape even though they are not legally allowed to do so. The fact that the downward trend in adolescent smoking accelerated as vaping became more popular suggests that the latter habit is displacing the former among teenagers, which under any rational analysis ought to count as a public health victory. To the extent that flavor restrictions make vaping less appealing to teenagers (which is precisely what the FDA aims to do), some of them may choose to smoke instead. Assuming they stick with that habit into adulthood, the result will be more, rather than fewer, premature deaths.
The FDA—which so far has approved just three brands of vaping products, all in tobacco flavors—nevertheless seems determined to restrict consumer choice in a way that is likely to undermine public health. The agency discounts the importance of flavor variety to adult vapers, and it refuses even to consider the possibility that many teenagers who vape would otherwise be smoking. When it comes to adolescents, its only priority is discouraging vaping, even if the result is more smoking.
The FDA's bias against flavor variety is inconsistent with the mission it was given under the Tobacco Control Act. That law requires the FDA to determine whether approval of a product is "appropriate for the protection of the public health," taking into account "the risks and benefits to the population as a whole, including users and nonusers of the tobacco product." The FDA is supposed to consider "the increased or decreased likelihood that existing users of tobacco products will stop using such products" as well as "the increased or decreased likelihood that those who do not use tobacco products will start using such products."
One of the companies that took advantage of the "loophole" decried by the FDA is Puff Bar, which makes disposable e-cigarettes in a variety of flavors. In July 2020, the FDA ordered Puff Bar to "remove their flavored disposable e-cigarettes and youth-appealing e-liquid products from the market because they do not have the required premarket authorization." Puff Bar responded by reformulating its products, which now contain synthetic nicotine. Other companies, such as the e-liquid manufacturer Vapor Salon, went the same route. Last August, Vapor Salon explained that "the main purpose of this is to be outside of the FDA's regulations."
The FDA sees those decisions as patently outrageous. But when regulators impose requirements so burdensome and expensive that almost no business can hope to comply with them, based on nebulous standards they apply in unpredictable and seemingly arbitrary ways, it is hardly surprising that manufacturers would look for a way out.
Puff Bar's website still claims the company's products "are not—and never were—banned." But the FDA says every vaping product sold in the United States, except for the brands it has approved (Vuse Solo, two Logic devices, and NJOY Ace), is "marketed unlawfully" and "subject to enforcement action at the FDA's discretion." Even before Congress amended the Tobacco Control Act, Puff Bar's original products were "marketed unlawfully," which is another way of saying they were banned. Now that Congress has authorized the FDA to regulate nicotine that is not derived from tobacco, even the reformulated Puff Bar products fall into that "unlawful" category. I have asked Puff Bar what it plans to do in response to that change, and I will update this post if I get a response.
As the FDA sees it, the entire vaping industry (except for three brands) exists only at its sufferance. The reality, however, is that the FDA does not have the resources to go after all those "unlawful" manufacturers. Even if it did, that would not stop black-market dealers from taking their place, which would hardly be an improvement for consumers or for regulators trying to protect them. The FDA's capricious exercise of its authority is apt to make a mockery of the control it is trying to assert.
