The FDA's Rejection of a Major Vaping Brand Shows It Is Arbitrarily Applying a Nebulous Legal Standard

The agency's obsession with adolescent vaping is driving decisions that undermine public health.

The Food and Drug Administration (FDA) recently issued "marketing denial orders" (MDOs) for the myblu vaping device and several of its tobacco-flavored proprietary pods. The decision, which the FDA announced last Friday, affects one of the leading e-cigarette brands and does not bode well for smokers who have switched to vaping or might be interested in doing so. The FDA concluded that allowing the sale of the myblu products would not be "appropriate for the protection of the public health," which illustrates how nebulous that standard is and how arbitrarily the FDA applies it.

The FDA seems determined to ban nearly every vaping product currently available in the United States. As of September 9, 2020, the deadline for seeking "premarket" approval, it had received some 6 million applications—one for every permutation of devices and e-liquids that manufacturers sought to introduce or keep on the market. Although the FDA was supposed to act on those applications by last September, it missed that court-ordered deadline. The agency now claims to have "completed the review of and made determinations on more than 99 percent" of the products whose manufacturers sought approval.

Out of all those products, the FDA has granted marketing orders for just two device brands: Vuse Solo, which was approved last October, and Logic, which was approved in March. The FDA also approved tobacco-flavored cartridges/capsules for those devices while rejecting applications for other flavors.

Myblu is made by Fontem US, a division of Imperial Tobacco. The FDA says the applications for Fontem's products were rejected partly because the company failed to present "sufficient evidence regarding design features, manufacturing, and stability." But the FDA also says "the applications did not demonstrate that the potential benefit to smokers who switch completely or significantly reduce their cigarette use would outweigh the risk to youth."

The latter concern is puzzling on its face. According to the most recent National Youth Tobacco Survey, disposable e-cigarettes are more popular among teenagers than vaping devices with prefilled or refillable pods, which in turn are more popular than mods or tank systems. The most popular brand by far, mentioned by about 27 percent of respondents, was Puff Bar, which makes disposable e-cigarettes. The second-most popular was Vuse (10.5 percent), followed by SMOK (8.6 percent), Juul (6.8 percent), and Suorin (2.1 percent). Myblu's share of the underage market seems to be tiny.

The approval of Vuse Solo, Logic Power, and Logic Pro was consistent with the FDA's bias against e-liquids in flavors other than tobacco, which it worries are too enticing for teenagers, although they are also highly popular among adults. The Vuse and Logic products are "closed system" devices, meaning they cannot be refilled with e-liquids made by other companies, while the cartridges and capsules that the FDA deemed acceptable contain nicotine solutions that taste like tobacco. Yet both of those things ostensibly are true of the myblu products that the FDA rejected. How can it be that allowing the marketing of Vuse Solo, Logic Power, and Logic Pro is "appropriate for the protection of the public health," while allowing the marketing of myblu is not?

Perhaps the FDA was concerned that myblu could be used with e-liquids made by other companies that offer a wider variety of flavors. Fontem claims the device is not compatible with third-party pods, saying "use of blu rechargeable devices with other brands may cause malfunctions and will void your warranty." But although the manufacturer does not approve, it is pretty easy to open a myblu pod and refill it with an e-liquid of your choice. If the FDA was not satisfied by the company's assurances on that score, it may have concluded that myblu is intolerable because it could be used to vape unapproved e-liquids.

"The rejection of the myblu Premarket Tobacco Application (PMTA) is the first announced MDO issued for a pod-based vape product made by a major tobacco company," Vaping360's Jim McDonald notes. "The denial is significant because the FDA is still reviewing PMTAs submitted by other large companies for pod-based devices—including Juul Labs' JUUL device and pods, British American Tobacco's Vuse Alto, and NJOY's Ace device. Those devices (and their refill pods) make up a majority of the convenience store/gas station segment of the vaping market." McDonald adds that "the myblu denials could indicate that the FDA will reject those other pod-based products too, perhaps because their nicotine delivery is more effective than the older-generation Vuse Solo and the two Logic products that have received marketing authorization."

Fontem plans to appeal the FDA's ban. "We are disappointed with the FDA's decision and disagree with the scientific evaluation and conclusions they reached," the company says. "We believe our products meet the regulatory requirements and plan to use the administrative appeals process to convince the agency that approval should be granted. Based on past practice, we expect the FDA will not seek to enforce the MDOs while this appeal remains ongoing, and we therefore expect the products to remain in the market during this period. All of our products remain available for sale and there is no legal prohibition against continuing to market the myblu vapor portfolio."

That last point is more complicated than Fontem suggests. The FDA says every "electronic nicotine delivery system" (ENDS) and e-liquid for which it has not issued a marketing order—i.e., every product except for Vuse Solo, the Logic devices, and their approved cartridges/capsules—is "marketed unlawfully" and "subject to enforcement action at the FDA's discretion." In other words, the entire industry (except for two brands) continues to operate only because the FDA does not have the resources to go after all those "unlawful" manufacturers (and even if it did, that would not stop black-market dealers from taking their place).

"Tobacco products subject to a negative action regarding a premarket submission, including those subject to an MDO, may not be offered for sale, distributed or marketed in the US," the FDA says in its press release about the rejection of Fontem's applications. "Such products may not be introduced or delivered for introduction into interstate commerce, and if the product is already on the market, the product must be removed from the market."

The agency adds that "FDA's highest enforcement priorities are ENDS products for which no application is pending, including, for example, those with an MDO or those for which no application was submitted." So while Fontem may "expect" that its products will "remain in the market" while it appeals the FDA's decision, the FDA is under no obligation to meet that expectation.

Let's take a step back and consider the legal standard that the FDA supposedly is applying. Under the Family Smoking Prevention and Tobacco Control Act, the 2009 law that the FDA successfully construed as giving it the authority to regulate e-cigarettes as "tobacco products," the agency is supposed to issue a marketing order only when it 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 required 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."

Right away there is an obvious problem with this standard, since it hinges not on the interests of individual consumers but on the FDA's prediction of how a product will affect "the population as a whole." That collectivist calculus is not only inherently difficult and uncertain; it is morally indefensible, since it means that cigarette smokers who could dramatically reduce the health risks they face by switching to a less hazardous source of nicotine can be denied that option based on the FDA's prophecy of how other people will behave.

The FDA concedes the harm-reducing potential of vaping products, which according to some estimates could prevent millions of smoking-related deaths in the United States if widely used as substitutes for cigarettes. But it worries that teenagers, who are not legally allowed to buy e-cigarettes, will nevertheless use them, especially if they can choose from a wide range of flavors. If those teenagers otherwise would be smoking, that should count as a public health victory. But the FDA refuses to consider the benefits of such substitution: It is determined to minimize underage vaping, regardless of the net impact on public health, which hardly seems consistent with its statutory mission.

When it comes to adults, by contrast, the FDA admits that it is obligated to consider the reduction in smoking-related morbidity and mortality that could be achieved by allowing the sale of vaping products. But it seems determined to ignore the cost of making vaping less appealing as an alternative to smoking by arbitrarily limiting flavors. If certain flavors are popular among teenagers, it reasons, they cannot be allowed, even though former smokers overwhelmingly prefer those flavors.

The FDA is legally required to consider the net impact of its decisions on morbidity and mortality. Yet the likelihood that restricting flavors will drive vapers back to smoking and discourage current smokers from switching, resulting in more premature deaths than would otherwise occur, seems to count for nothing in the FDA's analysis. The agency is so obsessed with adolescent vaping (an "epidemic" that seems to be fast receding) that it is actively undermining public health instead of promoting it.