The FDA’s rejection of a major vaping brand shows that they are haphazardly applying a nebulous legal standard
The Food and Drug Administration (FDA) recently issued Marketing Denial Orders (MDOs) for the myblu vaping device and several of its proprietary tobacco-flavored capsules. The decision made by 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 may be interested. The FDA concluded that approving the sale of the myblu products was not “appropriate to protect public health,” showing how nebulous this standard is and how haphazard the FDA applies it.
The FDA seems determined to ban almost every vaping product currently available in the United States. As of September 9, 2020, the deadline for applying for “premarket” approval, around 6 million applications had been received – one for each permutation of devices and e-liquids that manufacturers wanted to launch or keep on the market. Although the FDA was supposed to process these applications by last September, it missed that court-ordered deadline. The agency now claims to have “completed the verification of more than 99 percent and made determinations on more than 99 percent” of the products whose manufacturers applied for approval.
Of all of these products, the FDA has issued marketing warrants for only two brands of devices: Vuse Solo, that was authorized last October and logicwhat was authorized March. The FDA also approved tobacco-flavored cartridges/capsules for these devices, while denying applications for other flavors.
Myblu is manufactured by Fontem US, a division of Imperial Tobacco. The FDA says The applications for Fontem products were rejected in part because the company had not provided “sufficient evidence of design features, manufacture and stability”. But the FDA also says, “The submissions have not demonstrated that the potential benefit for smokers who completely switch or significantly reduce their cigarette consumption would outweigh the risk for adolescents.”
The latter concern is puzzling at first glance. According to the latest National Youth Tobacco Survey, disposable e-cigarettes are more popular among teenagers than vaping devices with pre-filled or refillable pods, which in turn are more popular than mods or tank systems. That most popular brand by far, cited by about 27 percent of respondents, was Puff Bar, a manufacturer of 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 appears to be small.
The approval of Vuse Solo, Logic Power, and Logic Pro was consistent with the FDA’s bias against non-tobacco flavored e-liquids, which it fears may be too tempting for teens, although they are very popular among adults. The Vuse and Logic products are “closed system” devices, meaning they can’t be refilled with e-liquid from other companies, while the cartridges and pods that the FDA deems acceptable contain nicotine solutions that are similar to tobacco taste good. But both are said to apply to the myblu products that were rejected by the FDA. How is it that allowing the marketing of Vuse Solo, Logic Power, and Logic Pro is “appropriate to protect 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. font Expectations The device is not compatible with third-party pods and says “Using other brand Blu rechargeable devices may cause it to malfunction and will void your warranty.” But although the manufacturer does not agree, it is so quite easy to open a myblu pod and fill it with an e-liquid of your choice. If the FDA wasn’t happy with the company’s assurances in this regard, they may have concluded that myblu is intolerable given that it could be used to vaporize unapproved e-liquids.
“The myblu Premarket Tobacco Application (PMTA) rejection is the first announced MDO issued for a pod-based vape product manufactured by a major tobacco company,” Vaping360is Jim McDonald Remarks. “The rejection is significant as the FDA is still reviewing PMTAs submitted by other major companies for pod-based devices — including the JUUL device and pods from Juul Labs, British American Tobacco’s Vuse Alto, and the Ace- device from NJOY. These devices (and their refill pods) make up a large part of the convenience store/forecourt segment of the vaping market.” McDonald adds that “myblu’s denials may indicate that the FDA is rejecting these other pod-based products as well perhaps because their nicotine delivery is more effective than the older generation Vuse Solo and the two Logic products that have received marketing approval.”
Fontem plans to appeal the FDA’s ban. “We are disappointed with the FDA’s decision and disagree with the scientific assessment and the conclusions they have reached,” the company said says. “We believe our products meet regulatory requirements and plan to use the administrative appeals process to persuade the agency that approval should be granted. Based on past practice, we anticipate that the FDA will not attempt to enforce the MDOs while this appeal is pending and therefore anticipate that the products will remain on the market during this period. All of our products remain available for sale and there is no legal prohibition on further marketing the myblu vapor portfolio.”
This last point is more complicated than Fontem suggests. That’s what the FDA says everyone “Electronic Nicotine Delivery System” (ENDS) and e-liquid for which it has not obtained a marketing mandate – meaning any product other than Vuse Solo, the Logic devices and their approved cartridges/capsules – will be “unlawfully marketed” and “subject to enforcement action at the discretion of the FDA.” In other words, the entire industry (with the exception of two brands) continues to function because the FDA does not have the resources to prosecute all of these “unlawful” manufacturers (and even if it did, it would this does not prevent the black market traders from taking their place).
“Tobacco products that are subject to an adverse action on a premarket filing, including those subject to an MDO, may not be offered for sale, distributed, or marketed in the United States,” the FDA said says in its press release on the rejection of Fontem’s applications. “Such products shall not be imported or supplied for introduction into interstate commerce, and if the product is already on the market, the product shall be withdrawn from the market.”
The agency adds that “FDA’s highest enforcement priority are ENDS products for which no application is pending, including, for example, those with an MDO or those for which no application has been filed.” So while Fontem can “expect” that its products “keep on the market” while it is appealing the FDA’s decision, the FDA is under no obligation to meet that expectation.
Let’s take a step back and look at the legal standard that the FDA claims to be using. Under the Smoking Prevention and Tobacco Control in the Family Act, the 2009 law that successfully interpreted the FDA as giving it the power to regulate e-cigarettes as “tobacco products,” requiring the agency to issue a marketing order only if “appropriate to protect public health.” is consideration of “the risks and benefits to the population as a whole, including users and non-users of the tobacco product”. The FDA must consider “an increased or decreased likelihood that existing users of tobacco products will stop using such products,” as well as “an increased or decreased likelihood that those who do not use tobacco products will start using such products.”
There’s an immediately obvious problem with this standard, as it’s not about the interests of individual consumers, but about FDA’s prediction of how a product will affect “the population at large.” Not only is this collectivist calculus inherently difficult and uncertain; It is morally unacceptable as it means that cigarette smokers, who could drastically reduce their health risks by switching to a less dangerous source of nicotine, can be denied that option based on the FDA’s prophecy other people will behave.
The FDA acknowledges the harm-reducing potential of vaping products, which some estimates suggest may well be the case impede Millions of smoking-related deaths in the United States when widely used as a substitute for cigarettes. But she worries that teenagers who can’t legally buy e-cigarettes will still use them, especially if they have a wide range of flavors to choose from. If these teenagers otherwise smoked, it should be considered 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 public health impact, which seems hardly compatible with its statutory mandate.
In contrast, for adults, the FDA acknowledges that it has an obligation 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 attractive as an alternative to smoking by arbitrarily restricting flavors. If certain flavors are popular with teenagers, they cannot be allowed, even if they are ex-smokers predominantly prefer these flavors.
The FDA is required by law to consider the net impact of its decisions on morbidity and mortality. But the likelihood that flavor restriction will drive vapers back to smoking and discourage current smokers from switching, leading to more premature deaths than would otherwise be the case, doesn’t seem to count for anything in the FDA’s analysis. The agency is so obsessed with teenage vaping (an “epidemic” that seems to be receding fast) that it’s actively undermining public health rather than promoting it.