Recent marketing denial orders (MDOs) were issued by the Food and Drug Administration for several myblu devices and some of their tobacco-flavored proprietary pods. FDA’s announcement of this decision on Friday affects one the most popular e-cigarette brands. It does not bode well either for those who are switching to vaping, or may be considering doing so. FDA determined that the FDA would not allow the sale of myblu products. It is a reminder of how unclear and inconsistently applied that standard.
It seems that the FDA is determined to ban almost every vaping product 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. While the FDA had been required to respond by September last year, it failed to meet the court-imposed deadline. According to the agency, it claims to have completed the reviews and determined that more than 99 per cent of those products were approved.
The FDA granted marketing orders only for two brands of devices out of all the products: Vuse Solo (approved last October) and Logic. (approved in March). These devices were also approved by the FDA, which rejected all other flavours.
Fontem US manufactures Myblu, which is part of Imperial Tobacco. Fontem US’s applications were denied by FDA because Fontem failed to provide sufficient evidence of design features, manufacturing processes, or stability. The FDA says that “the FDA did not show that switching completely to a healthier lifestyle or drastically reducing their smoking habits would be more beneficial than the risks to young people.”
This last concern seems a bit puzzling. The most recent National Youth Tobacco Survey shows that disposable e-cigarettes have a higher popularity among teens than devices with refillable or prefilled pods. These are, in turn, more popular than tank or mod systems. Puff Bar makes disposable ecigarettes. It was mentioned as the most loved brand by nearly 27 percent. Vuse (10.1%) was second, followed by Juul (6.6%) and Juul 6.8 percent. Suorin is third at 2.1 percent. Myblu seems to have a small share in the market for underage girls.
Vuse Solo, Logic Power and Logic Pro were approved in accordance with FDA’s policy against eliquids in other flavors than tobacco. Although they are popular among adults, it is concerned that these e-liquids are not too appealing to teenagers. They are closed system devices that cannot be filled with other companies’ e-liquids. The FDA approved cartridges and capsules that contain nicotine solutions that taste similar to tobacco. Both of these things are true for the myblu products rejected by the FDA. It is possible that Vuse Solo, Logic Power and Logic Pro are allowed to be marketed, but myblu cannot.
The FDA may have been concerned about myblu being compatible with other e-liquids that provide a greater variety of flavors. Fontem asserts that the device cannot be used with third-party pods. Fontem states “blue rechargeable devices may malfunction and will void warranty.” Although Fontem does not allow this, the process of opening a myblu pod to refill with your favorite e-liquid is quite simple. The FDA may not have been satisfied with the manufacturer’s claims on this score. Myblu could potentially be used for unapproved eliquids.
“The myblu PremarketTobacco Application (PMTA), was rejected by the FDA. This is the first MDO that has been announced for pod-based vape products made by major tobacco companies.” Vaping360Jim McDonald of’s comments. “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. These devices and their refill pods make up the majority of the market for vaping at convenience stores/gas stations. 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 intends to appeal against the FDA’s ban. The company stated that they are dissatisfied with FDA’s decision. They also reject the FDA scientists’ conclusions. “We are confident that our products conform to regulatory requirements. We plan to make administrative appeals to persuade the agency to grant approval. We have seen that FDA has not sought to enforce MDOs in appeals. Accordingly, we believe the FDA will continue to allow the products to be sold during the appeal. Our products are still available to purchase and the FDA does not prohibit us from continuing to sell myblu’s vapor product portfolio.
Fontem does not suggest this, but it is certainly more complex. FDA claims Each “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.” The FDA doesn’t have the funds to pursue all the “unlawful” producers, so the whole industry, except for two, continues to function. However, this would not prevent black-market dealers taking over their places.
In a press statement, the FDA said that tobacco products that have received a negative decision regarding a submission to the premarket, such as those with an MDO, “may not be offered for sales, distributed or market in the US.” The FDA states that such products are not allowed to be brought or delivered in interstate commerce. Products already on the marketplace must be removed.
Agency adds, “FDA’s highest enforcement priority are ENDS product for which there is no application pending. These include, for example MDOs or applications that were not submitted.” Fontem can “expect” that its products “remain in market” during appeals to the FDA’s decision. The FDA, however, is not required to honor that expectation.
Let’s look back at what the FDA is actually applying. FDA successfully misunderstood the Family Smoking Prevention and Tobacco Control Act as giving the FDA the power to regulate ecigarettes. The FDA is required to only issue a marketing or directive when “appropriate for public health” and taking into consideration “the benefits and risks to the entire population, both users and those who are not using the tobacco product.” FDA should consider the “increased or decreased chance that tobacco product users will quit using it” and also “the increase or decrease likelihood that people who don’t use tobacco products will get started using such products.”
This standard is flawed because it does not consider the individual interests of consumers, but rather the FDA’s predictions of the product’s impact on “the whole population.” The collectivist calculation is both inherently hard and uncertain. However, it’s morally objectionable because it allows cigarette smokers to be denied the option of switching to less harmful nicotine sources. Other peopleWill behave.
FDA admits to the danger-reducing potential vaping products. According to some estimates, this could reduce the number of deaths from smoking in America by millions if they are widely used as replacements for cigarettes. It is concerned that teens, although not allowed legally to purchase e-cigarettes will still use them. They can even choose from many flavors. This should be considered a victory for public health if those teens would otherwise smoke. The FDA is refusing to accept the potential benefits of this substitution. It wants to reduce underage vaping regardless of its net effect on the public health. This seems inconsistent with the FDA’s statutory mandate.
The FDA, however, admits it has to take into account the potential reduction in the number of people who smoke and the mortality associated with vaping. It seems to be determined to disregard the fact that vaping is less attractive than smoking, by limiting flavor options. It argues that certain flavours are preferred by teenagers and should not be permitted, even though ex-smokers prefer them.
Legally, the FDA must consider how its decisions will impact mortality and morbidity. The FDA seems to ignore the possibility that restricting flavor will encourage current vapers to smoke again and deter them from switching to other products, leading to more premature deaths. This agency seems so focused on adolescent smoking (a “epidemic”, which is rapidly receding), that they actively undermine public health rather than promoting it.