As the FDA has not approved any vaping products, all are now “subject to enforcement action” – Reason.com
When a court-set deadline for the “pre-market” review of nicotine vaping products arrived and passed on Thursday, the Food and Drug Administration (FDA) had received millions of requests but no ‘had not approved any. As a result, according to the agency, every vaping product sold in the United States, including a myriad of e-liquids, devices and parts, is “illegally marketed” and “subject to enforcement action at at the discretion of the FDA “.
Seven years after the FDA officially declared its intention to regulate e-cigarettes as “tobacco products,” in other words, the entire industry remains in a legal vacuum, existing only through discretion. enforcement agency and its limited resources. The FDA is ridiculously arguing that it is bringing “regulatory certainty” to a market it says has great potential to reduce smoking-related illness and death. In reality, the agency, despite its promises of regulatory flexibility, is perpetuating a situation where companies that have tried to comply with the rules are unsure whether they will still be in business next week, next month, or next year.
As of September 9, 2020, the deadline set by U.S. District Judge Paul Grimm in response to a lawsuit filed by anti-vaping groups, the FDA had received 6.5 million applications from more than 500 manufacturers of “new tobacco products.” The vast majority of vaping liquids or devices. This was a far cry from the 25 annual requests originally expected by the FDA – a projection that suggested nearly all vaping companies would be deterred by the effort and expense required to comply with the agency’s intimidating regulations. Grimm gave the agency an extra year to act on these requests.
While the FDA boasts of having acted on “about 93% of the total claims submitted on time,” this figure is very misleading. Three-quarters of those actions involved 4.5 million claims from a single manufacturer, JD Nova, which the FDA deemed incomplete in August because they did not include an “adequate environmental assessment” for each of the products, many of which did not. ‘had never been sold. . In addition to seeking approval for hypothetical products, the company has submitted a separate application for each flavor, strength, and size of its existing e-liquids, as required by the FDA.
As Filtered‘s Alex Norcia noted at the time, the environmental assessment required by the FDA is “an expensive and complicated section that covers the environmental impact of a product from point of manufacture to disposal.” Because JD Nova did not meet this requirement to the satisfaction of the FDA, its claims were never officially filed. But later in the month, the FDA issued its first “refusal to market” (MDO) orders, rejecting 55,000 applications for “flavored” vaping products from three companies because they “lacked sufficient evidence that they offered adult smokers a sufficient advantage to defeat the public. threat to health posed by the alarming and well-documented levels of use of these products by young people. “
The FDA noted that the rejected products included “flavors such as Apple Crumble, Dr. Cola, and Cinnamon Toast Cereal.” Acting FDA Commissioner Janet Woodcock said that “flavored tobacco products are very appealing to young people”, so “assessing the impact of potential or actual use by young people is a critical factor in our decision. decision on which products can be marketed “.
For tobacco harm reduction advocates, this reasoning is alarming because it suggests a bias against e-liquids in flavors other than tobacco, which are extremely popular among smokers who switch to vaping. It also implies that the FDA’s requirements to overcome this bias may be impossible to meet, especially for small businesses that could not afford to spend hundreds of thousands or millions of dollars on new research.
âBased on the existing scientific evidence and the agency’s experience with pre-market reviews,â the FDA said, âthe evidence of benefits to adult smokers for such products would likely be under the form a randomized controlled trial or longitudinal cohort study, although the agency does not rule out the possibility that other types of evidence might be adequate if they were sufficiently robust and reliable. Since this evidence was absent in these applications, the FDA issues MDOs. “
Less than a week later, the FDA rejected three companies’ claims for around 800 other flavored products. He said he “would continue to review other tobacco pre-market applications for non-tobacco flavored PURPOSES. [electronic nicotine delivery systems] to determine whether there is sufficient product-specific scientific evidence of a benefit to adult smokers to overcome the risk posed to youth.
The FDA has yet to respond to requests from major manufacturers such as Juul, which in 2018 preemptively halted the sale of most of its flavors in response to the agency’s concerns over underage vaping. “I don’t understand how the FDA could not make a decision on Juul products,” Michelle Eakin, chair of the American Thoracic Society’s tobacco action committee, said in a press release. âJuul holds the largest share of the e-cigarette market and its products have been a major driver of the skyrocketing increase in e-cigarette use among young people. The FDA has delayed enough. What the agency is addressing to Juul, Puffbar and other companies that are driving the youth e-cigarette market, it isn’t doing its job. “
Critics like Eakin believe the FDA should ban all non-tobacco flavored vaping products, despite former smokers overwhelmingly preferring them because they appeal to teens as well. Under the Family Smoking Prevention and Tobacco Control Act, the 2009 law that the FDA used to assert its authority over e-cigarettes (although lawmakers did not consider this product category when they drafted the law. ), the agency is supposed to take into account the impact of a product. on âthe population as a whole,â which includes underage vaping. But this collectivist calculation also includes reductions in smoking facilitated by vaping products. If the ban on flavored options makes these products less attractive to current and former smokers, this policy could perversely lead to more tobacco-related deaths than would otherwise happen.
âThere is strong evidence that non-tobacco flavored e-cigarettes help adults quit smoking,â notes Michelle Minton, senior member of the Competitive Enterprise Institute. âIt appears that their availability in flavors other than tobacco is, in fact, one of the main reasons that e-cigarettes are at least twice as effective in quitting smoking than other nicotine replacement therapies. “
Because of the standard set by the Tobacco Control Act, it is not enough for a manufacturer to demonstrate that their products are much safer than combustible cigarettes. It is also not enough to plausibly project that more vaping means less smoking (in teens as well as adults) and therefore less premature death. A manufacturer must also persuade the FDA that the “public health” benefit of allowing their product to remain on the market outweighs the potential cost of vaping by adolescents who otherwise would never have used nicotine. .
In general, this shouldn’t be difficult, since the health risks of nicotine itself are minimal compared to the risks of smoking, the vast majority of teens who vape frequently are current or former smokers, and there is There is little evidence that vaping products are a âgatewayâ to teen smoking. On the contrary, recent trends suggest that the availability of these products has accelerated the downward trend in teenage smoking, and there is reason to believe that banning flavored e-liquids would have the opposite effect.
But if every manufacturer is to present “product-specific”, “robust and reliable” evidence that the benefits of each variation they sell will outweigh the costs, this is a recipe for weeding out all but the largest companies. and the richest. Even a manufacturer that presents a “randomized controlled trial” or a “longitudinal cohort study” indicating that flavored vaping products play an important role in reducing smoking faces speculation about “the impact of potential consumption. or real youth â.
Since 2015, Minton notes, the FDA “has approved new tobacco products from three companies, including flavored tobacco.” These products included “eight varieties of Swedish Match North America snus, the heated tobacco product, IQOS, manufactured by Philip Morris, and fuel-reduced nicotine cigarettes manufactured by 22nd Century Group.” In these cases, “the FDA was happy to accept more general evidence on the attractiveness of the product category to adults and youth, as well as their general risks to public health.” But when it comes to flavored vaping products, the FDA seems to be more demanding.
âAmerica’s tobacco and nicotine regulatory system is beyond repair,â says Gregory Conley, president of the American Vaping Association, which supports vaping as a harm-reducing alternative to smoking. “It is absolutely absurd that the same agency that found the time to ban over six million vaping products made by small companies is now saying it needs more time to review products with market share Worse yet, after spending more than five years peddling false hope to companies across America, the FDA can no longer even bother to grant formal extensions to the remaining pending applicants. brings even more uncertainty when the FDA previously committed to providing answers to the public.
Norcia reports that some manufacturers, having concluded that it is impossible to meet the FDA, are turning to synthetic nicotine, which is not derived from tobacco and therefore is arguably not subject to the agency’s jurisdiction. under the Tobacco Control Act. Assuming the legal strategy is successful, there could be many vaping products that are not even theoretically subject to FDA regulation. And if the FDA refuses to approve flavored products, vapers who prefer them will still find plenty of black market alternatives, which will also not be affected by the standards prescribed by the government. Given the recent experience with lung damage from black market THC vapers, this is a situation a public health agency should strive to avoid.