A federal appeals court has ordered the Food and Drug Administration to review the denial of marketing orders to six small e-cigarette and vaping makers.
The order, filed Tuesday in the 11th Circuit Court of Appeals, involved petitioners Bidi Vapor LLC, Diamond Vapor LLC, Johnny Copper LLC, Pop Vapor LLC, Union Street Brands LLC and Vapor Unlimited LLC.
Appeals judges were asked to consider “whether it was arbitrary and capricious” for the FDA to issue marketing denial orders to companies for their electronic nicotine-delivery systems “without regard to marketing plans and restrictions on access to corporate sales designed to minimize exposure and access for young people.
The judges determined that the FDA “refused to review plans to restrict access to marketing and sales, based on both its need for effectiveness and its experience that restrictions of access to marketing and sales do not sufficiently reduce the use of electronic nicotine products by young people”.
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As a result, judges deemed the marketing denial orders to be arbitrary and capricious, and sent the orders back to the agency.
The FDA could not be reached for comment on the order.
According to the court filing, between September 1 and September 16, 2021, the FDA “issued nearly identical marketing denial orders to each of the tobacco companies for their unflavored tobacco products.”
“The orders stated that the ‘essential basis for the (FDA’s) determination’ was that ‘all (the applications) lacked sufficient evidence demonstrating that the flavored (products) will provide a benefit to adult users that would be sufficient to outweigh the risks.’ for youth.”
The judges wrote that “we acknowledge the evidence in the dissent cataloged record of the grave risk to young people, and the FDA may find on remand that the marketing and sales access restriction plans submitted in the tobacco companies’ claims do not outweigh those risks.”
“We are not making moral judgments – only procedural judgment. Our review of administrative orders is limited, and we are only deciding that the FDA must at least review the relevant evidence available to it, which includes marketing and sales access companies. restriction plans.”
Amanda Wheeler, president of American Vapor Makers, said in a statement that “finally, the FDA is held legally accountable for its irresponsible and deeply misguided war on vaping.”
“The widespread harm that has already been done by the FDA should leave a shameful stain on the agency and individual officials who have disregarded the widely accepted science that vaping nicotine helps people quit smoking. , and that Americans have a fundamental right to make that choice for themselves.”
The FDA has been hesitant for years to allow any e-cigarettes to be marketed, especially those from small producers, but also those from the four major makers RJ Reynolds Vapor Co., Juul Labs Inc., NJoy and Fontem Ventures.
For example, in October, the FDA approved the tobacco-flavored version of Vuse Solo involving its closed electronic nicotine delivery system, power supply and two replacement cartridges.
Reynolds Vapor has acquired the ability to inform smokers of an FDA cleared message that Vuse Solo products “are appropriate for the protection of public health”.
However, the FDA has denied approval for 10 Vuse Solo flavored products, while the menthol flavored version remains under review.
Reynolds said in a statement that the FDA “is required to evaluate vapor product PMTAs against a rigorous, science-based standard.”
“It highlights years of scientific study and research devoted to ensuring that adult nicotine users aged 21 and over have access to innovative and potentially less harmful alternatives to traditional tobacco products.”
Decade of Debates
The FDA has been swept up in a decade of intense debate, highlighted by dozens of scientific studies either touting or refuting the public health role of non-combustible nicotine and tobacco products.
For public health and anti-tobacco advocates, they can accentuate what they see as the positives of the FDA’s decision on Vuse Solo, while worrying that the agency may have gone too far or not far enough. .
For example, Dr. Gerald Harmon, president of the American Medical Association, said the group “is deeply disappointed with the FDA’s action to allow RJ Reynolds’ high nicotine e-cigarette products to be marketed.”
The AMA’s position was “an immediate ban on all e-cigarette and vaping products from the market”.
“With this action, the FDA risks hooking another generation of young people to tobacco products,” Harmon said. “Licensing this product to the market indicates that it is safe, and nothing could be further from the truth.”
The FDA said it “considered the risks and benefits to the general population, including users and non-users of tobacco products, and most importantly, young people. This included reviewing the data available on the likelihood of use of the product by young people.
“Under the Pre-Market Tobacco Application (PMTA) process, manufacturers must demonstrate to the agency that, among other things, marketing the new tobacco product would be appropriate for the protection of public health.”
“These (Vuse) products were found to meet this standard because, among several key considerations, the agency determined that study participants who used only authorized products were exposed to fewer harmful and potentially harmful constituents. aerosols compared to users of burnt cigarettes.”
Gregory Conley, as president of the American Vaping Association, has been urging the FDA for a decade to embrace the potential reduced-risk role of vaping.
“For more than a decade, state and local governments have relied on FDA inaction to resist any recognition of harm reduction as a tobacco reduction strategy,” Conley said.
“Now that the FDA has acted, we hope that adult consumers and health communicators will begin to understand the harm reduction benefits offered by these and other smoke-free products.”