The FDA’s decision to order
The agency is conducting an additional review of Juul’s application and still has to determine the fate of hundreds of other e-cigarette applications—while also carrying out its new authority to regulate synthetic nicotine. Draft product standards to ban menthol in cigarettes and cigars are poised to be finalized soon as the agency also puts together a proposal to set limits on nicotine in cigarettes.
The efforts reflect President Joe Biden’s broader push to improve public health throughout his administration, with initiatives launched across federal health agencies on issues like tobacco use that disproportionately affect minority communities.
“The Biden Administration is taking historic, refocused actions to end our nation’s tobacco epidemic,” Robin Koval, CEO and president of anti-tobacco group Truth Initiative, said in a statement following the FDA’s June marketing denial order.
The agency late Tuesday administratively stayed that order pending further review but didn’t rescind it.
“The FDA must move swiftly to finalize, implement, and enforce its proposed actions to protect youth, help adult smokers, and advance public health equity,” Koval said.
Food and Drug Administration Commissioner Robert M. Califf, a cardiologist who previously led the agency in 2016, announced upon his return in February that limiting new tobacco use, especially among youth, would be one of his top priorities for the agency. He said in June that the denial order was “further progress on the FDA’s commitment to ensuring that all e-cigarette and electronic nicotine delivery system products currently being marketed to consumers meet our public health standards.”
Industry and consumer groups have pushed back on the decision, arguing that Juul and other e-cigarettes can serve as a less harmful alternative for smokers looking to stop using traditional combustible cigarettes.
Public health groups praised the move, but said the agency has more to do in its commitment to lower rates of tobacco use.
The FDA’s order on Juul’s products was “long overdue and most welcomed,” said Erika Sward, the American Lung Association’s assistant vice president of national advocacy. “The FDA really needs to work hard at not only using all of the tools they have in their tool belt to reduce tobacco prevalence, but also to do so in a way that reduces health disparities.”
The FDA announced June 23 that Juul’s applications “lacked sufficient evidence regarding the toxicological profile of the products to demonstrate that marketing of the products would be appropriate for the protection of the public health.”
The agency Tuesday temporarily suspended that denial order, determining that scientific issues unique to its application warrant additional review. The company still can’t legally market or sell its products because it doesn’t have marketing authorization, the FDA said.
Juul had persuaded the US Court of Appeals for the District of Columbia Circuit to temporarily block the FDA’s decision while the court considers whether to implement a longer stay pending appeal. Juul said in June 24 court filings that the FDA’s ban is arbitrary and capricious, and that the agency didn’t consider all relevant evidence before making a decision.
The FDA earlier this year granted orders allowing some products from Juul-competitor NJOY to remain on the market, and authorized products from British American Tobacco’s e-cigarette brand Vuse. The agency recently said in an update that it likely won’t be able to complete its review of the remaining e-cigarette product marketing applications until June 30, 2023—nearly two years after a court-imposed deadline of Sept. 9, 2021.
The FDA finalized a rule in 2016 that extended its regulatory authority to e-cigarettes and gave companies until 2022 to submit premarket applications. After the American Academy of Pediatrics and other groups sued over the deadline, a federal district court moved the date back to 2020—giving the FDA one year after that to finish assessing the applications.
In a May status report filed in the US District Court for the District of Maryland, the FDA said it resolved over 99% of the timely applications it’s received, and that it has 240 left. The FDA said it will be able to complete approximately 52% of these reviews by September of this year.
The new authority, which was part of a government spending package for fiscal 2022, marked a win for health advocacy groups that have long called for the FDA to take action against teen-friendly flavors of vaping products. These groups say that flavored, synthetic nicotine products aren’t likely to meet the FDA’s health standard for authorization.
Attorneys who counsel tobacco and vaping companies say Congress set unrealistic deadlines for manufacturers to submit premarket applications and for the FDA to review them. The law, which took effect April 14, gave companies until May 14 to apply, and all existing products that haven’t won authorization must come off the market by July 13.
The FDA said Tuesday that it’s still reviewing the “large number of applications” it received for non-tobacco-derived nicotine products, but declined to share the total number submitted. Synthetic nicotine products on the market after July 13 “without an FDA marketing granted order” would be considered in violation of federal law and “may be subject to FDA enforcement,” the agency added.
The FDA also plans to issue a draft rule to remove most nicotine from cigarettes, under Biden’s spring 2022 regulatory to-do list.
“Because tobacco-related harms primarily result from addiction to products that repeatedly expose users to toxins, FDA would take this action to reduce addictiveness to certain tobacco products, thus giving addicted users a greater ability to quit,” the administration said in the notice for the proposed rule.
Califf defended the plans in a separate statement, citing a 2018 study by the FDA that a potential nicotine product standard could result in more than 33 million people not becoming regular smokers by 2100, and a smoking rate of only 1.4%. Today, approximately 12.5% of Americans are smokers, according to the CDC.
The forthcoming proposal to limit nicotine levels has already received industry pushback.
Proposed Menthol Ban
The FDA is also moving toward finalizing its proposed bans on menthol in cigarettes and all characterizing flavors, including menthol, in cigars. The agency’s public comment period on the draft product standards ended Tuesday.
The rules, if finalized, would be a boon for public health, with the FDA noting in its proposal that menthol’s “flavor and sensory effects increase appeal and make menthol cigarettes easier to use, particularly among youth and young adults.”
But attorneys who specialize in tobacco control policy say the FDA needs to provide a reasonable amount of time for public input, and share evidence showing the standards wouldn’t unreasonably stretch the agency’s authority.
The FDA and public health groups have also framed the menthol bans as a way to combat tobacco-related health disparities among racial and ethnic minority groups. Nearly 85% of non-Hispanic Black smokers report using menthol cigarettes, compared with just 30% of non-Hispanic White smokers, according to the FDA.
Tim Andrews, Americans for Tax Reform’s director of consumer issues, has said the bans “will inevitably lead to further growth of illicit markets, put members of minority communities in danger, and divert law enforcement resources away from real crime.”
The FDA has said the menthol bans would only apply to tobacco manufacturers, wholesalers, and retailers, and not individual consumers.
Joelle Lester, director of Commercial Tobacco Control Programs at Mitchell Hamline School of Law’s Public Health Law Center, said the FDA should stand firm in the face of industry opposition. She said the agency is acting well within its authority to regulate tobacco products and their ingredients in line with the 2009 Tobacco Control Act.
“It’s really refreshing to have an administration be ready to take on the tobacco industry,” Lester said. “And hopefully it dramatically reduces the toll of illness and death caused by addiction to tobacco products.”