FDA bans most e-cigarette flavors
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HHS Secretary Alex Azar announced that companies that do not stop manufacturing, distributing and selling unauthorized flavored cartridge-based e-cigarettes — except for tobacco and menthol flavors — could face FDA enforcement action.
Azar also warned that manufacturers selling other electronic nicotine delivery systems (ENDS) products without taking sufficient measures to prevent minors’ access face risk for FDA action.
“We’ve developed a smart, targeted policy that protects our kids,” Azar said during a teleconference call with reporters. “The policy also keeps options available for adults to transition away from combustible cigarettes and ensures swift review of applications for products to return to the market in a form that protects public health.”
FDA commissioner Stephen Hahn, MD, said the new regulations are not empty threats.
“While we expect that responsible members of industry will comply with premarket requirements, we are ready to take action against any unauthorized e-cigarette products as outlined in our priorities,” he said. “The agency will closely be monitoring the use rates of all types of e-cigarette products, including tobacco and menthol flavored e-cigarettes among youth. The FDA will aggressively take additional steps if necessary.”
Today’s announcement comes 4 months after the Trump administration announced — but never finalized — a policy that would remove flavored e-cigarette products from the market. Under that earlier proposed policy, e-cigarette manufacturers would have to apply for and secure FDA approval before the e-cigarettes could go back on the market.
Though reports claimed Trump refused to finalize a policy that would negatively impact American jobs and his re-election chances, Azar said the delay was due to a need for more data as well as a balanced approach that encompasses all e-cigarette users.
Though Azar and Hahn said that e-cigarettes can aid in smoking cessation, other data suggest their use is harmful. Last week, the CDC announced that there were at least 55 deaths and 2,505 lung injuries in the United States, Washington, D.C., Puerto Rico and the U.S. Virgin Islands, that could be linked to e-cigarette use. Previously published studies also link e-cigarette use to multiple negative health conditions, including myocardial infarction, depression and sleep disturbances.
To further justify the FDA’s enforcement policy, Azar and Hahn cited data from the 2019 National Youth Tobacco Survey, which were recently published in JAMA. Among the survey’s findings: an estimated 27.5% of high schoolers reported current e-cigarette use, up from 20.8% the year before. Other data show that among 2019 Monitoring the Future survey respondents, the most popular e-cigarette flavor among eighth graders participating in the survey was mango, but among 10th and 12th graders, it was mint.
The stepped-up enforcement efforts announced today will begin by mid-February, 30 days after these announcements are published in the Federal Register, HHS stated in a press release. In addition, after May 12, the FDA intends to prioritize action against manufacturers that sell ENDS products that have not been submitted for premarket review.
Experts weigh in
Michael Siegel, MD, MPH, professor at Boston University School of Public Health, told Healio Primary Care that today’s announcement misses the mark on curbing the growing number of underage smokers using e-cigarettes.
“The FDA needs to stop focusing on the flavorings and for once, focus on the nicotine, which is the problem,” he said. “The epidemic we have is not one of youth flavor use, but of youth addiction to the Juul device, and that is occurring not because Juul is flavored but because Juul has more than 50 mg/mL of nicotine salts, compared to less than 25 mg/mL in most other products on the market.”
The FDA has to follow through on the efforts announced today and stay on top of e-cigarette use trends to curb growing e-cigarette use among teens, added Cristine Delnevo, PhD, MPH, director of the Rutgers Center for Tobacco Studies.
“The extent to which FDA's enforcement action aimed at flavored pod-based e-cigarettes will help curb or reverse the increased in e-cigarette use among young people is dependent on the strength and swiftness of FDA's action,” she told Healio Primary Care. “It will be important to monitor whether young people will simply switch to tobacco and/or menthol flavored pods. A notable percentage of young people who [use e-cigarettes] are addicted — most of them will likely simply switch. Whether or not e-cigarette-naive youth will initiate with nonflavored pod-based e-cigarettes warrants careful attention.”
Andrew Hyland, PhD, chair of health behavior at Roswell Park Comprehensive Cancer Center in Buffalo, New York, called the FDA’s action a “step in the right direction,” but also said more steps are needed curb e-cigarette use among youth. "Efforts to address tobacco use at the national level are rare and hold great potential to save lives. If this policy development is an early piece to more comprehensive efforts, that potential will be realized,” he told Healio Primary Care.
In an interview, Harold J. Farber, MD, MSPH, associate professor of pediatrics within the pulmonary section of Baylor College of Medicine, added “unfortunately the loopholes in the proposed regulations are so big that one could drive a truck through them. The flavor ban only applies to cartridge-based e-cigarette products. It does not apply to refillable or tank-based systems, so plenty of products with youth-appealing flavors will stay on the market. A comprehensive flavor ban of all characterizing flavors is needed — and justified by the evidence.”
Siegel agreed with the part of today’s announcement that allows e-cigarettes to continue to be available to adults who are trying to quit smoking.
“If the FDA had actually decided to ban all the flavored products, it would have been devastating to the public’s health because it would have resulted in hundreds of thousands of ex-smokers returning to smoking,” he said. “Because the proposal only affects closed systems, it allows adult ex-smokers who rely on vaping flavored e-juices to continue to buy these products at vape shops. That’s a huge public health win.” – by Janel Miller
Disclosures : Azar is HHS Secretary. Healio was unable to determine Delnevo, Hyland and Siegel’s relevant financial disclosures prior to this story’s posting.