Four menthol vaping products were authorized by the US Food and Drug Administration on Friday, the first non-tobacco-flavored e-cigarette products to get the agency’s sign-off.
The decision drew harsh criticism from pediatricians and anti-tobacco groups, which called it “a blow to public health” and warned of potential for “disastrous consequences” to children.
Friday’s authorizations do “not mean these tobacco products are safe nor are they ‘FDA approved,’” the agency said, but evidence submitted by the company showed that the products could be beneficial to adult smokers to help them make a switch from traditional cigarettes to e-cigarettes. The agency said there was sufficient evidence that the products would be “appropriate for the protection of public health.”
“Based upon our rigorous scientific review, in this instance, the strength of evidence of benefits to adult smokers from completely switching to a less harmful product was sufficient to outweigh the risks to youth,” Dr. Matthew Farrelly, director of the Office of Science in the FDA’s Center for Tobacco Products, said in a news release.
E-cigarettes were created to be a less-harmful alternative to cigarettes and were advertised by tobacco companies as a way to help people quit smoking, with flavored vapes being most popular. Massive advertising campaigns targeted children, helping lead to a vaping epidemic among young people — and eventually an FDA crackdown on flavors. Still, many flavored products remain available for purchase while the agency reviews marketing applications.
An FDA official told the US Senate Judiciary Committee last week that regulation of e-cigarettes was a “top priority.” However, the agency missed a September 2021 deadline to complete its review of e-cigarette makers’ applications to sell their products; a federal court had ruled that the FDA was violating the Tobacco Control Act by allowing e-cigarette products that did not have agency pre-authorization to stay on the market.
The FDA has been making its way through 27 million applications from companies seeking marketing authorization for e-cigarette products. Only 27 have gotten the FDA’s green light, and until now, tobacco was the only flavor to do so.
Anti-tobacco groups and doctors were quick to criticize Friday’s decision as short-sighted and risky, especially for young people.
“Today’s decision is hard to understand in light of the FDA’s own repeated conclusions that flavored e-cigarettes, including menthol-flavored products, appeal to kids and have fueled the youth e-cigarette epidemic. What has changed?” Yolonda C. Richardson, president and CEO of the Campaign for Tobacco-Free Kids, said in an email. “This decision is especially troubling given the FDA’s failure to do its job and clear the market of unauthorized, illegal e-cigarette products. Rather than authorizing the sale of flavored e-cigarettes, the FDA should be stepping up its enforcement efforts against the illegal products that are addicting our kids.”
The American Cancer Society Cancer Action Network said in an email that the FDA decision had “dealt a blow to public health,” even as the Biden White House continues to hold up a long-awaited ban on menthol cigarettes and flavored cigars.
“On the heels of the administration refusing to finalize rules to prohibit menthol in cigarettes and all flavors in cigars, this decision is a missed opportunity for the FDA to do the right thing,” said Lisa Lacasse, president of the American Cancer Society Cancer Action Network. “By authorizing the sale of menthol flavored e-cigarettes, including two disposable menthol e-cigarettes, the agency is continuing to allow Big Tobacco to addict yet another generation of youth to their products. Authorizing the sale of any flavored e-cigarette flies in the face of public health and fails to protect young people from a lifetime of addiction.”
The American Academy of Pediatrics said it is also “profoundly disappointed” by the FDA decision.
“Previous decisions by FDA to allow the marketing of flavored e-cigarettes had disastrous consequences for children that we are still working to overcome,” President Dr. Benjamin Hoffman said. “These products will inevitably end up in the backpacks of middle schoolers. Once that happens, FDA will have an obligation to immediately reverse this deeply unwise decision.”
Erika Sward, assistant vice president of nationwide advocacy for the American Lung Association, said it “opposes any flavored products being on the market. But what is most troubling is the fact that these are so highly addictive with 5% and 6% nicotine. And that is a recipe for more addiction, particularly among kids.”
“Menthol-flavored e-cigarettes are highly attractive to kids. And this is a one-two combination of a flavor plus such high levels of nicotine, and that’s a recipe for disaster,” Sward said.
About 10% of high school-age adolescents and nearly 5% of middle school students use e-cigarettes, according to the US Centers for Disease Control and Prevention. Over the past five years, there has been a 60% decline in the number of middle and high school students using e-cigarettes, according to the FDA. But when they do vape, teens and young adults are much more likely to use flavored e-cigarettes than adults.
According to the to the 2023 National Youth Tobacco Survey, more than 23% of high school e-cigarette users nationwide use menthol-flavored products.
The FDA said it has put “stringent marketing restrictions” on the newly authorized products in an effort to prevent youth access and exposure. The agency also said it will closely monitor how the products are marketed, and if the company fails to comply with regulatory requirements, the agency may suspend or withdraw authorization.
“All tobacco products are harmful and potentially addictive,” the FDA said. “Those who do not use tobacco products shouldn’t start.”
