Anti-tobacco advocates denounce FDA's approval of menthol e-cigarettes, asserting it disregards public health concerns.
The agency's decision encountering strident criticism from medical professionals and anti-smoking groups, who characterized it as a "detriment to public health" and predicted "dangerous repercussions" for children.
The items, produced by NJOY, a subsidiary of Altria, consist of disposable e-cigarettes and single-use pods compatible with the company's reusable vaping device. The nicotine content of the products ranges from 2.4% to 6%. The company declined to comment on CNN's request for a statement.
On Friday, the agency granted authorizations for these tobacco products, which "do not classify these tobacco products as safe nor do they hold FDA approval." However, evidence provided by the company suggested that the products could aid adult smokers in transitioning from traditional cigarettes to e-cigarettes. The agency concluded that there was sufficient evidence to establish that the products were "suitable for the preservation of public health."
Dr. Matthew Farrelly, director of the Office of Science in the FDA's Center for Tobacco Products, stated in a press release that the decision was reached based on the "thorough scientific review," and that the benefits to adult smokers from swapping to a less harmful product outweighed the risks for youth.
E-cigarettes were designed as a less harmful substitute for cigarettes and were promoted by tobacco companies as a means to help people quit smoking, with flavored vapes being the most sought-after option. Excessive marketing campaigns targeted children, contributing to a vaping craze among teenagers—subsequently triggering an FDA crackdown on flavors. Nevertheless, several flavored products continue to be available for sale while the agency examines marketing applications.
Following the FDA's recent statement, officials declared that the regulation of e-cigarettes was high priority. However, the agency failed to meet its September 2021 deadline to complete its review of e-cigarette manufacturers' applications to sell their products, overriding a federal court ruling that the FDA was contravening the Tobacco Control Act by allowing e-cigarette products without agency pre-authorization to remain on the market.
Since, the FDA has been scrutinizing approximately 27 million applications submitted by companies vying for marketing authorization for e-cigarette products. To date, only 27 have obtained the FDA's permission, with menthol being the only flavor approved until now.
Anti-smoking advocates and medical professionals were prompt in condemning the decision as imprudent and risky, especially for the young.
"The decision today is incomprehensible given the FDA's constant findings that flavored e-cigarettes, including menthol-flavored products, entice children and stoked the youth e-cigarette epidemic. What has altered?" Yolonda C. Richardson, president and CEO of the Campaign for Tobacco-Free Kids, stated in an email. "This decision is particularly unfortunate given the FDA's failure to execute its duties and clear the market of illegal, unauthorized e-cigarette products. Rather than authorizing the sale of flavored e-cigarettes, the FDA should be increasing its supervision efforts against the unlawful products that are hooking our youth."
The American Cancer Society Cancer Action Network stated in an email that the FDA's decision had "dealt a setback to public health," even as the Biden White House continues to hold off on the implementation of 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 act in accordance with the right course," 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 allowing Big Tobacco to hook another generation of youth to their products. Authorizing the sale of any flavored e-cigarettes defies public health, and fails to protect young people from a lifetime of addiction."
The American Academy of Pediatrics expressed disappointment with the FDA's decision.
"Previous decisions by FDA to permit marketing of flavored e-cigarettes resulted in calamitous consequences for children we are still endeavoring to mitigate," President Dr. Benjamin Hoffman stated. "These products will inevitably find their way into the backpacks of middle-schoolers. Once that occurs, FDA will have a responsibility to swiftly reverse this rash decision."
Erika Sward, assistant vice president of nationwide advocacy for the American Lung Association, stated that the organization opposes any flavored products being sold in the market. However, what is most troubling is the fact that these are exceedingly addictive with 5% and 6% nicotine. And this is a formula for increased addiction, particularly among children."
"Menthol-flavored e-cigarettes are especially alluring to children. And this is an alarming combination of a flavor, coupled with such high levels of nicotine—this is a formula for catastrophe," Sward stated.
Join CNN Health's email list
Join our email list to receive The Results Are In with Dr. Sanjay Gupta every Tuesday from the CNN Health team.
According to the US Centers for Disease Control and Prevention, about 10% of high school-aged adolescents and nearly 5% of middle school students use e-cigarettes. Over the previous five years, there has been a 60% decrease in the number of middle and high school students using e-cigarettes, according to the FDA. However, when they do vape, teens and young adults are significantly more likely to use flavored e-cigarettes than adults.
According to the 2023 National Youth Tobacco Survey, more than 23% of high school e-cigarette users nationwide use menthol-flavored products.
Federal authorities have imposed tough marketing limitations on freshly authorized goods to minimize underage usage and contact. The regulatory body has also vowed to meticulously scrutinize marketing practices, and if the company disregards regulatory stipulations, the authority could revoke or withhold authorization.
In a firm stance, the FDA cautioned that all tobacco products are hazardous and may lead to addiction. They strongly advised non-users to refrain from initiating tobacco product use.
