The US Food and Drug Administration granted approval on Friday to four menthol vaping products, marking the first time it has authorized e-cigarette products with flavors other than tobacco.
This decision has sparked strong criticism from pediatricians and anti-tobacco organizations, who argue that it undermines public health efforts and poses serious risks, especially to children.
The newly authorized products, manufactured by NJOY, a subsidiary of Altria, include disposable e-cigarettes and prefilled pods designed for use with the company’s reusable vaping device. These products contain nicotine levels ranging from 2.4% to 6%. CNN’s request for comment from the company went unanswered.
The US Food and Drug Administration emphasized that its recent authorizations of tobacco products, issued on Friday, do not equate to an endorsement of safety or FDA approval. The decision was based on evidence submitted by the manufacturer, indicating potential benefits for adult smokers seeking to switch from traditional cigarettes to e-cigarettes. The agency concluded that these products, despite concerns, could contribute positively to public health.
Dr. Matthew Farrelly, director of the FDA’s Center for Tobacco Products’ Office of Science, underscored in a press release that their scientific evaluation demonstrated enough evidence of harm reduction for adult smokers switching to less harmful alternatives.
Originally marketed by tobacco companies as a less harmful option than cigarettes and promoted for smoking cessation, e-cigarettes gained popularity with flavored varieties, which attracted young users. This led to a surge in youth vaping, prompting FDA scrutiny and restrictions on flavored products. Despite ongoing regulatory efforts, flavored e-cigarettes are still available as the agency reviews marketing applications.
Addressing the US Senate Judiciary Committee recently, an FDA official affirmed that regulating e-cigarettes remains a top priority. However, the agency faced challenges after a federal court ruling in 2021 compelled it to expedite the review process for e-cigarette makers’ applications, highlighting the need for stricter oversight under the Tobacco Control Act.
The FDA has been processing a massive backlog of 27 million applications from companies seeking approval to market e-cigarette products. So far, only 27 of these applications have been approved by the FDA, and until now, only tobacco-flavored products had received clearance.
Criticism swiftly followed Friday’s decision from anti-tobacco groups and medical professionals, who argued that it was shortsighted and posed significant risks, particularly for young people.
Yolonda C. Richardson, president and CEO of the Campaign for Tobacco-Free Kids, expressed bewilderment at the decision, questioning why the FDA would authorize flavored e-cigarettes despite acknowledging their appeal to youth and their role in the youth vaping epidemic. Richardson emphasized that the FDA should prioritize removing unauthorized and illegal e-cigarette products rather than permitting the sale of flavored options that could addict young people.
In response to the FDA’s move, the American Cancer Society Cancer Action Network conveyed disappointment, describing it as detrimental to public health. This criticism comes amid ongoing delays in implementing a planned ban on menthol cigarettes and flavored cigars, which the Biden administration has yet to finalize.
Lisa Lacasse, president of the American Cancer Society Cancer Action Network, criticized the FDA’s decision, noting that it follows the administration’s delay in finalizing rules to ban menthol in cigarettes and all flavors in cigars. She described the authorization of menthol-flavored e-cigarettes, including disposable options, as a missed opportunity for the FDA to prioritize public health. Lacasse argued that by allowing these products, the agency continues to enable Big Tobacco to addict another generation of youth, contrary to safeguarding public health and preventing lifelong addiction.
The American Academy of Pediatrics also expressed profound disappointment with the FDA’s move. Dr. Benjamin Hoffman, the president, emphasized the detrimental impact previous decisions allowing flavored e-cigarettes had on children and warned of the inevitable accessibility of these products to middle schoolers. He stressed that the FDA must swiftly reverse what he termed a deeply unwise decision once these products find their way into youth’s hands.
Erika Sward, assistant vice president of nationwide advocacy for the American Lung Association, underscored the organization’s opposition to any flavored e-cigarette products on the market. She highlighted the significant concern over the high nicotine levels of 5% and 6% in these newly authorized products, predicting increased addiction rates, especially among young people. Sward emphasized that menthol-flavored e-cigarettes, paired with such potent nicotine concentrations, present a dangerous combination that could lead to widespread harm.
According to the US Centers for Disease Control and Prevention, approximately 10% of high school students and nearly 5% of middle school students currently use e-cigarettes. The FDA reports a significant 60% decline in e-cigarette use among middle and high school students over the past five years. However, when teens and young adults do vape, they overwhelmingly prefer flavored e-cigarettes compared to adults.
The 2023 National Youth Tobacco Survey reveals that more than 23% of high school e-cigarette users across the country opt for menthol-flavored products.
To mitigate youth access and exposure, the FDA has implemented rigorous marketing restrictions on the newly authorized products. The agency emphasized its commitment to closely monitoring how these products are marketed. If the manufacturer fails to adhere to regulatory standards, the FDA reserves the right to suspend or withdraw its authorization.
The FDA reiterated its stance that all tobacco products pose harm and carry addiction risks. The agency strongly advises against initiating tobacco product use for those who do not currently use these products.