Earlier this month, the Food and Drug Administration authorized the first fruit-flavored vapes for sale in the United States, allowing a manufacturer to produce mango- and blueberry-flavored electronic cigarettes after years of insisting that such products posed a special danger to children and teenagers. The terrible decision rightfully earned rebukes from the American Academy of Pediatrics and many public health advocates.
But that’s not nearly as bad as another recent guidance change, which has drawn far less attention.
The new rule effectively gives companies permission to sell unapproved nicotine products, which can include fruit, candy and dessert-flavored e-cigarettes and nicotine pouches. Under the policy, products can stay on the market even without FDA authorization, as long as companies have submitted an application that the agency has agreed to review and the packaging avoids obvious appeals to children (such as cartoon characters).
This is a complete inversion of the way FDA approval is supposed to work, as Mitch Zeller, former director of the FDA’s Center for Tobacco Products, explained to me. Normally, manufacturers must first gather scientific data and submit it to the agency. Only after the FDA determines the potential public health benefits outweigh the risks can the product legally be sold.
“If you don’t get an authorization, you can never sell it,” he said. But now, the FDA is saying that these products can be sold before they are authorized. Some might later fail scientific review, for instance if levels of certain chemicals are too high or if the products contribute to youth addiction more than they help adult smokers quit cigarettes.
“It’s not consistent with how we would regulate almost anything else,” said Yolonda C. Richardson, president and CEO of the Campaign for Tobacco-Free Kids.
Overwhelming evidence shows that fruit-flavored vapes are especially appealing to children. Among the more than 1.6 million middle school and high school students who use e-cigarettes, nearly 90 percent use flavored products, with fruity flavors by far the most popular. Teens consistently cite tasty flavors as one of the primary reasons they start vaping in the first place.
While vaping is preferable to cigarette smoking, nicotine exposure before age 25 can alter brain development and impair attention and memory. It can also worsen anxiety and depression. Young people can become addicted quickly, particularly with today’s high-nicotine products, and studies have found that adolescents who vape are more likely to go on to smoke traditional cigarettes.
Companies that manufacture vaping products, including tobacco giants such as Philip Morris International, Altria and British American Tobacco, say they intend these devices to help cigarette smokers switch to less-harmful alternatives. This is an area of dispute, with many studies showing that e-cigarettes are not effective for smoking cessation, though others suggest they could work better than other nicotine-replacement therapies. People interested in using them for cessation purposes should be aware that vaping is not among the therapies approved by the FDA to help people quit smoking.
Recognizing that some adult smokers may reduce cigarette use in favor of vaping, the FDA has already authorized dozens of e-cigarettes and other nicotine-delivery products, including smokeless tobacco and nicotine pouches, which have also been raising alarms due to their appeal to young people. As Richardson said to me, “I don’t know why we need new ones, and I certainly don’t know why we need new ones that present a risk to kids.”
Zeller estimated that the FDA’s new loophole could allow anywhere from thousands to hundreds of thousands of unauthorized nicotine products onto the market. He argued it is unfair to companies that followed the rules and completed the rigorous approval process to now compete against unauthorized products sitting on the same store shelves. What’s more, consumers will have no way to distinguish between these products.
Asked for comment, a spokesperson for the Department of Health and Human Services responded that the new guidance applies only to products that are “complete and substantive enough” to be undergoing scientific review, and that the FDA continues to “implement an aggressive strategy to stop illegal imports of unlawful tobacco products.”
Indeed, illicit vapes coming from China, which reportedly now make up about 70 percent of the black market, are one of the primary ways children are accessing flavored vapes. But allowing more unauthorized nicotine products to be sold, rather than intensifying enforcement against all illegal vapes, makes little sense.
That brings me to the ultimate hypocrisy: Many supporters of HHS Secretary Robert F. Kennedy Jr. want Americans to overlook his wholesale dismantling of vaccine policy because he is supposedly prioritizing chronic-disease prevention. If that were truly the goal, the administration would be laser-focused on smoking, the leading cause of preventable death in the U.S. The last thing this country needs is a policy that addicts a new generation to nicotine while pretending it is in the name of public health.
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