The Food and Drug Administration plans to force stores to sell flavored e-cigarettes in parts of their facilities that are off-limits to minors, a requirement that would make it impossible for many to sell vaping products.
“We’re putting all manufacturers and retailers on notice: You may be subject to FDA enforcement for selling certain flavored … products without authorization,” FDA Commissioner Scott Gottlieb wrote in a blog post explaining the policy that was unveiled Wednesday.
The latest move will be one of several regulations that Gottlieb will see to completion before he exits the agency in a few weeks. Combating e-cigarette use among teens was one of his top priorities as FDA commissioner, and the latest decision means that some stores will choose to no longer sell flavored e-cigarettes because they cannot meet the building requirements.
FDA officials hope that the move will prevent stores and other sellers from illegally selling e-cigarettes to minors. Under the rule, nicotine “pods” that are used in e-cigarettes would only be allowed to sold on certain websites and vape shops that check to see whether a buyer is 18 or older and that limit how many products a customer can buy. The FDA ordered distributors to take flavored cigars off the market within 30 days. To be sold again, companies will need to have their products undergo review by the FDA.
More than 3.6 million middle and high school students used e-cigarettes at least once during the past month, an increase of 1.5 million from last year, according to government data. Policymakers have particularly cracked down on flavored vaping products because they mimic the taste of deserts and fruits, which can be attractive to children. The new rules won’t apply to mint, tobacco, or menthol flavors, though the FDA would consider limits there if data show that teens become attracted to these options.
Proponents of vaping counter that when adults are looking to quit they are looking for an alternative that tastes nothing like traditional cigarettes. They, as well as conservative groups, have worried that over-regulation will cause people to simply give up vaping and instead return to smoking combustible cigarettes. Traditional cigarette smoking has plummeted in the U.S., even among young people.
Vapers United said in a statement that FDA’s regulations were too vague because they didn’t specify how e-cigarette products should be sold in separate parts of a store.
“Without more explicit language, we are concerned that vapor retailers will not know how to comply with the guidelines, which could lead to an overcorrection that sees vapor products that adult smokers are trying to access to help them quit become harder to obtain,” Liz Mair, strategist for the group, said in an email.
Meanwhile, the American Cancer Action Network said it didn’t think FDA went far enough. It called for a total ban on flavored e-cigarettes.
“The plan unveiled today will not do nearly enough to improve the health of our nation by keeping kids off tobacco products,” the group’s president, Lisa Lacasse, said in a statement.
Gottlieb has been trying to find the balance between restricting young people from using e-cigarettes while also letting e-cigarettes undergo review by the FDA so the agency can sign off on them as less harmful than traditional cigarettes, or as a possible way of helping smokers quit. There is some evidence that the public wants to see a balance, too. According to a study released Wednesday by NORC at the University of Chicago, 55 percent of respondents said they favored restricting the sale of e-cigarettes and 39 percent support outlawing e-cigarettes entirely.
Under the plan laid out Wednesday, e-cigarette companies that were not on the market by 2007 will have until Aug. 8, 2021, to have FDA review their devices. The latest deadline is one year earlier than the deadline FDA had set before.
The FDA’s plan will collect comments for 30 days before it’s finalized. The agency is seeking information on whether it needs to provide more specific examples of how stores should set apart sections in its store. The rule generally means an area of the store, or the whole store, where no one under 18 would be allowed to enter. A walled-off area would qualify, but FDA is seeking input on whether any technologies could also be helpful in keeping minors away from the products.
Several outside public health groups have been concerned that the aggressive stance Gottlieb took against e-cigarettes would fall by the wayside after he leaves the agency.
Amid the speculation, Health and Human Services Secretary Alex Azar released a statement supporting FDA’s plans and saying that his agency “and the entire Trump Administration support a comprehensive, balanced policy approach to close the on-ramp for kids to become addicted to nicotine through e-cigarettes, while allowing for the promise of an off-ramp for adult smokers through access to potentially less harmful forms of nicotine delivery.”
Dr. Ned Sharpless, who directs the National Cancer Institute and supports regulation of tobacco products, is taking over as acting commissioner at FDA in April.
