FDA targets flavored e-cigs kids like
Move is in response to rise in teen vaping
WASHINGTON — With a few weeks left in his tenure as commissioner of the Food and Drug Administration, Dr. Scott Gottlieb moved Wednesday to restrict sales of flavored e-cigarettes to try to reduce the soaring rate of teen vaping.
The agency issued a proposal requiring that stores sequester flavored e-cigarettes to areas off limits to anyone younger than 18. Retailers, including convenience stores and gas stations, will be expected to verify the age of their customers.
“Evidence shows that youth are especially attracted to flavored e-cigarette products,” Gottlieb said in a statement, “and that minors are able to access these products from both brickand-mortar retailers as well as online, despite federal restrictions on sales to anyone under 18.”
The rate of teenage vaping has risen sharply in the past few years, with 3.6 million middle and high school students reporting that they had vaped last year, study by the Centers for Disease Control and Prevention shows.
Teenage smoking, though, continues to be at record lows, alongside the general decline in smoking rates, a pattern that public health experts warn could be reversed if nicotine addiction spurred by vaping leads young people to traditional tobacco products.
Last fall, the FDA began a crackdown on teenage vaping, threatening to ban most flavored e-cigarettes and warning retailers to stop selling the products to minors. It stopped short of prohibiting the flavors.
But the proposal issued Wednesday outlines details for how retailers must wall off the areas where the products can be sold.
For stores open to consumers of all ages, the guidelines call for a physically separated room, a spokesman said, adding that stores can’t simply hang a curtain to create a space for flavored e-cigarettes.
Retailers, including convenience store and gas station owners, are on Capitol Hill this week, lobbying against the FDA’s proposals. Some have threatened to fight the restrictions in court.
Lyle Beckwith, a senior vice president for the National Association of Convenience Stores representing thousands of retailers, said the group didn’t believe the FDA had the authority to impose the new requirements.
“The Tobacco Control Act clearly indicates they cannot discriminate against a specific channel of distribution, which is exactly what they are doing,” he said.
Conservative groups and vaping trade associations also have come out in opposition, saying the agency’s efforts to regulate
the e-cigarette industry amount to government overreach.
The new restrictions don’t apply to menthol, mint or tobacco flavors, which the FDA wants to keep available for adults who are using e-cigarettes to quit smoking combustible cigarettes.
The FDA will also track youth use of menthol and mint e-cigarettes, Gottlieb said. If they become too popular, he added, the FDA will reconsider the exemption.
Such a move would be especially harmful to Juul Labs. The vaping giant, under FDA pressure, already has moved sales of its flavored e-cigarettes online, except for menthol, mint and tobacco, which it sells in stores.
But some public health advocates say the moves are too late.
“While this announcement sounds big and bold, it isn’t really,” said Micah Berman, an associate professor at The Ohio State University College of Public Health and Moritz College of Law. “The FDA’s announcement exempts mint/menthol, which is the most popular flavor with kids and one that makes it easier to initiate use. And in any event, most kids are getting these products online or through older friends, not buying them in convenience stores.”
The proposal also calls for banning the sale of many flavored cigars.
“The data also indicate that eliminating flavors from cigars would likely help prevent cigar initiation by young people,” Gottlieb said.
Under the new rule, cigar companies would have 30 days to remove the products from the market and would have to apply for FDA approval to go back on the shelves.
In addition, all e-cigarettes, cigars and related products not on the market by Feb. 15, 2007, must seek FDA approval to sell them by August 2021. As part of their application, manufacturers must prove that their products are beneficial to public health. The agency’s original deadline for these products to comply with new, tougher regulations was extended by Gottlieb from August 2018 to 2022. Wednesday’s action chops one year off that extension.
The plan issued Wednesday still is a draft, and must undergo a 30-day comment period before it can be finalized. It’s an unusual regulatory approach, neither a new rule, nor a voluntary guideline. Instead, the FDA is telling ecigarette makers that if their products are sold in violation of this request, they can be taken off the market, and forced to apply for agency approval. The FDA can do this under its discretionary enforcement authority.
Gottlieb is scheduled to have stepped down by that time, and Ned Sharpless, director of the National Cancer Institute, was named this week to replace him as acting commissioner.