The Trump administration issued a new policy Friday that could allow major tobacco and vape companies to begin selling flavored e-cigarettes, delivering a win to top donors after a year of paring back federal tobacco-control efforts. The policy was announced hours after President Trump reportedly signed off on a plan to fire Dr. Marty Makary, the Food and Drug Administration commissioner, who has resisted allowing sales of flavored vapes for months over concerns about their appeal to young people. Mr. Trump later said he was not aware of plans to oust Dr. Makary.
In a policy posted on the F.D.A. website, the agency said it would take steps to remove illicit e-cigarettes from the market and allow sales of those that have already crossed hurdles toward agency approval.
The guidance, issued without public comment or rule making, could allow companies such as Reynolds American, Altria and Juul to stock prime shelf space in gas stations and convenience stores with flavored e-cigarettes.
Thus far, the F.D.A. has authorized those companies to sell only tobacco- or menthol-flavored vapes, enabling illicit products in candy and fruit flavors to gain a majority of the $6 billion e-cigarette market in the United States.
Mitch Zeller, a former F.D.A. tobacco chief under Democratic and Republican administrations, said the plan to stop enforcing rules on e-cigarettes would allow an untold number of products on the market, making an end run around rules the agency had previously defended up to the Supreme Court. The scientific process was meant to approve products shown in studies to help cigarette smokers transition to vapes without attracting a new generation of nicotine users.
“I don’t see how this solves for anything other than a gift to companies that are eligible and allowing illegal products to remain on the market because F.D.A. is going to look the other way,” he said.
A summary of the guidance, which has not yet been released, relies on the F.D.A.’s authority to declare “enforcement discretion,” a stance the agency takes when it plans to set aside its rules. The agency has been slowly working through more than 25 million applications for e-cigarette authorization, but has approved only a few dozen items.
Products that are in advanced stages of review would be allowed to be marketed, according to the new F.D.A. summary.
“Reading between the lines on the guidance, this appears to be definitely something that would benefit the larger companies than the smaller ones,” said Brian King, a former F.D.A. tobacco chief and vice president at the Campaign for Tobacco-Free Kids.
E-cigarettes are viewed by public-health experts as an important tool to help transition the roughly 28 million Americans who smoke cigarettes to a less harmful product. Though some studies suggest that vaping can lead to chronic obstructive pulmonary disease, cigarettes remain the leading cause of preventable death and disease.
The F.D.A. said in the guidance that it would create a list of covered vapes and continue to take action against those with “underage-appealing elements,” or those resembling a video game, jewelry, or a highlighter or pen, popular products for teens disguising e-cigarettes in schools.
“I think there’s clearly an openness to flavors,” said Tony Abboud, executive director of the Vapor Technology Association, which represents foreign and domestic e-cigarette makers, adding: “It’s great to see that the F.D.A. is now focusing on these other features which are truly child appealing, rather than just focusing on flavors.”
Luis Pinto, a spokesman for Reynolds American, said the company would work with the F.D.A. on implementation of the new guidance and applauded the agency’s pledge to step up enforcement of illicit products.
“It is imperative there is a clear and consistent pathway for products to reach the market to address demand from adult consumers and continue progress toward a Smokeless America,” Mr. Pinto said, referring to the company’s effort to convert its Camel and Newport cigarette customers to other products.
The new guidance would also tacitly allow additional nicotine pouches like Zyn to be sold. It could also allow existing pouch makers to offer products with higher nicotine levels, resembling some marketed overseas.
Major tobacco companies, including Reynolds and Altria, have been reliable donors to Mr. Trump’s MAGA Inc. PAC and pet projects, such as the planned ballroom at the White House.
Dr. Makary had resisted the approval of flavored vapes, despite months of requests from the White House, according to three people familiar with the matter. In February, his deputy, Dr. Sara Brenner, issued a memo delaying the approval of mango- and blueberry-flavored vapes, citing concerns about their appeal to young people. Earlier this month, the F.D.A. authorized those vapes by Glas, a small Los Angeles company.
As the Trump administration made widespread cuts to federal staff and services last year, tobacco control was hard hit. Though Congress eventually restored funding, programs such as a successful ad campaign prompting people to call cigarette quit lines have gone dark.
Rates of adolescent vaping have fallen steadily in recent years, but concerns trace back to 2019, when about a quarter of high school seniors reported in a federal survey that they vaped in the last month, many favoring fruit and dessert flavors.
Under pressure from public-health groups, the first Trump administration announced a plan in 2019 to ban nearly all flavored vapes. It ultimately relented, though, issuing a policy that would ban flavors in products like Juul, devices that use detachable cartridges. That left the door open to flavored disposable products, which soon overtook a thriving illicit market in flavors like strawberry ice cream and blue raspberry.
All the while, major tobacco companies have struggled to gain a foothold in the market. They have abided by F.D.A. rules, selling tobacco- and menthol-flavored products that the agency has deemed “appropriate for the protection of public health.”
Christina Jewett covers the Food and Drug Administration, which means keeping a close eye on drugs, medical devices, food safety and tobacco policy.
The post With Commissioner Under Pressure, F.D.A. Opens Door to Flavored Vapes appeared first on New York Times.
