By Yasmeen Abutaleb, Emma Rumney and Chris Prentice
WASHINGTON, May 26 (Reuters) – The U.S. FDA’s new, looser regulation of new vapes and nicotine pouches will potentially unleash hundreds more such products on the market in the coming weeks and months, according to three current and former Trump administration officials.
The Food and Drug Administration said earlier this month it will use ‘enforcement discretion’ to look the other way when manufacturers sell unauthorized vaping products as long as their license applications meet certain standards. It had for years required a pre-marketing authorization for the products, partly to limit youth vape access.
The Trump Administration’s swift policy change – announced days before FDA Commissioner Marty Makary resigned – circumvented months of public comment typical for such sweeping changes, two former FDA tobacco chiefs said, and raised questions about the risk to public health and consumers.
Tobacco executives have aggressively lobbied President Donald Trump for change, including in a meeting earlier this month where they argued that the FDA’s previous policy allowed a vast illegal market of mostly Chinese vapes, according to one of the officials briefed on the meeting.
Around 100 to 200 products could immediately benefit from the new policy, the official said. A source briefed on the FDA’s process said around 1,000 applications are currently at the scientific review stage, indicating they have already presented enough data to be considered for the new policy.
The number of products in position to benefit has not been reported elsewhere.
The FDA change mirrors “a longstanding ask by industry,” said Brian King, who ran the FDA’s Center for Tobacco Products and is now at the Campaign for Tobacco-Free Kids.
The group said the new guidance puts children at risk by allowing the legal sale of more flavored vapes, which can be enticing to them.
Some 1.4 million U.S. teens, or around 5%, acknowledged vaping last year, according to FDA data, down from a peak of over 6 million in 2019.
“Clearly, we want to keep nicotine out of the hands of young people, but for adults who smoke, we need alternatives,” said Vaughan Rees of Harvard University’s School of Public Health, who said he does not receive industry funds.
Health and Human Services spokesman Andrew Nixon said the new guidance strengthens enforcement against the flood of illegal and unauthorized nicotine products and supports a more orderly transition to a regulated marketplace.
“President Trump consistently pledged to expand access to vapes and nicotine pouches in light of an abundance of evidence finding that these products are beneficial for Americans trying to quit smoking,” White House spokesman Kush Desai said in a statement. “The only guiding factor behind the Trump administration’s health policymaking is Gold Standard Science.”
Tobacco companies and market research firm Euromonitor say at least 70% of U.S. vape sales are illegal, with one estimate valuing them at $8 billion in 2024.
TRUMP AND FLAVORED VAPES
Trump’s interest in flavored vapes dates back to his first term, and he still believes vapes are critical to maintaining support among young men, according to three officials. His first FDA commissioner, Scott Gottlieb, proposed banning most flavored cartridge-based e-cigarettes after vape brand Juul turbo-charged youth use.
Trump initially allowed the policy to move forward, but reversed course after Gottlieb left and blasted then-Health Secretary Alex Azar for banning fruit-flavored vapes, fearing it would hurt him in the 2020 presidential election, according to a former official.
Since 2024, tobacco companies and other industry groups have worked to curry favor with Trump via donations to his campaign, inauguration and ballroom, official records show, as well as via influential connections in Washington.
In his second term, the Trump administration has killed a plan to ban menthol cigarettes, launched efforts to fast-track FDA reviews and cracked down on unauthorized Chinese vapes.
In the days before the May meeting, Reynolds American, a unit of British American Tobacco, donated $5 million to Trump-aligned super PAC Maga Inc, campaign finance filings show.
After the meeting with tobacco executives, Trump called Health Secretary Robert F. Kennedy Jr., who directed FDA and HHS staff to make the change, one official said.
Reynolds did not respond to requests for comment on its lobbying.
A WIN FOR TOBACCO COMPANIES
Barclays analyst Pallav Mittal said the shift will catalyse sales for the industry. Barclays expects Philip Morris International to sell up to an additional 12 million of its best-selling Zyn nicotine pouches this year since it will likely launch a new version, he said.
Reynolds may look to launch flavored versions of its vape brand Vuse, analysts said. Reynolds said it was reviewing the change, while Philip Morris did not comment on plans for its not-yet-licensed products.
Tony Abboud, head of the Vapor Technology Association, said it was unclear whether members of the group, which does not represent tobacco companies, would benefit from the shift.
Abboud argues flavored vapes help adult smokers switch, while youth vaping has fallen despite illegal sales. He met with White House officials, and Makary, before the policy decision.
Former FDA tobacco head Mitch Zeller said under the new policy, adult smokers may use untested products that could later be found to contain harmful levels of chemicals or offer limited benefits for quitting.
The political influence on the FDA is “really bad for public health,” he said, “and it’s really bad for the public’s faith in government.”
(Reporting by Emma Rumney in London, Yasmeen Abutaleb in Washington and Chris Prentice in New York; Editing by Caroline Humer and Bill Berkrot)
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