The U.S. Food and Drug Administration’s recent changes to vaping regulations have stirred complications. Senior officials at the FDA’s tobacco center were caught off guard by a new decision that could allow more unauthorized electronic cigarettes and nicotine pouches onto the U.S. market. These guidelines were released shortly before the resignation of former FDA Commissioner Marty Makary. They permit companies to introduce certain nicotine-based products before a complete review by regulators.
According to anonymous agency staff, some FDA officials assigned to enforce vaping regulations were not informed about these changes until the night before the document was published. The unexpected release has led to confusion internally regarding policy development and authorization. Meetings have been conducted to address the implementation of the six-page memo, which deviates from the FDA’s long-standing requirement for scientific verification of health benefits before introducing new products.
“It begs the question of whether the true subject matter experts may have actually opposed this policy and were ordered to do it anyway,”
observed Mitch Zeller, a former FDA tobacco director, expressing concerns about public trust in the FDA. The vaping guidelines bypassed a usual period for public input and revisions, with the FDA publishing them as finalized policy shortly after reports suggested President Donald Trump had approved firing Makary, who resigned amid industry complaints directed toward the White House.
A Health and Human Services spokesperson reaffirmed that the approach helps protect against youth nicotine addiction while supporting alternatives for adult smokers seeking to quit combustible tobacco products. Responses from Makary were unavailable.
Most health experts agree that e-cigarettes are less harmful than traditional cigarettes and note their promotion as a smoking alternative in the U.K. and Europe. However, the FDA has faced challenges policing the U.S. market. The agency has authorized products from five companies while rejecting millions of applications, primarily due to flavors enticing to children. Despite this, unauthorized vapes remain prevalent.
Recent shifts in policy reflect changes at national and state levels. Underage vaping among U.S. teens has decreased to its lowest in over a decade following COVID-19 disruptions and new restrictions. President Trump, who assumed office last year, had vowed to support the vaping industry. Major tobacco firms like Reynolds American and Altria have contributed significantly to political committees backing Trump, investing heavily in e-cigarettes and nicotine pouches alongside traditional cigarettes.
Despite these campaigns, FDA, under Makary, gave little attention to vaping issues. Internal memos indicate that a deputy halted an FDA decision that would approve fruit-flavored vapes, citing that the products weren’t likely to attract children, especially with digital age verification. These mango and blueberry products were eventually authorized during Makary’s final week, days before the FDA issued guidelines allowing unauthorized nicotine products.
The guidelines mandate the publication of a list of unauthorized e-cigarettes and pouches subject to ‘enforcement discretion,’ allowing sale without regulatory removal attempts. Although no public list exists, the policy may allow previously blocked flavors. Former FDA tobacco director Brian King remarked that this shows a growing openness to flavored products with the dual intention of authorization and reduced enforcement action.
The new approach may have limited effect on flavors currently available in U.S. markets. Unauthorized vapes featuring popular flavors like mango and gummy bear prevail, filling gaps left by Juul after it removed its high-nicotine products in 2017. Now, Juul aims to compete with disposable Chinese vapes making up a major share of U.S. sales.
“The choice we face is not whether flavored vaping products should be sold in the U.S. They already are,”
stated Robyn Gougelet, Juul vice president, emphasizing the need for regulated, responsibly marketed products.
FDA’s new focus on vapes will target products designed to appeal to youth, such as those resembling children’s toys. Jonathan Foulds, a tobacco-addiction specialist at Penn State University, suggests that the agency’s disclaimer is an acknowledgment of the overwhelming presence of illegal products.
“They’re making it clear what should be common sense: ‘We’re going to focus on the worst actors,’”
Foulds asserted.
The impact of the FDA’s policy on the vaping industry remains uncertain. Multinational tobacco firms may benefit due to their resources, enabling progression into scientific review processes. Meanwhile, smaller companies fear losing competitive edge, as remarked by Tony Abboud from the Vapor Technology Association, noting larger firms’ interest in reducing competition.
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