FDA’s New Vaping Guidelines Stir Controversy

Recent changes in the Food and Drug Administration’s (FDA) tobacco center have surprised senior officials. New guidelines could allow more unauthorized electronic cigarettes and nicotine pouches into the U.S. market. These changes were released just before former FDA Commissioner Marty Makary resigned. The new guidelines permit certain nicotine-based products to be marketed without full regulatory review.

Some FDA officials, who enforce vaping regulations, were not informed of these changes. They discovered them night before the document was issued. The surprise release of this document has led to confusion within the FDA about its origin and authorization. Recent internal meetings have focused on implementing this unexpected policy shift. The six-page memo challenges a long-standing FDA requirement that demands scientific verification of health benefits before introducing new products.

FDA drafting new policies without staff input is highly unusual. This raises questions about whether subject matter experts opposed this policy but were overruled. Mitch Zeller, the former FDA tobacco director, noted this issue affects public trust in institutions like the FDA.

“It begs the question of whether the true subject matter experts may have actually opposed this policy and were ordered to do it anyway,” said Mitch Zeller.

The guidelines bypassed a federally required public comment period. They were published as final policy shortly after media reports indicated President Donald Trump had approved removing Makary. Makary resigned following industry lobbying complaints close to the White House. A Health and Human Services spokesperson avoided addressing the guidance’s origins. Andrew Nixon from the department claimed the approach strengthens protections against youth nicotine addiction while supporting alternatives for adults moving away from tobacco products.

Health researchers often agree e-cigarettes are less harmful than tobacco. In Europe, they are promoted as safer alternatives for smokers. However, in the U.S., the FDA has struggled to control the market for over a decade. It authorized vaping products for five companies but rejected millions of applications due to youth-friendly flavors like fruit and candy. Despite unauthorized vapes being readily available, changes in Washington and across the U.S. indicate shifting trends.

Underage vaping among U.S. teens has dropped to levels not seen in over 10 years. This decline follows pandemic disruptions and new restrictions. President Trump, who took office last year, pledged to save the vaping industry. Major tobacco companies, such as Reynolds American and Altria, have invested in political support for Trump and his policies. Besides cigarettes, these companies have invested heavily in e-cigarettes and nicotine pouches.

Despite such efforts, vaping issues received little attention from the FDA under Makary. He seldom addressed e-cigarettes and expressed skepticism about declining underage use. When FDA staff planned to change their stance on flavored products, Makary and agency leaders intervened. In February, a decision was blocked to authorize fruit-flavored vapes, seen as unlikely to attract children with digital age-verification tech. Mango- and blueberry-flavored products were finally approved in Makary’s last week before the new guidelines were posted. These new guidelines will allow unauthorized nicotine products without strict enforcement against them.

This shift is expected to allow flavors previously restricted by regulators. Former FDA tobacco director Brian King expressed concerns about the agency’s openness to flavored products. U.S. stores already have many illegal flavored vapes, and this approach may not affect what’s available. Unauthorized vapes such as mango, gummy bear, and strawberry are common in gas stations, vape shops, and convenience stores. After Juul removed its high-nicotine flavored products in 2017, these disposables filled the gap. Juul now competes directly with disposable Chinese vapes, holding 80% of U.S. sales.

“The choice we face is not whether flavored vaping products should be sold in the U.S. They already are,” said Robyn Gougelet, a Juul vice president.

The FDA will focus on vapes with youth-appealing features. Meanwhile, illegal products still flood the market, according to Jonathan Foulds, a Penn State University tobacco-addiction specialist.

“The reality is they’re just deluged by illegal products coming across the border,” said Jonathan Foulds.

The policy’s impact on the vaping industry remains uncertain. Larger tobacco companies could benefit from the requirement of “scientific review” for product approvals while smaller companies struggle to compete. As former FDA tobacco director Brian King stated, only a few applications reach the level of detailed health data needed for consideration. Lobbyists for smaller firms worry the policy may harm their clients. Tony Abboud of the Vapor Technology Association noted that larger companies favor seeing competitors removed from the market.