FDA staff blindsided by move allowing more e-cigarettes and nicotine pouches onto US market

WASHINGTON — Top officials at the Food and Drug Administration’s tobacco center were blindsided by a recent decision that opened the door to allowing more unauthorized e-cigarettes and nicotine pouches into the U.S. market, The Associated Press has learned.

The guidelines, published online earlier this month before the resignation of former FDA Commissioner Marty Makary, will allow companies to bring certain nicotine-based products to market before they are fully reviewed by regulators.

Some FDA officials tasked with enforcing vaping regulations were not consulted about the changes and only learned of them the night before the document was released, according to two employees who spoke on condition of anonymity to discuss confidential agency matters. Employees said the sudden emergence of the document led to internal confusion about how the policy came to be and who authorized it.

In recent days, agency officials have held hours-long meetings grappling with how to implement the six-page memo, which overturns the FDA’s longstanding policy requiring scientific verification of the health benefits of smokers before any new product is brought to market.

It is highly unusual for the FDA to draft new policies without input from the staff who oversee them.

“It begs the question of whether the actual experts on the subject actually opposed this policy and were ordered to do so anyway,” said Mitch Zeller, who is retiring as the FDA’s tobacco director in 2022. “And that depends on the public’s ability to have trust and confidence in institutions like the FDA.”

The vaping rules bypassed a federally required deadline to allow public comment and revisions. Instead, the FDA issued the final policy after months of complaints about Makary from industry lobbyists close to the White House. He resigned from the agency last week.

A spokesperson for Health and Human Services did not address the origins of the guidance in a written statement.

“This approach strengthens protection against nicotine addiction in youth while supporting evidence-based alternatives for adult smokers who want to move away from combustible tobacco products,” Andrew Nixon said in a statement.

Messages seeking comment from Makary were not immediately responded to on Friday.

Most health researchers agree that e-cigarettes are significantly less harmful than traditional cigarettes, and the products have been promoted as alternatives to smokers in the UK and other European countries.

In the US, the FDA has struggled to regulate the market for more than a decade. While the agency has authorized e-cigarette products from five companies, it has rejected millions of other applications, mostly due to the presence of fruit, candy and other sweet flavors appealing to children. However, unauthorized e-cigarettes are still widely available.

But recent changes in Washington and across the United States reflect a changing landscape.

Underage e-cigarette use among U.S. teens has fallen to its lowest level in more than 10 years following the disruptions of the pandemic and new state and federal restrictions.

President Donald Trump came to power last year after promising to “save” the vaping industry. Major tobacco companies such as Reynolds American and Altria have contributed millions to political action committees supporting Trump and other administration priorities, including Trump’s inauguration and the White House ballroom proposal.

Despite the influence campaign, vaping issues have taken a backseat at the FDA under Makary. When Makary touched on e-cigarettes on rare occasions, he expressed skepticism about data showing underage use was declining.

As FDA staff prepared to change course on flavors, Makary and other agency leaders intervened.

In February, one of Makary’s aides blocked an FDA decision that would have allowed the first fruit-flavored e-cigarettes, according to internal memos later released by the agency. FDA reviewers determined that the products were less likely to be used by children when combined with digital age verification technology.

The mango- and blueberry-flavored products were finally approved during Makary’s final week heading the FDA, just days before the agency issued new guidelines allowing unauthorized nicotine products.

Under the guidance, the FDA is required to publish a list of e-cigarettes and pouches that are not yet authorized but would be subject to “enforcement discretion,” meaning they could be sold without regulators aiming for their removal. While there is no public list of products that may be eligible, the policy is expected to also allow new flavors that were previously blocked by regulators.

“What we’re seeing is a broader opening and response from the agency to flavored products, both in terms of a stronger desire for authorization and less desire to enforce against flavored products,” said Brian King, a former FDA tobacco director who now serves on the Campaign for Tobacco-Free Kids.

Although the FDA’s new approach breaks precedent, it may have little impact on flavors currently available at gas stations, vape shops and grocery stores.

The U.S. market has been flooded for years by unauthorized e-cigarettes containing mango, gummy bear, strawberry and dozens of other flavors.

These disposable e-cigarettes filled the gap left by Juul when it pulled its high-nicotine-flavored products from the market after they became commonplace in U.S. schools starting in 2017. The company currently sells only FDA-approved, tobacco- and menthol-flavored e-cigarettes.

Juul and other companies now see a chance to compete directly with disposable Chinese e-cigarettes, which by some estimates account for 80% of U.S. sales.

“The choice we face is not whether flavored vaping products will be sold in the U.S. They already are,” Juul vice president Robyn Gougelet said. “The choice is whether these products should be regulated and marketed responsibly, or whether they should be illegal, untested and smuggled into the country.”

Rather than targeting flavors, the FDA said the new enforcement approach would target e-cigarettes with specific features that appeal to young people, such as designs that resemble children’s toys.

“The reality is that they are being inundated with illegal products crossing the border,” said Jonathan Foulds, a tobacco addiction expert at Penn State University. “So they make clear what common sense should be: ‘We’re going to focus on the worst actors.’”

It remains to be seen whether the FDA’s new approach will be generally adopted by the e-cigarette industry, which includes multinational tobacco companies as well as hundreds of smaller companies selling devices imported from China.

As written, the guidance suggests that only e-cigarettes under “scientific review” will be eligible to be released without FDA authorization. King noted that typically only a small number of applications reach this stage, which requires detailed health data on smokers switching to the new product.

“This will certainly benefit larger tobacco companies that have the resources to progress far enough through the application review process and therefore will not be prioritized for application,” King said.

Lobbyists for small companies say it’s too early to tell whether the policy will help or hinder their clients, but they fear being left behind.

“Big companies would rather see their biggest competitors out of the market,” said Tony Abboud of the Vapor Technology Association.

The Associated Press receives support from the Health and Science Department, the Howard Hughes Medical Institute Science and Education Media Group and the Robert Wood Johnson Foundation. He/she is solely responsible for all content.

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