With commissioner under pressure, FDA opens door to flavored vapes

WASHINGTON – 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 Donald 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. Trump later said he was not aware of plans to oust Makary.

In a policy posted on the FDA website, the agency said it would take steps to remove illicit e-cigarettes from the market and allow sales of those that have 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 FDA 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 FDA tobacco chief under Democratic and Republican administrations, said the plan to stop enforcing rules on e-cigarettes would allow an untold number of products onto 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.

A summary of the guidance, which has not yet been released, relies on the FDA’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 FDA 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, vice president at the Campaign for Tobacco-Free Kids.

Major tobacco companies, including Reynolds and Altria, have been reliable donors to Trump’s MAGA Inc. political action committee.

This article originally appeared in The New York Times.