Home Politics America The FDA PMTA Process Favors Products by Tobacco Companies

The FDA PMTA Process Favors Products by Tobacco Companies

In what many may consider curious but not surprising, the FDA is rejecting PMTAs for vaping products manufactured by small businesses selling solely the safer alternatives, and authorizing more heated tobacco products produced by tobacco companies, even if the latter are proven to be less safe than the former.

Diane Caruana

February 8, 2023

On January 26th, the US Food and Drug Administration (FDA) authorized three heated tobacco products manufactured by Philip Morris International(PMI). The agency issued marketing granted orders (MGOs) for three tobacco-flavored heat sticks—Marlboro Sienna, Marlboro Bronze and Marlboro Amber, all of which can be used with PMI’s IQOS device.

In 2019, the FDA had granted PMTAs to IQOS and several Marlboro HeatSticks, meaning that PMI would have demonstrated that these products would be “appropriate for the protection of public health.” Meanwhile a number of studies have indicated that while safer than cigarettes, heated tobacco products are not as safe as vapes. Yet the latter keep getting the rejected.

“It will add to the small availability of FDA-authorized safer nicotine alternatives, but is also a reminder that the PMTA process favors well-financed manufacturers, mainly with ties to the tobacco industry,” highlighted Filter.

Former CTP director left job at FDA for one at PMI

It may be worth mentioning that in July 2022, the then director of the Office of Science at the Food and Drug Administration’s Center for Tobacco Products (CTP), Matthew Holman, had announced he was leaving his position at the FDA for a job at PMI.

At the time, Filter revealed that in a letter addressed to his colleagues, Holman, who had become the CTP’s director only earlier that month, had written that he would be departing “effective immediately,” revealing that the former OS head “has been on leave since before my tenure began at the Center” and saying that “he recused himself, consistent with agency ethics policies, from all CTP/FDA work while exploring career opportunities outside of government.”

However, the president of American Vapor Manufacturers and a vape shop owner in Arizona, Amanda Wheeler naturally believed that there was more to it. “Dr. Holman is not leaving the FDA, he’s escaping,” she told Filter. “It is hard to avoid the sense that the most serious and essential work on tobacco harm reduction is being done outside of an agency that appears beyond repair.”