FDA Asked to Clarify PMTA Process

U.S. senators Ted Budd, Rand Paul and Joe Manchin, sent a letter to Food and Drug Administration Commissioner Robert Califf requesting he explain and clarify the FDA’s approach to nicotine product regulation and urging him to reform the tobacco product application process, according to Vaping360.

“Since 2009, more than 26 million premarket tobacco product applications (PMTAs) have been submitted for new tobacco products in the U.S.,” the senators wrote.

“Of those 26 million applications, the CTP [Center for Tobacco Products] has authorized fewer than 50. Remarkably, it has also authorized a total of only 16 modified-risk tobacco products (MRTPs) for only four unique products and their accessories.

“This miniscule authorization rate is not in keeping with the CTP policy acknowledging that tobacco products fall on a continuum of risk. The availability of scientifically substantiated, authorized PMTAs or MRTPs could potentially improve health outcomes for smokers currently using riskier products.”

The Tobacco Control Act requires that the CTP review and decide on PMTAs and MRTPs within 180 days, however, the FDA has not delivered on this timeline.

The senators cited the Reagan-Udall Foundation’s report on the CTP and posed a series of questions to Califf.

The senators are asking Califf to respond to their questions within 30 days.