According to Vaping360, U.S. Senators Ted Budd, Rand Paul and Joe Manchin sent a letter to U.S. Food and Drug Administration Commissioner Robert Califf asking him to explain and clarify the FDA’s approach to regulating nicotine products and Urging him to reform the application process for tobacco products.
"Since 2009, more than 26 million new tobacco product premarket applications (PMTAs) have been submitted in the United States," the senators wrote.
“Of these 26 million applications, the CTP (Centre for Tobacco Products) approved less than 50. Notably, it also approved a total of 16 modified risk tobacco products for only four unique products and their accessories. "
“This negligible authorization rate is inconsistent with CTP policy, which recognizes that tobacco products fall on a risk continuum. Obtaining a scientifically substantiated authorized Tobacco Product Premarket Application (PMTA) or Tobacco Product Risk Modification (MRTP) may improve current use Health status of smokers of riskier products."
The Tobacco Control Act requires the Center for Tobacco Products to review and decide PMTA and MRTP 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 asked California a series of questions.
Senators gave Calif 30 days to answer their questions.
