An FDA spokesperson told Filter that the “FDA thanks Dr. Holman for his federal service and wishes him well. The work of the Center for Tobacco Products’ Office of Science is essential to our mission to protect Americans from tobacco-related disease and death. We are confident in the expertise and ability of our staff to continue this critical public health work while the Center for Tobacco Products conducts a nationwide search to identify the next Director for the Office of Science.”
Meanwhile, in light of recent events Amanda Wheeler, the president of American Vapor Manufacturers and a vape shop owner in Arizona, naturally believes that there is more to this. “Dr. Holman is not leaving the FDA, he’s escaping,” 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.”
Commissioner Califf has just announced a review of the CTP
As a result of the constant and relentless criticism received by the CTP over the way it has handled the ongoing PMTA process for vaping products, FDA head Robert Califf, has recently announced he will be commissioning external experts to conduct “a comprehensive evaluation” of the center.
It is no secret that the FDA has been under fire for multiple reasons related to the authorization of safer nicotine alternative products. Earlier this month the agency was heavily criticised by Senators Dick Durbin (D-Ill.) and Susan Collins (R-Maine). In a letter citing STAT’s reporting the agency’s lack of action with regards to a Synthetic Nicotine ban announced earlier this year, the Senators said that the FDA “appears to be on the brink of failing yet again at protecting our nation’s children.”
Similarly, president of the Campaign for Tobacco-Free Kids Matt Myers, highlighted that the FDA should exercise its authority to pull the products off the market. “All unauthorized synthetic nicotine products are now illegal and by law must be removed from the market now, not at some undetermined date in the future.”
Moreover, the agency has been constantly reprimanded for not sticking to the stipulated cut off point and complete the PMTA process on time. And, to add insult to injury, earlier this month the FDA was forced to temporarily suspend the Marketing Denial Orders (MDOs) it had just issued Juul, saying that a more thorough review was required.
Certainly in a bid to appear like these misteps are being taking seriously, Commissioner Califf announced the CTP review. “I have discussed this evaluation with the relevant leadership of these centers and offices, all of whom welcome the opportunity to work towards organizational excellence,” he said in a press release.
