The US FDA Issues First PMTA Denial For a Menthol-Flavoured Vape Range

On rejecting the range, the FDA said Logic Technology Development didn’t prove that its menthol products are more likely to help adult smokers quit more than non-flavoured products. This coupled with the fact that the products may encourage minors to try the products led to the FDA’s decision to dismiss the products. 

“In this case, the applicant did not provide sufficient scientific evidence to show that the potential benefit to adult smokers outweighs the risks to youth,” said Director of the FDA’s Center for Tobacco Products (CTP), Brian King.

The FDA is pressured to dismiss and ban vaping products

Meanwhile, as a result of the constant and relentless criticism received by t the CTP over the way it has handled the ongoing PMTA process, earlier this year FDA head Robert Califf, announced he will be commissioning external experts to conduct “a comprehensive evaluation” of the center.

Last July, 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 in the 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, the FDA was also forced to temporarily suspend the Marketing Denial Orders (MDOs) it had just issued Juul, saying that a more thorough review was required.

The FDA’s Center for Tobacco Products faces a review

Certainly in a bid to appear like these missteps 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.

“Each of these areas are full of hardworking and talented individuals who have dedicated their careers to working across a variety of scientific, policy, legal and administrative activities. FDA employees deserve the best support possible so they can fulfil their strong commitment to public health—and the American public that we serve.”