Friday, April 19, 2024

Sen. Dick Durbin Calls For FDA to Release PMTA List


Sen. Dick Durbin, D-Illinois, said that he has requested that the Food and Drug Administration (FDA) publish a comprehensive and detailed list of submitted premarket tobacco applications (PMTA) that they currently reviewed, approved, or have pending.

The National Association of Convenience Stores (NACS) has pressed the FDA to publish the PMTA list after the agency said that it would develop more transparency for the current applications.

The Food Industry Association, the National Association of Truckstop Operators, the Petroleum Marketers Association of America, and the Society of Independent Gasoline Marketers of America signed the letter with NACS requesting transparency from the FDA.

“The PMTA list will be critical to support compliance across the tobacco trade channel, helping inform distributors, wholesalers, and retailers which ENDS products are being marketed legally in accordance with FDA’s compliance policy,” NACS and the retail associations wrote in a letter to the FDA, obtained by the Vaping Post.

“Relatedly, such a list also would facilitate enforcement against those manufacturers that continue to introduce illegally marketed products without premarket authorization or, in the case of deemed, currently marketed products, without a PMTA submitted by the deadline,” NACS added.

FDA’s Mitch Zeller, the director of the agency’s Center for Tobacco Products, confirmed in September that all PMTAs would be available in a database format.

Durbin is the most recent figure to press the FDA on this matter, including the continued lobbying of the trade associations, industry representatives, and shop owners.

“In order to protect public health and uphold the duty to enforce against products on the market that are out of compliance, I urge FDA to immediately publish a comprehensive product listing of all relevant e-cigarette applications received by FDA,” Durbin wrote.

“While I appreciate the sheer volume of applications submitted to FDA, and the agency’s intention to prioritize review of those with the greatest market share and public health impact, we know from recent years that youth shift patterns of e-cigarette use based upon what products are available to them,” says Durbin.

This story is developing.

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