FDA Enforces Products Not Submitted PMTA

Time： 2023-09-09

U.S. FDA officials stated that they will continue to enforce the law on the retail side and focus enforcement resources on products that have not submitted PMTA.

According to cstoredecisions on September 5, the American Tobacco Stores Association (NATO) stated that Brian King, director of the U.S. FDA’s Center for Tobacco Products (CTP), spoke at the Colorado Smoker-Friendly Tobacco Conference and reiterated the FDA’s previous The statement stated that it will continue to enforce the law on the retail side and focus enforcement resources on products that have not submitted PMTA.

He focused on the current and possible upcoming FDA tobacco regulations, emphasizing that "after February 15, 2007, the FDA only authorized the sale of 45 types of tobacco products, including 23 types of e-cigarette products." He emphasized that compliance inspections of tobacco retailers will continue to be strengthened, and that the FDA will continue to focus its enforcement resources on products that have not submitted PMTAs, products for which the FDA has issued a Marketing Denial Order (MDO), and flavored e-cigarettes (tobacco or (Except for menthol flavor) and other products that cannot be prevented from attracting teenagers.

Director King's presentation focused on FDA's current tobacco regulations and possible upcoming regulations.

While the FDA has previously publicly announced that the agency plans to issue final regulations banning the use of menthol in cigarettes and flavoring in cigars sometime this August, Commissioner Kim said the final regulations should be issued by the end of 2023.

The FDA has also previously publicly announced that the agency plans to issue new proposed regulations for public comment by the end of 2023 to set maximum limits for nicotine in cigarettes and other combustible tobacco products. However, Director King said nicotine cap regulations will be released sometime after the FDA issues final regulations for menthol cigarettes and flavored cigars later this year.

FDA will continue to conduct compliance inspections of retailers to determine whether retail stores are selling tobacco and e-cigarette products that have been denied marketing authorization by the agency or are undergoing premarket review by FDA without a final denial or authorization order that the agency has not yet issued. Sales information for this product.

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