FDA to Continue Enforcement on Tobacco Retailers in the US

According to a report on September 5th, the National Association of Tobacco Outlets (NATO) in the United States stated that Brian King, the Director of the Center for Tobacco Products (CTP) at the FDA, reiterated the agency's previous statement during a tobacco-friendly conference in Colorado. King expressed that the FDA will continue to enforce regulations on the retail end, with a particular focus on products that have not submitted premarket tobacco product applications (PMTA).

He emphasized the current and potentially forthcoming FDA tobacco regulations, underscoring that "after February 15, 2007, the FDA only authorized the sale of 45 tobacco products, including 23 e-cigarette products." He particularly emphasized the continuous strengthening of compliance checks on tobacco retailers, with the FDA consistently focusing its enforcement resources on products that have not submitted PMTA, are subject to a Marketing Denial Order (MDO), and flavored e-cigarettes (excluding tobacco or menthol flavors) that fail to prevent youth appeal.

The speech by Director King highlighted the current tobacco regulations of the FDA and the potential upcoming regulations.

Despite the previous public announcement by the FDA that the agency planned to release the final regulations banning the use of menthol in cigarettes and the addition of flavors in cigars in August of this year, Commissioner King stated that the final regulations are expected to be published by the end of 2023.

The FDA previously announced its plans to release new proposed regulations by the end of 2023 to solicit public opinion on setting a maximum limit for nicotine in cigarettes and other combustible tobacco products. However, Director King stated that the nicotine cap regulations will be published at some point after the FDA releases the final regulations for menthol cigarettes and flavored cigars later this year.

The FDA will continue to conduct compliance checks on retailers to determine if they are selling tobacco and e-cigarette products that have been refused marketing authorization by the agency or are undergoing pre-market review by the FDA without receiving a final refusal or authorization order. The agency has not yet released sales information for these products.