FRONT END NATO Update
FDA Director Provides Update on Federal Tobacco Regulations From premarket tobacco applications and synthetic nicotine regulation to proposed menthol and flavor bans and graphic warning labels, the Food and Drug Administration’s Center for Tobacco Products director weighs in on what’s in the agency’s 2022 crosshairs. Thomas Briant • NATO
On Dec. 2, 2021, the Food and Drug Administration (FDA) Center for Tobacco Products Director Mitch Zeller presented a live webinar on FDA tobacco regulations. The presentation focused on premarket tobacco applications (PMTA), the new graphic cigarette health warnings and synthetic nicotine products, and gave insights into what might await the category in the new year. PREMARKET TOBACCO APPLICATIONS
FDA regulations required that manufacturers of cigars (excluding premium cigars), pipe tobacco, electronic cigarette products, hookah tobacco and oral nicotine products, which were introduced in the market after Feb. 15, 2007, and on the market as of Aug. 8, 2016, file a PMTA with the agency by Sept. 9, 2020. A PMTA filing allowed the product to continue to be sold while the 20
CSTORE DECISIONS • January 2022
FDA reviewed the PMTA to determine if the product should remain on the market. More than 15,000 PMTAs covering nearly 6.7 million tobacco products were filed with the FDA by Sept. 9, 2020. The vast majority of these PMTAs were for electronic nicotine delivery systems (ENDS). According to Zeller, manufacturers must provide robust, reliable evidence that the product’s potential benefit for adult smokers outweighs the risk to youth. Then, the FDA must review each PMTA and assess the scientific evidence an applicant submits to determine whether the product is “appropriate for the protection of the public health,” based on risks and benefits to users and nonusers, i.e., whether current tobacco users would stop or reduce their usage, or current nonusers start using tobacco products. As of early December, the FDA had reviewed about 99% of the 15,000-plus PMTA applications. The agency continues working on PMTAs that cover some 55,000 ENDS. Zeller indicated that the FDA has issued
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