NATO Asks FDA to Extend Comment Period on Three ANPRM

Time needed to gather data, research and information that the agency is seeking on all three issues will take industry members, including NATO, longer than 90 days, NATO says.  

The National Association of Tobacco Outlets (NATO) submitted formal comments to the U.S. Food and Drug Administration (FDA) for each of three Advanced Notice of Proposed Rulemakings (ANPRM) issued by the FDA, requesting an additional 90 days to submit comments.

Last month, the FDA issued the three ANPRM to request comments from the public, including the tobacco industry, to determine whether to proceed with new regulations that would set a maximum level of nicotine in cigarettes, restrict the use of flavors in tobacco products and regulate premium cigars. Each of the ANPRMs provide the public a period of 90 days to submit comments to the FDA.

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NATO explained that the requests for additional time were submitted for two main reasons.

First, the FDA issued the three ANPRMs within a 10-day time span last month and compiling the data, research and information that the agency is seeking on all three issues will take industry members, including NATO, longer than 90 days.

Second, NATO is developing surveys on each of the ANPRMs for NATO retail members and their adult customers to complete. These surveys are in response to the FDA’s request for “information” that the agency can review in determining whether to draft new regulations on lower nicotine in cigarettes, restricting flavors in tobacco products, and regulating premium cigars. Conducting the surveys, compiling and analyzing the information, and then drafting NATO comments on each of the ANPRMs will take more time than the 90 days the FDA has initially provided to submit comments.