Tobacco Product Standard for N-Nitrosonornicotine Level in Finished Smokeless Tobacco Products (Proposed Rule)
The proposed rule would establish a product standard for all finished smokeless tobacco products. Specifically, the proposed rule would require that all finished smokeless tobacco products comply with a limit for N-nitrosonornicotine (NNN) in such products in order to be marketed and distributed for sale in the United States. This proposed product standard would require that the mean level of NNN in any batch of finished smokeless tobacco products not exceed 1.0 microgram (µg) of NNN per gram of tobacco on a dry weight basis at any time through the product’s labeled expiration date as determined by product testing. The proposed standard also includes requirements on the sale and distribution of smokeless tobacco products, product testing, labeling, and recordkeeping.
Regulatory Impact Analysis
Federal Register: 82 FR 8004-8053, January 23, 2017
Docket: FDA-2016-N-2527