FDA to require substantial equivalence reviews for new tobacco products
FDA to require substantial equivalence reviews for new tobacco products
The U.S. Food and Drug Administration announced today that any tobacco product introduced or changed after Feb. 15, 2007 must be reviewed by the agency. In FDA guidance published today, the agency outlines a pathway for marketing a product whereby the company marketing the product must prove that it is substantially equivalent to products commercially available on Feb. 15, 2007.