Department of Health and Human Services January 6, 2011 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry and FDA staff entitled ``Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products.'' In general, the Federal Food, Drug, and Cosmetic Act (the FD&C Act) requires a premarket application and market authorization order for new tobacco products before they may be marketed; alternatively, manufacturers may submit a 905(j) report intended to demonstrate substantial equivalence to a predicate tobacco product. The guidance provides recommendations on submitting information intended to demonstrate that a new tobacco product is substantially equivalent to a predicate tobacco product. Manufacturers of tobacco products first introduced or delivered for introduction into interstate commerce for commercial distribution after February 15, 2007, and prior to March 22, 2011, must submit a report no later than March 22, 2011, or the products can no longer be legally marketed. Manufacturers of a new tobacco product first introduced or delivered for introduction into interstate commerce for commercial distribution after February 15, 2007 and before March 22, 2011, who submit a substantial equivalence report before March 23, 2011, may continue to market the tobacco product unless FDA issues an order finding that the product is not substantially equivalent. Because it is important that FDA's recommendations on submitting a substantial equivalence reports be available to assist new tobacco product manufacturers in preparing substantial equivalence reports in advance of March 23, 2011, this guidance document will be implemented immediately. This guidance, however, remains subject to comment in accordance with the Agency's good guidance practices (GGPs).