U.S. FDA - more on “Substantial Equivalence” Reports for Tobacco Products..

January 13, 2011 -

Family Smoking Prevention & Tobacco Control Act..

From the FDA Law Blog..

Last week, FDA released Agency's first guidance for tobacco product manufacturers concerning the introduction of “new” tobacco products. The guidance was issued in final form since some manufacturers will need it to help them submit reports to FDA over the next few months.

January 6, 2011 - FDA - mission based on law to ensure new tobacco products do not pose an increased threat to the American public..

A “new tobacco product” is a product that was not sold in the U.S. before February 15, 2007. Any change made to a tobacco product after that date also makes it a “new tobacco product.” In general, a tobacco product manufacturer must obtain an order after review of a premarket application under section 910(c)(1)(A)(i) of the Federal Food, Drug, and Cosmetic Act (“the Act”) before the manufacturer may introduce a “new tobacco product.” Such an order is not required, however, if a manufacturer submits a report under section 905(j) of the Act for the new tobacco product (a “905(j) report”) and FDA issues an order finding that the tobacco product is (1) “substantially equivalent” to a tobacco product commercially marketed in the United States prior to February 15, 2007 or to a product found to be “substantially equivalent” to such a product (the “predicate tobacco product”), and (2) in compliance with the requirements of the law. The guidance describes the information manufacturers should submit in the 905(j) report in order for FDA to make a “substantial equivalence” determination.

For more see reference..

Reference: 905(j) “Substantial Equivalence” Reports for Tobacco Products by David B. Clissold, FDA Law Blog, 1/10/2011.