WASHINGTON - The FDA unveiled guidelines Wednesday on how tobacco manufacturers can gain agency approval for certain types of new products, reports the Wall Street Journal.
The newspaper writes that the FDA said certain products like cigarettes, roll-your-own tobacco and smokeless that were introduced or changed nearly four years ago, must be reviewed by the agency to show that they are "substantially equivalent" to products commercially available on Feb. 15, 2007.
"Substantially equivalent" means the products must be the same in terms of ingredients, design, composition, heating source and other characteristics to an existing, single predicate product or have different characteristics, but not raise different questions of public health. Products that aren't similar could be prohibited from the market or removed from the market.
The guidance released by the FDA is a requirement of the Family Smoking Prevention and Tobacco Control Act, which became law in June 2009. FDA may deny applications for substantial equivalence if the marketing of that modified product would raise different questions of public health. An example would be a product that poses an increased health risk to users of the product or to nonusers by causing more of them to start smoking.
According to the FDA, to continue to market these products, manufacturers of tobacco products that were introduced or changed after Feb. 15, 2007, must apply for equivalency by March 22, 2011. Manufacturers that intend to introduce new products after that date must submit an application for the new product and obtain a marketing order from the FDA before introducing the product to market.
FDA also intends to issue guidance on materials the agency believes would show that a tobacco product was on the market on Feb. 15, 2007, as well as hold a Webinar Series in order to provide more assistance to manufacturers. Information on the Webinar Series (available soon) and application process details and answers to questions can be found here.
The FDA welcomes public comment on this issue. Go to regulations.gov and insert docket number FDA-2010-N-0646 into the "search" box and follow the prompts.??