January 6, 2011 - The U.S. Food and Drug Administration (FDA) announced today, January 5th that certain tobacco products 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.
The Family Smoking Prevention & Tobacco Control Act, which became law June 22, 2009, contains a special provision for new tobacco products that were introduced into the market between February 15, 2007 and March 22, 2011, and for existing tobacco products for which changes were made in this time period.
In general, in order to continue to market these products, manufacturers of tobacco products that were introduced or changed after February 15, 2007, which include cigarettes, roll-your-own tobacco and all smokeless products must apply for equivalency by March 22, 2011. Manufacturers intending to introduce new products into the market 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.
“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.
"This specific part of the law is meant to ensure that new tobacco products are evaluated by the FDA before they are cleared to enter the marketplace. The law requires FDA to carefully examine the impact those products may have on the public health," said Lawrence R. Deyton, director of the agency's Center for Tobacco Products. "Products that are equivalent to those which were on the market on February 15, 2007, may be cleared to go to market; those that are not may be prohibited from the market, or withdrawn if they are already available, if the changes raise different questions of public health."
In general, in order to continue to market these products, manufacturers of tobacco products that were introduced or changed after Feb. 15, 2007, which include cigarettes, roll-your-own tobacco and all smokeless products must apply for equivalency by Mar. 22, 2011. Manufacturers intending to introduce new products into the market 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.
“No known existing tobacco product is safe, and a market order issued by the FDA for these products should never be interpreted as such” said Deyton. “One of the FDA’s missions required by this new law is to ensure new products do not pose an increased threat to the American public. These products will not be safer, but we are required by this law to not allow even more dangerous products to cause further harm to those Americans who use tobacco products.”
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.
References: FDA to require substantial equivalence reviews for new tobacco products Certain products introduced or changed in the United States since Feb. 15, 2007 to be reviewed, FDA NEWS RELEASE, 1/5/2011; FDA's 'Substantial Equivalence'
Will review tobacco products introduced, changed since Feb. 15, 2007, CSP Daily News, 1/6/2011.