The Family Smoking Prevention & Tobacco Control Act, which became law June 22, 2009, contains a special provision for new tobacco products that were introduced [image-nocss] 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market on February 15, 2007, may be cleared to go to market; those that are not may be prohibited from the market, or withdrawn if they are already available, if the changes raise different questions of public health."
Health & Human Services Secretary Kathleen Sebelius added, "This piece of the Tobacco Control Act [sets] a clear deadline for tobacco companies to provide important product information to the FDA so the agency can then begin evaluating tobacco products for any potential new risks to public health."
The Family Smoking Prevention & Tobacco Control Act granted the FDA regulatory authority over tobacco products. Generally, the law allows the FDA to deny applications for a new product if marketing the product poses a harm to public health. 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.
FDA also intends to issue guidance on materials the agency believes would show that a tobacco product was on the market on February 15, 2007, as well as hold a Webinar Series in order to provide more assistance to manufacturers.
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