FDA to Require Reviews of New Tobacco Products

Tobacco companies will have to obtain approval from the Food and Drug Administration (FDA) for all new products brought to market, as well as some products released after Feb. 15, 2007, the agency announced Jan. 5.

In 2009, Congress granted the FDA the authority to regulate tobacco in The Family Smoking Prevention and Tobacco Control Act. The new regulations are in line with the legislation, and are intended to assure that new products do not increase risks to public health. 

“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 Lawrence R. Deyton, M.S.P.H., M.D., who directs the FDA’s Center for Tobacco Products. “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..”

Under the new rules, any tobacco product put on the market after the 2007 deadline will need FDA approval, unless it is “substantially equivalent” to a product marketed before the deadline.  Any product marketed before Feb. 16, 2007 will not require FDA approval. 

To obtain permission to market a new product — or to prove that a tobacco product is substantially equivalent to one previously on the market — tobacco companies will need to submit information about each product’s “ingredients, design, composition, heating source and other characteristics.” Products will be considered substantially equivalent if all of those aspects are identical to those of a product previously approved by the FDA or grandfathered in.

If the characteristics of the two products differ, the new product may still be considered substantially equivalent if it does “not raise different questions of public health.”

Companies that introduced or will introduce new products or new versions of old products between Feb. 16, 2007 and Mar. 21, 2011 will need to submit applications showing that the products are substantially equivalent to products introduced on or before Feb. 15, 2007.

“This piece of the Tobacco Control Act protects the health of all Americans,” said Kathleen Sebelius, secretary of Health and Human Services. “It does this by setting 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 agency will host a January webinar series for businesses and public health organizations on substantial equivalence.

Public comments about the new regulations can be left by visiting www.regulations.gov, entering FDA-2010-N-0646 into the search box, and following the prompts on the screen.