FDA to require 'substantially equivalent' reviews of new tobacco products

SILVER SPRING, Md. — Certain tobacco products introduced to the market or changed after Feb. 15, 2007, are subject to enhanced scrutiny by the Food and Drug Administration, the agency said Wednesday.

The FDA said it would require the companies making the products — ranging from roll-your-own tobacco to smokeless tobacco products — to prove they are “substantially equivalent” to those on the market on or before that date in order to keep them on the market — meaning they must be the same in terms of ingredients, design, composition, heating source and other characteristics. The new policy was adopted under the FDA’s authority to regulate tobacco products, mandated by the Family Smoking Prevention and Tobacco Control Act of 2009.

“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,” FDA Center for Tobacco Products director Lawrence Deyton said. “The law requires [the] FDA to carefully examine the impact those products may have on the public health.”

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