FDA Issues Guidelines Limiting Marketing of New Tobacco

The FDA strikes again, and this time it has to do with the marketing of tobacco products. According to a report published on the FDA website, advertising or marketing a tobacco product that was released after February 15, 2007 could become a thing of the past.

A substantially equivalent tobacco product has been found by FDA to either have the same characteristics as a predicate tobacco product; or has different characteristics than the predicate tobacco product but the information submitted demonstrates that the new product does not raise different questions of public health.

predicate tobacco product is one that was commercially marketed in the United States (other than in a test market) as of Feb. 15, 2007, or a product previously found to be substantially equivalent by FDA and in compliance with the requirements of the Food Drug & Cosmetic Act (FD&C Act).

If the new product raises different questions of public health, the product is not substantially equivalent. However, a tobacco product that is modified by adding or deleting a tobacco additive, or increasing or decreasing the quantity of an existing tobacco additive, may be considered for exemption from demonstrating substantial equivalence.

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