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.
A 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.
