The FDA recently issued a draft guidance, The Prohibition of Distributing Free Samples of Tobacco Products, for public comment. When finalized, this guidance will help tobacco product manufacturers, distributors, and retailers understand—and comply with—the prohibition of distributing free samples of tobacco products. The free sample ban prohibits tobacco product manufacturers, distributors, and retailers from distributing free samples of tobacco products, except for smokeless tobacco products distributed in “qualified adult-only facilities” in accordance with the regulations. In the draft guidance, the FDA interprets this to mean that manufacturers, distributors, and retailers may distribute tobacco products to consumers only through a tobacco product sales transaction and only in exchange for money.
When the FDA first issued the free sample ban in 2010, the prohibition applied to cigarettes (including roll-your-own tobacco), cigarette tobacco, and smokeless tobacco. As a result of the FDA’s final deeming rule, which went into effect on Aug. 8, 2016, the ban on distributing free samples applies to all tobacco products (and their components and parts) that are subject to the FDA’s tobacco product authority. This prohibition includes newly-regulated tobacco products such as e-cigarettes, cigars, and hookah tobacco.
This draft guidance explains, among other things, what and who are subject to the prohibition, as well as how the prohibition of distributing free samples applies to the distribution of tobacco products through:
The prohibition on free samples of tobacco products is among the FDA’s most important provisions to help reduce youth access to tobacco products. When finalized, The Prohibition of Distributing Free Samples of Tobacco Products draft guidance will better assist manufacturers, distributors, and retailers in complying with these regulations.
For more information, please read the guidance.
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