October 18, 2017
Authored and Edited by Jeffrey D. Smyth; Thomas L. Irving
On October 11, 2017, FDA released Guidance for Industry on the Prohibition of Distributing Free Samples of Tobacco Products. The Guidance provides recommendations to tobacco product manufacturers, distributors, and retailers, regarding the scope of FDA’s free sample ban and examples of permissible activities.
In March 2010, FDA published “Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents” (21 CFR Part 1140). These regulations sought to limit youth access to tobacco products by restricting the distribution of free tobacco product samples, the sale of cigarettes and smokeless tobacco to individuals under 18 years of age, and the sale of cigarettes and smokeless tobacco to individuals under 27 years of age without photo identification.
On August 8, 2016, FDA’s “Deeming Rule” expanded FDA’s tobacco product authority to include all products meeting the statutory definition of a tobacco product (except for certain accessories).
The Guidance discusses the scope of the free sample ban in view of the Deeming Rule, noting that FDA’s free sample ban prohibits distributing free samples of “cigarettes, smokeless tobacco, or other tobacco products” and automatically applies to all tobacco products subject to FDA’s authority, including newly covered tobacco products. Furthermore, the Guidance explains that unlike other provisions, the free sample ban extends to all tobacco products, even those not derived from tobacco, and that it is also impermissible to distribute free samples of components of tobacco products. The Guidance noted the most expensive part of a tobacco product may be a component (e.g., the aerosolizing apparatus in e-cigarettes) and that obtaining the most expensive component for free facilitates use by minors.
The Guidance also explains permissible situations in which tobacco products may be provided to consumers at less than full price without violating the ban. For example, coupons or discounts on tobacco products (including “buy one get one free”) may be offered as long as they are part of the same tobacco product sales transaction. Similarly, programs that grant free tobacco products as a reward or games of chance that award free tobacco products must provide the “free” product only in the context of a monetary tobacco product sales transaction.
FDA does not consider this regulation to apply to a business that distributes free samples to another business as part of a genuine effort to market tobacco products to that business.
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