The U.S. Food and Drug Administration recently finalized is industry guidance on the prohibition of distributing free tobacco product samples. This guidance is intended to assist tobacco product retailers, manufacturers, and distributors in interpreting the requirements related to the distribution of tobacco products through non-monetary exchanges, membership and rewards programs, contests and games of chance, and business-to-business exchanges, among others.

Significantly, the finalized guidance issued appears to be almost identical to the draft guidance published earlier this year. In the guidance, the FDA provides specific examples for various scenarios in which a tobacco product may be distributed to consumers, including discounts and coupons, membership and reward programs, and contests/games of chance. The FDA’s guidance pertaining to these scenarios remains largely unchanged from the FDA’s draft guidance.

The FDA guidance states that the FDA intends to consider the facts of potential violations on a case-bycase basis; nevertheless, a key take-away from the guidance is that retailers, manufacturers, and distributors may not provide consumers truly “free” samples of tobacco products that are not tied to sales transactions requiring monetary payment. This is to further the FDA’s stated goal of reducing youth access to tobacco products. As the FDA explains in its briefing notice pertaining to the recently finalized guidance:

While retailers are prohibited from distributing free samples of tobacco products to customers, they are not prohibited from, for example, offering significant discounts on the kinds of “sampling kits” they previously provided for free so that customers would try new products.

There is, however, a subtle but significant difference in the language of the draft and final guidance with respect to business-to-business exchanges. The recently finalized guidance states:

FDA does not consider this regulation to apply to businesses distributing free samples in a limited quantity (i.e., no more than necessary to achieve a business or market goal, such as awareness of and exposure to the product for the purposes of product or inventory selection) to another business as part of a genuine effort to sell or market a tobacco product to that business.

This language appears to be stronger than what was initially in the draft guidance:

To the extent applicable, FDA does not intend to enforce this regulation with respect to businesses distributing free samples in a limited quantity (i.e., no more than necessary to achieve a business or marketing goal, such as awareness of and exposure to the product for the purposes of product or inventory selection) to another business as part of a genuine effort to sell or market a tobacco product to that business.

This revision seems to demonstrate the FDA’s recognition of the practice of providing free samples to retailers to further business or marketing efforts. This type of practice is often seen in the cigar industry, for example. We take this as a positive indication from FDA that the agency does not intend to stop this established marketing practice, provided certain requirements are met.