FDA Issues Proposed Guidance on Sampling Ban

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FDA Sampling Guidance

The U.S. Food and Drug Administration (FDA)’s Center for Tobacco Products released a proposed guidance document describing the agency’s recommendations on how retailers, manufacturers and distributors can comply with new federal tobacco regulation that prohibits distributing or giving away free samples of tobacco products. The FDA is currently seeking comments from the public about the proposed guidance with a deadline of February 17, 2017, to ensure the agency takes the comments into consideration before it begins to work on the final version of the guidance. You can submit your comments by clicking here.

The recommendations outlined in the proposed guidance documents are not legally binding but instead represents the FDA’s current thinking on the topic of the free sample ban.

Background on Free Samples
The Family Smoking Prevention and Tobacco Control Act prohibits the distribution of free samples of all tobacco products regulated by the FDA, including cigarettes, roll-your-own tobacco, smokeless tobacco, cigars, pipe tobacco, e-cigarettes, e-liquids, vapor products, hookah tobacco, nicotine dissolvable products, nicotine gel products, and components and parts of tobacco products such as e-cigarettes and vapor apparatus. The law exempts the the distribution of certain small quantities of smokeless tobacco in a “qualified adult-only facility” that meets a number of specific requirements.

FDA regulations prohibit retailers, distributors, and manufacturers from distributing fee samples of tobacco products to consumers except through a sales transaction that involves a consumer paying money for a tobacco product. Providing a sample in exchange for information such as a telephone number or email address is also prohibited. Certain price promotions such as “buy one, get one” or “two for the price of one” does not violate the free sample ban and is allowed. Also, tobacco products can be sold at a discounted price and do not violate the free sample ban. Coupons can also be redeemed that take cents or dollars off the price of a tobacco product to allow it to be sold at a discount but “buy one and a receive a coupon redeemable later for a free tobacco product” is prohibited unless the retailer can verify that the person redeeming the coupon is the original purchaser that earned the coupon for the free tobacco product.

Essentially, the FDA’s position on whether a tobacco product is a free sample is focused on the payment of money by a consumer at the time the “free” sample product is provided to the consumer. For more news on FDA regulations and its impact, visit natocentral.org.