Sampling Do’s and Don’ts: FDA’s New Rules

The FDA has finalized its guidance restricting the sampling of tobacco products.

FDAs Sampling Do's and Dont's

In October, the FDA issued its final guidance on the sampling of premium cigars and other covered tobacco products. The sampling restrictions apply to all covered tobacco products, cigars, roll-your-own and pipe tobacco. In general, the FDA’s final guidance reflects the draft guidance that the agency published in January.

The release prohibits distribution of free samples of tobacco products. While that sounds dramatic, the definition of “free samples” outlined in the document gives retailers and manufacturers some leeway. In fact, the FDA outlines several examples of situations that would not violate the free sample ban in the guidance document, giving specific instructions on how to handle non-monetary transactions, membership and rewards programs, contests and games of chance, and business-to-business exchanges.

Essentially, free samples are not allowed unless there is an exchange of money. “This means that retailers must charge consumers money for tobacco products and may not, for example, distribute tobacco products in exchange for providing contact information or signing up for a mailing list,” states the document. However, “there are situations in which the sale of tobacco products to consumers at less than full price does not violate the ban.”

The free sample ban will not prevent manufacturers, distributors and retailers from selling tobacco products at a discount or accepting coupons that allow consumers to purchase tobacco products at a discount—as long as the coupon in question is for less than the purchase price of the item. Buy-one-get-one-free promotions are also allowed, since money is exchanged.

In the case of loyalty programs, where points are awarded for purchases and can be redeemed for free merchandise, retailers can continue to offer merchandise rewards as long as they require that those items are redeemed during a tobacco product purchase so that a transaction also takes place. “Rewards programs that offer a tobacco product as a ‘reward,’ such as punch card programs (i.e., get a hole punched in the card for each purchase and receive a tobacco product when all the holes have been punched), are prohibited except where the ‘reward’ is distributed as part of a tobacco product sales transaction that requires monetary payment,” states the guidance document.