IPCPR Legislative | FDA Issues Final Guidance on Sampling

FDA Issues Final Guidance on Sampling

13 Oct FDA Issues Final Guidance on Sampling

Earlier this week, the FDA issued it’s final guidance on sampling of premium cigars and other covered tobacco products.  The sampling restrictions include all covered tobacco products, cigars, roll your own, and pipe tobacco.  This final guidance widely reflects the draft guidance published in January.  The final guidance can be found here: The Prohibition of Distributing Free Samples of Tobacco Products

So what does the guidance say?

Transactions only – In short, any sampling must be in conjunction with a monetary transaction. The FDA provides several examples of situations that would not violate the free sample ban.

  • Coupons and Discounts –  Coupons, promotions such as 50% off, buy one get one free, and loyalty program rewards are permitted.  Both coupons and discounts are acceptable as long as they accompany a tobacco product transaction and the necessary age and ID verification requirements take place.
  • Rewards Program ­& Membership Clubs – Rewards programs (i.e. a free cigar on the 10th purchase) are permissible but the reward must occur at the time of a purchase.  Membership clubs or programs and accompanying incentives can occur without a transaction BUT a system to verify the individual and account holder must be in place.
  • Contests, Lotteries and Games of Chance – Free samples resulting from winning a contest, lottery or game of chance are allowed ONLY IF they occur at the time of sale of a tobacco product.


B2B Sampling – FDA makes an allowance for the distribution of a “limited quantity” of free samples from one business to another in order to sell or market a tobacco product. Limited quantity is not explicitly defined other than “the amount necessary to achieve a business or market goal.” This is only applicable for business to business and does not allow for sampling by consumers.

For additional information, dates, and IPCPR guidance on how to comply with the Deeming Rule, visit the IPCPR FDA Toolbox at www.ipcprlegislative.org.

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