FDA Releases Updated Guidance on Free Sample Ban of Tobacco Products

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Another area of the sample ban that has been an issue within the cigar industry in particular has been in terms of donations. The popular non-profit group Cigars for Warriors has been hit hard in the past year due to the Deeming Ruling not because they are a manufacturer but because they rely on cigars to be donated to them that they in turn send to soldiers and members of the military. Before the deeming rule, manufacturers were a major source of these cigars but as soon as the deeming rules were announced in the summer of 2016, those donations ended because of the sample ban. Because no transaction has taken place, donations from manufacturers are not legal. A consumer, however, can donate a cigar because they have purchased it but the level of donations from consumers versus manufacturers is disproportionate and has left Cigars for Warriors’ nearly depleted of inventory to donate to soldiers.

The FDA does not believe the sample ban applies on a B2B level as long as it is done on a limited quantity basis. They define this as “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.” These samples must be part of a “genuine effort to sell or market a tobacco product to that business” as well. Some interpret this to mean that samples may be legal also between a manufacturer and member of the media, though the FDA still has yet to clearly state if this is the case or if (or how) the sample ban applies to members of the media.

You can view the full FDA “Prohibition of Distributing Free Samples of Tobacco Products” document by clicking here. For all the latest FDA and legislation news, click here.