FDA is seeking comments on the draft guidance for 60 days.
The Food and Drug Administration (FDA) issued draft guidance on Tuesday, Jan. 17 that allows manufacturers to provide free samples to retailers in “limited quantities” if it is part of an effort to market or sell that product to the retailer.
This guidance is intended to help tobacco product manufacturers, distributors and retailers understand the prohibition of distributing free samples of tobacco products set forth in Tit le 21, Code of Federal Regulations (CFR), Part 1140 and to explain what you should do in order to comply with the regulations. The document explains, among other things, what activities and which persons are subject to the regulations, as well as how the prohibition of distributing free samples applies to the distribution of tobacco products through: non-monetary exchanges; membership and rewards programs; contests and games of chance; and business-to-business exchanges.
FDA is requesting public comments regarding its interpretation of the free sample ban set forth in this guidance within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.
To access the full guidance: