Post by papipeguy on Aug 13, 2016 7:45:09 GMT -5
6 weeks ago I submitted a question to the FDA asking them to distinguish between samples and gifts. My thinking was that if a shop or any vendor "gifts" someone a bit of tobacco is it really a free sample. I realized that it is semantics but the two words do have different definitions. Anyway, here's the response from the FDA. It's pretty much what I expected but a lawyer should have a field day with this if push comes to shove.
Thank you for submitting a question to the U.S. Food and Drug Administration (FDA) during our May 25, 2016 webinar regarding its recently finalized rule, “Deeming Tobacco Products to be Subject to the Federal Food, Drug and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act” (Deeming rule). Below, you will find information related to your submission and links to some related websites.
You asked about free samples under the Deeming rule for newly deemed products. In this rule, FDA is not modifying the existing restriction on distributing free samples of “tobacco products” (21 CFR 1140.16(d)), as defined under section 201(rr) of the FD&C Act. As a result, the prohibition on the distribution of free samples applies to all newly deemed tobacco products, including their components and parts, but not accessories. Allowing prospective adult buyers to smell or handle one of the newly deemed products is not considered distribution of a "free sample" as long as the product is not actually consumed, in whole or in part, in the retail facility for free and the prospective buyer does not leave the facility with a free tobacco product. We believe that in most circumstances, retail facilities, including electronic nicotine delivery systems (ENDS) retail establishments, can allow customers to touch, hold, and smell their products without violating the free sample ban. However, if the prospective buyer lights and draws, puffs on, or otherwise consumes the tobacco product, or leaves the retail establishment with a free tobacco product, this would constitute a "free sample" in violation of 21 CFR 1140.16.
Final Rule and Accompanying Documents
• Final Rule: Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products
• Small Entity Compliance Guide: FDA Deems Certain Tobacco Products Subject to FDA Authority, Sales and Distribution Restrictions, and Health Warning Requirements for Packages and Advertisements
• Premarket Tobacco Product Applications for Electronic Nicotine Delivery Systems (ENDS); Draft Guidance for Industry
• Tobacco Product Master Files; Guidance for Industry
Resources for Additional Information
FDA continues to update its Deeming webpage to provide information designed to help industry understand the Deeming rule. We have also created a chart that may help you determine which provisions apply to you and the timeframes for complying. In addition, FDA has posted Tobacco Compliance Webinars to our website.
We also encourage you to subscribe to FDA’s “This Week in CTP.” By subscribing, you’ll receive updates about regulatory activities, retailer notices, upcoming events, and public education campaigns.
Should you have further questions after reviewing this information, you may contact CTP using the following communication methods:
Email:
SmallBiz.Tobacco@fda.hhs.gov
Phone:
1-877-287-1373
Mail:
Food and Drug Administration
Center for Tobacco Products
10903 New Hampshire Avenue
Silver Spring, MD 20993
May 25, 2016 Webinar Question: Free Samples
Please distinguish between free sample and gift from the retailer.
IM1070277
