Thank you for contacting the U.S. Food and Drug Administration (FDA) 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).
You asked about the lowest price that may be charged for sampling 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.
For More Information
To assist the newly-regulated tobacco industry in complying with the requirements being announced, the FDA is also publishing several other regulatory documents that provide additional clarity, instructions and/or the FDA’s current thinking on issues specific to the newly-regulated products.
Final Rule and Accompanying Documents
Resources for Additional Information
FDA continues to update its
Deeming webpage to provide information designed to help industry understand the Deeming rule. We anticipate that many of your questions will be addressed by the resources available on this website. 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, including one specifically addressing
requirements for vape shops, to our website and updates will be provided as additional webinars are available.
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
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Center for Tobacco Products
Food and Drug Administration
CTP Call Center:
1-877-CTP-1373
www.fda.gov/tobaccoproducts