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Vaping free samples given at a vaping exhibition here in Spain (2016)

FDA releases a guidance document relevant to free samples

Earlier this month, the U.S. Food and Drug Administration (FDA), released draft guidance documents pertaining to the sampling of deemed tobacco products in retail stores.

Diane Caruana

January 26, 2017

Following the implementation of the FDA’s deeming rule last August, retailers selling “tobacco products” (electronic cigarettes do not contain any tobacco), are not allowed to give out any free samples of their products, which include e-cigs, vape pens, any other electronic nicotine delivery systems (ENDS), cigars, hookah tobacco, pipe tobacco, nicotine gels, dissolvable tobacco, and any components/parts of these items that even if they contain no tobacco.

The agency’s draft guidance states that retailers may only hand out any of these products in exchange for money. However, there are some exceptions, (which naturally come with a set of regulations and restrictions), including cases of membership and reward programs, coupons and discounts, and certain contests and games of choice. The FDA pointed out that potential violations will be dealt with on a case to case basis, after several considerations would have been made. Details pertaining to what is permissible or not are listed in the draft guidance.

Some retailers may be considered as manufacturers

Some conveniance stores that mix and prepare e-liquids and assemble vaporizers may be considered as tobacco products manufacturers.

An article published on the NACS (National Association of Convenience Stores) website, last week on the 19th of January, pointed out that although this draft may not mean much for convenience stores, some such outlets that mix and prepare e-liquids and assemble vaporizers may be considered as tobacco products manufacturers.

“These outlets, due to these activities, must comply with additional FDA regulations, including registration requirements, submitting lists of products and ingredients to the FDA, and submitting pre-market tobacco product applications to the FDA for review and authorization. Failure to comply with these requirements could subject retailers to fines and enforcement action from the FDA” read the website.

The draft guidance should be useful in assisting retailers selling tobacco products, by clarifying what activities subject such stores to additional requirements and /or which other activities are exempt from the latter. The draft guidance documents will be open for public comment for sixty days.