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FDA expands sample rules to ban most sweepstakes, vaping contests, and other freebies

The FDA deeming regulations are often viewed as a thorn in the side of both consumers and vape shops alike, and now the agency has just updated its policies regarding free samples and other giveaways.  In 2010, the agency issued regulations that prohibits the distribution of free samples of tobacco products.  The ruling was later expanded in May 2016 to also include e-cigs, e-liquids, and other vaping supplies. 

As of August 8, 2016, vape shops are no longer allowed to offer free samples to their customers, but the regulations have just been revised once again.  According to an announcement of October 11, 2017, the FDA is now prohibiting other forms of creative marketing involving freebies, including the following:

  • Membership and rewards programs
  • Many forms of business-to-business exchanges (but not all)
  • Contests and games of chance
  • All forms of non-monetary exchanges

The new rules will also apply to all tobacco stores and vape shops, as the agency now classifies all of these related items as tobacco products. The newly updated policy is entitled The Prohibition of Distributing Free Samples of Tobacco Products and is readily available for review on the FDA website.

Delving deeper into the new FDA guidelines

The document takes special care to clearly define such terms as distributor, manufacturer, and retailer, perhaps as a dedicated effort to cover any potential loopholes.  Essentially, the new rules apply to any vendor of vaping supplies or products “derived from tobacco.”  Even though e-liquids are 100% tobacco-free, the FDA still considers them tobacco products simply because they contain nicotine, in most cases. 

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The issue of “tobacco products” is at the very heart of the debate regarding the legality of the FDA deeming regulations as they apply to electronic cigarettes.  In fact, a consolidated lawsuit filed by Nicopure Labs and eleven co-plaintiffs is currently making its way through the judicial process with this issue as a primary basis for their argument. 

Until the FDA deeming regulations are either overturned or rewritten to exclude vaping products entirely, vape shops must adhere to the newly updated guidelines.  Some of the legal ramifications include:

  • Vape shops are prohibited from offering free e-cigarettes or related products in exchange for consumers signing up for a mailing list.
  • Vape shops are prohibited from offering coupons for free items.
  • Free e-cigarettes or related products issued through awards programs are also prohibited. An example might be punch card programs.
  • Distribution of free e-cig and vaping supplies via paid membership programs is also banned.
  • Free e-cigs or vaping products issued through sweepstakes, raffles, games of chance, and other contents are now prohibited by the FDA.

The newly revised FDA ruling also offers guidance for those rare instances where coupons, sweepstakes, and contests are not legally prohibited.  The document also makes clear that certain forms of business-to-business exchanges remain unregulated as long as the free samples are distributed “in a limited quantity” and “necessary to achieve a business or market goal.”

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