FDA Issues New Guidance on E-Cigarette Free Samples

October 18, 2017

E-Cig Free Sample Ban.

Last week, the Food and Drug Administration (“FDA”) issued finalized guidance regarding the distribution of free samples of e-cigarettes and other tobacco products.

What do e-cigarette marketers need to know about product sampling, coupons and other promotions?

FDA E-Cigarette Rules

In 2010, the FDA issued regulations that, among other things, prohibited the distribution of free samples of tobacco products (except for smokeless tobacco distributed in “qualified adult-only facilities”).

As we have previously reported, the FDA issued a separate rulemaking in May 2016 that expanded the definition of “tobacco products” – and the ban on distributing free samples – to include e-cigarettes and related components, such as e-liquids and atomizers.

New FDA Guidance

On October 11, 2017, the FDA finalized guidance concerning the general ban on distributing e-cigarette and e-liquid free samples.

The FDA clarified in its guidance that certain e-cigarette marketing practices amount to the distribution of free samples and, therefore, are banned by FDA regulations.  Such prohibited marketing practices include:

  • distributing e-cigarettes or related components in exchange for consumers providing contact information or signing up for a mailing list;
  • distributing either of the following that could be redeemed subsequently by someone other than the purchaser of such products:
    • coupons for free e-cigarettes or components (e.g., “buy one e-liquid vial, get a coupon for a free e-liquid vial”);
    • rewards of free e-cigarettes or components issued through awards programs (e.g., punch card programs);
  • providing free e-cigarettes or related components to members of a paid membership program (e.g., club members) outside of a tobacco product sales transaction; and
  • giving away free e-cigarettes or components as prizes through a contest, sweepstakes or other game of chance (e.g., raffle) that can be entered outside of a tobacco product sales transaction.

The FDA also provided guidance on certain narrowly crafted discounts, coupons, samples, contests/sweepstakes and other promotions that are not prohibited by FDA regulations.

Is Your E-Cigarette Promotion Legally Compliant?

Across the country, lawmakers and regulators are cracking down on e-cigarette marketing.  While the above-referenced FDA announcement provides much-needed guidance on its free sample ban for e-cigarettes and related components, the prohibition’s exceptions are narrow, and the FDA noted that other applicable federal, state and local laws restrict how such promotions may be held.  As such, businesses and individuals operating in the e-cigarette space should be sure to speak with an experienced marketing attorney before commencing any e-cigarette marketing campaign.

If you are interested in learning more about this topic, need to review your e-cigarette marketing practices, or are being investigated by a regulatory agency, please e-mail us at info@kleinmoynihan.com or call us at (212) 246-0900.

The material contained herein is provided for informational purposes only and is not legal advice, nor is it a substitute for obtaining legal advice from an attorney.  Each situation is unique, and you should not act or rely on any information contained herein without seeking the advice of an experienced attorney.

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Related Blog Posts:

Vermont Vapor Up in Smoke for Allegedly Deceptive E-Cig Marketing Practices

Navigating the Maze of E-Cig Marketing Regulations

Summary of the Newly Proposed E-Cig Regulations


David Klein

David Klein is one of the most recognized attorneys in the technology, Internet marketing, sweepstakes, and telecommunications fields. Skilled at counseling clients on a broad range of technology-related matters, David Klein has substantial experience in negotiating and drafting complex licensing, marketing and Internet agreements.
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