May 9, 2017
Last week, the U.S. Food and Drug Administration (“FDA”) disclosed in an Alabama federal court filing its plan to defer enforcement of all future e-cig marketing compliance deadlines for a period of three months.
Why should e-cigarette marketers remain cautious?
FDA’s 2016 E-Cig Rulemaking
In May 2016, the FDA finalized a set of new rules extending its regulatory authority to cover e-cigarettes. Several federal e-cig marketing regulations have already taken effect under the FDA rulemaking, including restrictions on:
- free samples;
- e-cigarette labeling and advertising; and
- marketing e-cigarettes in combination with other FDA-regulated products (e.g., food and cosmetics).
Other FDA regulations concerning e-cigarette packaging, advertising and applications for marketing authorization are scheduled to take effect in 2018 and 2019.
Federal Lawsuit and Enforcement Deferral Announcement
In July 2016, e-liquid distributor Cyclops Vapor 2, LLC and manufacturers/retailers Tiger Vapor, LLC and Karma S Clouds, LLC sued the FDA in the U.S. District Court for the Middle District of Alabama (Case No. 16-cv-556), challenging the legal validity of the FDA’s 2016 rulemaking. The plaintiffs claim that the FDA’s expansive rulemaking unlawfully exceeds the agency’s statutory authority under the Federal Food, Drug and Cosmetic Act.
On May 1, 2017, the above-referenced plaintiffs and the FDA filed a joint motion to extend all deadlines in the case, stating in relevant part:
“Due to the recent change in administrations, new leadership personnel at the Department of Health and Human Services seek additional time to more fully consider the issues raised in this case . . . . The FDA has represented that it will defer enforcement of all future compliance deadlines under the deeming rule for e-cigarette products for 3 months, and that it plans to issue guidance to that effect.”
As of this writing, the FDA has not clarified when the disclosed three-month deferral period will take effect, which of the FDA e-cigarette rulemaking deadlines will be deferred, or whether the enforcement deferral might signal a larger push by the new administration for deregulation in the e-cig marketing space.
E-Cigarette Marketers: Proceed with Caution
Lawmakers and regulators across the country are implementing stricter regulations in connection with e-cigarette marketing, often in the same vein as notoriously restrictive tobacco advertising laws already on the books. While the above-referenced federal court filing suggests a temporary reprieve from certain FDA enforcement action, it is important to note that a growing number of additional e-cig marketing regulations and licensure requirements have been implemented at the state, county and city levels. In this rapidly developing regulatory landscape, e-cigarette manufacturers and related marketing affiliates are at risk of regulatory action and other adverse legal consequences. 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.
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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