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In a first for FDA’s Center for Tobacco Products, Civil Monetary Penalty complaints have been filed against four manufacturers of e-liquids for violation of the Food Drug and Cosmetic Act (FD&CA) by selling tobacco products without an FDA marketing order.

FDA had previously notified each of the four companies via warning letters that they risked enforcement action as their products were in violation of US law. Despite these warnings the firms continued to manufacture and sell their e-liquid products in the US marketplace.

It is illegal to manufacture, sell, or distribute e-liquids, or any tobacco product, that the FDA has not authorized. Violators can expect agency enforcement actions which include civil monetary penalties, seizures, injunctions and criminal prosecution. In each of the aforementioned cases, FDA is seeking the maximum allowable civil monetary penalty for tobacco products of $19,192 for a single violation.

These penalties are the latest in FDA’s crackdown on the illegal sale of tobacco products. Between January 2021 through February 17, 2023, the FDA issued more than 550 warning letters to firms—both large and small—for manufacturing, selling, and/or distributing new tobacco products without marketing authorization from the FDA. After receiving warning letters, a majority of these companies have complied and removed their products from the market. Manufacturers that continue to violate the law risk subsequent enforcement.

EAS Consulting Group and Labstat, both part of the Certified Group, offer support for FDA tobacco marketing applications including regulatory reviews, laboratory testing, FDA correspondence and preparations for an FDA inspection. If we can be of assistance to your firm, please contact us.

Posted in FDA and USDA Regulatory Update.