U.S. Tobacco Companies Revive Challenge to FDA Over Labeling

U.S. tobacco companies on Wednesday filed a lawsuit against the U.S. Food and Drug Administration hoping to stop the agency from enforcing a directive on changes to a tobacco product’s labeling or quantity.


The lawsuit brought by subsidiaries of Imperial Tobacco Group, Reynolds American Inc and Altria against the FDA in the U.S. District Court for the District of Columbia is the second this year over the directive.

Tobacco companies withdrew an earlier lawsuit in June after the FDA said it would hold off on enforcement actions while it considered additional input on the policy.

The FDA released a new version of the directive on Sept. 8, but plaintiffs said it had not meaningfully changed from the original.

The companies claim that even with the revisions the guidance unlawfully imposes on their commercial speech rights under the First Amendment and exposes them to civil or criminal penalties, according to the lawsuit.

The FDA guidelines were initially issued by the FDA in March to help clarify what changes to a tobacco product require regulatory approval under the 2009 Tobacco Control Act.

The FDA said that significant modifications to a product’s label that make it distinct from the original version, such as a logo or recognizable color pattern, or changes to the quantity sold in each package, could require authorization.

Altria spokesman Brian May said in a statement that the company continued to disagree with the FDA's requirements.

A spokesman for Reynolds American, David Howard, called the FDA’s actions an attempted “end run” around the Tobacco Control Act.

An FDA spokesman declined to comment, and a representative for Imperial Tobacco Group could not immediately be reached for comment.

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According to the tobacco companies' lawsuit, the Tobacco Control Act limits the FDA's ability to require approval for tobacco product changes to two narrow circumstances: products claiming to reduce tobacco-related risks, or when prior approval is required by regulation.

Although the guidance is framed as non-binding recommendations, rather than a formal regulation, it creates legal obligations with “clear and draconian consequences,” the lawsuit said. Plaintiffs also say the FDA failed to follow proper rulemaking procedures required for such a substantive measure.

Plaintiffs are seeking an order declaring the directive unlawful, vacating it and stopping the FDA from enforcing it.