Altria Group Inc. filed a lawsuit Wednesday against the U.S. Food and Drug Administration, alleging the agency’s process for reviewing premarket tobacco product applications does not comply with federal regulations that require timely authorization of products.
The complaint was filed by Helix Innovations LLC and NJOY LLC, both owned by Altria, and challenges the FDA’s current system for reviewing a range of tobacco products, including nicotine pouches and vaping devices.
Altria cites federal tobacco and administrative statutes
The filing asserts that federal laws require the agency to comply with its obligations under the Family Smoking Prevention and Tobacco Control Act and the Administrative Procedure Act and to authorize products in a timely manner. The complaint alleges the FDA has not met those obligations.
