DOJ Decision Weakens FDA’s Ability to Impose Monetary Penalties on Retailers that Sell Unauthorized Tobacco Products

WASHINGTON, D.C. – In yet another U.S. Government action that benefits the tobacco industry and harms public health, the U.S. Department of Justice has decided not to appeal a court decision that ruled against the FDA’s use of civil money penalties for retailers that are found selling illegal tobacco products. This decision backs away from one of the FDA’s strongest enforcement tools against the many unauthorized e-cigarettes and other illegal tobacco products currently on the market – including flavored products with proven youth appeal.

This latest action aligns with other recent U.S. Government actions that are favorable toward Big Tobacco. In May, the FDA announced guidance that allows many e-cigarette and nicotine pouch products to be marketed without the scientific review and FDA authorization required by federal law. The Campaign for Tobacco-Free Kids recently filed a federal lawsuit, joined by a coalition of public health organizations, pediatricians and parents, challenging this unlawful action.

In the latest action, the U.S. Solicitor General on Tuesday sent a letter to House Speaker Mike Johnson notifying him that the Justice Department has decided not to seek U.S. Supreme Court review of a decision by the U.S. Court of Appeals for the Fifth Circuit that found the civil money penalties to be an unconstitutional denial of the right to a jury trial (Texas Tobacco Barn v. HHS). The Fifth Circuit decision was based on a Supreme Court ruling in a securities fraud case in 2024 (SEC v. Jarkesy). The government’s latest position represents a significant and harmful shift. Until now, the Justice Department has consistently defended the FDA’s use of civil money penalties, including after the 2024 Supreme Court decision. The government stood a reasonable chance of prevailing at the Supreme Court, which has long recognized a “public rights” exception to the Seventh Amendment’s right to a jury trial, including cases involving protection of public health.

Of note, the Solicitor General’s letter suggests it may not be unconstitutional to levy civil money penalties against foreign companies that import and sell unauthorized products. Federal law is clear: Tobacco companies – regardless of whether they are U.S. or foreign manufacturers – are prohibited from introducing new tobacco products, including e-cigarettes and nicotine pouches, without prior FDA scientific review and authorization.

To protect public health, and especially the health of young people, the U.S. Government should be taking stronger enforcement actions against all unauthorized tobacco products. It should not give a free pass to big tobacco companies that have spent millions on high-powered lobbying and campaign contributions to undermine public health and evade regulation.