FDA issues warning letters to distributors of food, dietary supplements and unapproved drugs that contain ...

A Kansas City company is illegally marketing pills that have opioid-like effects and could face possible action, the U.S. Food and Drug Administration wrote in a warning letter sent Tuesday.

The FDA has issued warnings to seven companies for illegally marketing kratom-based products containing 7-OH, a compound not approved for food or supplements, citing safety concerns and unproven ...

The Stop Gas Station Heroin coalition today commended the U.S. Food and Drug Administration (FDA) for issuing warning letters to companies marketing "7" — a dangerous semi-synthetic alkaloid often ...

The warning reflects growing concern over a surge in opioid products marketed to US consumers containing concentrated levels of 7-hydroxymitragynine (7-OH).

By Stephanie Brown HealthDay ReporterTUESDAY, July 15, 2025 (HealthDay News) -- The U.S Food and Drug Administration has ...

“There are no FDA-approved drugs containing 7-OH, and it is illegal to market any drugs containing 7-OH,” the FDA said.

Kratom, made from the leaves of a tropical tree called Mitragyna speciosa that is native to Southeast Asia, contains two main ...

The U.S. Food and Drug Administration is bringing attention to an unlawful dietary supplement that is turning up in online ...

The letters, many of which were already available online, detail why the regulators initially declined to approve some drugs.

As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months ...