The U.S. Food and Drug Administration has issued seven warning letters to companies illegally marketing products containing 7-hydroxymitragynine (7-OH), which is found in trace amounts in kratom.

Based on peer-reviewed research from leading experts, highly concentrated or semi-synthetic 7-OH products pose significant ...

The Office of Prescription Drug Promotion "is concerned that, despite receiving this previous Warning Letter, Sprout continues to promote Addyi in a similarly misleading manner," it added.

The agency claims Whoop is marketing an unauthorized medical device intended to diagnose, cure, treat or prevent a disease.

The FDA has not published more than a dozen letters that flagged hazards at food companies, including potential contamination, two sources said.

Elanco Animal Health (NYSE:ELAN) has received a warning letter from the FDA related to promotional materials for its canine drug Zenrelia. In the letter, the FDA said that an agency review of ...

AACE pharmaceuticals was slammed in a warning letter by the FDA that cited significant violations by its contract manufacturer Brassica Pharma, including sanitary conditions and made up lab records.

BD received a warning letter after the Food and Drug Administration found fault with the practices at a facility that manufactures Pyxis medication management system medical devices. The letter ...

DexCom received a warning letter from the Food and Drug Administration following inspections of its San Diego and Mesa, Ariz. facilities and is working on a written response.

EyePoint was handed an FDA warning letter at its facility in Watertown, Massachusetts, in July, according to a notice from the agency posted Tuesday.