FDA Issues Warning Letters to 11 Supplement Companies

On May 9, the FDA posted warning letters to 11 companies for selling adulterated dietary supplements that either contained new dietary ingredients (NDIs) for which the FDA had not received the required premarket NDI notifications, or contained unsafe food additives. FDA also determined some of the dietary supplements to be unapproved drugs because they were intended for use in the cure, mitigation, treatment, or prevention of disease. As noted in the warning letters, the FDA has not evaluated whether the unapproved products are effective for their intended use, the proper dosage, potential interaction with FDA-approved drugs or other substances, or whether they have dangerous side effects or other safety concerns.

The dietary supplements at issue contained one or more of the following ingredients: 5-alpha-hydroxy-laxogenin, higenamine, higenamine HCl, hordenine, hordenine HCl, and octopamine. Notably, the FDA has previously expressed concern over potential adverse effects from some of these ingredients, such as the potential effects that higenamine may have on the cardiovascular system.

The FDA requested the companies respond to the warning letters within 15 working days and describe how they will address the issues, or provide reasoning and substantiation as to why they believe the products are not in violation of the law. Failure to adequately address could result in legal action, such as product seizure and/or injunction.