BioNeurix Receives Warning Letter from FDA

WASHINGTON Earlier this year, FDA warned BioNeurix Corp. that it is making unlawful claims on its website, www.pharma-tree.com.

In the Oct. 15 letter, the agency declared that its products "Blood Sugar 360", "Amoryn", "Seredyn" and "Mellodyn" are promoted for conditions that cause them to be drugs because they are intended to cure, mitigate, treat or prevent a disease. The agency cited several claims referencing diabetes.

The marketing claims violate the Federal Food, Drug, and Cosmetic Act, FDA alleged.

BioNeurix was given the customary 15 days to respond to FDA's warning letter.