FDA Sends Warning Letter to Mc-Cor for Promoting Supplement as Drug

A Puerto Rican drugmaker is drawing FDA scrutiny for promoting a supplement as a diabetes drug online.

An agency review of Mc-Cor’s website revealed numerous drug-like claims about its Glucocor capsules, according to a warning letter. The letter cites claims about the product’s supposed ability to maintain glucose levels for Type 1 and Type 2 diabetes — claims reserved for prescription drug products under the FD&C Act — that appeared on the company’s site and its Facebook page.

These claims led the agency to declare Glucocor an unapproved drug, and to an allegation of misbranding as well, since the product label adequate directions for the unapproved use.

None of the disputed claims had been removed from the company’s website.