FDA Shows No Love to Libido Edge Labs

CINCINNATI Libido Edge Labs, Newark, OH, is under regulatory scrutiny for its marketing and distribution of a range of creams and pills for men and women to address hormone and sexual health. FDAs Cincinnati District Office sent a warning letter to the company June 10, 2010, raising concerns about several products including Natural Progesterone Cream USP with Adrenal Support, Testosterone Cream Formula for Women, Testosterone Cream Formula for Men, Total HGH Cream and LibidoEdge Capsules Natural Sexual Enhancement. The agency cited several regulatory issues related to the products, including product labeling and health claims.

FDA noted any over-the-counter (OTC) topical hormone-containing products represented for drug use are subject to new drug regulations; as they have not been approved, they are therefore unapproved new drugs. The agency cited product labeling for the creams that promote their use for addressing depression, weight loss, bone density and cholesterol levels. Further, while the products are labeled as containing homeopathic human growth factor, it is not an active ingredient listed in the Homeopathic Pharmacopeia of the United States (HPUS), meaning the products are not homeopathic drugs subject to certain enforcement policies.

Regarding the LibidoEdge Capsules, FDA stated as the product is specifically marketed for impotence, a disease condition, the product is therefore an OTC drug product, not a dietary supplement, and must be approved before sale.