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Posted June 27, 2012

Maker of Pain Relief, Virility, and Idebenone Products Warned of Violations by FDA

On June 19, 2012, the U.S. FDA warned ABCO Laboratories of Fairfield, Caliornia, a contract manufacturer, of violations of FDA regulations for its products IBU-RELIEF 12, Sexual Virility Max, and Idebenone Capsules.

IBU-RELIEF cream, which is marketed as a homeopathic drug for "pain relief", lists two ingredients not approved as external analgesics -- arnica montana (a homeopathic remedy) and ibuprofen. Ibuprofen is also not recognized as a homepathic drug. The FDA considers the product an unapproved new drug.

Sexual Virility Max, a dietary supplement, was found to contain two synthetic chemical analogues of sildenafil, the active pharmaceutical ingredient found in Viagra. The FDA considers the product an unapproved new drug and in violation of several FDA rules. (See's Product Review of Sexual Enhancement Supplements for tests of supplements containing permitted ingredients.)

In addition, the FDA found that the compnay was producing Idebenone Capsules and warned that idebenone is not approved as an ingredient in dietary supplements (nor is it approved as a drug in the U.S.).

The FDA also warned the company that it was not producing dietary supplements according to Current Good Manufacturing Pratice regulations.

For more details, see the Warning Letter using the link below.