FDA Takes Actions Against Companies Manufacturing and Marketing Unapproved Drug Products

October 21, 2010 9:05 AM

Last week, FDA issued warnings to eight companies marketing unapproved over-the-counter (OTC) chelation products, and also entered a consent decree prohibiting a Montana manufacturer from continuing to make or sell drugs with unapproved health claims. The eight companies marketing OTC chelation products make unproven claims, in violation of federal law, that the drugs can remove toxic metals from the body and some claim that the products can treat a number of serious conditions. In a press release, FDA stresses that the products are unapproved, may cause serious health risks such as dehydration and kidney failure, and may also delay patients seeking effective medical care. Further, the agency notes that the only approved chelation products are available by prescription for use in specific indications.

FDA also reported that two individuals doing business as Risingsun Health and The Center for Complimentary and Alternative Health of Livingston, Montana “signed a consent decree that prohibits them from manufacturing and selling unapproved new drugs and adulterated or misbranded dietary supplements in violation of the law.” According to a FDA news release, Risingsun manufactured and distributed unapproved, ineffective products claimed to treat serious diseases and conditions such as skin cancer, breast cancer, and epilepsy. Deborah M. Autor, director of the Office of Compliance in FDA’s Center for Drug Evaluation and Research stated that “FDA will not tolerate unsubstantiated health or disease claims that may mislead customers.”