On June 1, 2012, the U.S. Food and Drug Administration (“FDA”) issued an alert to consumers on the product Reumofan Plus. Purportedly marketed as a dietary supplement, Reumofan Plus is manufactured in Mexico by the company Riger Naturals. According to the Agency the product poses a risk to consumers and those currently taking the product should cease use and contact a health professional immediately. The alert issued by the FDA may be accessed here.
The FDA warned of several deficiencies it found with the product. In particular, the FDA noted that the label, which appears solely in Spanish, identifies the product for use in the treatment of various diseases and conditions, including arthritis, muscle pain, osteoporosis, and bone cancer, among others. Under FDA regulations, while dietary supplements may contain structure-function claims, statements that a product may be used to treat a disease or condition may cause a product to be regulated as a drug.
In the case of Reumofan Plus, the deficiencies the FDA allegedly discovered go far beyond simple marketing issues. Rather, the FDA’s alert also discusses how the product was discovered to contain diclofenac sodium and methocarbamol. Diclofenac sodium is used as a prescription non-steroidal anti-inflammatory drug (“NSAID”), particularly the drug Voltaren. Methocarbamol is a prescription muscle relaxant, i.e., the drugs Robaxin and Rabdolax. To make matters worse, the FDA notes that the product has also been the subject of several adverse events. Judging from the Alert, it appears that Reumofan Plus and the manufacturer thereof, Riger Naturals, have run the gamut with the types of regulatory violations alleged by the FDA.