The Food and Drug Administration is warning consumers to avoid a vitamin B dietary supplement from Healthy Life Chemistry by Purity First because it contains two potentially dangerous anabolic steroids.
The agency says the company's B-50 supplements tested positive for methasterone and dimethazine, two steroids sometimes used illegally by bodybuilders. Neither ingredient is listed on the product's labeling.
Federal regulators have received 29 reports of side effects connected with the product, including fatigue, muscle cramping and pain. Some of the cases have resulted in hospitalization, but there have been no reports of death or liver failure.
The product is manufactured by Mira Health Products Ltd. of Farmingdale, N.Y. and sold online and in stores. The FDA says the company has declined a government request to voluntarily recall the product.A vitamin B dietary supplement called B-50 contains two anabolic steroids and has been cited as causing unusual hair growth in women and impotence in men, U.S. health regulators said on Friday, warning consumers to avoid the product.
The product, sold by Healthy Life Chemistry By Purity First, contains the steroids methasterone and dimethazine, both of which are potentially dangerous. The ingredients are not listed on the label and should not be in a dietary supplement, the Food and Drug Administration said.
Women who used the product reported unusual hair growth and missed menstruation, and men reported impotence and low testosterone, the FDA said.
The FDA said Healthy Life Chemistry has refused to voluntarily recall the product, which is manufactured by Mira Health Products. Both companies are based in Farmingdale, New York. It is sold through various websites and retail stores.
The company could be liable to criminal prosecution if it continues to sell B-50, the FDA said.
A person who answered the phone at Healthy Life Chemistry said she could not to speak about the FDA's letter, but said she would ask a supervisor to return the Reuters call.
The FDA said it first became aware of the problem from a physician who treated 20 patients with similar symptoms of fatigue and muscle pain as well as abnormal lab tests. All the patients had been referred by another physician who had been prescribing a regime of dietary supplements. The one common product was the Healthy Life Chemistry product.
The FDA collected samples of the product and discovered the steroids.