FDA Issues Warning to Natures Health

WASHINGTONFDA issued a warning letter to Natures Health Co. LLC, Salt Lake City, in late September, after the agency determined the company was promoting several of its dietary supplements on its website using health claims that cause the products to be considered drugs. According to the agency, a range of products carry therapeutic claims that position the products to be used in the cure, mitigation, treatment or prevention of disease.

For example, products Cardiac Balance I and II and Notoginseng are promoted under a subhead Stroke & Herbs" with claims discussing control of arrhythmia, prevention of platelet aggregation, and dissolving blood clots. Personal testimonials are also included under the subhead, related to patients with diagnosed coronary artery disease who took the Cardiac Balance products for six months and symptoms disappeared or alleviated significantly."

Other sections and products include Osteoporosis and Herbs (Shark Cartilage keeps tumors from growing"); High Blood Pressure and Herbs (rubber tree has a relaxant effect on coronary artery"); Hepatitis A, B, C and Herbs (milk thistle seed helps relieve symptoms of acute and chronic hepatitis, hepatocirrhosis, fatty liver, damage of liver"); Multiple Sclerosis and Herbs; Anti-Diabetes; CancerEase (Cell Balance reduces the viability of tumors"); Parkinson Disease and Herbs; Gonorrhea and Herbs (Baicalein can restrain the activity of Neisseria gonorrhoeae, which is the causative agent of gonorrhea"); and Urinary Balance. FDA added, The unlawful disease treatment and prevention claims on your website were too numerous to list in this letter."

FDA noted the products have not been approved as safe and effective for the referenced uses by the agency as new drugs. Further, as the products are offered for conditions that are not amenable to self-diagnosis, the labeling bears inadequate directions for use, causing them to be misbranded. The agency advised the company to promptly correct any violative marketing, as failure to do so could result in enforcement action including possible seizure of products and injunctions against the company and its distributors.