Nature's Health Company, LLC – FDA Warning Letter

The FDA issued a Warning Letter to Nature's Health Company, LLC, based on a review of their website, www.nature-s-health.com. The FDA determined that 18 products, including "Cardiac Balance I(60)," "Notoginseng," "Shark Cartilage (30)," "Milk Thistle Seed," and "Cell Balance," were promoted for conditions that classify them as drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act).

The therapeutic claims, including those in personal testimonials, establish the products as drugs intended for the cure, mitigation, treatment, or prevention of disease. Examples of claims include "Increases contraction force of cardiac muscle" for Cardiac Balance I(60), "Notoginseng can stop congealing in vessel, thin blood and dissolve blood clots," and "Shark cartilage appears to contain a substance with the ability to block the growth of new blood vessels" for Shark Cartilage(30).

These products are considered "new drugs" under section 201(p) of the Act because they are not generally recognized as safe and effective for their promoted uses and lack prior FDA approval, violating section 505(a). Furthermore, the products are misbranded under section 502(f)(1) because adequate directions for use by a layman cannot be written for conditions not amenable to self-diagnosis and