FDA WARNING_LETTER - Nature's Health Supply - May 31, 2013

On July 15, 2013, the FDA issued a Warning Letter to Eric Sclar of Nature's Health Supply, Inc., following a May 2013 review of ten company websites. The FDA determined that products sold on these websites, including "Diabetes Daily Care," "Prostate Miracle," and "Cholesterol Metabolizer," were promoted with therapeutic claims that classify them as unapproved new drugs under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)].

The letter cited numerous examples of claims from the websites, such as "Unique, Natural Formula, which Safely and Effectively Improves Sugar Metabolism in Type 1, Type 2, Hyperglycemia – and Pre-Diabetes" for "Diabetes Daily Care," and "Prostate Miracle® is 95% effective in treating an enlarged prostate." These claims, along with personal testimonials and metatags, establish the products' intended use for the cure, mitigation, treatment, or prevention of disease.

Since these products are not generally recognized as safe and effective for their claimed conditions, they are considered "new drugs" under section 201(p) of the Act [21 U.S.C. § 321(p)] and require prior FDA approval, which they lack. Furthermore, the products are deemed