Nature's Pearl Corporation – FDA Warning Letter, Dec 31, 2011

The FDA reviewed Nature's Pearl Corporation's website in December 2011 and determined that their "Nature's Pearl® Premium Muscadine Grape Seed Supplement" is promoted for conditions that classify it as a drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act). The therapeutic claims, including "Inhibition of Cancer Cell Growth by Muscadine Grape Seed & Muscadine Grape Skin Extracts" and references to treating various cancers, establish the product's intended use in disease cure, mitigation, treatment, or prevention, violating the Act.

The product is considered a "new drug" under section 201(p) because it is not generally recognized as safe and effective for these uses and lacks prior FDA approval as required by section 505(a). Furthermore, the product is misbranded under section 502(f)(1) as it is offered for conditions not amenable to self-diagnosis and treatment, thus lacking adequate directions for layperson use.

Additionally, the website's claim "Nature's Pearl® has been certified by the FDA to be in Full Compliance under FDA 21 CFR 111" is false and misleading under section 403(a)(1), as FDA does not certify compliance with dietary supplement current good manufacturing practices.

Nature's Pearl Corporation must take prompt action to correct these violations. Failure to