FDA WARNING_LETTER - Matrix Health Products, Inc.

On May 15, 2013, the FDA reviewed Earth's Bounty's website, www.earthsbounty.com, and determined that their Earth's Bounty, Colloidal Silver, Tahitian Organic Noni Juice, Tahitian Original Noni Juice, Tahitian Pure Noni Juice, Hawaiian Noni Juice, and Hawaiian Noni Juice Capsules products are 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 on the website, including those for cancer, heart disease, diabetes, pain, inflammation, and infections, establish these products as drugs intended for disease cure, mitigation, treatment, or prevention.

These products are considered "new drugs" under section 201(p) of the Act because they are not generally recognized as safe and effective for the claimed conditions and lack prior FDA approval. Furthermore, they are misbranded under section 502(f)(1) of the Act because they are offered for conditions not amenable to self-diagnosis and treatment, thus lacking adequate directions for layperson use. The introduction of misbranded drugs into interstate commerce violates section 301(a) of the Act.

The FDA also noted an issue with the Colloidal Silver product label image on the website, where ingredients are not listed immediately below the nutrition label, as required by 21 CFR