FDA WARNING_LETTER - Natural Health Team - November 30, 2011

The FDA issued a Warning Letter to Dr. James A. Howenstine of Natural Health Team, following a November 2011 review of his website (www.mynaturalhealthteam.com, redirecting to www.savingmyhealth.com) and his book, "A Physician's Guide to Natural Health Products That Work."

The FDA determined that 15 products—"Alpha Lipoic Acid (ALA) 100 mg", "Arctic Omega", "Beyond Any Multiple", "Coral Calcium", "L-Lysine", "Nanonized Detoxifying Formula", "Noni Concentrate", "Oral Guard", "Samento", "Thymic Extract", "Xlear", "Zeolite", "LifeOne", and "Del Immune V"—are promoted with claims that establish them as unapproved new drugs under the Federal Food, Drug, and Cosmetic Act. These claims, found on the website and in the book, suggest the products are intended for the cure, mitigation, treatment, or prevention of diseases such as diabetes, heart attacks, strokes, cancer, herpes, autism, Lyme disease, lupus, rheumatoid arthritis, psoriasis, multiple sclerosis, hepatitis, asthma, sinusitis, HIV, and cystic fibrosis.

Since these products are not generally recognized as safe and effective for these uses, they are considered "new drugs" requiring prior FDA approval, which they lack. Furthermore, because the conditions they claim to treat are not amenable to self-diagnosis and