FDA WARNING_LETTER - Nutritional Counselors of America - January 03, 2008

On December 3-4, 7, 2007, and January 3, 2008, an FDA inspection of Nutritional Counselors of America in Spencer, Tennessee, revealed several violations. The FDA determined that some products, including Zinc Citrate, L-Glycine, Graviola, Hawthorne Berry, Cloves, and Olive Leaf Extract, are unapproved new drugs under Section 201(g)(1)(B) and 201(p) of the Federal Food, Drug, and Cosmetic Act (the Act) due to disease treatment/prevention claims on their labels (e.g., "aids in healing of burns and wounds," "helps prevent epilepsy"). These products lack FDA approval required by Section 505(a) of the Act.

Furthermore, "L-Glycine," "Graviola," "Hawthorne Berry," "Cloves," "Vanadyl Sulfate," "Olive Leaf Extract," and "Pine Bark Extract" are misbranded under Section 502(f)(1) for lacking adequate directions for use. The "Maturity" product is misbranded under Section 403(a)(1) due to false and misleading nutrient daily value percentages (e.g., 50mg Thiamin declared as 33% DV instead of 3333%). Both "Maturity" and "Multivite" are misbranded under Sections