FDA WARNING_LETTER - Food for Health International, LLC - May 04, 2012

On October 5, 2012, the FDA issued a Warning Letter to Food for Health International, LLC, following an inspection from April 12 to May 4, 2012, of their dietary supplement manufacturing facility in Salt Lake City, Utah. The inspection revealed numerous violations of Current Good Manufacturing Practice (CGMP) regulations for dietary supplements (21 CFR Part 111), causing their products to be adulterated under section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act).

Additionally, the product "Activz Control" was found to be an unapproved new drug under section 201(g)(1)(B) and 201(p) of the Act, due to therapeutic claims on its label and website (e.g., "promotes blood sugar balance," "reducing bad cholesterol," "decreasing hypertension," "fight free radicals that cause disease"). These claims establish the product's intent for disease treatment or prevention, making it an unapproved new drug that is also misbranded under section 502(f)(1) for lacking adequate directions for use by a layperson.

Key CGMP violations included: 1. Failure to establish required specifications for manufacturing processes, components (purity, strength, composition, contamination limits), labels, packaging, and finished product identity, purity, strength, and composition (21 CFR 1