FDA WARNING_LETTER - Intensive Nutrition Incorporated - March 11, 2013

On January 22, 2014, the FDA issued a Warning Letter to Intensive Nutrition Incorporated following an inspection from March 4-11, 2013, at their San Leandro, CA facility, which manufactures, packages, labels, holds, and distributes dietary supplements.

The inspection revealed significant violations of FDA's Current Good Manufacturing Practice (CGMP) regulations for dietary supplements (21 CFR Part 111). Additionally, product labeling, including that on their website, was reviewed.

Key violations include: * **Unapproved New Drug:** The "Tanalbit" product is promoted with therapeutic claims (e.g., "effectively remove pathogenic yeast and bacteria cells," "anticarcinogenic and antimutagenic compounds") that cause it to be an unapproved new drug under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act). * **Adulterated Products (CGMP Violations):** Both "Tanalbit" and "Tabit" dietary supplements are adulterated under Section 402(g)(1) of the Act due to CGMP violations, including: * Failure to use appropriate, scientifically valid methods for identity testing (21 CFR 111.75(h)(1)). * Failure to establish finished product specifications for identity, purity, strength, composition, and