Herbal Nitro Inc. – FDA Warning Letter, May 10, 2011

On September 22, 2011, the FDA issued a Warning Letter to Herbal Nitro Inc. following an inspection from May 3-10, 2011. As an own-label dietary supplement distributor contracting manufacturing, Herbal Nitro Inc. is considered a manufacturer and is responsible for its products. The inspection revealed significant violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 111), rendering their dietary supplements adulterated under Section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. Failure to establish specifications for identity, purity, strength, and composition for components used in manufacturing (21 CFR 111.70(b)). 2. Failure to establish product specifications for identity, purity, strength, composition, and contamination limits for finished dietary supplements (21 CFR 111.70(e)). 3. Failure to verify that finished dietary supplements (e.g., male libido enhancement capsules, alluraTRIM appetite suppressant capsules) met product specifications (21 CFR 111.75(c)). 4. Failure to conduct at least one appropriate test to verify the identity of dietary ingredient components (e.g., (b)(4) Blend, (b)(4) Extract), instead relying improperly on supplier Certificates of Analysis (21 CFR 111