FDA WARNING_LETTER - Quantum Herbal Products - June 28, 2012

The FDA inspected Quantum Herbal Products, Inc. from June 13-28, 2012, identifying significant violations of dietary supplement Current Good Manufacturing Practice (CGMP) regulations (21 CFR Part 111), causing products to be adulterated.

Key violations include: 1. **Unapproved New Drugs:** "Breath Freely Formula" and "Colloidal Silver" are promoted with therapeutic claims (e.g., "effective as corticosteroids," "potent non-toxic natural antibiotic"), classifying them as unapproved new drugs under sections 201(g)(1)(B) and 201(p) of the Act, violating sections 301(d) and 505(a). 2. **Dietary Supplement CGMP Violations:** * Failure to conduct identity testing for dietary ingredients (e.g., Slippery Elm Powder) before use (21 CFR 111.75(a)(1)(i)). * Failure to establish required specifications for manufacturing processes, in-process materials, and finished products (21 CFR 111.70(a), (c), (e)), and ensure Quality Control approval (21 CFR 111.105(a)). * Failure to follow written procedures for product complaints, investigate complaints, and maintain complete complaint records (21 CFR 11