# FDA WARNING_LETTER - Quantum Herbal Products - June 28, 2012

Source: https://www.keypedia.com/records/warning_letter/quantum-herbal-products/fa54ad40-0328-434b-b063-99890071677f

> FDA WARNING_LETTER for Quantum Herbal Products on June 28, 2012. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Quantum Herbal Products
- Inspection Date: 2012-06-28
- Product Type: Food
- Office Name: New York District Office
- Summary: 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

## Related Officers

- [Kristen C. Jackson](https://www.keypedia.com/people/kristen-c-jackson/9d19b70c-6db1-4249-8372-f2140f326c9a)
- [Program Director](https://www.keypedia.com/people/ronald-m-pace/a79d2af4-650e-4220-8de1-92bbd284457d)

Company: https://www.keypedia.com/companies/quantum-herbal-products/9046ae32-e62c-4436-be8c-7cd90cad6cda

Office: https://www.keypedia.com/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d