FDA WARNING_LETTER - Essential Pharmaceutical Corp - October 17, 2019

The FDA conducted an inspection of Essential Pharmaceutical Corp. (Pomona, CA) on October 8-10 and 17, 2019, identifying serious violations of the Federal Food, Drug, and Cosmetic Act.

**Violations:**

1. **Unapproved New Drug:** "BIO-MINT Nasal Spray" is marketed as an OTC drug but is an unapproved new drug, violating sections 505(a) and 301(d) of the Act. It is also misbranded under section 502(ee) and its introduction into interstate commerce is prohibited by section 301(a). The product is a drug intended as a nasal decongestant, antihistamine, and antiseptic, but is not generally recognized as safe and effective (GRASE) and does not conform to applicable monographs (21 CFR Part 341) regarding ingredient combinations (phenylephrine HCL, pyrilamine maleate, benzalkonium chloride).

2. **Adulterated Dietary Supplements (CGMP Violations - 21 CFR Part 111):** * Failure to establish specifications for components (identity, purity, strength, composition, contamination limits), e.g., D-Biotin, Bitter Melon Extract. Microbiological specifications were not considered identity specifications, and heavy metal contamination limits were absent. FTIR testing lacked valid reference standards. (21 CFR