FDA WARNING_LETTER - Mayor Laboratories Inc - May 24, 2012

An FDA inspection of Mayor Laboratories, Inc. (May 16-24, 2012) revealed significant Current Good Manufacturing Practice (CGMP) violations (21 CFR Part 111), rendering dietary supplements adulterated. Product labeling also showed misbranding (21 U.S.C. § 343, 21 CFR Part 101).

Several products, including Vitamist sprays, are promoted with therapeutic claims (e.g., for Crohn's, autism) classifying them as unapproved new drugs (21 U.S.C. § 321(g)(1)(B), § 321(p)). Marketing these without FDA approval violates 21 U.S.C. § 355(a) and § 331(d). Additionally, some drug products are misbranded (21 U.S.C. § 352(f)(1)) due to inadequate directions for use, violating 21 U.S.C. § 331(a).

CGMP violations for dietary supplements include failure to establish comprehensive specifications for manufacturing processes, components, and finished products (21 CFR 111.70). The firm also failed to conduct identity testing for dietary ingredients or qualify suppliers for COA reliance (21 CFR 111.75). Master Manufacturing Records lacked necessary specifications (21 CFR 111.205(b)(1)), and written manufacturing procedures were absent (21 CFR 111.353).

Dietary supplement misbranding issues include non-compliant nutrition information, missing Supplement Facts panels (21 CFR 101.36), inadequate product identification (21 CFR 101.3(g)), and omission of adverse event reporting contact information (21 U.S.C. § 343(y)).

Mayor Laboratories must respond within fifteen working days with corrective actions. Failure to comply may lead to legal action, including seizure or injunction, and FDA reinspection fees.