FDA WARNING_LETTER - CC Pollen Company - April 14, 2025

The FDA issued a Warning Letter to CC Pollen Company on January 9, 2026, following an inspection from April 7 to April 14, 2025. The inspection revealed significant violations of the Federal Food, Drug, and Cosmetic Act, leading to their Bee Pollen Granules and Royal Jelly capsules being classified as adulterated and misbranded. The adulteration stemmed from serious non-compliance with Current Good Manufacturing Practice (CGMP) regulations for dietary supplements (21 CFR Part 111). Key CGMP violations included the failure to establish finished product specifications for identity, purity, strength, and composition; inadequate quality control approval of component specifications; failure to reject non-conforming components (specifically a Silica lot); absence of written master manufacturing records for each unique formulation; and insufficient identity testing of dietary ingredients prior to use. Additionally, the Royal Jelly capsules were misbranded due to an incorrect serving size declared on the label, which contradicted the product"s directions for use. The company"s initial response to these observations was deemed inadequate due to a lack of supporting documentation for proposed corrective actions. CC Pollen Company is required to provide a written response to the FDA within 15 working days, detailing specific corrective actions, preventive measures, and comprehensive supporting documentation to address these violations and avoid potential legal action.