FDA WARNING_LETTER - Deggeh Foods, Inc. - January 10, 2022

The FDA inspected Deggeh Foods, Inc. (Bronx, NY) from November 2021 to January 2022, identifying serious violations of the Federal Food, Drug, and Cosmetic Act. Four products (Actibest® Health Plus Capsules, Best Hemorrhoids Rapid Action Herbal Healing Formula, StomachAID capsules, and Moringa Tea Bags) are deemed unapproved new drugs (21 U.S.C. 321(p)) due to disease claims. Three of these (Actibest®, StomachAID, Moringa Tea Bags) are also misbranded drugs (21 U.S.C. 352(f)(1)) for lacking adequate directions for use, requiring professional supervision. The facility also violated Current Good Manufacturing Practice (CGMP) for dietary supplements (21 CFR Part 111), rendering products adulterated. CGMP deficiencies included failure to establish specifications, written procedures for quality control, product complaints, packaging/labeling, traceability, holding/distribution, environmental monitoring, returned products, and cleaning/pest control for the plant and equipment. Additionally, several dietary supplements (StomacAID, Actibest®, Best Hemorrhoids) were misbranded (Section 403) due to numerous labeling non-compliances, such as incorrect nutrition presentation, inaccurate serving sizes, missing net quantity, undeclared ingredients, proprietary blend issues, missing statements of identity, absent manufacturer details, and lack of disclaimers or dual-language repetition. The Moringa Tea Bags product, a conventional food, was also misbranded for improper nutrient content claims, incorrect nutrition format, serving size, and missing business information. The firm must respond within 15 working days with specific corrective actions and documentation to prevent recurrence, or face potential legal action.