Regal Health Food International, Inc. – FDA Warning Letter, Apr 2, 2024

The FDA issued a Warning Letter to Mr. Piatigorsky on November 29, 2023, regarding misbranded Regal Gourmet Snacks Milk Chocolate Raisins (16oz., UPC #028744201002) with a best-by date of “04/07/24.” The product was found to be misbranded under section 403(w) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 343(w)] because its label failed to declare peanuts, a major food allergen.

This misbranding was identified following a consumer complaint on June 6, 2023, which led to a product recall. The firm indicated that milk chocolate peanuts were mistakenly packed into tubs labeled “Milk Chocolate Raisins” due to an error by packers.

The firm proposed corrective actions including retraining employees, additional labeling of work-in-progress, enhanced product and label confirmation steps, and using a dedicated line to minimize errors. The FDA will verify these actions during the next inspection.

The letter also noted that the facility is subject to the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food regulation (21 CFR Part 117). Failure to comply with preventive controls for undeclared allergens is prohibited by section 301(uu) of the Act [2