Hearthy Foods, Inc. – FDA Warning Letter, Apr 14, 2025

The U.S. Food and Drug Administration (FDA) issued a warning letter to Hearthy Foods, Inc. following inspections of its Los Angeles facility conducted between March 19 and April 14, 2025. The investigation identified serious violations of federal food safety and dietary supplement manufacturing regulations. For its conventional food products, specifically whey protein, the company failed to perform hazard analyses for environmental pathogens like Salmonella and Listeria. Inspectors observed poor hygiene, such as employees touching unsanitized surfaces before handling food, and found accumulated filth on production equipment. Furthermore, the company failed to properly label milk allergens and omitted specific ingredients from product packaging. Regarding dietary supplements, including collagen and creatine, Hearthy Foods failed to establish quality specifications for ingredients and finished goods. The facility lacked essential manufacturing and batch records, quality control procedures, and failed to exclude pests, as evidenced by rodent droppings in storage areas. To address these violations, Hearthy Foods must submit a written response within 15 working days detailing its corrective actions and providing supporting documentation, such as new safety protocols and training records. Failure to rectify these issues may lead to legal action, including product seizures or injunctions.