Penn Herb Company, Ltd. – FDA Warning Letter, Jun 8, 2026

The FDA issued a warning letter to Penn Herb Company, Ltd. following an inspection of its Philadelphia facility conducted between May 12 and June 8, 2026. The inspection revealed significant violations of the Federal Food, Drug, and Cosmetic Act and the associated Current Good Manufacturing Practice (CGMP) regulations for dietary supplements. Consequently, several products—including Ashwagandha Root, Mexican Sarsaparilla Root, and Black Walnut Hulls—are considered adulterated due to inadequate manufacturing conditions. Key violations included a failure to establish proper identity and contamination specifications for raw ingredients; for instance, the company relied on basic sensory checks that could not distinguish between similar botanical species. Additionally, the firm failed to set quality standards for finished products beyond simple capsule weight. Investigators also documented serious sanitation failures, such as equipment contaminated with debris from previous production runs, the improper reuse of spilled powder using unsanitized tools, and the use of an unapproved skin antiseptic to clean food-contact surfaces. The FDA also noted a labeling violation regarding the failure to declare "tree nuts" as a major allergen on the Black Walnut Hulls product. Penn Herb Company is required to provide a written response within 15 working days detailing the specific steps taken to correct these violations and prevent their recurrence. Failure to address these concerns may result in legal action, including product seizure or injunctions.