FDA WARNING_LETTER - Half Hill Farm Inc - May 30, 2025

The U.S. Food and Drug Administration (FDA) issued a warning letter to Half Hill Farm Inc. following an inspection of its Woodbury, Tennessee, facility conducted from May 28 to May 30, 2025. The letter identifies significant violations of the Federal Food, Drug, and Cosmetic Act regarding the marketing of the company’s Turkey Tail, Chaga, and Red Reishi Mushroom Extracts.

The FDA determined these products are being sold as unapproved new drugs because the company’s website uses scientific citations and research references to claim the extracts can treat, prevent, or mitigate serious diseases, including various cancers and viral infections. Under federal law, products intended for such uses must undergo an FDA approval process to prove safety and effectiveness. Additionally, the products are classified as misbranded because they lack adequate directions for use. Because the diseases mentioned require professional medical diagnosis and supervision, the FDA concluded it is impossible for a layperson to use the products safely as labeled.

Although the company provided a prior response to inspectional observations, the FDA found it insufficient as it lacked documentation proving that corrective label changes were made. Half Hill Farm Inc. must now investigate the violations, implement corrective actions to ensure compliance with federal regulations, and provide a written response to the FDA within 15 working days. Failure to address these concerns may result in legal action, including product seizures or injunctions.