FDA WARNING_LETTER - Hadassah Healing Oils Ltd - May 01, 2026

On June 17, 2026, the FDA issued a warning letter to South Africa-based Hadassah Healing Oils Ltd following a May 2026 review of the company’s website. The regulatory action centers on the marketing of the "Prostate Blend" product, which the FDA classified as an unapproved new drug. The agency found that the company’s website featured claims suggesting the product could heal prostate cancer, treat benign prostate enlargement, and relieve urinary symptoms. Under the Federal Food, Drug, and Cosmetic Act, products intended to diagnose, cure, mitigate, or treat diseases are classified as drugs and must receive FDA approval for safety and effectiveness before being sold in interstate commerce. Because Hadassah Healing Oils Ltd lacks this approval, the distribution of "Prostate Blend" violates federal law. The FDA has ordered the company to identify the root causes of these violations and implement corrective strategies to prevent recurrence. A formal written response outlining these steps and providing supporting documentation must be submitted to the agency within fifteen business days. Continued non-compliance could lead to legal actions such as product seizure or court-ordered injunctions.