Warning Letter — Hadassah Healing Oils Ltd
The FDA issued a warning letter to Hadassah Healing Oils Ltd on June 17, 2026, following an evaluation by the Center for Drug Evaluation and Research (CDER).
This affects Hadassah Healing Oils Ltd and its regulatory, marketing, and quality assurance departments responsible for product labeling and manufacturing compliance.
The issuance of a warning letter by CDER suggests that the company's products may be marketed with unapproved therapeutic claims or manufactured in a manner that does not comply with drug standards. This indicates a heightened level of regulatory scrutiny regarding the distinction between cosmetic/essential oil products and regulated drug products, potentially necessitating significant changes to labeling, marketing, or manufacturing processes to avoid further enforcement action.
Regulatory and clinical departments should conduct a comprehensive review of all product labeling and online marketing materials to ensure no therapeutic or disease-treating claims are being made for products not intended to be regulated as drugs. Internal verification of current good manufacturing practice (CGMP) compliance for any product meeting the drug definition is also recommended.
FDA Warning Letter issued to: Hadassah Healing Oils Ltd. 06/17/2026 — Center for Drug Evaluation and Research (CDER). Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/hadassah-healing-oils-ltd-729191-06172026
Open in openFDA / FDA.gov