JFDA Suspends Ashwagandha Product Approvals Over Safety Concerns

The Jordan Food and Drug Administration (JFDA) has suspended approvals for all natural products and nutritional supplements containing awithania somnifera (aka ashwagandha), effective from the start of August, citing safety concerns and regulatory non-compliance. JFDA Director General Nizar Mahidat announced that the suspension includes halting the distribution and registration of Ashwagandha products and ceasing the acceptance of new registration applications. This decision is based on the identification of misuse, reports of hepatotoxicity and gastrointestinal adverse effects, and the proliferation of unsubstantiated health claims in advertising. These claims include assertions of weight loss, depression alleviation, immune enhancement, cardiovascular health improvement, cholesterol reduction, arthritis treatment, and hypertension management benefits that have not been approved by regulatory standards. The sanctioned use of Ashwagandha remains limited to alleviating fatigue, anxiety, and exhaustion. Mah idat highlighted that the JFDA has formally communicated this suspension to all stakeholders, following assessments by the Preparations and Products, Natural Medicines, and Special Foods Committees. This action underscores the JFDA's commitment to upholding pharmacovigilance and ensuring the therapeutic safety and efficacy of natural health products in Jordan. The suspension affects approximately 17 licensed natural preparations and supplements containing Ashwagandha. The JFDA urges consumers to seek immediate medical consultation if experiencing symptoms such as emesis, diarrhea, jaundice, or icterus, and to adhere strictly to the dosing guidelines outlined in the product's informational insert. Source: Jordan News Agency