April 2016

FDA Issues Statement on Acacia rigidula Use in Dietary Supplements

According to the U.S. Food and Drug Administration (FDA), Acacia rigidula has not yet been lawfully identified as a new dietary ingredient. Certain conditions, including a history of use or other evidence of safety establishing that it is reasonably expected to be safe, have not been provided. Therefore, any products marketed as dietary supplements that contain Acacia rigidula are considered adulterated. The FDA has already issued warning letters to six companies marketing products with Acacia rigidula on product labels.

Natural Medicines currently lists 46 Commercial Products containing Acacia rigidula. All 46 products have received the lowest NMBER rating.

The information in this brief report is intended for informational purposes only, and is meant to help users better understand health concerns. This information should not be interpreted as specific medical advice. Users should consult with a qualified healthcare provider for specific questions regarding therapies, diagnosis and/or health conditions, prior to making therapeutic decisions. Copyright © 2023 NatMed. Commercial distribution or reproduction prohibited. NatMed is the leading provider of high-quality, evidence-based, clinically-relevant information on natural medicine, dietary supplements, herbs, vitamins, minerals, functional foods, diets, complementary practices, CAM modalities, exercises and medical conditions. Monograph sections include interactions with herbs, drugs, foods and labs, contraindications, depletions, dosing, toxicology, adverse effects, pregnancy and lactation data, synonyms, safety and effectiveness.