Acacia rigidula is labeled as a dietary ingredient in some products marketed as dietary supplements. However, the FDA is not aware of any information demonstrating that A. rigidula was lawfully marketed as a dietary ingredient in the United States before October 15, 1994. As a result, A. rigidula is a new dietary ingredient, and for dietary supplements that contain A. rigidula to be lawfully marketed, one of the following must apply:
- the product containing the dietary ingredient must contain only dietary ingredients that have been present in the food supply as an article used in food in a form in which the food has not been chemically altered, or
- there must be a history of use or other evidence of safety establishing that the dietary ingredient, when used under the conditions recommended or suggested in the product labeling, will reasonably be expected to be safe; and at least 75 days before the product is introduced or delivered for introduction into interstate commerce, the manufacturer or distributor must notify FDA of the basis on which the manufacturer or distributor has concluded that a dietary supplement containing such dietary ingredient will reasonably be expected to be safe.
Because neither of these conditions has been met by those marketing products that contain A. rigidula as a dietary ingredient, these products are deemed to be adulterated.
Acacia rigidula is also known as:
- Vachellia rigidula
- Chaparro Prieto
On March 15, 2016, the FDA issued warning letters to six companies regarding a total of six products for which the product labeling lists A. rigidula as a dietary ingredient.
The FDA considers these products to be adulterated because they contain a new dietary ingredient, A. rigidula, and because they have not satisfied the conditions described above regarding the use of A. rigidula as a new dietary ingredient.
Under existing law, including the Dietary Supplement Health and Education Act passed by Congress in 1994, the FDA can take action to remove products from the market, but the agency must first establish that such products are adulterated (e.g., that the product is unsafe or lacks evidence of safety) or misbranded (e.g., that the labeling is false or misleading).
The companies have 15 business days from the date of receipt of the letter to communicate to the agency the specific steps they will take to bring their products into compliance with the law. The warning letters also caution the companies that the FDA may take further enforcement action without warning if they do not immediately cease distribution of the products.
The agency will continue to update this page in the event additional actions are taken related to A. rigidula.
For More Information:
- FDA Research on BMPEA and Acacia rigidula
- Warning Letters