March 15, 2016
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.