In an effort to better alert the public of unlawful ingredients in dietary supplements, the Food and Drug Administration (FDA) has created the Dietary Supplement Ingredient Advisory List, a new reference tool for consumers and manufacturers.
Available on the FDA website, the list includes ingredients that may not lawfully be included in dietary supplements. Consumers may wish to avoid supplements that include these ingredients as they may not fit the definition of a dietary ingredient or may require pre-market notification that was not submitted; inclusion in this list does not necessarily mean the ingredient poses a safety concern.
“It is important to note that the List is not exhaustive; it will always be a work in progress,” said Frank Yiannas, the FDA’s Deputy Commissioner for Food Policy and Response. “We expect the List will evolve as new ingredients are identified and others are removed.” In addition, the FDA will continue to communicate with the public regarding any safety concerns identified with new dietary supplement ingredients.
In a press statement, Yiannas also noted that the agency recently sent out warning letters to 8 companies that were marketing dietary supplements containing DMHA and 3 companies marketing supplements with phenibut; neither one of these currently meets the FDA’s definition of a lawful dietary ingredient. “We take these violations very seriously and stand ready to take enforcement action without further notice if the companies do not immediately cease distribution of the products,” said Yiannas. In February 2019, the FDA went after 17 companies selling unapproved and/or misbranded products (most sold as dietary supplements) claiming to prevent, treat, or cure Alzheimer disease and other serious disease and health conditions.
Consumers who wish to receive alerts related to updates to the Dietary Supplement Ingredient Advisory List can sign up here.
For more information visit FDA.gov.