Dietary Supplement Ingredients to Avoid Listing Launched

FDA has launched a new tool to alert the public when it becomes aware of ingredients that appear to be unlawfully marketed in dietary supplements — the online Dietary Supplement Ingredient Advisory List. The listing is intended to tell industry to avoid making or selling dietary supplements containing ingredients on the list, according to FDA deputy commissioner for food policy and response Frank Yiannas. Consumers should also avoid using products containing any of the listed ingredients, the agency says.

Ingredients will continue to be added to the list following an initial FDA assessment indicating the ingredient may not lawfully be in dietary supplements. “This could be for reasons including the ingredient does not fit the definition of a dietary ingredient,” Yiannas says, “or the ingredient requires a pre-market notification that was not submitted; however, inclusion of an ingredient on this list is not necessarily an indication of safety concerns. The FDA will continue to communicate separately and clearly any time we identify safety concerns about dietary ingredients or dietary supplements.”

Yiannis says the listing is needed as the dietary supplement marketplace grows and introducing new ingredients often raises complex questions involving science, policy, and the law. “In the time it takes the FDA to make a final determination, consumers and industry might mistakenly conclude that a lack of action by the FDA indicates that these ingredients are lawful,” he says. “It also provides an opportunity for stakeholders to share information with us that they think might be relevant to our determination.”