FDA launches new tool informing consumers of ingredients unlawfully marketed in dietary supplements

April 17, 2019

FDA has launched a new tool to alert the public of ingredients that appear to be unlawfully marketed in dietary supplements. 

FDA has launched a new tool to alert the public of ingredients that appear to be unlawfully marketed in dietary supplements. The Dietary Supplement Ingredient Advisory List contains ingredients unlawfully marketed in dietary supplements, so that consumers know what to avoid. The reasons an ingredient may appear on the list states FDA is because it does not meet the definition of a dietary ingredient, or a new dietary ingredient notification has not been submitted for it. FDA notes that the inclusion of an ingredient on the list may therefore not necessarily be an indication of safety concerns.

Coinciding with the announcement, FDA sent warning letters to eight companies marketing dietary supplements that contain DMHA, and three companies marketing dietary supplements with the ingredient phenibut. “Today’s actions are part of the FDA’s overall efforts to strengthen the agency’s regulation in a manner that strikes the right balance between preserving consumer access to lawful dietary supplements while also protecting Americans from the potential dangers of products that don’t meet the agency’s standards for dietary supplements,” says Frank Yiannas, deputy commissioner for food policy and response, in a statement.

The Council for Responsible Nutrition (CRN; Washington, D.C.) responded positively to FDA’s new tool. “CRN applauds the launch of FDA’s new Dietary Supplement Ingredient Advisory List. Protecting consumers from ingredients that appear to be unlawfully marketed in dietary supplements is a critical component of FDA’s regulatory oversight, and so we are pleased that a new platform to alert consumers more rapidly than in the past has been established,” said Andrew Shao, PhD, interim senior vice president, scientific and regulatory affairs, for CRN, in a press release. “By embracing FDA’s new tool, the industry demonstrates support for the agency’s efforts to preserve the balance between access and safety for the 170 million Americans taking dietary supplements each year.”

The list will continue to updated, and consumers can sign up to receive email updates and changes to the list. FDA is also allowing industry stakeholders to submit their feedback.