Officials with the U.S. Food and Drug Administration (FDA) recently published an updated draft guidance that aims to improve the new dietary ingredient (NDI) premarket safety notifications from dietary supplement companies to the FDA.
The notifications will help the FDA detect safety concerns in products before these products are marketed to consumers.
The current Dietary Supplement Health and Education Act (DSHEA) requires manufacturers and distributors to inform the FDA of a new dietary ingredient at least 75 days prior to selling the dietary supplement.
NDIs are defined as ingredients that have not been commercialized within the U.S. prior to Oct. 15, 1994, excluding ingredients that are not chemically altered when added to the food supply.
If dietary supplements have an NDI without notifying the FDA, the supplements are labeled as adulterated.
“This revised draft guidance is an important step forward in the agency’s work to protect public health from potentially dangerous new dietary ingredients,” Steven Tave, acting director of the FDA’s Office of Dietary Supplement Programs, said. “Notification of new dietary ingredients is the only pre-market opportunity the agency has to identify unsafe supplements before they are available to consumers. The revised draft guidance is intended to improve the quality of industry’s new dietary ingredient reporting, so the FDA can more effectively monitor the safety of dietary supplements.”
