Drugs

Dietary Supplement NDI Enforcement Discretion

FDA has published a draft guidance, Policy Regarding Certain New Dietary Ingredients and Dietary Supplements Subject to the Requirement for Premarket Notification, indicating the agency’s intent to exercise enforcement discretion for a limited period and in limited circumstances to encourage dietary supplement firms to correct past failures to submit a required new dietary ingredient (NDI) notification. The document says the Federal Food, Drug, and Cosmetic Act requires the manufacturer or distributor of a new dietary ingredient that has not been present in the food supply as an article used for food, or a dietary supplement that contains an NDI, to submit a premarket safety notification to FDA at least 75 days before introducing the product into interstate commerce. Without such a notification, the law says, the NDI is deemed to be adulterated.

FDA says it is aware that some manufacturers and distributors have marketed products for which a premarket NDI notification was required but never submitted. “To increase the amount of safety information we have about NDI-containing dietary supplements in the marketplace and to promote risk-based regulation, we are informing manufacturers, distributors, and other interested persons of our intent to exercise enforcement discretion….”

A separate agency notice says the enforcement discretion relates solely to the failure to submit an NDI notification and not to NDI-containing dietary supplements that are adulterated for safety reasons or that violate any other regulatory requirements pertaining to dietary supplements.

If the draft is finalized without change, FDA says, the enforcement discretion would start when the guidance is published, would last 180 days, and would apply only to products on the market when the Federal Register notice announcing the draft guidance was published.

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