On May 19, 2022, the U.S. Food and Drug Administration (FDA) released new draft guidance for manufacturers and distributors of dietary supplements.
The draft guidance, entitled Draft Guidance for Industry: Policy Regarding Certain New Dietary Ingredients and Dietary Supplements Subject to the Requirement for Pre-market Notification, states that the FDA plans to exercise enforcement discretion for late new dietary ingredient (NDI) notifications.
What is the current policy?
Currently, manufacturers and distributors need to notify the FDA if their dietary supplement contains an NDI (unless a legal exception applies) before marketing (per the Dietary Supplement Health and Education Act of 1994).
What does this guidance propose?
The draft guidance proposes an enforcement discretion only for the failure to submit an NDI notification.
If this guidance document is finalized, it would mean that manufacturers and distributors that are delinquent in NDI submissions would get an opportunity to correct without FDA enforcement actions. For a limited time and under limited circumstances, the FDA would not take actions against these past notification failures.
According to the draft guidance, the enforcement discretion period to submit the late NDI would:
- Start once the guidance is published
- Last 180 days
- Apply only to products on the market when the draft guidance was published in the Federal Register
What is the purpose of the draft guidance?
In the press release, the FDA states that this enforcement discretion aims “at increasing the amount of safety information… about the dietary supplement marketplace…” The FDA can “gain more safety information about the dietary supplement marketplace and better protect public health.”
Where can I learn more about cGMPs for dietary supplements?
CITI Program offers a course entitled Biotility: cGMP for Dietary Supplements available for organizational subscriptions or for individual purchase. This course explains requirements to establish and maintain regulatory compliance with 21 CFR Part 111 Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements.
