NDI-1435 IMG-1 Original Notification
Summary
FDA received an original New Dietary Ingredient notification (NDI-1435) for the substance identified as IMG-1, filed under docket FDA-2025-S-0023-0128. The notification was submitted through regulations.gov as a pre-market safety filing required under 21 CFR Part 190.6. NDI notifications initiate FDA's 75-day review period during which the agency may determine whether the ingredient poses a safety concern, without formally approving or rejecting the filing.
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What changed
FDA received an original New Dietary Ingredient notification for the substance designated IMG-1 (NDI-1435), submitted under the pre-market notification requirement codified at 21 CFR Part 190.6. The notification was filed in docket FDA-2025-S-0023-0128 and is accessible via regulations.gov.
Dietary supplement manufacturers and ingredient suppliers should be aware that the NDI notification process requires submission of safety data at least 75 days before marketing a dietary ingredient not marketed in the United States before October 15, 1994. While FDA does not formally approve NDI notifications, the agency may issue an objection letter if it determines the ingredient is not reasonably expected to be safe, which could affect the commercial viability of IMG-1 pending outcome of the review period.
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Apr 24, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
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