Summary: FDA announces draft guidance for industry on their policy to exercise enforcement discretion on delinquent notifications to encourage firms to submit NDIN to correct past failures. Read on to learn more.

NDINs must be submitted within a limited time and scope amnesty

In 1994, Dietary Supplement Health and Education Act of 1994 (DSHEA) was enacted. New Dietary Ingredient (NDI) are pathway was developed. Notification of an NDI must be made to FDA at least 75 days prior to introducing the NDI or dietary supplement containing the NDI into interstate commerce. The NDI must contain detailed information related to the identity, manufacturing, intended use, and safety of the NDI.

The FDA estimates there should have been more than 4,600 NDINs submitted since the passage of DSHEA, however, there have only been about 1,200 submissions. Per the recently issued draft guidance, companies having the NDI/supplement containing the NDI on the market as of May 20, 2022 will have a limited time to file these notices.

FDA is accepting submissions for 180 days after the final guidance is published in the Federal Register. While the date of publication of the final guidance is not yet known, timing is of the essence for companies that wish to prepare a robust submission under this limited enforcement discretion policy.

Contact the regulatory experts at SGS Nutrasource today to learn more about the NDIN requirements, preparation and submission.

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