# Premarket Notification for a New Dietary Ingredient
> **Food and Drug Administration** · Final rule. · Published 1997-09-23 · Effective 1997-10-23 · 62 FR 49886
## Document
- **Document number:** 97-24737
- **Category:** fda-device
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 62 FR 49886
- **CFR reference:** 21 CFR 190
- **Publication date:** 1997-09-23
- **Effective date:** 1997-10-23
- **HHS docket:** Docket No. 96N-0232
## Abstract

The Food and Drug Administration (FDA) is establishing the procedure by which a manufacturer or distributor of dietary supplements or of a new dietary ingredient is to submit under the Federal Food, Drug, and Cosmetic Act (the act) the information on which it has concluded that a dietary supplement containing a new dietary ingredient will reasonably be expected to be safe. FDA is issuing this regulation to enable industry to comply with the requirements of the Dietary Supplement Health and Education Act of 1994 (the DSHEA).

## Source
- [Federal Register document](https://www.federalregister.gov/documents/1997/09/23/97-24737/premarket-notification-for-a-new-dietary-ingredient)
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