Premarket Notification for a New Dietary Ingredient
fda-device · Food and Drug Administration · Rule · Published 1997-09-23 · Effective 1997-10-23 · 62 FR 49886
Document
Document number
97-24737
Federal Register citation
62 FR 49886
CFR reference
21 CFR 190
Type
Rule
Action
Final rule.
Category
fda-device
Sub-agency
Food and Drug Administration
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).