Food Labeling; Requirements for Nutrient Content Claims, Health Claims, and Statements of Nutritional Support for Dietary Supplements
fda-food · Food and Drug Administration · Rule · Published 1997-09-23 · Effective 1999-03-23 · 62 FR 49859
Document
Document number
97-24730
Federal Register citation
62 FR 49859
CFR reference
21 CFR 101
Type
Rule
Action
Final rule.
Category
fda-food
Sub-agency
Food and Drug Administration
Publication date
1997-09-23
Effective date
1999-03-23
HHS docket
Docket No. 95N-0282
Abstract
The Food and Drug Administration (FDA) is amending its nutrient content claims regulations to change the terminology used to describe dietary supplements; provide for the use of statements that characterize the percentage level of dietary ingredients that do not have Reference Daily Intakes (RDI's) or Daily Reference Values (DRV's); and withdraw the provision that dietary supplements of vitamins and minerals may not give prominence to any ingredient that is not a vitamin or a mineral on its label or in labeling. The agency is also amending its regulations to specify how (i.e., text, placement, and type size) the disclaimer that must be contained in statements made in accordance with the Federal Food, Drug, and Cosmetic Act (the act) is to be presented. Additionally, FDA is removing the definition of ``dietary supplements,'' and revising the terminology used to describe these products in the regulations on health claims for food products. FDA is taking this action to implement, in part, the Dietary Supplement Health and Education Act of 1994 (the DSHEA).