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Food Labeling: Health Claims; Zinc and the Body's Ability to Fight Infection and Heal Wounds in Adults

other · Food and Drug Administration · Rule · Published 1998-06-22 · Effective 1998-06-22 · 63 FR 34112

Document

Document number
98-16461
Federal Register citation
63 FR 34112
CFR reference
21 CFR 101
Type
Rule
Action
Interim final rule.
Category
other
Sub-agency
Food and Drug Administration
Publication date
1998-06-22
Effective date
1998-06-22
HHS docket
Docket No. 98N-0421

Abstract

The Food and Drug Administration (FDA) is issuing an interim final rule to prohibit the use on foods of a claim relating to the relationship between zinc and the body's ability to fight infection and heal wounds in adults. This rule is in response to a notification of a health claim submitted under section 303 of the FDA Modernization Act of 1997 (FDAMA). FDA has reviewed statements that the petitioner submitted in that notification, and, in conformity with the requirements of FDAMA, the agency is prohibiting the claim because the statements submitted as the basis of the claim are not ``authoritative statements'' of a scientific body, as required by FDAMA; therefore, section 303 of FDAMA does not authorize use of this claim. As provided for in section 301 of FDAMA, this rule is effective immediately upon publication.

Source

Authoritative
Federal Register document
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