Food Labeling: Health Claims; Calcium Consumption by Adolescents and Adults, Bone Density and The Risk of Fractures
other · Food and Drug Administration · Rule · Published 1998-06-22 · Effective 1998-06-22 · 63 FR 34101
Document
Document number
98-16457
Federal Register citation
63 FR 34101
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-0423
Abstract
The Food and Drug Administration (FDA) is issuing this interim final rule to prohibit the use on foods of a claim relating to the relationship between calcium, bone density, and the risk of fractures. This interim final rule is in response to a notification of a health claim submitted under section 303 of the FDA Modernization Act of 1997 (FDAMA). FDA is prohibiting the claim because section 303 of FDAMA does not apply when FDA has an existing regulation authorizing a health claim about the relationship between the nutrient and the disease or health-related condition at issue. A health claim concerning the relationship between calcium and osteoporosis is already authorized. As provided for in section 301 of FDAMA, this rule is effective immediately upon publication.