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2010-09-24
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Food Labeling: Health Claims; Vitamin K and Promotion of Proper Blood Clotting and Improvement in Bone Health in Adults
Part IV
Rules and Regulations
D09002ee1bdff86e2
D09002ee1bdff880f
United States
Department of Health and Human Services
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United States Government Agency or Subagency
United States
Food and Drug Administration
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org
United States Government Agency or Subagency
The Food and Drug Administration (FDA) is issuing an interim final rule to prohibit the use on foods of a health claim relating to relationships between vitamin K and the promotion of proper blood clotting and improvement in bone health in adults. 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 has reviewed the notification, and, in conformity with the requirements of FDAMA, the agency is prohibiting the claim as a health claim because the claim does not characterize the relationship of the nutrient vitamin K to a disease or health-related condition, as required by section 303 of FDAMA; therefore, section 303 of FDAMA does not authorize use of this claim as a health claim. Although the claim is not a health claim, it may be the type of claim permissible as a structure/function claim. As provided for in section 301 of FDAMA, this rule is effective immediately upon publication. DATES: The interim final rule is effective June 22, 1998; comments by September 8, 1998. ADDRESSES: Submit written comments to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
63 FR 34115
https://www.govinfo.gov/app/details/FR-1998-06-22/98-16462
98-16462
fr22jn98-38
4160-01-F
Docket No. 98N-0420
https://www.govinfo.gov/app/details/FR-1998-06-22/98-16462
https://www.govinfo.gov/content/pkg/FR-1998-06-22/html/98-16462.htm
https://www.govinfo.gov/content/pkg/FR-1998-06-22/pdf/98-16462.pdf
3 p.
34115
34117
63 FR 34115
Code of Federal Regulations
Title 21 Part 101
21 CFR Part 101
Food Labeling: Health Claims; Vitamin K and Promotion of Proper Blood Clotting and Improvement in Bone Health in Adults; Federal Register Vol. 63, Issue
RULE
98-16462
IV
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
1998-06-22
1998-09-08
Docket No. 98N-0420
4160-01-F
98-16462
Interim final rule.
The Food and Drug Administration (FDA) is issuing an interim final rule to prohibit the use on foods of a health claim relating to relationships between vitamin K and the promotion of proper blood clotting and improvement in bone health in adults. 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 has reviewed the notification, and, in conformity with the requirements of FDAMA, the agency is prohibiting the claim as a health claim because the claim does not characterize the relationship of the nutrient vitamin K to a disease or health-related condition, as required by section 303 of FDAMA; therefore, section 303 of FDAMA does not authorize use of this claim as a health claim. Although the claim is not a health claim, it may be the type of claim permissible as a structure/function claim. As provided for in section 301 of FDAMA, this rule is effective immediately upon publication. DATES: The interim final rule is effective June 22, 1998; comments by September 8, 1998. ADDRESSES: Submit written comments to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
The interim final rule is effective June 22, 1998; comments by September 8, 1998. ADDRESSES: Submit written comments to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Christine J. Lewis, Center for Food Safety and Applied Nutrition (HFS-451), Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 202-205-4168.
Federal Register
Vol. 63, no. 119
Office of the Federal Register, National Archives and Records Administration
1998-06-22
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Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-1998-06-22
P0b002ee180a6a39a
0097-6326
0042-1219
0364-1406
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https://www.govinfo.gov/app/details/FR-1998-06-22
https://www.govinfo.gov/content/pkg/FR-1998-06-22/pdf/FR-1998-06-22.pdf
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