United States Government Publishing Office
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United States
National Archives and Records Administration
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government publication
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FR
Regulatory Information
1996_register
executive
2010-09-24
article
Regulation of Medical Foods
Proposed Rules
D09002ee1be02a1ae
D09002ee1be02a24f
United States
Department of Health and Human Services
originator
org
United States Government Agency or Subagency
United States
Food and Drug Administration
originator
org
United States Government Agency or Subagency
The Food and Drug Administration (FDA) is soliciting comments to initiate a reevaluation of its approach to the regulation of the broad group of heterogeneous products that are marketed as medical foods. FDA's goal is to arrive at a regulatory regime that will ensure that: These products are safe for their intended uses, especially because they are likely to be the sole or a major source of nutrients for sick and otherwise vulnerable people; claims for these products are truthful, not misleading, and supported by sound science; and the labeling of these products is adequate to inform consumers about how to use them in a safe and appropriate manner. The agency believes that there is a need to reevaluate its policy for regulating medical foods because of a number of developments, including enactment of a statutory definition of ``medical food,'' the rapid increase in the variety and number of products that are marketed as medical foods, safety problems associated with the manufacture and quality control of these products, and the potential for fraud as claims that are not supported by sound science proliferate for these products.
61 FR 60661
https://www.govinfo.gov/app/details/FR-1996-11-29/96-30441
96-30441
fr29no96-42
RIN 0905-AD91
4160-01-P
Docket No. 96N-0364
https://www.govinfo.gov/app/details/FR-1996-11-29/96-30441
https://www.govinfo.gov/content/pkg/FR-1996-11-29/html/96-30441.htm
https://www.govinfo.gov/content/pkg/FR-1996-11-29/pdf/96-30441.pdf
11 p.
60661
60671
61 FR 60661
Code of Federal Regulations
Title 21 Chapter
21 CFR Chapter
Regulation Identification Number 0905-AD91
RIN 0905-AD91
Regulation of Medical Foods; Federal Register Vol. 61, Issue
PRORULE
96-30441
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
1997-02-27
Docket No. 96N-0364
4160-01-P
96-30441
Advance notice of proposed rulemaking.
The Food and Drug Administration (FDA) is soliciting comments to initiate a reevaluation of its approach to the regulation of the broad group of heterogeneous products that are marketed as medical foods. FDA's goal is to arrive at a regulatory regime that will ensure that: These products are safe for their intended uses, especially because they are likely to be the sole or a major source of nutrients for sick and otherwise vulnerable people; claims for these products are truthful, not misleading, and supported by sound science; and the labeling of these products is adequate to inform consumers about how to use them in a safe and appropriate manner. The agency believes that there is a need to reevaluate its policy for regulating medical foods because of a number of developments, including enactment of a statutory definition of ``medical food,'' the rapid increase in the variety and number of products that are marketed as medical foods, safety problems associated with the manufacture and quality control of these products, and the potential for fraud as claims that are not supported by sound science proliferate for these products.
Written comments by February 27, 1997.
Robert J. Moore, Center for Food Safety and Applied Nutrition (HFS-456), Food and Drug Administration, 200 C St. SW., Washington, DC 20204, 202-205-4605.
Federal Register
Vol. 61, no. 231
Office of the Federal Register, National Archives and Records Administration
1996-11-29
continuing
daily
deposited
born digital
262 p.
Table of Contents:
AE 2.7:
GS 4.107:
AE 2.106:
KF70.A2
https://www.govinfo.gov/app/details/FR-1996-11-29
P0b002ee180a32661
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0042-1219
0364-1406
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https://www.govinfo.gov/app/details/FR-1996-11-29
https://www.govinfo.gov/content/pkg/FR-1996-11-29/pdf/FR-1996-11-29.pdf
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FR-1996-11-29
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