| Food labeling: health claims; B-complex vitamins, lowered homocysteine levels, and the risk in adults of cardiovascular disease--FDA. Interim final rule. | |
| | |
MedLine Citation:
|
PMID: 10180286 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
|
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 B-complex vitamins (folic acid, vitamin B6, vitamin B12), lowering elevated serum homocysteine levels, and the risk in adults of cardiovascular disease. 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 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. |
| | |
Authors:
|
- |
Related Documents
:
|
14555416 - Final report on the safety assessment of triacetin. 11275886 - Efficacy of high-level disinfectants for reprocessing gi endoscopes in simulated-use te... 18572146 - Classification and evaluation of microfluidic devices for continuous suspension fractio... 19182016 - The challenges of clinical validation of emerging technologies: computer-assisted devic... 7046046 - Purinergic regulation of food intake. 12631406 - Determining how low-income food shoppers perceive, understand, and use food labels. |
Publication Detail:
|
Type: Journal Article |
Journal Detail:
|
Title: Federal register Volume: 63 ISSN: 0097-6326 ISO Abbreviation: Fed Regist Publication Date: 1998 Jun |
Date Detail:
|
Created Date: 1998-07-22 Completed Date: 1998-07-22 Revised Date: 2004-11-17 |
Medline Journal Info:
|
Nlm Unique ID: 7808722 Medline TA: Fed Regist Country: UNITED STATES |
Other Details:
|
Languages: eng Pagination: 34097-101 Citation Subset: H |
Export Citation:
|
APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
|
Adult Cardiovascular Diseases / prevention & control Drug Approval / legislation & jurisprudence* Food Labeling / legislation & jurisprudence* Homocysteine / blood Humans Risk Factors United States United States Food and Drug Administration Vitamin B Complex / therapeutic use* |
| Chemical | |
Reg. No./Substance:
|
12001-76-2/Vitamin B Complex; 454-28-4/Homocysteine |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
Previous Document: Food labeling: health claims; antioxidant vitamin A and beta-carotene and the risk in adults of athe...
Next Document: Food labeling: health claims; calcium consumption by adolescents and adults, bone density and the ri...