Document Detail

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    
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.
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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    
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MeSH Terms
Cardiovascular Diseases / prevention & control
Drug Approval / legislation & jurisprudence*
Food Labeling / legislation & jurisprudence*
Homocysteine / blood
Risk Factors
United States
United States Food and Drug Administration
Vitamin B Complex / therapeutic use*
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

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