title: Food labeling: health claims; B-complex vitamins, lowered homocysteine levels, and the risk in adults of cardiovascular disease--FDA. Interim final rule.
abstract: 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.
mesh_terms: D000328:Adult; D002318:Cardiovascular Diseases / Q000517:prevention & control; D017277:Drug Approval / Q000331:legislation & jurisprudence*; D005515:Food Labeling / Q000331:legislation & jurisprudence*; D006710:Homocysteine / Q000097:blood; D006801:Humans; D012307:Risk Factors; D014481:United States; D014486:United States Food and Drug Administration; D014803:Vitamin B Complex / Q000627:therapeutic use*