Food labeling: health claims; vitamin K and promotion of proper blood clotting and improvements in bone health in adults--FDA. Interim final rule.
The Food and Drug Administration (FDA) is issuing an interim final rule too 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.
D000328:Adult; D001777:Blood Coagulation; D001842:Bone and Bones; D004348:Drug Labeling / Q000331:legislation & jurisprudence*; D005515:Food Labeling / Q000331:legislation & jurisprudence*; D006801:Humans; D014481:United States; D014486:United States Food and Drug Administration; D014812:Vitamin K / Q000627:therapeutic use*