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FDA Supports B Vitamin Qualified Health Claim for Vascular Health

Since November of 2000, the Food and Drug Administration have allowed for new applications of of vitamin B to be explored as one of the many recommended ways to address vascular disease. While suggestive, but inconclusive, the FDA has approved various statements in support of vitamin B intake for vascular health.

The FDA stated that:

Based on its review of the scientific evidence published subsequent to November 30, 1999, FDA finds that: (1) although the totality of the publicly available scientific evidence demonstrates a lack of significant scientific agreement as to the validity of a relationship between the B vitamins and risk of vascular disease in the general population, the scientific evidence in support of a qualified claim (1) outweighs the scientific evidence against the claim; and (2) it may appropriately exercise enforcement discretion with respect to use of the qualified claim about the strength of the scientific evidence in the general population, provided that the general conditions stated in the Pearson implementation notice and the specific conditions set forth in this letter are met.

What The FDA Allows For Supplements To Say

The following qualified health claims for conventional foods and dietary supplements are included in the FDA’s letter of enforcement discretion:

  • "As part of a well-balanced diet, rich in fresh fruits and vegetables, daily intake of at least 400 µg folic acid, 3 mg vitamin B6 and 5 µg vitamin B12 may reduce the risk of vascular disease."
  • "The scientific evidence is suggestive but not conclusive for a relationship between folic acid, vitamin B6 and vitamin B12 and reduced risk of vascular disease in the general population."
  • the available scientific information does not support identification of specific amounts of folic acid, vitamin B6 and vitamin B12 that might be useful for reduction in risk of vascular disease.
  • "the qualified claim should indicate that diets low in saturated fat and cholesterol may reduce the risk of heart disease"
  • "It is known that diets low in saturated fat and cholesterol may reduce the risk of heart disease. The scientific evidence about whether folic acid, vitamin B6 and vitamin B12 may also reduce the risk of heart disease and other vascular diseases is suggestive, but not conclusive. Studies in the general population have generally found that these vitamins lower homocysteine, an amino acid found in the blood. It is not known whether elevated levels of homocysteine may cause vascular disease or whether high homocysteine levels are caused by other factors. Studies that will directly evaluate whether reducing homocysteine may also reduce the risk of vascular disease are not yet complete."

Additional Resources

*These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.

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