From The February 2001 Issue of Nutrition Science News

B Vitamins Get "Qualified" Health Claim

Washington—In a shift of policy begun in 1994, the FDA issued several "qualified" health claims for nutrients last year—a positive sign for supplement manufacturers and retailers.

In a Nov. 28, 2000, letter, FDA stated the weight of scientific evidence was more positive then negative regarding the relationship between three B vitamins—folic acid, B6, and B12—and reduced vascular disease rates. However, the evidence was "suggestive, but not conclusive." Therefore, FDA would allow only a "qualified health claim" for the vitamins.

The qualified claim, which could help supplement makers better explain the benefits of their products to customers, must include references to all of the following:

1. That diets low in saturated fat and cholesterol may reduce the risk of heart disease
2. That the scientific evidence is suggestive but not conclusive.
3. That studies have shown these vitamins lower homocysteine, but the relationship between lowered homocysteine and vascular disease risk is not known.
4. That it is not known whether lowering homocysteine through intake of those B vitamins will reduce the risk of vascular disease.