FDA will allow qualified health claims for magnesium and reduced risk of high blood pressure

FDA announced in a letter of enforcement discretion, that it does not intend to object to the use of certain qualified health claims that pertain to magnesium consumption and the reduced risk of high blood pressure.

The U.S. Food and Drug Administration (FDA) announced in a letter of enforcement discretion, that it does not intend to object to the use of certain qualified health claims that pertain to magnesium consumption and the reduced risk of high blood pressure. The letter is in response to a health claim petition submitted on behalf of The Center for Magnesium Education and Research. The model claim proposed in the petition reads as follows: “Supportive but inconclusive scientific evidence suggests that diets with adequate magnesium may reduce the risk of high blood pressure (hypertension), a condition associated with many factors.”

After reviewing the petition, FDA determined that the totality of the scientific evidence supports a qualified health claim on the relationship between magnesium and hypertension. The qualified health claims would apply to conventional foods and dietary supplements. FDA has listed the following qualified health claims in its letter of enforcement discretion:

  • “Inconsistent and inconclusive scientific evidence suggests that diets with adequate magnesium may reduce the risk of high blood pressure (hypertension), a condition associated with many factors.”
  • “Consuming diets with adequate magnesium may reduce the risk of high blood pressure (hypertension). However, the FDA has concluded that the evidence is inconsistent and inconclusive.”
  • “Some scientific evidence suggests that diets with adequate magnesium may reduce the risk of high blood pressure (hypertension), a condition associated with many factors. The FDA has concluded that the scientific evidence supporting this claim is inconsistent and not conclusive.”

“We are pleased FDA recognizes the role of magnesium in reducing the risk of hypertension in addition to this essential nutrient’s many other functions in the body,” stated Andrea Wong, PhD, senior vice president of scientific and regulatory affairs for the Council for Responsible Nutrition (CRN; Washington, D.C.), in a press release. CRN was a sponsor of the petition. “CRN’s contribution to the petition is an example of our continued commitment to scientific research to advance regulatory and nutrition policy change,” added Wong.

“We are encouraged by the fact that the FDA recognizes that magnesium consumption can benefit human health via helping to support healthy blood pressure. It is an auspicious beginning, and we believe that continued scientific conclusions of magnesium’s role in blood pressure support will be understood and embraced by both industry and consumers," said Ohad Cohen, CEO of Gadot Biochemical Industries (Haifa Bay, Israel), a leading supplier of magnesium and other minerals.

“We believe that in the future more evidence will arise showing full support about the help of magnesium for blood pressure reduction," added Cohen. "Some supportive or suggested mechanism that needs to be checked and verified is the theory that magnesium may prevent inner walls calcification of the arteries. We believe that checking this mechanism may show that the arteries remain more flexible and expendable and therefore blood pressure may be reduced. We have not found clear evidence of this theory, however, our intensive work with this mineral can point out that this mechanism may be feasible.”

This article was updated to include comments from Gadot Biochemical Industries on 1/12/22 at 1:35PM.