01.10.22
The U.S. Food and Drug Administration (FDA) has announced a qualified health claim for products containing magnesium, provided that claims regarding its impact on high blood pressure are appropriately worded.
In a 42-page letter of enforcement discretion, issued in response to a petition from the Center for Magnesium Education and Research, LLC, the agency said it will allow for a qualified health claim in both conventional foods and dietary supplements containing magnesium on hypertension. The claims listed are:
- “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 are inconsistent and not conclusive.
The Council for Responsible Nutrition (CRN), which was one of the organizations which filed the petition on behalf of the Center for Magnesium Education and Research, LLC, applauded today’s announcement.
“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,” Andrea Wong, PhD, senior vice president of scientific and regulatory affairs, said. “CRN’s contribution to the petition is an example of our continued commitment to scientific research to advance regulatory and nutrition policy change.”
CRN reported that it was the only trade association representing the dietary supplements industry to support the petition.
In a 42-page letter of enforcement discretion, issued in response to a petition from the Center for Magnesium Education and Research, LLC, the agency said it will allow for a qualified health claim in both conventional foods and dietary supplements containing magnesium on hypertension. The claims listed are:
- “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 are inconsistent and not conclusive.
The Council for Responsible Nutrition (CRN), which was one of the organizations which filed the petition on behalf of the Center for Magnesium Education and Research, LLC, applauded today’s announcement.
“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,” Andrea Wong, PhD, senior vice president of scientific and regulatory affairs, said. “CRN’s contribution to the petition is an example of our continued commitment to scientific research to advance regulatory and nutrition policy change.”
CRN reported that it was the only trade association representing the dietary supplements industry to support the petition.
