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FDA Announces Qualified Health Claim for Magnesium and Reduced Risk of High Blood Pressure

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In a letter of enforcement discretion released on Jan 10., the U.S. Food and Drug Administration (FDA) announced that it does not intend to object to the use of certain qualified health claims regarding the consumption of magnesium and a reduced risk of high blood pressure (hypertension), provided that the claims are appropriately worded to avoid misleading consumers and other factors for the use of the claim are met.

The FDA responded to a health claim petition submitted on behalf of The Center for Magnesium Education and Research, LLC. The petition requested that the FDA authorize a health claim about the relationship between the consumption of magnesium and a reduced risk of high blood pressure. A health claim characterizes the relationship between a substance and a disease or health-related condition.

After reviewing the petition and other evidence related to the proposed health claim, the FDA determined that the totality of the scientific evidence supports a qualified health claim on the relationship between magnesium and a reduced risk of high blood pressure in conventional foods and dietary supplements. This letter also discusses the factors that the FDA intends to consider in the exercise of its enforcement discretion for the use of a qualified health claim in both conventional foods and dietary supplements and about the relationship between the consumption of magnesium and a reduced risk of high blood pressure (hypertension).

The following qualified health claims for conventional foods and dietary supplements are included in the FDA’s 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.”

In response, the Council for Responsible Nutrition (CRN), who sponsored the petition with other organizations and filed it on behalf of the Center for Magnesium Education and Research LLC, released the following statement: “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, CRN senior vice president of scientific and regulatory affairs. “CRN’s contribution to the petition is an example of our continued commitment to scientific research to advance regulatory and nutrition policy change.”

 

For more information, visit www.fda.gov or www.crnusa.org.

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