FDA Approves Magnesium Qualified Health Claims

Denis Storey
January 24, 2022

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In a rare – but welcome – regulatory shift, the U.S. Food and Drug Administration (FDA) announced on Jan. 10 that it won’t 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.”

The agency revealed its decision in response to a petition from The Center for Magnesium Education and Research, which asked regulators to sign off on a health claim about the relationship between the magnesium intake and a lowered risk of high blood pressure.

The FDA’s letter added that:

  • “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.”

It’s worth noting that because of the agency’s concerns about consumer safety, the FDA added a caveat that a supplement couldn’t contain more than 350 mg of magnesium to make the permitted qualified health claim.

Research suggests that as many as three out of four American consumers don’t include the daily recommended amount of magnesium. Studies suggest magnesium helps promote better sleep quality, eases anxiety, and helps with migraines.

“We’re pleased the 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,” Dr. Andrea Wong, CRN’s senior vice president of scientific and regulatory affairs, said in release praising the change. “CRN’s contribution to the petition is an example of our continued commitment to scientific research to advance regulatory and nutrition policy change.”