FDA Approves Magnesium Qualified Health Claims

by | January 24, 2022

In a rare shift, the FDA said it won’t object to “certain qualified health claims regarding the consumption of magnesium.”

The agency revealed its decision in response to a petition from The Center for Magnesium Education and Research. The group wanted regulators to approve health claims regarding the mineral 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, 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. The FDA has concluded that the scientific evidence supporting this claim is inconsistent and not conclusive.”

The FDA added that a product couldn’t contain more than 350 mg to qualify.

Magnesium popularity persists

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

“Magnesium is the fourth most abundant mineral, after calcium, sodium and potassium, that the body requires daily,” Candace Pumper, a staff dietitian with the Ohio State University Wexner Medical Center in Columbus told U.S. World and News Report.

CRN reports that magnesium typically ranks among the top 10 bestselling dietary supplements.

“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.”

Related Content

The New Gold Standard for Collaboration

The New Gold Standard for Collaboration

TraceGains Network is a collaborative platform where R&D, procurement, quality assurance, and regulatory ...
The Form 483 Solution — What You Need to Know

The Form 483 Solution — What You Need to Know

FDA inspectors issue Form 483s when issues are found at a facility. Corrective actions may be required so it's ...
A Look Inside TraceGains Network

A Look Inside TraceGains Network

A look at the capabilities of TraceGains Neworks and how it helps both customers and suppliers.

Pin It on Pinterest

Share This