FDA Helps Certified Well being Declare for Magnesium and Lowered Hypertension Threat

FDA Helps Certified Well being Declare for Magnesium and Lowered Hypertension Threat

The Meals and Drug Administration (FDA) has responded to a well being declare petition submitted on behalf of The Heart for Magnesium Training and Analysis requesting that the Company authorize a well being declare characterizing the connection between the consumption of magnesium and a diminished threat of hypertension. 

The FDA has decided that present proof helps a certified well being declare supplied that the declare is appropriately worded to keep away from deceptive customers. In response to the Company, “certified well being claims are supported by scientific proof, however don’t meet the extra rigorous ‘important scientific settlement’ normal required for a certified well being declare.”

To research the connection between magnesium consumption and threat of hypertension, the company evaluated 85 intervention research and 43 observational research. A big variety of these research had been discovered to be inconclusive. Whereas a small variety of intervention research confirmed a statistically important reducing of blood strain with magnesium consumption, the bulk confirmed no impact in any respect. 

Primarily based on these findings, the FDA intends to think about exercising enforcement discretion for the next certified well being claims for standard meals and dietary dietary supplements containing magnesium:

  • “Inconsistent and inconclusive scientific proof means that diets with ample magnesium might scale back the chance of hypertension (hypertension), a situation related to many components.”
  • “Consuming diets with ample magnesium might scale back the chance of hypertension (hypertension). Nonetheless, the FDA has concluded that the proof is inconsistent and inconclusive.”
  • “Some scientific proof means that diets with ample magnesium might scale back the chance of hypertension (hypertension), a situation related to many components. The FDA has concluded that the scientific proof supporting this declare is inconsistent and never conclusive.”

Further data might be discovered within the Company’s letter of enforcement discretion.

Reference

FDA publicizes certified well being declare for magnesium and diminished threat of hypertension. Information launch. US Meals and Drug Administration. January 10, 2022. Accessed January 12, 2022. https://www.fda.gov/meals/cfsan-constituent-updates/fda-announces-qualified-health-claim-magnesium-and-reduced-risk-high-blood-pressure.