FDA approves qualified claim for magnesium and blood pressure
To be more precise, the US Food and Drug Administration said yesterday it would not “object to the use of certain qualified health claims regarding the consumption of magnesium and a reduced risk of high blood pressure (hypertension).” This is the standard formula for the ‘approval’ of such claims.
To be compliant, claims for this effect must use the following language:
- “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.”
Hailing a victory
Despite the fact that the wording of such claims makes them problematical for use on labels, the official recognition of magnesium’s benefits has been seen as a victory for the industry.
“I’m delighted to learn that the FDA will allow the use of certain qualified health claims regarding magnesium and high blood pressure. Major kudos and Mahalo to Hawaii-based Andrea Rosanoff, PhD., the director of the Center for Magnesium Education & Research. Her team has been submitting data to the FDA for many years to make this claim possible,” said Patrick Sullivan, Jr founder ad CEO of Jigsaw Health, which concentrates on magnesium products formulated with the company’s MagSRT ingredient.
The Council for Responsible Nutrition, which participated in the submission of the petition on behalf of Rosanoff’s magnesium center, also lauded the development.
“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’s 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.”
Sullivan noted that data from the company’s recent Scottsdale Magnesium Study, which concluded in 2019, mirrors the evidence submitted to FDA that swayed the move on the qualified health claim. He said the study showed that MagSRT decreased participants’ systolic blood pressure by 11% over a 90-day period, dropping from an average of 145 to 129, and, significantly, those values returned to baseline by 30 days after supplementation was ended.
“We chose not to publish this blood pressure data because — on the advice of regulatory counsel — we were concerned that even though we had good data, the FDA may penalize us for attempting to make a ‘drug claim”’for Jigsaw MagSRT,” Sullivan said.
Kissing your sister
Consultant Mark Miller, PhD, said blood pressure is a multifaceted phenomenon, and qualified health claims are called ‘qualified’ for a reason, so he advised caution on getting too enthusiastic about the development.
“The Qualified Health Claim by the FDA is an acknowledgment from the FDA that there is some evidence for a role of magnesium in reducing the risk for hypertension. However, the tepid nature of Qualified Health Claims may be confusing to consumers. They are not as compelling or evocative as an Authorized Health Claim. It is the regulatory equivalent of kissing your sister,” Miller said.
“Hypertension has so many contributing components to it, but magnesium may offer benefits by competing with calcium to limit vascular contractions and attenuating the outflow of the sympathetic nervous system. As such it has value, but proceed with caution,” he added.