01.13.22
Ohad Cohen, chief executive officer of Israel-based Gadot Biochemical Industries, discussed his optimism surrounding the FDA’s recent decision to allow for qualified health claims about reduced hypertension risk for products containing dietary magnesium. Gadot is a supplier of magnesium and other minerals for supplements and food fortification.
“We are encouraged by the fact that the FDA recognizes that magnesium consumption can benefit human health via helping to support healthy blood pressure,” Cohen said. “It is an auspicious beginning, and we believe that continued scientific conclusions of magnesium’s role in blood pressure support will be understood and embraced by both industry and consumers.”
Cohen said that there are many compelling studies published associating magnesium with the management of vascular calcification, a phenomenon associated with blood pressure increases.
“We believe that in the future more evidence will arise showing full support about the help of magnesium for blood pressure reduction. Some supportive or suggested mechanism that needs to be checked and verified is the theory that magnesium may prevent inner wall calcification of the arteries. We believe that checking this mechanism may show that arteries remain more flexible and expendable and therefore blood pressure may be reduced. We have not found clear evidence of this theory, however, our intensive work with this mineral can point out that this mechanism may be feasible,” Cohen said.
On January 10, FDA first announced that it would use its regulatory discretion to allow these qualified health claims for magnesium in a letter issued in response to a petition filed by the Center for Magnesium Education and Research, LLC. Specifically, they listed three claims that they said they would use enforcement discretion to allow ahead of the rulemaking process, all three of which categorize the evidence that as “inconsistent and inconclusive.”
“We are encouraged by the fact that the FDA recognizes that magnesium consumption can benefit human health via helping to support healthy blood pressure,” Cohen said. “It is an auspicious beginning, and we believe that continued scientific conclusions of magnesium’s role in blood pressure support will be understood and embraced by both industry and consumers.”
Cohen said that there are many compelling studies published associating magnesium with the management of vascular calcification, a phenomenon associated with blood pressure increases.
“We believe that in the future more evidence will arise showing full support about the help of magnesium for blood pressure reduction. Some supportive or suggested mechanism that needs to be checked and verified is the theory that magnesium may prevent inner wall calcification of the arteries. We believe that checking this mechanism may show that arteries remain more flexible and expendable and therefore blood pressure may be reduced. We have not found clear evidence of this theory, however, our intensive work with this mineral can point out that this mechanism may be feasible,” Cohen said.
On January 10, FDA first announced that it would use its regulatory discretion to allow these qualified health claims for magnesium in a letter issued in response to a petition filed by the Center for Magnesium Education and Research, LLC. Specifically, they listed three claims that they said they would use enforcement discretion to allow ahead of the rulemaking process, all three of which categorize the evidence that as “inconsistent and inconclusive.”
