The Food and Drug Administration (FDA) recently debuted a new eligible health claim for magnesium. In early January 2022, the FDA ruled that the current data support the qualified health claim that there is a relationship between a reduced risk of high blood pressure and magnesium1. There are three types of label claims utilized by the FDA: Health claims, structure/function claims, and nutrient content claims.
FDA health claims are categorized as qualified or authorized claims. An authorized health claim shall meet significant scientific agreement (SSA) standards and/or be based on respected statements from federal scientific bodies. Since 1990 the FDA has only authorized twelve health claims. Whereas a qualified health claim stems from emerging evidence and does not meet SSA principles. A qualified claim is not approved by the Code of Federal Regulations, a letter of enforcement discretions reflects the claim’s scientific evidence. As of January 2022, there are thirty-eight letters of enforcement discretions for qualified health claims.
High blood pressure affects approximately 47% of adults in the United States, and the growing link between magnesium intake and high blood pressure is on the rise. Magnesium inhibits a protective role in improving circulating volume, vascular stiffness, and resistance1. Magnesium intake in America is 30% below the recommended daily valve, its deficiency has been linked to cardiovascular risk factors.
There was an initial petition for the qualified health claim regarding high blood pressure and magnesium. The FDA reviewed approximately forty different publications that assessed intervention studies to prove there is a link between magnesium intake and the reduced risk of high blood pressure. After extensive reviews, the FDA determined there is some credible evidence that magnesium intake from foods and supplements may reduce the risk of high blood pressure. If your company needs assistance with a qualified or authorized health claim to the FDA, EMMA International can assist. Contact us by phone at 248-987-4497 or by email at info@emmainternational.com.
1FDLI (March 2022) FDA allows a qualified health claim for magnesium and reduced risk of high blood pressure Retrieved on May 2, 2022, from https://www.fdli.org/2022/03/fda-allows-qualified-health-claim-for-magnesium-and-reduced-risk-of-high-blood-pressure/
