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2022 FDLI Update 4 (2022)
FDA Allows Qualified Health Claim for Magnesium and Reduced Risk of High Blood Pressure

handle is hein.journals/fdliup2022 and id is 8 raw text is: 4 f FDA Allows Qualified Health Claim for Magnesium and Reduced Risk of High Blood Pressure by Megan Maisano & Dana Engel Gerstein The Food and Drug Administration (FDA) recent- ly announced a new qualified health claim for magnesium. In a letter of enforcement discretion, released on January 10, FDA ruled that the current evidence supports a qualified health claim regarding the relationship between magnesium and reduced risk of high blood pres- sure (hypertension). Background Health Claims': There are three label claims that are defined by statute or FDA regulations: health claims, nutrient content claims, and structure/function claims. Health claims specif- ically describe the relationship between a food, food compo- nent, or dietary ingredient and a reduced risk of disease or health-related condition. Based on the strength of the scientif- ic evidence, health claims can be categorized as authorized or qualified. Authorized health claims must meet significant sci- entific agreement (SSA) standards or be based on authoritative statements from federal scientific bodies. Since 1990, FDA has 1\Nj Y. Megan Maisano is Director of Regulatory Affairs at National Dairy Council. She provides regulatory and scientific guidance to support dairy- related communications, outreach strategies, and educational materials. authorized twelve health claims. One example of such a claim is the relationship between calcium, vitamin D, and osteoporosis (21 C.F.R 4 101.72). Qualified health claims, however, stem from emerging evidence and do not meet SSA criteria. Unlike autho- rized health claims, qualified claims are not approved or pub- lished in the Code of Federal Regulations. Rather, in response to a petition submitted by a food manufacturer or other entity, FDA issues a letter of enforcement discretion with specific qual- ifying language to reflect the limitations of the claim's scientific evidence. As of January 2022, there are thirty-eight current letters of enforcement discretion for qualified health claims. Hypertension and Magnesium2: High blood pressure remains a considerable public health concern in the United States. Hyper- tension, defined as blood pressure at or above 130/80 mmHg, affects 47% of adults and increases the risk for heart disease and stroke (the leading causes of death in the United States). There is a growing body of evidence on the relationship between magnesium intake and hypertension. Magnesium may exhibit Dana Engel Gerstein is Vice President of Regulatory and Scientific Affairs at National Dairy Council. With a background in public health obesity prevention initiatives, Dana's work at NDC supports making healthy eating accessible, economical, and sustainable. 4 UPDATE Spring2022 www.fdli.org

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