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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


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).
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


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

4       UPDATE    Spring2022


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