(a)Relationship between sodium and hypertension (high blood
(1) Hypertension, or high blood pressure, generally means a systolic blood
pressure of greater than 140 millimeters of mercury (mm Hg) or a diastolic
blood pressure of greater than 90 mm Hg. Normotension, or normal blood
pressure, is a systolic blood pressure below 140 mm Hg and diastolic blood
pressure below 90 mm Hg. Sodium is specified here as the chemical entity or
electrolyte “sodium” and is distinguished from sodium chloride, or salt,
which is 39 percent sodium by weight.
(2) The scientific evidence establishes that diets high in sodium are
associated with a high prevalence of hypertension or high blood pressure and
with increases in blood pressure with age, and that diets low in sodium are
associated with a low prevalence of hypertension or high blood pressure and
with a low or no increase of blood pressure with age.
(b)Significance of sodium in relation to high blood pressure.
(1) High blood pressure is a public health concern primarily because it is a
major risk factor for mortality from coronary heart disease and stroke.
Early management of high blood pressure is a major public health goal that
can assist in reducing mortality associated with coronary heart disease and
stroke. There is a continuum of mortality risk that increases as blood
pressures rise. Individuals with high blood pressure are at greatest risk,
and individuals with moderately high, high normal, and normal blood pressure
are at steadily decreasing risk. The scientific evidence indicates that
reducing sodium intake lowers blood pressure and associated risks in many
but not all hypertensive individuals. There is also evidence that reducing
sodium intake lowers blood pressure and associated risks in many but not all
normotensive individuals as well.
(2) The populations at greatest risk for high blood pressure, and those most
likely to benefit from sodium reduction, include those with family histories
of high blood pressure, the elderly, males because they develop hypertension
earlier in life than females, and black males and females. Although some
population groups are at greater risk than others, high blood-pressure is a
disease of public health concern for all population groups. Sodium intake,
alcohol consumption, and obesity are identified risk factors for high blood
(3) Sodium intakes exceed recommended levels in almost every group in the
United States. One of the major public health recommendations relative to
high blood pressure is to decrease consumption of salt. On a population-wide
basis, reducing the average sodium intake would have a small but significant
effect on reducing the average blood pressure, and, consequently, reducing
mortality from coronary heart disease and stroke.
(4) Sodium is an essential nutrient, and experts have recommended a safe
minimum level of 500 milligrams (mg) sodium per day and an upper level of
2,400 mg sodium per day, the FDA Daily Value for sodium.
(1) All requirements set forth in § 101.14 shall be met.
(i)Nature of the claim. A health claim associating diets low in sodium with reduced risk of high
blood pressure may be made on the label or labeling of a food described in
paragraph (c)(2)(ii) of this section, provided that:
(A) The claim states that diets low in sodium “may” or “might” reduce the
risk of high blood pressure;
(B) In specifying the disease, the claim uses the term “high blood
(C) In specifying the nutrient, the claim uses the term “sodium”;
(D) The claim does not attribute any degree of reduction in risk of high
blood pressure to diets low in sodium; and
(E) The claim indicates that development of high blood pressure depends on
(ii)Nature of the food. The food shall meet all of the nutrient content requirements of § 101.61 for a “low sodium” food.
(1) The claim may identify one or more of the following risk factors for
development of high blood pressure in addition to dietary sodium
consumption: Family history of high blood pressure, growing older, alcohol
consumption, and excess weight.
(2) The claim may include information from paragraphs (a) and (b) of this
section, which summarizes the relationship between dietary sodium and high
blood pressure and the significance of the relationship.
(3) The claim may include information on the number of people in the United
States who have high blood pressure. The sources of this information must be
identified, and it must be current information from the National Center for
Health Statistics, the National Institutes of Health, or “Nutrition and Your
Health: Dietary Guidelines for Americans,” U.S. Department of Health and
Human Services (DHHS) and U.S. Department of Argiculture (USDA), Government
(4) The claim may indicate that it is consistent with “Nutrition and Your
Health: U.S. Dietary Guidelines for Americans, DHHS and USDA, Government
(5) In specifying the nutrient, the claim may include the term “salt” in
addition to the term “sodium.”
(6) In specifying the disease, the claim may include the term “hypertension”
in addition to the term “high blood pressure.”
(7) The claim may state that individuals with high blood pressure should
consult their physicians for medical advice and treatment. If the claim
defines high or normal blood pressure, then the health claim must state that
individuals with high blood pressure should consult their physicians for
medical advice and treatment.
(e)Model health claims. The following are model health claims that may be used in food labeling
to describe the relationship between dietary sodium and high blood
(1) Diets low in sodium may reduce the risk of high blood pressure, a disease
associated with many factors.
(2) Development of hypertension or high blood pressure depends on many
factors. [This product] can be part of a low sodium, low salt diet that
might reduce the risk of hypertension or high blood pressure.