§ 101.75Health claims: dietary saturated fat and cholesterol and risk of coronary
(a)Relationship between dietary saturated fat and cholesterol and risk of
coronary heart disease.
(1) Cardiovascular disease means diseases of the heart and circulatory
system. Coronary heart disease is the most common and serious form of
cardiovascular disease and refers to diseases of the heart muscle and
supporting blood vessels. High blood total- and low density lipoprotein
(LDL)- cholesterol levels are major modifiable risk factors in the
development of coronary heart disease. High coronary heart disease rates
occur among people with high blood cholesterol levels of 240
milligrams/decaliter (mg/dL) (6.21 millimoles per liter (mmol/L)) or above
and LDL-cholesterol levels of 160 mg/dL (4.13 mmol/L) or above. Borderline
high risk blood cholesterol levels range from 200 to 239 mg/dL (5.17 to 6.18
mmol/L) and 130 to 159 mg/dL (3.36 to 4.11 mmol/L) of LDL-cholesterol.
Dietary lipids (fats) include fatty acids and cholesterol. Total fat,
commonly referred to as fat, is composed of saturated fat (fatty acids
containing no double bonds), and monounsaturated and polyunsaturated fat
(fatty acids containing one or more double bonds).
(2) The scientific evidence establishes that diets high in saturated fat and
cholesterol are associated with increased levels of blood total- and
LDL-cholesterol and, thus, with increased risk of coronary heart disease.
Diets low in saturated fat and cholesterol are associated with decreased
levels of blood total- and LDL-cholesterol, and thus, with decreased risk of
developing coronary heart disease.
(b)Significance of the relationship between dietary saturated fat and
cholesterol and risk of coronary heart disease.
(1) Coronary heart disease is a major public health concern in the United
States, primarily because it accounts for more deaths than any other disease
or group of diseases. Early management of risk factors for coronary heart
disease is a major public health goal that can assist in reducing risk of
coronary heart disease. There is a continuum of mortality risk from coronary
heart disease that increases with increasing levels of blood
LDL-cholesterol. Individuals with high blood LDL-cholesterol are at greatest
risk. A larger number of individuals with more moderately elevated
cholesterol also have increased risk of coronary events; such individuals
comprise a substantial proportion of the adult U.S. population. The
scientific evidence indicates that reducing saturated fat and cholesterol
intakes lowers blood LDL-cholesterol and risk of heart disease in most
individuals. There is also evidence that reducing saturated fat and
cholesterol intakes in persons with blood cholesterol levels in the normal
range also reduces risk of heart disease.
(2) Other risk factors for coronary heart disease include a family history of
heart disease, high blood pressure, diabetes, cigarette smoking, obesity
(body weight 30 percent greater than ideal body weight), and lack of regular
(3) Intakes of saturated fat exceed recommended levels in many people in the
United States. Intakes of cholesterol are, on average, at or above
recommended levels. One of the major public health recommendations relative
to coronary heart disease risk is to consume less than 10 percent of
calories from saturated fat, and an average of 30 percent or less of total
calories from all fat. Recommended daily cholesterol intakes are 300 mg or
less per day.
(1) All requirements set forth in § 101.14 shall be met.
(i)Nature of the claim. A health claim associating diets low in saturated fat and cholesterol
with reduced risk of coronary heart disease may be made on the label or
labeling of a food described in paragraph (c)(2)(ii) of this section
(A) The claim states that diets low in saturated fat and cholesterol “may” or
“might” reduce the risk of heart disease;
(B) In specifying the disease, the claim uses the terms “heart disease” or
“coronary heart disease;”
(C) In specifying the nutrient, the claim uses the terms “saturated fat” and
“cholesterol” and lists both;
(D) The claim does not attribute any degree of risk reduction for coronary
heart disease to diets low in dietary saturated fat and cholesterol;
(E) The claim states that coronary heart disease risk depends on many
(ii)Nature of the food. The food shall meet all of the nutrient content requirements of § 101.62 for a “low saturated fat,” “low cholesterol,” and “low fat” food;
except that fish and game meats (i.e., deer, bison, rabbit, quail, wild
turkey, geese, and ostrich) may meet the requirements for “extra lean” in
(1) The claim may identify one or more of the following risk factors in
addition to saturated fat and cholesterol about which there is general
scientific agreement that they are major risk factors for this disease: A
family history of coronary heart disease, elevated blood total and
LDL-cholesterol, excess body weight, high blood pressure, cigarette smoking,
diabetes, and physical inactivity.
(2) The claim may indicate that the relationship of saturated fat and
cholesterol to heart disease is through the intermediate link of “blood
cholesterol” or “blood total- and LDL cholesterol.”
(3) The claim may include information from paragraphs (a) and (b) of this
section, which summarize the relationship between dietary saturated fat and
cholesterol and risk of coronary heart disease, and the significance of the
(4) In specifying the nutrients, the claim may include the term “total fat”
in addition to the terms “saturated fat” and “cholesterol”.
(5) The claim may include information on the number of people in the United
States who have coronary heart disease. The sources of this information
shall be identified, and it shall 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
Agriculture (USDA), Government Printing Office.
(6) The claim may indicate that it is consistent with “Nutrition and Your
Health: Dietary Guidelines for Americans,” DHHS and USDA, Government
(7) The claim may state that individuals with elevated blood total- or
LDL-cholesterol should consult their physicians for medical advice and
treatment. If the claim defines high or normal blood total- or
LDL-cholesterol levels, then the claim shall state that individuals with
high blood cholesterol should consult their physicians for medical advice
(e)Model health claims.The following are model health claims that may be used in food labeling to
describe the relationship between dietary saturated fat and cholesterol and
risk of heart disease:
(1) While many factors affect heart disease, diets low in saturated fat and
cholesterol may reduce the risk of this disease;
(2) Development of heart disease depends upon many factors, but its risk may
be reduced by diets low in saturated fat and cholesterol and healthy
(3) Development of heart disease depends upon many factors, including a
family history of the disease, high blood LDL-cholesterol, diabetes, high
blood pressure, being overweight, cigarette smoking, lack of exercise, and
the type of dietary pattern. A healthful diet low in saturated fat, total
fat, and cholesterol, as part of a healthy lifestyle, may lower blood
cholesterol levels and may reduce the risk of heart disease;
(4) Many factors, such as a family history of the disease, increased blood-
and LDL-cholesterol levels, high blood pressure, cigarette smoking,
diabetes, and being overweight, contribute to developing heart disease. A
diet low in saturated fat, cholesterol, and total fat may help reduce the
risk of heart disease; and
(5) Diets low in saturated fat, cholesterol, and total fat may reduce the
risk of heart disease. Heart disease is dependent upon many factors,
including diet, a family history of the disease, elevated blood
LDL-cholesterol levels, and physical inactivity.
[58 FR 2757, Jan. 6, 1993]
Title 21 published on 2014-04-01.
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