§ 101.82Health claims: Soy protein and risk of coronary heart disease
(a)Relationship between diets that are low in saturated fat and
cholesterol and that include soy protein and the risk of CHD.
(1) Cardiovascular disease means diseases of the heart and circulatory
system. CHD is one of the most common and serious forms of cardiovascular
disease and refers to diseases of the heart muscle and supporting blood
vessels. High blood total cholesterol and low density lipoprotein
(LDL)-cholesterol levels are associated with increased risk of developing
CHD. High CHD rates occur among people with high total cholesterol levels of
240 milligrams per deciliter (mg/dL) (6.21 millimole per liter (mmol/L)) or
above and LDL-cholesterol levels of 160 mg/dL (4.13 mmol/L) or above.
Borderline high risk total 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. 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 CHD.
(2) Populations with a low incidence of CHD tend to have relatively low blood
total cholesterol and LDL-cholesterol levels. These populations also tend to
have dietary patterns that are not only low in total fat, especially
saturated fat and cholesterol, but are also relatively high in plant foods
that contain dietary fiber and other components.
(3) Scientific evidence demonstrates that diets low in saturated fat and
cholesterol may reduce the risk of CHD. Other evidence demonstrates that the
addition of soy protein to a diet that is low in saturated fat and
cholesterol may also help to reduce the risk of CHD.
(b)Significance of the relationship between diets that are low in
saturated fat and cholesterol and that include soy protein and the risk
(1) CHD is a major public health concern in the United States. It accounts
for more deaths than any other disease or group of diseases. Early
management of risk factors for CHD is a major public health goal that can
assist in reducing risk of CHD. High blood total and LDL-cholesterol are
major modifiable risk factors in the development of CHD.
(2) Intakes of saturated fat exceed recommended levels in the diets of many
people in the United States. One of the major public health recommendations
relative to CHD 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.
Scientific evidence demonstrates that diets low in saturated fat and
cholesterol are associated with lower blood total and LDL-cholesterol
levels. Soy protein, when included in a low saturated fat and cholesterol
diet, also helps to lower blood total and LDL-cholesterol levels.
(1) All requirements set forth in § 101.14 shall be met.
(i)Nature of the claim. A health claim associating diets that are low in saturated fat and
cholesterol and that include soy protein with reduced risk of heart disease
may be made on the label or labeling of a food described in paragraph
(c)(2)(iii) of this section, provided that:
(A) The claim states that diets that are low in saturated fat and cholesterol
and that include soy protein “may” or “might” reduce the risk of heart
(B) In specifying the disease, the claim uses the following terms: “heart
disease” or “coronary heart disease”;
(C) In specifying the substance, the claim uses the term “soy
(D) In specifying the fat component, the claim uses the terms “saturated fat”
(E) The claim does not attribute any degree of risk reduction for CHD to
diets that are low in saturated fat and cholesterol and that include soy
(F) The claim does not imply that consumption of diets that are low in
saturated fat and cholesterol and that include soy protein is the only
recognized means of achieving a reduced risk of CHD; and
(G) The claim specifies the daily dietary intake of soy protein that is
necessary to reduce the risk of coronary heart disease and the contribution
one serving of the product makes to the specified daily dietary intake
level. The daily dietary intake level of soy protein that has been
associated with reduced risk of coronary heart disease is 25 grams (g) or
more per day of soy protein.
(ii)Nature of the substance.
(A) Soy protein from the legume seed Glycine max.
(B) FDA will assess qualifying levels of soy protein in the following
fashion: FDA will measure total protein content by the appropriate method of
analysis given in the “Official Methods of Analysis of the AOAC
International,” as described at § 101.9(c)(7). For products that contain no sources of protein other than soy, FDA
will consider the amount of soy protein as equivalent to the total protein
content. For products that contain a source or sources of protein in
addition to soy, FDA will, using the measurement of total protein content,
calculate the soy protein content based on the ratio of soy protein
ingredients to total protein ingredients in the product. FDA will base its
calculation on information identified and supplied by manufacturers, such as
nutrient data bases or analyses, recipes or formulations, purchase orders
for ingredients, or any other information that reasonably substantiates the
ratio of soy protein to total protein. Manufacturers must maintain records
sufficient to substantiate the claim for as long as the products are
marketed and provide these records, on written request, to appropriate
(iii)Nature of the food eligible to bear the claim.
(A) The food product shall contain at least 6.25 g of soy protein per
reference amount customarily consumed of the food product;
(B) The food shall meet the nutrient content requirements in § 101.62 for a “low saturated fat” and “low cholesterol” food; and
(C) The food shall meet the nutrient content requirement in § 101.62 for a “low fat” food, unless it consists of or is derived from whole
soybeans and contains no fat in addition to the fat inherently present in
the whole soybeans it contains or from which it is derived.
(1) The claim may state that the development of heart disease depends on many
factors and may identify one or more of the following risk factors for heart
disease about which there is general scientific agreement: A family history
of CHD; elevated blood total and LDL-cholesterol; excess body weight; high
blood pressure; cigarette smoking; diabetes; and physical inactivity. The
claim may also provide additional information about the benefits of exercise
and management of body weight to help lower the risk of heart
(2) The claim may state that the relationship between intake of diets that
are low in saturated fat and cholesterol and that include soy protein and
reduced risk of 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 diets that are low in
saturated fat and cholesterol and that include soy protein and CHD and the
significance of the relationship;
(4) The claim may state that a diet low in saturated fat and cholesterol that
includes soy protein is consistent with “Nutrition and Your Health: Dietary
Guidelines for Americans,” U.S. Department of Agriculture (USDA) and
Department of Health and Human Services (DHHS), Government Printing Office
(5) The claim may state that individuals with elevated blood total and
LDL-cholesterol should consult their physicians for medical advice and
treatment. If the claim defines high or normal blood total and
LDL-cholesterol levels, then the claim shall state that individuals with
high blood cholesterol should consult their physicians for medical advice
(6) The claim may include information on the number of people in the United
States who have 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,” USDA and DHHS, GPO;
(e)Model health claim. The following model health claims may be used in food labeling to
describe the relationship between diets that are low in saturated fat and
cholesterol and that include soy protein and reduced risk of heart
(1) 25 grams of soy protein a day, as part of a diet low in saturated fat and
cholesterol, may reduce the risk of heart disease. A serving of [name of
food] supplies __ grams of soy protein.
(2) Diets low in saturated fat and cholesterol that include 25 grams of soy
protein a day may reduce the risk of heart disease. One serving of [name of
food] provides __ grams of soy protein.
At 64 FR 57732, Oct. 26, 1999, § 101.82 was added. Paragraph (c)(2)(ii)(B) contains information collection
and recordkeeping requirements and will not become effective until approval
has been given by the Office of Management and Budget.
Title 21 published on 2014-04-01.
The following are only the Rules published in the Federal Register after the published date of Title 21.
For a complete list of all Rules, Proposed Rules, and Notices view the Rulemaking tab.
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