[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR101.82]

[Page 145-147]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                           SERVICES--CONTINUED
 
PART 101--FOOD LABELING--Table of Contents
 
           Subpart E--Specific Requirements for Health Claims
 
Sec. 101.82  Health claims: Soy protein and risk of coronary heart disease (CHD).

    (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 
of CHD. (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

[[Page 146]]

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.
    (c) Requirements. (1) All requirements set forth in Sec. 101.14 
shall be met.
    (2) Specific requirements--(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 disease;
    (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 
protein'';
    (D) In specifying the fat component, the claim uses the terms 
``saturated fat'' and ``cholesterol'';
    (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 protein;
    (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 Sec. 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 regulatory officials.
    (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 
Sec. 101.62 for a ``low saturated fat'' and ``low cholesterol'' food; 
and
    (C) The food shall meet the nutrient content requirement in 
Sec. 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.
    (d) Optional information. (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

[[Page 147]]

also provide additional information about the benefits of exercise and 
management of body weight to help lower the risk of heart disease;
    (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 (GPO);
    (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 and treatment;
    (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 disease:
    (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.

[64 FR 57732, Oct. 26, 1999]

    Effective Date Note: At 64 FR 57732, Oct. 26, 1999, Sec. 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.