[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: 21CFR101.73]

[Page 127-128]
 
                        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. 101.73  Health claims: dietary lipids and cancer.

    (a) Relationship between fat and cancer. (1) Cancer is a 
constellation of more than 100 different diseases, each characterized by 
the uncontrolled growth and spread of abnormal cells. Cancer has many 
causes and stages in its development. Both genetic and environmental 
risk factors may affect the risk of cancer. Risk factors include a 
family history of a specific type of cancer, cigarette smoking, alcohol 
consumption, overweight and obesity, ultraviolet or ionizing radiation, 
exposure to cancer-causing chemicals, and dietary factors.
    (2) Among dietary factors, the strongest positive association has 
been found between total fat intake and risk of some types of cancer. 
Based on the totality of the publicly available scientific evidence, 
there is significant scientific agreement among experts, qualified by 
training and experience to evaluate such evidence, that diets high in 
total fat are associated with an increased cancer risk. Research to 
date, although not conclusive, demonstrates that the total amount of 
fats, rather than any specific type of fat, is positively associated 
with cancer risk. The mechanism by which total fat affects cancer has 
not yet been established.
    (3) A question that has been the subject of considerable research is 
whether the effect of fat on cancer is site-specific. Neither human nor 
animal studies are consistent in the association of fat intake with 
specific cancer sites.
    (4) Another question that has been raised is whether the association 
of total fat intake to cancer risk is independently associated with 
energy intakes, or whether the association of fat with cancer risk is 
the result of the higher energy (caloric) intake normally associated 
with high fat intake. FDA has concluded that evidence from both animal 
and human studies indicates that total fat intake alone, independent of 
energy intake, is associated with cancer risk.
    (b) Significance of the relationship between fat intake and risk of 
cancer. (1) Cancer is ranked as a leading cause of death in the United 
States. The overall economic costs of cancer, including direct health 
care costs and losses due to morbidity and mortality, are very high.
    (2) U.S. diets tend to be high in fat and high in calories. The 
average U.S. diet is estimated to contain 36 to 37 percent of calories 
from total fat. Current dietary guidelines from the Federal Government 
and other national health professional organizations recommend that 
dietary fat intake be reduced to a level of 30 percent or less of energy 
(calories) from total fat. In order to reduce intake of total fat, 
individuals should choose diets which are high in vegetables, fruits, 
and grain products (particularly whole grain products), choose lean cuts 
of meats, fish, and poultry, substitute low-fat dairy products for 
higher fat products, and use fats and oils sparingly.
    (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 low in fat with reduced risk of cancer 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 fat ``may'' or ``might'' 
reduce the risk of some cancers;
    (B) In specifying the disease, the claim uses the following terms: 
``some types of cancer'' or ``some cancers'';

[[Page 128]]

    (C) In specifying the nutrient, the claim uses the term ``total 
fat'' or ``fat'';
    (D) The claim does not specify types of fat or fatty acid that may 
be related to the risk of cancer;
    (E) The claim does not attribute any degree of cancer risk reduction 
to diets low in fat; and
    (F) The claim indicates that the development of cancer depends on 
many factors.
    (ii) Nature of the food. The food shall meet all of the nutrient 
content requirements of Sec. 101.62 for a ``low fat'' food; except that 
fish and game meats (i.e., deer, bison, rabbit, quail, wild turkey, 
geese, ostrich) may meet the requirements for ``extra lean'' in 
Sec. 101.62.
    (d) Optional information. (1) The claim may identify one or more of 
the following risk factors for development of cancer: Family history of 
a specific type of cancer, cigarette smoking, alcohol consumption, 
overweight and obesity, ultraviolet or ionizing radiation, exposure to 
cancer-causing chemicals, and dietary factors.
    (2) The claim may include information from paragraphs (a) and (b) of 
this section which summarize the relationship between dietary fat and 
cancer and the significance of the relationship.
    (3) The claim may indicate that it 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.
    (4) The claim may include information on the number of people in the 
United States who have cancer. 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,'' USDA and DHHS, 
Government Printing Office.
    (e) Model health claims. The following model health claims may be 
used in food labeling to describe the relationship between dietary fat 
and cancer:
    (1) Development of cancer depends on many factors. A diet low in 
total fat may reduce the risk of some cancers.
    (2) Eating a healthful diet low in fat may help reduce the risk of 
some types of cancers. Development of cancer is associated with many 
factors, including a family history of the disease, cigarette smoking, 
and what you eat.

[58 FR 2801, Jan. 6, 1993; 58 FR 17343, Apr. 2, 1993]