[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR101.76]

[Page 136-137]
 
                        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.  101.76  Health claims: fiber-containing grain products, fruits, and vegetables and cancer.

    (a) Relationship between diets low in fat and high in fiber-
containing grain products, fruits, and vegetables and cancer risk. (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, overweight and obesity, alcohol consumption, ultraviolet or 
ionizing radiation, exposure to cancer-causing chemicals, and dietary 
factors.
    (2) The scientific evidence establishes that diets low in fat and 
high in fiber-containing grain products, fruits, and vegetables are 
associated with a reduced risk of some types of cancer. Although the 
specific role of total dietary fiber, fiber components, and the multiple 
nutrients and other substances contained in these foods are not yet 
fully understood, many studies have shown that diets low in fat and high 
in fiber-containing foods are associated with reduced risk of some types 
of cancer.
    (b) Significance of the relationship between consumption of diets 
low in fat and high in fiber-containing grain products, fruits, and 
vegetables 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 low in grain products, 
fruits, and vegetables. Studies in various parts of the world indicate 
that populations who habitually consume a diet high in plant foods have 
lower risks of some cancers. These diets generally are low in fat and 
rich in many nutrients, including, but not limited to, dietary fiber. 
Current dietary guidelines from Federal government agencies and 
nationally recognized health professional organizations recommend 
decreased consumption of fats (less than 30 percent of calories), 
maintenance of desirable body weight, and increased consumption of 
fruits and vegetables (five or more servings daily), and grain products 
(six or more servings daily).
    (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 and high in fiber-containing grain 
products, fruits, and vegetables 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:

[[Page 137]]

    (A) The claim states that diets low in fat and high in fiber-
containing grain products, fruits, and vegetables ``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'';
    (C) The claim is limited to grain products, fruits, and vegetables 
that contain dietary fiber;
    (D) The claim indicates that development of cancer depends on many 
factors;
    (E) The claim does not attribute any degree of cancer risk reduction 
to diets low in fat and high in fiber-containing grain products, fruits, 
and vegetables;
    (F) In specifying the dietary fiber component of the labeled food, 
the claim uses the term ``fiber'', ``dietary fiber'' or ``total dietary 
fiber''; and
    (G) The claim does not specify types of dietary fiber that may be 
related to risk of cancer.
    (ii) Nature of the food. (A) The food shall be or shall contain a 
grain product, fruit, or vegetable.
    (B) The food shall meet the nutrient content requirements of Sec.  
101.62 for a ``low fat'' food.
    (C) The food shall meet, without fortification, the nutrient content 
requirements of Sec.  101.54 for a ``good source'' of dietary fiber.
    (d) Optional information. (1) The claim may include information from 
paragraphs (a) and (b) of this section, which summarize the relationship 
between diets low in fat and high in fiber-containing grain products, 
fruits, and vegetables, and some types of cancer and the significance of 
the relationship.
    (2) 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, overweight and obesity, alcohol consumption, 
ultraviolet or ionizing radiation, exposure to cancer causing chemicals, 
and dietary factors.
    (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 characterize the relationship between diets low 
in fat and high in fiber-containing grain products, fruits, and 
vegetables and cancer risk:
    (1) Low fat diets rich in fiber-containing grain products, fruits, 
and vegetables may reduce the risk of some types of cancer, a disease 
associated with many factors.
    (2) Development of cancer depends on many factors. Eating a diet low 
in fat and high in grain products, fruits, and vegetables that contain 
dietary fiber may reduce your risk of some cancers.

[58 FR 2548, Jan. 6, 1993]