21 CFR 101.76 - Health claims: fiber-containing grain products, fruits, and vegetables and cancer.

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§ 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 § 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:
(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 § 101.62 for a “low fat” food.
(C) The food shall meet, without fortification, the nutrient content requirements of § 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]

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.

  • 2014-12-10; vol. 79 # 237 - Wednesday, December 10, 2014
    1. 79 FR 73201 - Uniform Compliance Date for Food Labeling Regulations
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule.
      This rule is effective December 10, 2014. Submit electronic or written comments by February 9, 2015.
      21 CFR Part 101

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United States Code

Title 21 published on 2014-04-01

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR 101 after this date.

  • 2014-12-10; vol. 79 # 237 - Wednesday, December 10, 2014
    1. 79 FR 73201 - Uniform Compliance Date for Food Labeling Regulations
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Final rule.
      This rule is effective December 10, 2014. Submit electronic or written comments by February 9, 2015.
      21 CFR Part 101