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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 2]
[Revised as of April 1, 2014]
[CITE: 21CFR101.78]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER B--FOOD FOR HUMAN CONSUMPTION

PART 101 -- FOOD LABELING

Subpart E--Specific Requirements for Health Claims

Sec. 101.78 Health claims: fruits and vegetables and cancer.

(a) Relationship between substances in diets low in fat and high in 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, alcohol consumption, overweight and obesity, ultraviolet or ionizing radiation, exposure to cancer-causing chemicals, and dietary factors.

(2) Although the specific roles of the numerous potentially protective substances in plant foods are not yet understood, many studies have shown that diets high in plant foods are associated with reduced risk of some types of cancers. These studies correlate diets rich in fruits and vegetables and nutrients from these diets, such as vitamin C, vitamin A, and dietary fiber, with reduced cancer risk. Persons consuming these diets frequently have high intakes of these nutrients. Currently, there is not scientific agreement as to whether the observed protective effects of fruits and vegetables against cancer are due to a combination of the nutrient components of diets rich in fruits and vegetables, including but not necessarily limited to dietary fiber, vitamin A (as beta-carotene) and vitamin C, to displacement of fat from such diets, or to intakes of other substances in these foods which are not nutrients but may be protective against cancer risk.

(b) Significance of the relationship between consumption of diets low in fat and high in 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 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, vitamin A (as beta-carotene), and vitamin C. 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 (5 or more servings daily), particularly those fruits and vegetables which contain dietary fiber, vitamin A, and vitamin C.

(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 substances in diets low in fat and high in 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 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 characterizes fruits and vegetables as foods that are low in fat and may contain vitamin A, vitamin C, and dietary fiber;

(D) The claim characterizes the food bearing the claim as containing one or more of the following, for which the food is a good source under 101.54: dietary fiber, vitamin A, or vitamin C;

(E) The claim does not attribute any degree of cancer risk reduction to diets low in fat and high in fruits and vegetables;

(F) In specifying the fat component of the labeled food, the claim uses the term "total fat" or "fat";

(G) The claim does not specify types of fats or fatty acids that may be related to risk of cancer;

(H) In specifying the dietary fiber component of the labeled food, the claim uses the term "fiber", "dietary fiber", or "total dietary fiber";

(I) The claim does not specify types of dietary fiber that may be related to risk of cancer; and

(J) The claim indicates that development of cancer depends on many factors.

(ii) Nature of the food. (A) The food shall be or shall contain a 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 at least one of the following: vitamin A, vitamin C, or 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 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, alcohol consumption, overweight and obesity, ultraviolet or ionizing radiation, exposure to cancer-causing chemicals, and dietary factors.

(3) The claim may use the word "beta-carotene" in parentheses after the term vitamin A, provided that the vitamin A in the food bearing the claim is beta-carotene.

(4) The claim may indicate that it is consistent with "Nutrition and Your Health: Dietary Guidelines for Americans," U.S. Department of Agriculture (USDA) and the Department of Health and Human Services (DHHS), Government Printing Office.

(5) 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 substances in diets low in fat and high in fruits and vegetables and cancer:

(1) Low fat diets rich in fruits and vegetables (foods that are low in fat and may contain dietary fiber, vitamin A, and vitamin C) may reduce the risk of some types of cancer, a disease associated with many factors. Broccoli is high in vitamins A and C, and it is a good source of dietary fiber.

(2) Development of cancer depends on many factors. Eating a diet low in fat and high in fruits and vegetables, foods that are low in fat and may contain vitamin A, vitamin C, and dietary fiber, may reduce your risk of some cancers. Oranges, a food low in fat, are a good source of fiber and vitamin C.

[58 FR 2639, Jan. 6, 1993]

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