21 CFR 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.
(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”;
(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 § 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 § 101.62.
(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.
Title 21 published on 2015-12-03
The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 101 after this date.