Source: https://www.ecfr.gov/cgi-bin/retrieveECFR?gp=1&h=L&mc=true&r=SUBPART&n=sp21.2.101.e
Timestamp: 2020-04-07 19:25:25
Document Index: 94009142

Matched Legal Cases: ['art 101', '§101', '§101', '§101', '§101', '§101', '§101', '§101', '§101', '§101', '§101', '§101', '§101', '§101', '§101', 'art 56', '§56', '§56', 'art 50', '§101', '§101', '§101', '§25', '§25', '§25', '§101', '§101', '§101', '§101', '§101', '§101', '§101', '§101', '§101', '§101', '§101', '§101', '§101', '§101', '§101', '§101', '§101', '§101', '§101', '§101', '§101', '§101', 'art 51', '§101', '§101', 'art 51', 'art 51', 'art 51', 'art 51', '§101', '§101', '§101', '§101', '§101', '§101', '§101', '§101', '§101', '§101', 'art 51', 'art 51', '§101', '§101', '§101']

Title 21 → Chapter I → Subchapter B → Part 101 → Subpart E
§101.70 Petitions for health claims.
§101.71 Health claims: claims not authorized.
§101.72 Health claims: calcium, vitamin D, and osteoporosis.
§101.73 Health claims: dietary lipids and cancer.
§101.74 Health claims: sodium and hypertension.
§101.75 Health claims: dietary saturated fat and cholesterol and risk of coronary heart disease.
§101.76 Health claims: fiber-containing grain products, fruits, and vegetables and cancer.
§101.77 Health claims: fruits, vegetables, and grain products that contain fiber, particularly soluble fiber, and risk of coronary heart disease.
§101.78 Health claims: fruits and vegetables and cancer.
§101.79 Health claims: Folate and neural tube defects.
§101.80 Health claims: dietary noncariogenic carbohydrate sweeteners and dental caries.
§101.81 Health claims: Soluble fiber from certain foods and risk of coronary heart disease (CHD).
§101.82 Health claims: Soy protein and risk of coronary heart disease (CHD).
§101.83 Health claims: plant sterol/stanol esters and risk of coronary heart disease (CHD).
(d) If clinical or other human investigations are included in a petition, the petition shall include a statement that they were either conducted in compliance with the requirements for institutional review set forth in part 56 of this chapter, or were not subject to such requirements in accordance with §56.104 or §56.105, and a statement that they were conducted in compliance with the requirements for informed consent set forth in part 50 of this chapter.
A. Preliminary requirements. A complete explanation of how the substance conforms to the requirements of §101.14(b) (21 CFR 101.14(b)). For petitions where the subject substance is a food ingredient or a component of a food ingredient, the petitioner should compile a comprehensive list of the specific ingredients that will be added to the food to supply the substance in the food bearing the health claim. For each such ingredient listed, the petitioner should state how the ingredient complies with the requirements of §101.14(b)(3)(ii), e.g., that its use is generally recognized as safe (GRAS), listed as a food additive, or authorized by a prior sanction issued by the agency, and what the basis is for the GRAS claim, the food additive status, or prior sanctioned status.
Also, the summary shall demonstrate that the substance that is the subject of the proposed claim conforms to the definition of the term “substance” in §101.14(a)(2).
F. The petitioner is required to submit either a claim for categorical exclusion under §25.30 or §25.32 of this chapter or an environmental assessment under §25.40 of this chapter.
(2) Within 100 days of the date of receipt of the petition, FDA will notify the petitioner by letter that the petition has either been filed for comprehensive review or denied. The agency will deny a petition without reviewing the information contained in “B. Summary of Scientific Data” if the information in “A. Preliminary Requirements” is inadequate in explaining how the substance conforms to the requirements of §101.14(b). If the petition is denied, the notification will state the reasons therefor, including justification of the rejection of any report from an authoritative scientific body of the U.S. Government. If filed, the date of the notification letter becomes the date of filing for the purposes of this regulation. If FDA does not act within such 100 days, the petition shall be deemed to be denied unless an extension is mutually agreed upon by FDA and the petitioner. A petition that has been denied, or has been deemed to be denied, without filing will not be made available to the public. A filed petition will be available to the public to the extent provided under paragraph (e) of this section.
(c) Requirements. (1) All requirements set forth in §101.14 shall be met.
(ii) Nature of the food. (A) The food shall meet or exceed the requirements for a “high” level of calcium as defined in §101.54(b);
(d) Optional information. (1) The claim may include the term “vitamin D” if the food meets or exceeds the requirements for a “high” level of vitamin D as defined in §101.54(b);
(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”;
(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.
(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.
(a) Relationship between sodium and hypertension (high blood pressure). (1) Hypertension, or high blood pressure, generally means a systolic blood pressure of greater than 140 millimeters of mercury (mm Hg) or a diastolic blood pressure of greater than 90 mm Hg. Normotension, or normal blood pressure, is a systolic blood pressure below 140 mm Hg and diastolic blood pressure below 90 mm Hg. Sodium is specified here as the chemical entity or electrolyte “sodium” and is distinguished from sodium chloride, or salt, which is 39 percent sodium by weight.
(2) Specific requirements—(i) Nature of the claim. A health claim associating diets low in sodium with reduced risk of high blood pressure 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 sodium “may” or “might” reduce the risk of high blood pressure;
(B) In specifying the disease, the claim uses the term “high blood pressure”;
(C) In specifying the nutrient, the claim uses the term “sodium”;
(ii) Nature of the food. The food shall meet all of the nutrient content requirements of §101.61 for a “low sodium” food.
(3) The claim may include information on the number of people in the United States who have high blood pressure. 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,” U.S. Department of Health and Human Services (DHHS) and U.S. Department of Argiculture (USDA), Government Printing Office.
(4) The claim may indicate that it is consistent with “Nutrition and Your Health: U.S. Dietary Guidelines for Americans, DHHS and USDA, Government Printing Office.
(5) In specifying the nutrient, the claim may include the term “salt” in addition to the term “sodium.”
(6) In specifying the disease, the claim may include the term “hypertension” in addition to the term “high blood pressure.”
(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”;
(F) In specifying the dietary fiber component of the labeled food, the claim uses the term “fiber”, “dietary fiber” or “total dietary fiber”; and
(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.
(2) Specific requirements—(i) Nature of the claim. A health claim associating diets low in saturated fat and cholesterol and high in fruits, vegetables, and grain products that contain fiber, particularly soluble fiber, with reduced risk of heart disease 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 saturated fat and cholesterol and high in fruits, vegetables, and grain products that contain fiber “may” or “might” reduce the risk of heart disease;
(B) In specifying the disease, the claim uses the following terms: “heart disease” or “coronary heart disease;”
(D) In specifying the dietary fiber, the claim uses the term “fiber,” “dietary fiber,” “some types of dietary fiber,” “some dietary fibers,” or “some fibers;” the term “soluble fiber” may be used in addition to these terms;
(E) In specifying the fat component, the claim uses the terms “saturated fat” and “cholesterol;” and
(B) The food shall meet the nutrient content requirements of §101.62 for a “low saturated fat,” “low cholesterol,” and “low fat” food.
(D) The content of soluble fiber shall be declared in the nutrition information panel, consistent with §101.9(c)(6)(i)(A).
(2) The claim may indicate that the relationship of diets low in saturated fat and cholesterol, and high in fruits, vegetables, and grain products that contain fiber to heart disease is through the intermediate link of “blood cholesterol” or “blood total- and LDL-cholesterol.”
(4) In specifying the nutrients, the claim may include the term “total fat” in addition to the terms “saturated fat” and “cholesterol.”
(5) 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 (GPO).
(7) The claim may include information on the number of people in the United States who have heart disease. The sources of this information shall be identified, and it shall 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, GPO.
(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:
(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;
(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.
(a) Relationship between folate and neural tube defects—(1) Definition. Neural tube defects are serious birth defects of the brain or spinal cord that can result in infant mortality or serious disability. The birth defects anencephaly and spina bifida are the most common forms of neural tube defects and account for about 90 percent of these defects. These defects result from failure of closure of the covering of the brain or spinal cord during early embryonic development. Because the neural tube forms and closes during early pregnancy, the defect may occur before a woman realizes that she is pregnant.
(b) Significance of folate—(1) Public health concern. Neural tube defects occur in approximately 0.6 of 1,000 live births in the United States (i.e., approximately 6 of 10,000 live births; about 2,500 cases among 4 million live births annually). Neural tube defects are believed to be caused by many factors. The single greatest risk factor for a neural tube defect-affected pregnancy is a personal or family history of a pregnancy affected with a such a defect. However, about 90 percent of infants with a neural tube defect are born to women who do not have a family history of these defects. The available evidence shows that diets adequate in folate may reduce the risk of neural tube defects but not of other birth defects.
(3) Those who may benefit. Based on a synthesis of information from several studies, including those which used multivitamins containing folic acid at a daily dose level of ≥400 mcg (≥0.4 mg), the Public Health Service has inferred that folate alone at levels of 400 mcg (0.4 mg) per day may reduce the risk of neural tube defects. The protective effect found in studies of lower dose folate measured by the reduction in neural tube defect incidence, ranges from none to substantial; a reasonable estimate of the expected reduction in the United States is 50 percent. It is expected that consumption of adequate folate will avert some, but not all, neural tube defects. The underlying causes of neural tube defects are not known. Thus, it is not known what proportion of neural tube defects will be averted by adequate folate consumption. From the available evidence, the Public Health Service estimates that there is the potential for averting 50 percent of cases that now occur (i.e., about 1,250 cases annually). However, until further research is done, no firm estimate of this proportion will be available.
(1) General requirements. The health claim for a food meets all of the general requirements of §101.14 for health claims, except that a food may qualify to bear the health claim if it meets the definition of the term “good source.”
(2) Specific requirements—(i) Nature of the claim—(A) Relationship. A health claim that women who are capable of becoming pregnant and who consume adequate amounts of folate daily during their childbearing years may reduce their risk of having a pregnancy affected by spina bifida or other neural tube defects may be made on the label or labeling of food provided that:
(B) Specifying the nutrient. In specifying the nutrient, the claim shall use the terms “folate,” “folic acid,” “folacin,” “folate, a B vitamin,” “folic acid, a B vitamin,” or “folacin, a B vitamin.”
(C) Specifying the condition. In specifying the health- related condition, the claim shall identify the birth defects as “neural tube defects,” “birth defects spina bifida or anencephaly,” “birth defects of the brain or spinal cord anencephaly or spina bifida,” “spina bifida and anencephaly, birth defects of the brain or spinal cord,” “birth defects of the brain or spinal cord;” or “brain or spinal cord birth defects.”
(ii) Nature of the food—(A) Requirements. The food shall meet or exceed the requirements for a “good source” of folate as defined in §101.54;
(iv) Nutrition labeling. The nutrition label shall include information about the amount of folate in the food. This information shall be declared after the declaration for iron if only the levels of vitamin A, vitamin C, calcium, and iron are provided, or in accordance with §101.9 (c)(8) and (c)(9) if other optional vitamins or minerals are declared.
(3) Optional information—(i) Risk factors. The claim may specifically identify risk factors for neural tube defects. Where such information is provided, it may consist of statements from §101.79(b)(1) or (b)(2) (e.g., Women at increased risk include those with a personal history of a neural tube defect-affected pregnancy, those with a close relative (i.e., sibling, niece, nephew) with a neural tube defect; those with insulin-dependent diabetes mellitus; those with seizure disorders who are being treated with valproic acid or carbamazepine) or from other parts of this paragraph (c)(3)(i).
(v) Prevalence. The claim may provide estimates, expressed on an annual basis, of the number of neural tube defect-affected births among live births in the United States. Current estimates are provided in §101.79(b)(1), and are approximately 6 of 10,000 live births annually (i.e., about 2,500 cases among 4 million live births annually). Data provided in §101.79(b)(1) shall be used, unless more current estimates from the U.S. Public Health Service are available, in which case the latter may be cited.
(vii) Diets adequate in folate. The claim may identify diets adequate in folate by using phrases such as “Sources of folate include fruits, vegetables, whole grain products, fortified cereals, and dietary supplements.” or “Adequate amounts of folate can be obtained from diets rich in fruits, dark green leafy vegetables, legumes, whole grain products, fortified cereals, or dietary supplements.” or “Adequate amounts of folate can be obtained from diets rich in fruits, including citrus fruits and juices, vegetables, including dark green leafy vegetables, legumes, whole grain products, including breads, rice, and pasta, fortified cereals, or a dietary supplement.”
(c) Requirements. (1) All requirements set forth in §101.14 shall be met, except that noncariogenic carbohydrate sweetener-containing foods listed in paragraph (c)(2)(ii) of this section are exempt from §101.14(e)(6).
(2) Specific requirements—(i) Nature of the claim. A health claim relating noncariogenic carbohydrate sweeteners, compared to other carbohydrates, and the nonpromotion of dental caries may be made on the label or labeling of a food described in paragraph (c)(2)(iii) of this section, provided that:
(B) The claim shall state that the noncariogenic carbohydrate sweetener present in the food “does not promote,” “may reduce the risk of,” “useful [or is useful] in not promoting,” or “expressly [or is expressly] for not promoting” dental caries.
(C) In specifying the nutrient, the claim shall state “sugar alcohol,” “sugar alcohols,” or the name or names of the substances listed in paragraph (c)(2)(ii) of this section, e.g., “sorbitol.” D-tagatose may be identified as “tagatose.”
(D) In specifying the disease, the claim uses the following terms: “dental caries” or “tooth decay.”
(iii) Nature of the food. (A) The food shall meet the requirement in §101.60(c)(1)(i) with respect to sugars content, except that the food may contain D-tagatose or isomaltulose.
(C) When carbohydrates other than those listed in paragraph (c)(2)(ii) of this section are present in the food, the food shall not lower plaque pH below 5.7 by bacterial fermentation either during consumption or up to 30 minutes after consumption, as measured by the indwelling plaque pH test found in “Identification of Low Caries Risk Dietary Components,” dated 1983, by T. N. Imfeld, in Volume 11, Monographs in Oral Science, 1983. The Director of the Office of the Federal Register has approved the incorporation by reference of this material in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You may obtain copies from Karger AG Publishing Co., P.O. Box, Ch-4009 Basel, Switzerland, or you may examine a copy at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal__register/code__of__federal__regulations/ibr__locations.html.
(c) Requirements. (1) All requirements set forth in §101.14 shall be met. The label and labeling of foods containing psyllium husk shall be consistent with the provisions of §101.17(f).
(2) Specific requirements—(i) Nature of the claim. A health claim associating diets that are low in saturated fat and cholesterol and that include soluble fiber from certain foods with reduced risk of heart disease may be made on the label or labeling of a food described in paragraph (c)(2)(iii) of this section, provided that:
(A) The claim states that diets that are low in saturated fat and cholesterol and that include soluble fiber from certain foods “may” or “might” reduce the risk of heart disease.
(B) In specifying the disease, the claim uses the following terms: “heart disease” or “coronary heart disease”;
(C) In specifying the substance, the claim uses the term “soluble fiber” qualified by the name of the eligible source of soluble fiber (provided in paragraph (c)(2)(ii)) of this section. Additionally, the claim may use the name of the food product that contains the eligible source of soluble fiber;
(D) In specifying the fat component, the claim uses the terms “saturated fat” and “cholesterol”;
(1) 3 g or more per day of β-glucan soluble fiber from either whole oats or barley, or a combination of whole oats and barley.
(2) 7 g or more per day of soluble fiber from psyllium seed husk.
(ii) Nature of the substance—Eligible sources of soluble fiber. (A) Beta (β) glucan soluble fiber from the whole oat and barley sources listed below. β-glucan soluble fiber will be determined by method No. 992.28 from the “Official Methods of Analysis of the AOAC INTERNATIONAL,” 16th ed. (1995), which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be examined at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal__register/code__of__federal__regulations/ibr__locations.html;
(1) Oat bran. Oat bran is produced by grinding clean oat groats or rolled oats and separating the resulting oat flour by suitable means into fractions such that the oat bran fraction is not more than 50 percent of the original starting material and provides at least 5.5 percent (dry weight basis (dwb)) β-glucan soluble fiber and a total dietary fiber content of 16 percent (dwb), and such that at least one-third of the total dietary fiber is soluble fiber;
(2) Rolled oats. Rolled oats, also known as oatmeal, produced from 100 percent dehulled, clean oat groats by steaming, cutting, rolling, and flaking, and provides at least 4 percent (dwb) of β-glucan soluble fiber and a total dietary fiber content of at least 10 percent.
(3) Whole oat flour. Whole oat flour is produced from 100 percent dehulled, clean oat groats by steaming and grinding, such that there is no significant loss of oat bran in the final product, and provides at least 4 percent (dwb) of β-glucan soluble fiber and a total dietary fiber content of at least 10 percent (dwb).
(5) Whole grain barley and dry milled barley. Dehulled and hull-less whole grain barley with a β-glucan soluble fiber content of at least 4 percent (dwb) and a total dietary fiber content of at least 10 percent (dwb). Dry milled barley grain products include barley bran, barley flakes, barley grits, pearl barley, barley flour, barley meal, and sieved barley meal that are produced from clean, sound dehulled or hull-less barley grain using standard dry milling techniques, which may include steaming or tempering, and that contain at least 4 percent (dwb) of β-glucan soluble fiber and at least 8 percent (dwb) of total dietary fiber, except barley bran and sieved barley meal for which the minimum β-glucan soluble fiber content is 5.5 percent (dwb) and minimum total dietary fiber content is 15 percent (dwb). Dehulled barley, hull-less barley, barley bran, barley flakes, barley grits, pearl barley, and barley flour are as defined in the Barley Glossary (AACC Method 55-99), published in Approved Methods of the American Association of Cereal Chemists, 10th ed. (2000), pp. 1 and 2, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from the American Association of Cereal Chemists, Inc., 3340 Pilot Knob Rd., St. Paul, Minnesota, 55121, or may be examined at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal__register/code__of__federal__regulations/ibr__locations.html. Barley meal is unsifted, ground barley grain not subjected to any processing to separate the bran, germ, and endosperm. Sieved barley meal is an endosperm cell wall-enriched fraction of ground barley separated from meal by sieving or by air classification.
(6) Barley betafiber. Barley betafiber is the ethanol precipitated soluble fraction of cellulase and alpha-amylase hydrolyzed whole grain barley. Barley betafiber is produced by hydrolysis of whole grain barley flour, as defined in paragraph (c)(2)(ii)(A)(5) of this section, with a cellulase and alpha-amylase enzyme preparation, to produce a clear aqueous extract that contains mainly partially hydrolyzed beta-glucan and substantially hydrolyzed starch. The soluble, partially hydrolyzed beta-glucan is separated from the insoluble material by centrifugation, and after removal of the insoluble material, the partially hydrolyzed beta-glucan soluble fiber is separated from the other soluble compounds by precipitation with ethanol. The product is then dried, milled and sifted. Barley betafiber shall have a beta-glucan soluble fiber content of at least 70 percent on a dry weight basis.
(B)(1) Psyllium husk from the dried seed coat (epidermis) of the seed of Plantago (P.) ovata, known as blond psyllium or Indian psyllium, P. indica, or P. psyllium. To qualify for this claim, psyllium seed husk, also known as psyllium husk, shall have a purity of no less than 95 percent, such that it contains 3 percent or less protein, 4.5 percent or less of light extraneous matter, and 0.5 percent or less of heavy extraneous matter, but in no case may the combined extraneous matter exceed 4.9 percent, as determined by U.S. Pharmacopeia (USP) methods described in USP's “The National Formulary,” USP 23, NF 18, p. 1341, (1995), which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from the U.S. Pharmacopeial Convention, Inc., 12601 Twinbrook Pkwy., Rockville, MD 20852, or may be examined at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal__register/code__of__federal__regulations/ibr__locations.html;
(2) FDA will determine the amount of soluble fiber that is provided by psyllium husk by using a modification of the Association of Official Analytical Chemists' International (AOAC's) method for soluble dietary fiber (991.43) described by Lee et al., “Determination of Soluble and Insoluble Dietary Fiber in Psyllium-containing Cereal Products,” Journal of the AOAC International, 78 (No. 3):724-729, 1995, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from the AOAC INTERNATIONAL, 481 North Frederick Ave., suite 500, Gaithersburg, MD 20877, or may be examined at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039 or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal__register/code__of__federal__regulations/ibr__locations.html;
(1) One or more of the whole oat or barley foods from paragraphs (c)(2)(ii)(A)(1), (2), (3), and (5) of this section, and the whole oat or barley foods shall contain at least 0.75 gram (g) of soluble fiber per reference amount customarily consumed of the food product; or
(2) The food containing the oatrim from paragraph (c)(2)(ii)(A)(4) of this section or the barley betafiber from paragraph (c)(2)(ii)(A)(6) of this section shall contain at least 0.75 g of beta-glucan soluble fiber per reference amount customarily consumed of the food product; or
(3) Psyllium husk that complies with paragraph (c)(2)(ii)(B) of this section, and the psyllium food shall contain at least 1.7 g of soluble fiber per reference amount customarily consumed of the food product;
(B) The amount of soluble fiber shall be declared in the nutrition label, consistent with §101.9(c)(6)(i)(A).
(C) The food shall meet the nutrient content requirement in §101.62 for a “low saturated fat” and “low cholesterol” food; and
(D) The food shall meet the nutrient content requirement in §101.62(b)(2) for a “low fat” food, unless the food exceeds this requirement due to fat content derived from whole oat sources listed in paragraph (c)(2)(ii)(A) of this section.
(2) The claim may state that the relationship between intake of diets that are low in saturated fat and cholesterol and that include soluble fiber from the eligible food sources from paragraph (c)(2)(ii) of this section and reduced risk of heart disease is through the intermediate link of “blood cholesterol” or “blood total- and LDL-cholesterol;”
(5) The claim may state that a diet low in saturated fat and cholesterol that includes soluble fiber from whole oats or barley 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 (GPO);
(2) Specific requirements—(i) Nature of the claim. A health claim associating diets that are low in saturated fat and cholesterol and that include soy protein with reduced risk of heart disease may be made on the label or labeling of a food described in paragraph (c)(2)(iii) of this section, provided that:
(A) The claim states that diets that are low in saturated fat and cholesterol and that include soy protein “may” or “might” reduce the risk of heart disease;
(C) In specifying the substance, the claim uses the term “soy protein”;
(B) FDA will assess qualifying levels of soy protein in the following fashion: FDA will measure total protein content by the appropriate method of analysis given in the “Official Methods of Analysis of the AOAC International,” as described at §101.9(c)(7). For products that contain no sources of protein other than soy, FDA will consider the amount of soy protein as equivalent to the total protein content. For products that contain a source or sources of protein in addition to soy, FDA will, using the measurement of total protein content, calculate the soy protein content based on the ratio of soy protein ingredients to total protein ingredients in the product. FDA will base its calculation on information identified and supplied by manufacturers, such as nutrient data bases or analyses, recipes or formulations, purchase orders for ingredients, or any other information that reasonably substantiates the ratio of soy protein to total protein. Manufacturers must maintain records sufficient to substantiate the claim for as long as the products are marketed and provide these records, on written request, to appropriate regulatory officials.
(B) The food shall meet the nutrient content requirements in §101.62 for a “low saturated fat” and “low cholesterol” food; and
(C) The food shall meet the nutrient content requirement in §101.62 for a “low fat” food, unless it consists of or is derived from whole soybeans and contains no fat in addition to the fat inherently present in the whole soybeans it contains or from which it is derived.
(2) The claim may state that the relationship between intake of diets that are low in saturated fat and cholesterol and that include soy protein and reduced risk of heart disease is through the intermediate link of “blood cholesterol” or “blood total and LDL-cholesterol”;
(4) The claim may state that a diet low in saturated fat and cholesterol that includes soy protein 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 (GPO);
(6) The claim may include information on the number of people in the United States who have heart disease. The sources of this information shall be identified, and it shall 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, GPO;
Effective Date Note: At 64 FR 57732, Oct. 26, 1999, §101.82 was added. Paragraph (c)(2)(ii)(B) of this section contains information collection and recordkeeping requirements and will not become effective until approval has been given by the Office of Management and Budget.
(c) Requirements—(1) General. All requirements set forth in §101.14 shall be met, except §101.14(a)(4) with respect to the disqualifying level for total fat per 50 grams (g) in dressings for salad and spreads and §101.14(e)(6) with respect to dressings for salad.
(2) Specific requirements—(i) Nature of the claim. A health claim associating diets that include plant sterol/stanol esters with reduced risk of heart disease may be made on the label or labeling of a food described in paragraph (c)(2)(iii) of this section, provided that:
(ii) Nature of the substance—(A) Plant sterol esters. (1) Plant sterol esters prepared by esterifying a mixture of plant sterols from edible oils with food-grade fatty acids. The plant sterol mixture shall contain at least 80 percent beta-sitosterol, campesterol, and stigmasterol (combined weight).
(2) FDA will measure plant sterol esters by the method entitled “Determination of the Sterol Content in Margarines, Halvarines, Dressings, Fat Blends and Sterol Fatty Acid Ester Concentrates by Capillary Gas Chromatography,” developed by Unilever United States, Inc., dated February 1, 2000. The method, which is incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51, may be obtained from the Center for Food Safety and Applied Nutrition, Office of Nutrition, Labeling and Dietary Supplements, Nutrition Programs Staff, 5001 Campus Dr., College Park, MD 20740, and may be examined at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal__register/code__of__federal__regulations/ibr__locations.html.
(2) FDA will measure plant stanol esters by the following methods developed by McNeil Consumer Heathcare dated February 15, 2000: “Determination of Stanols and Sterols in Benecol Tub Spread”; “Determination of Stanols and Sterols in Benecol Dressing”; “Determination of Stanols and Sterols in Benecol Snack Bars”; or “Determination of Stanols and Sterols in Benecol Softgels.” These methods are incorporated by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. Copies may be obtained from the Center for Food Safety and Applied Nutrition, Office of Nutrition, Labeling and Dietary Supplements, Nutrition Programs Staff, 5001 Campus Dr., College Park, MD 20740, or may be examined at the Food and Drug Administration's Main Library, 10903 New Hampshire Ave., Bldg. 2, Third Floor, Silver Spring, MD 20993, 301-796-2039, and at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: http://www.archives.gov/federal__register/code__of__federal__regulations/ibr__locations.html.
(C) The food must meet the limit for total fat in §101.14(a)(4), except that spreads and dressings for salad are not required to meet the limit for total fat per 50 g if the label of the food bears a disclosure statement that complies with §101.13(h); and
(D) The food must meet the minimum nutrient contribution requirement in §101.14(e)(6) unless it is a dressing for salad.