mandatory nutrition labelling

A vast set of other label claims on food packaging. 15, 1977, as amended at 51 FR 25017, July 9, 1986; 58 FR 2188, 2876, Jan. 6, 1993; 66 FR 17358, Mar. (o) Except as provided in 101.10, compliance with requirements for nutrient content claims in this section and in the regulations in subpart D of this part, will be determined using the analytical methodology prescribed for determining compliance with nutrition labeling in 101.9. (1) CHD is a major public health concern in the United States. (3) An appropriately descriptive term, or when the nature of the food is obvious, a fanciful name commonly used by the public for such food. (1) The claim may identify one or more of the following risk factors for heart disease about which there is general scientific agreement: A family history of coronary heart disease, elevated blood-, total- and LDL-cholesterol, excess body weight, high blood pressure, cigarette smoking, diabetes, and physical inactivity. For products that are blends of fats and/or oils and for foods in which fats and/or oils constitute the predominant ingredient, i.e., in which the combined weight of all fat and/or oil ingredients equals or exceeds the weight of the most predominant ingredient that is not a fat or oil, the listing of the common or usual names of such fats and/or oils in parentheses shall be in descending order of predominance. (1) The labeling of any dietary supplement in solid oral dosage form (e.g., tablets or capsules) that contains iron or iron salts for use as an iron source shall bear the following statement: WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Subpart FSpecific Requirements for Descriptive Claims That Are Neither Nutrient Content Claims nor Health Claims. Several formats are possible in the EU under the Food Information to Consumers Regulation and/or the Nutrition and Health Claims Regulation. (B) The food has a reference amount customarily consumed of 30 g or less or 2 tablespoons or less and does not provide more than 40 calories per reference amount customarily consumed and, except for sugar substitutes, per 50 g (for dehydrated foods that must be reconstituted before typical consumption with water or a diluent containing an insignificant amount, as defined in 101.9(f)(1), of all nutrients per reference amount customarily consumed, the per 50 g criterion refers to the as prepared form). Signatures obtained under paragraph (d) of this section that meet the definition of electronic signatures in 11.3(b)(7) of this chapter are exempt from the requirements of part 11 of this chapter. (3) Example 4. The statement *Ingredients not in regular butter shall immediately follow the ingredient statement in the same type size. (1) AOAC Reseller. A. (iv) Any vitamins or minerals listed in paragraph (c)(8)(iv) of this section voluntarily added to the food as nutrient supplements. 2. (12) Game meats (i.e., animal products not covered under the Federal Meat Inspection Act or the Poultry Products Inspection Act, such as flesh products from deer, bison, rabbit, quail, wild turkey, or ostrich) may provide required nutrition information on labeling in accordance with the provisions of paragraph (a)(2) of this section. If the claim defines high or normal blood total and LDL cholesterol levels, then the claim shall state that individuals with high blood cholesterol should consult their physicians for medical advice and treatment. (3) Paragraph (c)(1) of this section shall not apply to a factual statement that a food, including foods intended specifically for infants and children less than 2 years of age, is unsweetened or contains no added sweeteners in the case of a food that contains apparent substantial inherent sugar content, e.g., juices. On a population-wide basis, reducing the average sodium intake would have a small but significant effect on reducing the average blood pressure, and, consequently, reducing mortality from coronary heart disease and stroke. Such notice will inform the petitioner that the petition is undergoing agency review and that the petitioner will subsequently be notified of the agency's decision to file for comprehensive review or deny the petition. The nutrient values used to determine the claim when comparing a single manufacturer's product to the labeled product shall be either the values declared in nutrition labeling or the actual nutrient values, provided that the resulting label is internally consistent to (i.e., that the values stated in the nutrition information, the nutrient values in the accompanying information and the declaration of the percentage of nutrient by which the food has been modified are consistent and will not cause consumer confusion when compared), and that the actual modification is at least equal to the percentage specified in the definition of the claim. (i) Nature of the claim. For information on the availability of this material at NARA, call 2027416030, or go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html. (C) Submit a petition, under 21 CFR 10.30, to request an alternative means of compliance. (iii) The percent of the Daily Value of all dietary ingredients declared under paragraph (b)(2)(i) of this section shall be listed, except that the percent Daily Value for protein, when present, shall be calculated using the corrected amount of protein as specified in 101.9(c)(7)(ii); no percent of the Daily Value shall be given for subcomponents for which DRVs or RDIs have not been established (e.g., total sugars). Attached hereto and constituting a part of this petition, are the following: A. (a) This section applies to any food that purports to be a beverage that contains any fruit or vegetable juice (i.e., the product's advertising, label, or labeling bears the name of, or variation on the name of, or makes any other direct or indirect representation with respect to, any fruit or vegetable juice), or the label or labeling bears any vignette (i.e., depiction of a fruit or vegetable) or other pictorial representation of any fruit or vegetable, or the product contains color and flavor that gives the beverage the appearance and taste of containing a fruit or vegetable juice. (1) Claims about the food or an ingredient therein that suggest that a nutrient or an ingredient is absent or present in a certain amount (e.g., high in oat bran) are implied nutrient content claims and must comply with paragraph (a) of this section. Contains 13 g of fat per serving.) is declared adjacent to the most prominent claim or to the nutrition label, except that if the nutrition label is on the information panel, the quantitative information may be located elsewhere on the information panel in accordance with 101.2. The footnote shall state: *The % Daily Value tells you how much a nutrient in a serving of food contributes to a daily diet. For beverages, a manufacturer may use fluid ounces. Most food product labels have specific requirements about what information you must state on the label, where it appears, and the format. (2) Within 15 days of receipt of the petition the petitioner will be notified by letter of the date on which the petition was received. (b) Any firm that intends to undertake a labeling experiment that requires exemptions from certain requirements of 101.9 and 105.66 of this chapter should submit a written proposal containing a thorough discussion of each of the following information items that apply to the particular experiment: (1) A description of the labeling format to be tested; (2) A statement of the criteria to be used in the experiment for assigning foods to categories, e.g., nutrient or other values defining low and reduced; (3) A draft of the material to be used in the store, e.g., shelf tags, booklets, posters, etc. (1) Statements of weight shall be in terms of avoirdupois pound and ounce. (2) Populations with a low incidence of CHD tend to have relatively low blood total cholesterol and LDL-cholesterol levels. (e) Conditions affecting expiration of exemptions: (1) An exemption of a shipment or other delivery of a food under paragraph (d) (1) or (3) of this section shall, at the beginning of the act of removing such shipment or delivery, or any part thereof, from such establishment become void ab initio if the food comprising such shipment, delivery, or part is adulterated or misbranded within the meaning of the act when so removed. (F) No appeal. (16) Food products sold from bulk containers: Provided, That nutrition information required by this section be displayed to consumers either on the labeling of the bulk container plainly in view or in accordance with the provisions of paragraph (a)(2) of this section. (3) Within 90 days of the date of receipt of the petition that is accepted for review (i.e., that has not been found to be incomplete and consequently denied, FDA will notify the petitioner by letter of the agency's decision to grant the petitioner permission to use the proposed term, with any conditions or limitations on such use specified, or to deny the petition, in which case the letter shall state the reasons therefor. 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.. Failure to make and keep the records or provide the records to appropriate regulatory authorities, as required by this paragraph (g)(11), would result in the food being misbranded under section 403(a)(1) of the act. (iv) If you add a nutrient to the food specified in paragraphs (d)(2)(i)(D), (d)(2)(i)(E), or (d)(2)(i)(F) of this section to meet the 10 percent requirement, that addition must be in accordance with the fortification policy for foods in 104.20 of this chapter. For the purposes of this section, restaurant food includes two categories of food. (2) The product shall be labeled on the outside of its shipping container with the statement(s): (i) When the variation concerns net weight and/or drained weight or volume, Product Mislabeled. The terms food-grade and to maintain freshness are optional. Nonmandatory label information on the information panel shall not be considered in determining the sufficiency of available space for the placement of the nutrition label. Failure of the petition to fully address the requirements of this section shall be grounds for denial of the petition. 28, 1978; 43 FR 24519, June 6, 1978; 48 FR 8054, Feb. 25, 1983; 55 FR 17433, Apr. For the purpose of obtaining uniform type size in declaring the quantity of contents for all packages of substantially the same size, the term area of the principal display panel means the area of the side or surface that bears the principal display panel, which area shall be: (a) In the case of a rectangular package where one entire side properly can be considered to be the principal display panel side, the product of the height times the width of that side; (b) In the case of a cylindrical or nearly cylindrical container, 40 percent of the product of the height of the container times the circumference; (c) In the case of any otherwise shaped container, 40 percent of the total surface of the container: Provided, however, That where such container presents an obvious principal display panel such as the top of a triangular or circular package of cheese, the area shall consist of the entire top surface. (iii) The percentages for vitamins and minerals shall be expressed to the nearest 2-percent increment up to and including the 10-percent level, the nearest 5-percent increment above 10 percent and up to and including the 50-percent level, and the nearest 10-percent increment above the 50-percent level. (8) Nutrient information for vitamins and minerals (except sodium) shall be separated from information on other nutrients by a bar and may be arrayed vertically as shown in paragraph (d)(12) of this section (e.g., Vitamin D 2 mcg 10%, Calcium 260 mg 20%, Iron 8 mg 45%, Potassium 235 mg 6%) or may be listed horizontally. (ii) If the food meets these conditions without the benefit of special processing, alteration, formulation, or reformulation to lower fat content, it is labeled to clearly refer to all foods of its type and not merely to the particular brand to which the label attaches (e.g., frozen perch, a low fat food). Recommended daily cholesterol intakes are 300 mg or less per day. (a) Definitions. [This product] can be part of a low sodium, low salt diet that might reduce the risk of hypertension or high blood pressure. 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. (i) Foods in small packages that have a total surface area available to bear labeling of less than 12 square inches, Provided, That the labels for these foods bear no nutrition claims or other nutrition information in any context on the label or in labeling or advertising, except as provided in 101.8(c). (3) The claim may include information from paragraphs (a) and (b) of this section, which summarize the relationship between dietary saturated fat and cholesterol and risk of coronary heart disease, and the significance of the relationship. (5) Information on calories shall immediately follow the subheading Amount per serving and shall be declared in one line. (5) Protein products shipped in bulk form for use solely in the manufacture of other foods and not for distribution to consumers in such container are exempt from the labeling requirements of this paragraph. Specifically, the study estimated that the effect of a FAFH meal on total daily intake is reduced by 21 calories among adults and by 34 calories among young children for each year the subnational mandates were in place, which are large enough to reduce body weight over time. Implied nutrient content claims and related label statements. Any name in Latin form shall be in accordance with internationally accepted rules on nomenclature, such as those found in the International Code of Botanical Nomenclature and shall include the designation of the author or authors who published the Latin name, when a positive identification cannot be made in its absence. Appearance by any appellant at the hearing may be by mail or in person, with or without counsel. (a) This section pertains to petitions for claims, expressed or implied, that: (1) Characterize the level of any nutrient which is of the type required to be in the label or labeling of food by section 403(q)(1) or (q)(2) of the Federal Food, Drug, and Cosmetic Act (the act); and. (iv) Monounsaturated fat or Monounsaturated (VOLUNTARY): A statement of the number of grams of monounsaturated fat in a serving defined as cis-monounsaturated fatty acids may be declared voluntarily except that when polyunsaturated fat is declared, or when a claim about fatty acids or cholesterol is made on the label or in labeling of a food other than one that meets the criteria in 101.62(b)(1) for a claim for fat free, label declaration of monounsaturated fat is required. Contents of the disk should be in a standard format, such as ASCII format. 15 U.S.C. The following are examples of model health claims that may be used in food labeling to describe the relationship between folate and neural tube defects: (1) Examples 1 and 2. (Petitioners interested in submitting a disk should contact the Center for Food Safety and Applied Nutrition for details.) (B) The sugars D-tagatose and isomaltulose. Comments or questions about document content can not be answered by OFR staff. (i) The subheading Serving Size shall be placed under the heading Supplement Facts and aligned on the left side of the nutrition label. There is a continuum of mortality risk from coronary heart disease that increases with increasing levels of blood LDL-cholesterol.

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