or destroyed by or under the supervision of the issuing entity, within 10 working days from the date of receipt of the order. These criteria are not intended to classify as disease claims statements that refer to the ability of a product to maintain healthy structure or function, unless the statement implies disease prevention or treatment. (l) The standards required in this section are incorporated by reference into this section with the approval of the Director of the Federal Register under 5 U.S.C. (iv) The treatment of raw foods with ionizing radiation not to exceed the maximum dose of 1 kiloGray in accordance with 179.26 of this chapter. Folate intake should not exceed 250% of the DV (1,000 mcg). It is also available for inspection at the National Archives and Records Administration (NARA). (2) In case such person is not such operator, such shipment or delivery is made to such establishment under a written agreement, signed by and containing the post office addresses of such person and such operator, and containing such specifications for the processing, labeling, or repacking, as the case may be, of such food in such establishment as will ensure, if such specifications are followed, that such food will not be adulterated or misbranded within the meaning of the act upon completion of such processing, labeling, or repacking. B. 4 1 mg -tocopherol (label claim) = 1 mg -tocopherol = 1 mg RRR- -tocopherol = 2 mg all rac--tocopherol. (ii) Deny the petition, in which case the letter shall state the reasons therefor. While vitamin D is required for optimal bone mineralization, it is more effective when calcium intake is adequate. (A) Relationship. (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). [Name of sugar from paragraph (c)(2)(ii)(B) of this section], the sugar in [name of food], unlike other sugars, does not promote tooth decay. (v) Certification that the information submitted is true and accurate, that the person submitting it is authorized to do so, and that each registered restaurant or similar retail food establishment will be subject to the requirements of section 403(q)(5)(H) of the Federal Food, Drug, and Cosmetic Act and this section. See nutrition information for fat content). (ii) Foods, other than infant formula, represented or purported to be specifically for infants through 12 months of age shall bear nutrition labeling, except that: (A) Such labeling shall not declare a percent Daily Value for saturated fat, trans fat, cholesterol, sodium, dietary fiber, total sugars, or added sugars and shall not include a footnote. If the calorie declaration is provided on a sign that does not include the food's name, price, or both, the calorie declaration, accompanied by the term Calories or Cal and the amount of the serving or displayed food item on which the calorie declaration is based must be clear and conspicuous. (5) Section 101.9(j)(17) for foods in packages that have a total surface area available to bear labeling greater than 40 square inches but whose principal display panel and information panel do not provide sufficient space to accommodate all required label information, except that the ingredient list shall continue to be located immediately below the nutrition label, or, if there is insufficient space below the nutrition label, immediately contiguous and to the right of the nutrition label as specified in 101.4(g). Claims or other nutrition information, except as provided in 101.8(c), subject the food to the provisions of this section; (iii) Sold only in such facilities, Provided, That the food bears no nutrition claims or other nutrition information in any context on the label or in labeling or advertising. (11) If a product is promoted on the label, labeling, or advertising for a use that differs in quantity by twofold or greater from the use upon which the reference amount in 101.12(b) was based (e.g., liquid cream substitutes promoted for use with breakfast cereals), the manufacturer shall provide a second column of nutrition information based on the amount customarily consumed in the promoted use, in addition to the nutrition information per serving derived from the reference amount in 101.12(b), except that nondiscrete bulk products that are used primarily as ingredients (e.g., flour, sweeteners, shortenings, oils), or traditionally used for multipurposes (e.g., eggs, butter, margarine), and multipurpose baking mixes are exempt from this requirement. A claim about the level of sodium or salt in a food may only be made on the label or in the labeling of the food if: (1) The terms sodium free, free of sodium, no sodium, zero sodium, without sodium, trivial source of sodium, negligible source of sodium, or dietary insignificant source of sodium may be used on the label or in the labeling of foods, provided that: (i) The food contains less than 5 milligrams (mg) of sodium per reference amount customarily consumed and per labeled serving or, in the case of a meal product or a main dish product, less than 5 mg of sodium per labeled serving; and, (ii) The food contains no ingredient that is sodium chloride or is generally understood by consumers to contain sodium, unless the listing of the ingredient in the ingredient statement is followed by an asterisk that refers to the statement below the list of ingredients, which states: Adds a trivial amount of sodium, adds a negligible amount of sodium or adds a dietarily insignificant amount of sodium; and. (4) If a food is commonly combined with other ingredients or is cooked or otherwise prepared before eating, and directions for such combination or preparations are provided, another column of figures may be used to declare nutrition information on the basis of the food as consumed in the format required in paragraph (e) of this section; e.g., a dry ready-to-eat cereal may be described with the percent Daily Value and the quantitative amounts for the cereal as sold (e.g., per ounce), and the percent Daily Value and the quantitative amounts for the cereal and milk as suggested in the label (e.g., per ounce of cereal and 12cup of vitamin D fortified skim milk); and a cake mix may be labeled with the percent Daily Value and the quantitative amounts for the dry mix (per serving) and the percent Daily Value and the quantitative amounts for the serving of the final cake when prepared, as shown in paragraph (e)(5) of this section: Provided, that, the type and quantity of the other ingredients to be added to the product by the user and the specific method of cooking and other preparation shall be specified prominently on the label. (A) The names and the quantitative amounts by weight of each (b)(2)-dietary ingredient shall be presented under the heading Amount Per Serving. When the quantitative amounts by weight are presented in a separate column, the heading may be centered over a column of quantitative amounts, described by paragraph (b)(2)(ii) of this section, if space permits. (4) Reasonable variations in the spelling of the terms defined in part 101 and their synonyms are permitted provided these variations are not misleading (e.g., hi or lo). (E) The claim states that coronary heart disease risk depends on many factors. The principal display panel shall be large enough to accommodate all the mandatory label information required to be placed thereon by this part with clarity and conspicuousness and without obscuring design, vignettes, or crowding. (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; (3) The claim may include information from paragraphs (a) and (b) of this section, which summarize the relationship between diets that are low in saturated fat and cholesterol and that include soy protein and CHD and the significance of the relationship; (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); (5) The claim may state that individuals with elevated blood total and LDL-cholesterol should consult their physicians for medical advice and treatment. (2) A declaration of three-fourths pound avoirdupois weight shall be expressed as Net Wt. (n) For quantities, the following abbreviations and none other may be employed (periods and plural forms are optional): (o) Nothing in this section shall prohibit supplemental statements at locations other than the principal display panel(s) describing in nondeceptive terms the net quantity of contents; Provided, that such supplemental statements of net quantity of contents shall not include any term qualifying a unit of weight, measure, or count that tends to exaggerate the amount of the food contained in the package; for example, jumbo quart and full gallon. (E) A statement signed and dated by a responsible individual employed at the covered establishment certifying that the covered establishment has taken reasonable steps to ensure that the method of preparation (e.g., types and amounts of ingredients in the recipe, cooking temperatures) and amount of a standard menu item offered for sale adhere to the factors on which its nutrient values were determined. 552(a) and 1 CFR part 51. The requirement for such certification may be satisfied by a guarantee under section 303(c)(2) of the act which contains such a specific statement. (2) If the flavor consists of two or more ingredients, the label either may declare each ingredient by its common or usual name or may state All flavor ingredients contained in this product are approved for use in a regulation of the Food and Drug Administration. Any flavor ingredient not contained in one of these regulations, and any nonflavor ingredient, shall be separately listed on the label. (2) If a product consists of two or more separately packaged foods that are intended to be eaten individually and that are enclosed in an outer container (e.g., variety packs of cereals or snack foods), the nutrition information shall: (i) Be specified per serving for each food in a location that is clearly visible to the consumer at the point of purchase; and. (ii) Containing not less than 40 g of food, or combinations of foods, from each of at least two of the following four food groups, except as noted in paragraph (m)(1)(ii)(E) of this section. 101.71 Health claims: claims not authorized. If retailers choose to provide such information, they should do so in a manner that conforms to the guidelines in 101.45. (2) For menus, this statement must appear on the bottom of each page of the menu. No physical product will be sentThis product is for personal use only. High blood total and LDL cholesterol are major modifiable risk factors in the development of CHD. (A) The manufacturer, packer, or distributor shall provide on the label of packages that qualify for and use this exemption an address or telephone number that a consumer can use to obtain the required nutrition information (e.g., For nutrition information, call 1-800-123-4567). (4) The terms reduced calorie, reduced in calories, calorie reduced, fewer calories, lower calorie, or lower in calories may be used on the label or in the labeling of foods, except as limited by 101.13(j)(1)(i) and except meal products as defined in 101.13(l) and main dish products as defined in 101.13(m), provided that: (i) The food contains at least 25 percent fewer calories per reference amount customarily consumed than an appropriate reference food as described in 101.13(j)(1); and, (A) The identity of the reference food and the percent (or fraction) that the calories differ between the two foods are declared in immediate proximity to the most prominent such claim (e.g., reduced calorie cupcakes 3313 percent fewer calories than regular cupcakes); and. Location means a fixed position or site. Standard menu item means a restaurant-type food that is routinely included on a menu or menu board or routinely offered as a self-service food or food on display. (2) Medical foods defined by section 5(b) of the Orphan Drug Act. (iv) For nutrition information provided by other reasonable means: (A) A detailed description of the means used to determine the nutrition information; (B) A recipe or formula used as a basis for the nutrient determination; (C) Any data derived in determining the nutrient values for the standard menu item, e.g., nutrition information about the ingredients used with the source of the nutrient information; (d) Voluntary registration to be subject to the menu labeling requirements -. 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. Attached hereto, and constituting a part of this petition, are the following: A. (3) Petitions for the use of an implied claim in a brand name. We further considered data from the National Health and Nutrition Examination Survey, 2003-2004, 2005-2006, and 2007-2008 conducted by the Centers for Disease Control and Prevention, in the U.S. Department of Health and Human Services. The serving size may be provided in accordance with the provisions of paragraphs (b)(2)(i), (b)(2)(ii), and (b)(2)(iii) of this section, or alternatively in ounces with an appropriate visual unit of measure, as described in paragraph (b)(5)(iii) of this section (e.g., declared as separate components: 3 oz dry macaroni (84 g/about 23 cup) and 1 oz dry cheese mix (28 g/about 2 tbsp); declared as a composite value: 4 oz (112 g/about 23 cup macaroni and 2 tbsp dry cheese mix)). (4) As soon as practicable following the agency's decision to either grant or deny the petition, FDA will publish a notice in the Federal Register informing the public of his decision. (1) When Calories are declared, they shall be listed first in the column of names, beneath a light bar separating the heading Amount Per Serving from the list of names. (5) As soon as practicable following the granting of a petition, the Commissioner of Food and Drugs will publish a notice in the Federal Register informing the public of such fact. Spread some cheer with holiday gift labels. Looks like you already have an account! (i) Guidance in the development of data bases may be found in the FDA Nutrition Labeling Manual: A Guide for Developing and Using Data Bases, available from the FDA Office of Food Labeling. (1) A relative claim using the terms more, fortified, enriched, added, extra, and plus may be used on the label or in labeling of foods to describe the level of protein, vitamins, minerals, dietary fiber, or potassium, except as limited by 101.13(j)(1)(i) and except meal products as defined in 101.13(l) and main dish products as defined in 101.13(m), provided that: (i) The food contains at least 10 percent more of the RDI for vitamins or minerals or of the DRV for protein, dietary fiber, or potassium (expressed as a percent of the Daily Value) per reference amount customarily consumed than an appropriate reference food; and, (ii) Where the claim is based on a nutrient that has been added to the food, that fortification is in accordance with the policy on fortification of foods in 104.20 of this chapter; and. information or personal data. This exemption is contingent on the food bearing no nutrition claims or other nutrition information in any context on the label or in labeling or advertising. The undersigned, ________________________ submits this petition under section 403(r)(4) of the Federal Food, Drug, and Cosmetic Act (the act) with respect to (statement of the claim and its proposed use). (A) Requirements. (B) The labeling requirements of paragraph (b)(2)(iii) of this section do not apply to alcoholic beverages that are foods on display and are not self-service foods. Vegetables primarily used for garnish or flavor (e.g., pimento, __ piece(s) (__ g); __ tbsp(s) (__ g) for chopped products, Fresh or canned chili peppers, jalapeno peppers, other hot peppers, green onion, All other vegetables without sauce: Fresh, canned, or frozen, 85 g for fresh or frozen; 95 g for vacuum packed; 130 g for canned in liquid, cream-style corn, canned or stewed tomatoes, pumpkin, or winter squash, __ piece(s) (__ g) for large pieces (e.g., Brussels sprouts); __ cup(s) (__ g) for small pieces (e.g., cut corn, green peas); 3 oz (84 g/visual unit of measure) if not measurable by cup, All other vegetables with sauce: Fresh, canned, or frozen, __ piece(s) (__ g) for large pieces (e.g., Brussels sprouts); __ cup(s) (__ g) for small pieces (e.g., cut corn, green peas); 4 oz (112 g/visual unit of measure) if not measurable by cup, __ piece(s) (__ g); __ tbsp(s) (__ g) for sliced products, Pickles and pickled vegetables, all types, Vegetable sauces or purees, e.g., tomato sauce, tomato puree, The disclosure level for cholesterol specified in, (B) A single-ingredient or a mixture of frozen or canned fruits and vegetables, (C) An enriched cereal-grain product that conforms to a standard of identity in, (D) A raw, single-ingredient seafood or game meat, Less than 2 g saturated fat per RA and per 100 g, Less than 95 mg cholesterol per RA and per 100 g, At least 10 percent of the RDI or DRV per LS of two nutrients (for a main dish product) or of three nutrients (for a meal product) of: vitamin A, vitamin C, calcium, iron, protein, or fiber, (F) A food not specifically listed in this table, At least 10 percent of the RDI or the DRV per RA of one or more of vitamin A, vitamin C, calcium, iron, protein or fiber, (A) A food with a RA that is greater than 30 g or 2 tablespoons (tbsp.). The information must be presented in a clear and conspicuous manner, including using a color, type size, and contrasting background that render the information likely to be read and understood by the ordinary individual under customary conditions of purchase and use. These other sources of information included: (i) Serving sizes used in dietary guidance recommendations or recommended by other authoritative systems or organizations; (ii) Serving sizes recommended in comments; (iii) Serving sizes used by manufacturers and grocers; and. The listing of these names on the label shall be followed by statements of: (1) The part of the plant (e.g., root, leaves) from which the dietary ingredient is derived (e.g., Garlic bulb or Garlic (bulb)), except that this designation is not required for algae. The statement shall be in terms of fluid measure if the food is liquid, or in terms of weight if the food is solid, semisolid, or viscous, or a mixture of solid and liquid; except that such statement may be in terms of dry measure if the food is a fresh fruit, fresh vegetable, or other dry commodity that is customarily sold by dry measure. Except as provided for in paragraph (f) of this section, if a statement of the added sugars content is not required and, as a result, not declared, the statement Not a significant source of added sugars shall be placed at the bottom of the table of nutrient values in the same type size. However, the upper limit of peak bone mass is genetically determined. 552(a) and 1 CFR part 51. (4) Except as provided in 101.11, foods that contain insignificant amounts of all of the nutrients and food components required to be included in the declaration of nutrition information under paragraph (c) of this section, Provided, That the food bears no nutrition claims or other nutrition information in any context on the label or in labeling or advertising. (7) Because protein hydrolysates function in foods as both flavorings and flavor enhancers, no protein hydrolysate used in food for its effects on flavor may be declared simply as flavor, natural flavor, or flavoring. The ingredient shall be declared by its specific common or usual name as provided in 102.22 of this chapter. If any part of the material submitted is in a foreign language, it shall be accompanied by an accurate and complete English translation. The following model health claims may be used in food labeling to describe the relationship between calcium and osteoporosis: Adequate calcium throughout life, as part of a well-balanced diet, may reduce the risk of osteoporosis. Added sugars content shall be indented under Total Sugars and shall be prefaced with the word Includes followed by the amount (in grams) Added Sugars (Includes `X' g Added Sugars). (ii) In the case of refrigerated food that is sold in the refrigerated state, express the volume at 40 F (4 C). The product was perfect and my students were so excited to receive their awards at the end of our "Jedi Academy" Math training day for May the 4th! (B) For quantities less than 10 g, exact gram weights shall be used. 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. (1) Coronary heart disease is a major public health concern in the United States, primarily because it accounts for more deaths than any other disease or group of diseases. 101.42 Nutrition labeling of raw fruit, vegetables, and fish. (iv) If the amount of the topping included on the basic preparation of the menu item decreases based on the total number of toppings ordered for the menu item (such as is sometimes the case with pizza toppings), the calories for each topping must be declared as single values representing the calories for each topping when added to a one-topping menu item, specifying that the calorie declaration is for the topping when added to a one-topping menu item. (5) When a scientifically valid method pursuant to paragraph (c)(1) of this section is not available because the food is distilled, FDA will evaluate compliance with paragraph (b) of this section by verifying the absence of protein in the distilled component using scientifically valid analytical methods that can reliably detect the presence or absence of protein or protein fragments in the food. (i) The subheading Serving Size shall be placed under the heading Supplement Facts and aligned on the left side of the nutrition label. 22, 1996; 62 FR 31339, June 9, 1997; 62 FR 49867, 49880, Sept. 23, 1997; 63 FR 26980, May 15, 1998; 66 FR 17358, Mar. 1453, 1454, 1455; 21 U.S.C. The calories for each topping listed on the menu or menu board must be declared for each size of the menu item, or declared using a slash between the two calorie declarations for each topping where only two sizes of the menu item are available (e.g., adds 150/250 cal) or as a range for each topping in accordance with the requirements of paragraph (b)(2)(i)(A)(7) of this section where more than two sizes of the menu item are available (e.g., adds 100-250 cal). An inadequate intake of calcium or calcium and vitamin D contributes to low peak bone mass, which has been identified as one of many risk factors in the development of osteoporosis. Any water added in excess of the amount of water needed to reconstitute the ingredient to single strength shall be declared as water in the ingredient statement. (i) For purposes of declaration of percent of Daily Value as provided for in paragraphs (d), (e), and (f) of this section, foods represented or purported to be specifically for infants through 12 months, children 1 through 3 years, pregnant women, and lactating women shall use the RDIs that are specified for the intended group. (f) If a manufacturer can demonstrate that the word light has been associated, through common use, with a particular food to reflect a physical or organoleptic attribute (e.g., light brown sugar, light corn syrup, or light molasses) to the point where it has become part of the statement of identity, such use of the term light shall not be considered a nutrient content claim subject to the requirements in this part. Keep the whole graphic to 1 and 1/2 by 2 and 1/2 inches. (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. A statement identifying the descriptive term and the nutrient that the term is intended to characterize with respect to the level of such nutrient. Information about the relationship of a dietary property to a disease or health-related condition may only be provided in conformance with the requirements of 101.14 and part 101, subpart E. (2) That the lack of optimum nutritive quality of a food, by reason of the soil on which that food was grown, is or may be responsible for an inadequacy or deficiency in the quality of the daily diet.
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