(4) The warning statement shall appear on any labeling that contains warnings. If such data have already been submitted with an earlier application from the petitioner, the present petition may incorporate it by specific reference to the earlier petition. (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.. In addition, the summary of scientific data shall include a detailed analysis of the potential effect of the use of the proposed claim on food consumption, specifically any change due to significant alterations in eating habits and corresponding changes in nutrient intake resulting from such changes in food consumption. E. The petition shall include the following attachments: 1. (2) U.S. diets tend to be high in fat and high in calories. Subpart D - Specific Requirements for Nutrient Content Claims, 101.54 Nutrient content claims for good source, high, more, and high potency., 101.56 Nutrient content claims for light or lite.. Such notice will inform the petitioner: (i) That the petition is undergoing agency review (in which case a docket number will be assigned to the petition) and the petitioner will subsequently be notified of the agency's decision to grant the petitioner permission to use the proposed term or to deny the petition; or. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal. The most common filling is a mixture of rice, onion, tomato, herbs, and spices (most typically including mint, dill, and cumin); meat is rarely used in Egyptian stuffed cabbage. (C) Presenting the required nutrition information on any label panel. High CHD rates occur among people with high total cholesterol levels of 240 milligrams per deciliter (mg/dL) (6.21 millimole per liter (mmol/l)) or above and LDL cholesterol levels of 160 mg/dL (4.13 mmol/l) or above. (1) If a nutrient content claim is made with respect to the level of dietary fiber, that is, that the product is high in fiber, a good source of fiber, or that the food contains more fiber, and the food is not low in total fat as defined in 101.62(b)(2) or, in the case of a meal product, as defined in 101.13(l), or main dish product, as defined in 101.13(m), is not low in total fat as defined in 101.62(b)(3), then the label shall disclose the level of total fat per labeled serving. Please do not provide confidential It shall also include data showing that the actual level of the nutrient in the food qualifies the food to bear the corresponding term defined by regulation. (E) Sale or other disposition of shell eggs under order. [Name of sugar from paragraph (c)(2)(ii)(B) of this section], the sugar used to sweeten this food, unlike other sugars, may reduce the risk of dental caries. If not listed separately, the reference amount for the unprepared form (e.g., dry mixes, concentrates, dough, batter, fresh and frozen pasta) is the amount required to make the reference amount of the prepared form. (iii) Polyunsaturated fat or Poly-unsaturated (VOLUNTARY): A statement of the number of grams of polyunsaturated fat in a serving defined as cis,cis-methylene-interrupted polyunsaturated fatty acids may be declared voluntarily, except that when monounsaturated 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 polyunsaturated fat is required. (B) Using any of the following abbreviations: Calories from saturated fat - Sat fat cal. (h) The label of a food to which flavor is added shall declare the flavor in the statement of ingredients in the following way: (1) Spice, natural flavor, and artificial flavor may be declared as spice, natural flavor, or artificial flavor, or any combination thereof, as the case may be. (ii) Serving size: A statement of the serving size as specified in paragraph (b)(7) of this section which shall immediately follow the ____servings per container declaration. Chocolate Buttercream. (7) A light bar shall be placed beneath the headings Amount Per Serving and % Daily Value.. (a) Relationship between dietary saturated fat and cholesterol and risk of coronary heart disease. The protein digestibility-corrected amino acid score shall be determined by methods given in sections 5.4.1, 7.2.1, and 8.00 in Report of the Joint FAO/WHO Expert Consultation on Protein Quality Evaluation, except that when official AOAC procedures described in paragraph (c)(7) of this section require a specific factor other than 6.25, that specific factor shall be used. Folate may be expressed as a percent DV in conventional foods. Information appearing on the closure shall appear in the following priority: (ii) The name and address of the manufacturer, packer, or distributor. (5) Disease or health-related condition means damage to an organ, part, structure, or system of the body such that it does not function properly (e.g., cardiovascular disease), or a state of health leading to such dysfunctioning (e.g., hypertension); except that diseases resulting from essential nutrient deficiencies (e.g., scurvy, pellagra) are not included in this definition (claims pertaining to such diseases are thereby not subject to 101.14 or 101.70). 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 Agriculture (USDA), Government Printing Office. Persons consuming these diets frequently have high intakes of these nutrients. Where packages bear alternate principal display panels, information required to be placed on the principal display panel shall be duplicated on each principal display panel. Recommended daily cholesterol intakes are 300 mg or less per day. Information contained in paragraph (b)(3) of this section may be used. (i) Risk factors. Daily special means a menu item that is prepared and offered for sale on a particular day, that is not routinely listed on a menu or menu board or offered by the covered establishment, and that is promoted by the covered establishment as a special menu item for that particular day. 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, U.S. Department of Agriculture (USDA) and Department of Health and Human Services (DHHS), Government Printing Office (GPO). This includes data bases of nutrient values for specific varieties, species, or cultivars of raw fruits, vegetables, and fish not specifically identified among the 20 most frequently consumed. All persons lose bone with age. (12) A claim for categorical exclusion under 25.30 or 25.32 of this chapter or an environmental assessment under 25.40 of this chapter, and. (B) The food shall meet the nutrient content requirements of 101.62 for a low saturated fat, low cholesterol, and low fat food. Reference amounts for other foods shall be expressed in grams except when common household units such as cups, tablespoons, and teaspoons, are more appropriate or are more likely to promote uniformity in serving sizes declared on product labels. 1, 1993, as amended at 58 FR 44038, Aug. 18, 1993; 59 FR 425, Jan. 4, 1994; 59 FR 15050, Mar. All items that have the same nutrient values could be listed together with the nutrient values listed only once. (ii) If the product meets these conditions without the benefit of special processing, alteration, formulation, or reformulation to lower saturated 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. (iii) Claims described in paragraph (c)(5) of this section may not be made on the label or in the labeling of a food if the nutrient content of the reference food meets the definition for low saturated fat.. Looking for a showstopping appetizer for your next dinner or cocktail party? Reference amounts customarily consumed per eating occasion. (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. 271). (g) The data specified under the several lettered headings should be submitted on separate pages or sets of pages, suitably identified. (5) The claim may state that diets that include plant sterol or stanol esters and are low in saturated fat and cholesterol are 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). For Sviata Vecheria (Christmas Eve Supper) in many regions of Ukraine holubtsi constitute one of the twelve traditional dishes served on the night. (e) Model health claims. The methods used to cook fish should be those that do not add fat, breading, or seasoning (e.g., salt or spices). (3) If a food is a main dish product as defined in 101.13(m), and contains more than 19.5 g of fat, 6.0 g of saturated fat, 90 mg of cholesterol, or 720 mg of sodium per labeled serving, then that food must disclose, in accordance with the requirements as provided in paragraph (h)(1) of this section, that the nutrient exceeding the specified level is present in the food. The symbol < may be used in place of less than.. (1) Cardiovascular disease means diseases of the heart and circulatory system. 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. (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. A statement identifying the synonymous descriptive term, the existing term defined by a regulation under section 403(r)(2)(A)(i) of the act with which the synonymous term is claimed to be consistent. Dietary lipids (fats) include fatty acids and cholesterol. The plant stanol mixture shall contain at least 80 percent sitostanol and campestanol (combined weight). [This product] can be part of a low sodium, low salt diet that might reduce the risk of hypertension or high blood pressure. The filling will be piping hot, so enjoy with care! Early management of risk factors for coronary heart disease is a major public health goal that can assist in reducing risk of coronary heart disease. 2. Step 2: Prepare the filling. 101.65 Implied nutrient content claims and related label statements. (5) Except as provided for in paragraphs (j)(5) and (j)(13) of this section, nutrient information declared in the simplified format shall be presented in the same manner as specified in paragraphs (d) or (e) of this section, except that the footnote required in paragraph (d)(9) of this section is not required, and an asterisk shall be placed at the bottom of the label followed by the statement % DV = % Daily Value when Daily Value is not spelled out in the heading, as shown in paragraph (f)(4). 0209, 10903 New Hampshire Ave., Silver Spring, MD 20993. (iii) Claims described in paragraph (b)(5) of this section may not be made on the label or labeling of food if the reference food meets the definition for low calorie.. -glucan soluble fiber will be determined by method No. 100, No. (i) Compliance with the provisions of 101.9(g) may be achieved by use of a data base that has been developed following FDA guideline procedures and approved by FDA. ), or destroyed by or under the supervision of an officer or employee of the FDA, or, if applicable, of the State or locality, in accordance with the following procedures: (A) Order for relabeling, diversion, or destruction under the PHS Act. Doing business under the same name means sharing the same name. All information relied upon for the support of the health claim, including copies of publications or other information cited in review articles and used to perform meta-analyses. (ii) Nutrition information is not required for custom processed fish or game meats. (1) Because the use of a free or low claim before the name of a food implies that the food differs from other foods of the same type by virtue of its having a lower amount of the nutrient, only foods that have been specially processed, altered, formulated, or reformulated so as to lower the amount of the nutrient in the food, remove the nutrient from the food, or not include the nutrient in the food, may bear such a claim (e.g., low sodium potato chips). Let them sit for at least 5 minutes before serving. (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. [18], In regions heavily influenced by Polish immigrants, such as Chicago which claims the largest Polish population outside of Poland, Detroit, Pennsylvania, the southern tier of New York, and northeastern Ohio, the term usually refers instead to stuffed cabbage rolls, such as the Polish gobki. (4) Disqualifying nutrient levels means the levels of total fat, saturated fat, cholesterol, or sodium in a food above which the food will be disqualified from making a health claim. Fat and/or oil ingredients not present in the product may be listed if they may sometimes be used in the product. [58 FR 2757, Jan. 6, 1993, as amended at 81 FR 91722, Dec. 19, 2016]. (g) Applicability. Such representations may be made either by statements, photographs, or vignettes. 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)). (8) Alternatively, compliance with the provisions set forth in paragraphs (g)(1) through (6) of this section may be provided by use of an FDA approved database that has been computed following FDA guideline procedures and where food samples have been handled in accordance with current good manufacturing practice to prevent nutrition loss. 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. (A) The submission to FDA for approval should include but need not be limited to information on the following: Source of the data (names of investigators, name of organization, place of analyses, dates of analyses), number of samples, sampling design, analytical methods, statistical treatment of the data, and proposed quantitative label declarations. (ii) For the purpose of this section, a measurable amount of an essential nutrient in a food shall be considered to be 2 percent or more of the Daily Reference Value (DRV) of protein listed under 101.9(c)(7)(iii) and of potassium listed under 101.9(c)(9) per reference amount customarily consumed and 2 percent or more of the Reference Daily Intake (RDI) of any vitamin or mineral listed under 101.9(c)(8)(iv) per reference amount customarily consumed, except that selenium, molybdenum, chromium, and chloride need not be considered. For a substance to be eligible for a health claim: (1) The substance must be associated with a disease or health-related condition for which the general U.S. population, or an identified U.S. population subgroup (e.g., the elderly) is at risk, or, alternatively, the petition submitted by the proponent of the claim otherwise explains the prevalence of the disease or health-related condition in the U.S. population and the relevance of the claim in the context of the total daily diet and satisfies the other requirements of this section. One of the major public health recommendations relative to CHD risk is to consume less than 10 percent of calories from saturated fat and an average of 30 percent or less of total calories from all fat. Alternatively, when used as part of a nutrient content claim, the term antioxidant or antioxidants (as in high in antioxidants) may be linked by a symbol (e.g., an asterisk) that refers to the same symbol that appears elsewhere on the same panel of a product label followed by the name or names of the nutrients with recognized antioxidant activity. A claim about the level of fat, fatty acid, and cholesterol in a food may only be made on the label or in the labeling of foods if: (4) For dietary supplements, claims for fat, saturated fat, and cholesterol may not be made on products that meet the criteria in 101.60(b)(1) or (b)(2) for calorie free or low calorie claims. (ii) Move them to another location for holding pending appeal. (c) If nonclinical laboratory studies are included in a petition, the petition shall include, with respect to each nonclinical study contained in the petition, either a statement that the study has been conducted in compliance with the good laboratory practice regulations as set forth in part 58 of this chapter, or, if any such study was not conducted in compliance with such regulations, a brief statement of the reason for the noncompliance. The product is then dried, milled and sifted. 5, 1995; 61 FR 59001, Nov. 20, 1996; 63 FR 26980, May 15, 1998; 72 FR 1459, Jan. 12, 2007]. (ii) If there is no name of the establishment presented to the public (e.g., an establishment with the generic descriptor concession stand), the name of the parent entity of the establishment. (5) The claim may include information on the number of people in the United States who have coronary heart disease. 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; (C) The claim is limited to grain products, fruits, and vegetables that contain dietary fiber; (D) The claim indicates that development of cancer depends on many factors; (E) The claim does not attribute any degree of cancer risk reduction to diets low in fat and high in fiber-containing grain products, fruits, and vegetables; (F) In specifying the dietary fiber component of the labeled food, the claim uses the term fiber, dietary fiber or total dietary fiber; and. (iv) Frequent between-meal consumption of foods high in sugars and starches promotes tooth decay. The serving size amount must be right justified if adequate space is available. __ piece(s) (__ g) for distinct unit (e.g., individually packaged products); Other dessert toppings, e.g., fruits, syrups, spreads, marshmallow cream, nuts, dairy and non-dairy whipped toppings, Egg mixtures, e.g., egg foo young, scrambled eggs, omelets, __ piece(s) (__ g) for discrete pieces; __ cup(s) (__ g), Egg whites, sugared eggs, sugared egg yolks, and egg substitutes (fresh, frozen, dried), Mayonnaise, sandwich spreads, mayonnaise-type dressings, __ piece(s) (__ g) for discrete pieces; __ tbsp(s) (__ g) for others, Entrees with sauce, e.g., fish with cream sauce, shrimp with lobster sauce, __ cup(s) (__ g); 5 oz (140 g/visual unit of measure) if not measurable by cup, Entrees without sauce, e.g., plain or fried fish and shellfish, fish and shellfish cake, __ piece(s) (__ g) for discrete pieces; __ cup(s) (__ g); __ oz (__ g/visual unit of measure) if not measurable by cup, __ piece(s) (__ g) for discrete pieces; __ cup(s) (__ g); 3 oz (85 g/__ cup) for products that are difficult to measure the g weight of cup measure (e.g., tuna); 3 oz (85 g/__ pieces) for products that naturally vary in size (e.g., sardines), Substitute for luncheon meat, meat spreads, Canadian bacon, sausages, frankfurters, and seafood, __ piece(s) (__ g) for distinct pieces (e.g., slices, links); __ cup(s) (__ g); 2 oz (56 g/visual unit of measure) for nondiscrete bulk product, __ piece(s) (__ g) for distinct pieces (e.g., slices, links) or __ cup(s) (__ g); 2 oz (56 g/visual unit of measure) for nondiscrete bulk product, Substitutes for bacon bits - see Miscellaneous, __ piece(s) (__ g) for large pieces (e.g., dates, figs, prunes); __ cup(s) (__ g) for small pieces (e.g., raisins), Fruits for garnish or flavor, e.g., maraschino cherries, Fruit relishes, e.g., cranberry sauce, cranberry relish, Fruits used primarily as ingredients, avocado, Fruits used primarily as ingredients, others (cranberries, lemon, lime), __ piece(s) (__ g) for large fruits; __ cup(s) (__ g) for small fruits measurable by cup, All other fruits (except those listed as separate categories), fresh, canned or frozen, __ piece(s) (__ g) for large pieces (e.g., strawberries, prunes, apricots, etc.