cfr_sections
Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API
50 rows where agency = "FDA" and part_number = 101 sorted by section_id
This data as json, CSV (advanced)
Suggested facets: subpart, subpart_name
| section_id ▼ | title_number | title_name | chapter | subchapter | part_number | part_name | subpart | subpart_name | section_number | section_heading | agency | authority | source_citation | amendment_citations | full_text |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 21:21:2.0.1.1.2.1.1.1 | 21 | Food and Drugs | I | B | 101 | PART 101—FOOD LABELING | A | Subpart A—General Provisions | § 101.1 Principal display panel of package form food. | FDA | The term principal display panel as it applies to food in package form and as used in this part, means the part of a label that is most likely to be displayed, presented, shown, or examined under customary conditions of display for retail sale. 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. 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. 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. In determining the area of the principal display panel, exclude tops, bottoms, flanges at tops and bottoms of cans, and shoulders and necks of bottles or jars. In the case of cylindrical or nearly cylindrical containers, information required by this part to appear on the principal display panel shall appear within that 40 percent of the circumference which is most likely to be displayed, presented, shown, or examined under customary conditions of display for retail sa… | ||||
| 21:21:2.0.1.1.2.1.1.10 | 21 | Food and Drugs | I | B | 101 | PART 101—FOOD LABELING | A | Subpart A—General Provisions | § 101.11 Nutrition labeling of standard menu items in covered establishments. | FDA | [79 FR 71253, Dec. 1, 2014] | (a) Definitions. The definitions of terms in section 201 of the Federal Food, Drug, and Cosmetic Act apply to such terms when used in this section. In addition, for purposes of this section: Authorized official of a restaurant or similar retail food establishment means the owner, operator, agent in charge, or other person authorized by the owner, operator, or agent in charge to register the restaurant or similar retail food establishment, which is not otherwise subject to section 403(q)(5)(H) of the Federal Food, Drug, and Cosmetic Act, with FDA for the purposes of paragraph (d) of this section. Combination meal means a standard menu item that consists of more than one food item, for example a meal that includes a sandwich, a side dish, and a drink. A combination meal may be represented on the menu or menu board in narrative form, numerically, or pictorially. Some combination meals may include a variable menu item or be a variable menu item as defined in this paragraph where the components may vary. For example, the side dish may vary among several options ( e.g., fries, salad, or onion rings) or the drinks may vary ( e.g., soft drinks, milk, or juice) and the customer selects which of these items will be included in the meal. Covered establishment means a restaurant or similar retail food establishment that is a part of a chain with 20 or more locations doing business under the same name (regardless of the type of ownership, e.g., individual franchises) and offering for sale substantially the same menu items, as well as a restaurant or similar retail food establishment that is registered to be covered under paragraph (d) of this section. Custom order means a food order that is prepared in a specific manner based on an individual customer's request, which requires the covered establishment to deviate from its usual preparation of a standard menu item, e.g., a club sandwich without the bacon if the establishment usually includes bacon in its club sandwich. Daily special means a menu item that is … | |||
| 21:21:2.0.1.1.2.1.1.11 | 21 | Food and Drugs | I | B | 101 | PART 101—FOOD LABELING | A | Subpart A—General Provisions | § 101.12 Reference amounts customarily consumed per eating occasion. | FDA | [58 FR 44051, Aug. 18, 1993; 58 FR 60109, Nov. 15, 1993, as amended at 59 FR 371, Jan. 4, 1994; 59 FR 24039, May 10, 1994; 62 FR 40598, July 29, 1997; 62 FR 49848, Sept. 23, 1997; 63 FR 14818, Mar. 27, 1998; 64 FR 12890, Mar. 16, 1999; 66 FR 56035, Nov. 6, 2001; 81 FR 34041, May 27, 2016] | (a) The general principles and factors that the Food and Drug Administration (FDA) considered in arriving at the reference amounts customarily consumed per eating occasion (reference amounts) which are set forth in paragraph (b) of this section, are that: (1) FDA calculated the reference amounts for persons 4 years of age or older to reflect the amount of food customarily consumed per eating occasion by persons in this population group. These reference amounts are based on data set forth in appropriate national food consumption surveys. (2) FDA calculated the reference amounts for an infant or child under 4 years of age to reflect the amount of food customarily consumed per eating occasion by infants up to 12 months of age or by children 1 through 3 years of age, respectively. These reference amounts are based on data set forth in appropriate national food consumption surveys. Such reference amounts are to be used only when the food is specially formulated or processed for use by an infant or by a child under 4 years of age. (3) An appropriate national food consumption survey includes a large sample size representative of the demographic and socioeconomic characteristics of the relevant population group and must be based on consumption data under actual conditions of use. (4) To determine the amount of food customarily consumed per eating occasion, FDA considered the mean, median, and mode of the consumed amount per eating occasion. (5) When survey data were insufficient, FDA took various other sources of information on serving sizes of food into consideration. 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 (iv) Serving sizes used by other countries. (6) Because they reflect the amount customarily consumed, the reference amount and, in turn, the serving size declared on the product l… | |||
| 21:21:2.0.1.1.2.1.1.12 | 21 | Food and Drugs | I | B | 101 | PART 101—FOOD LABELING | A | Subpart A—General Provisions | § 101.13 Nutrient content claims—general principles. | FDA | [58 FR 2410, Jan. 6, 1993; 58 FR 17341, 17342, Apr. 2, 1993, as amended at 58 FR 44030, Aug. 18, 1993; 59 FR 393, Jan. 4, 1994; 59 FR 15051, Mar. 31, 1994; 60 FR 17205, Apr. 5, 1995; 61 FR 11731, Mar. 22, 1996; 61 FR 40332, Aug. 2, 1996; 61 FR 67452, Dec. 23, 1996; 62 FR 31339, June 9, 1997; 62 FR 49867, Sept. 23, 1997; 63 FR 14818, Mar. 27, 1998; 63 FR 26980, May 15, 1998; 81 FR 59131, Aug. 29, 2016; 89 FR 106162, Dec. 27, 2024] | (a) This section and the regulations in subpart D of this part apply to foods that are intended for human consumption and that are offered for sale, including conventional foods and dietary supplements. (b) A claim that expressly or implicitly characterizes the level of a nutrient of the type required to be in nutrition labeling under § 101.9 or under § 101.36 (that is, a nutrient content claim) may not be made on the label or in labeling of foods unless the claim is made in accordance with this regulation and with the applicable regulations in subpart D of this part or in part 105 or part 107 of this chapter. (1) An expressed nutrient content claim is any direct statement about the level (or range) of a nutrient in the food, e.g., “low sodium” or “contains 100 calories.” (2) An implied nutrient content claim is any claim that: (i) Describes the food or an ingredient therein in a manner that suggests that a nutrient is absent or present in a certain amount (e.g., “high in oat bran”); or (ii) Suggests that a food, because of its nutrient content, may be useful in maintaining healthy dietary practices, where there is also implied or explicit information about the nutrition content of the food ( e.g., “healthy”). (3) Except for claims regarding vitamins and minerals described in paragraph (q)(3) of this section, no nutrient content claims may be made on food intended specifically for use by infants and children less than 2 years of age unless the claim is specifically provided for in parts 101, 105, or 107 of this chapter. (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”). (5) For dietary supplements, claims for calories, 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, except, in the case of calorie claims, when an equivalent amount of a similar dietary supplement (e.g., anoth… | |||
| 21:21:2.0.1.1.2.1.1.13 | 21 | Food and Drugs | I | B | 101 | PART 101—FOOD LABELING | A | Subpart A—General Provisions | § 101.14 Health claims: general requirements. | FDA | [58 FR 2533, Jan. 6, 1993; 58 FR 17097, Apr. 1, 1993, as amended at 58 FR 44038, Aug. 18, 1993; 59 FR 425, Jan. 4, 1994; 59 FR 15050, Mar. 31, 1994; 61 FR 40332, Aug. 2, 1996; 62 FR 49867, Sept. 23, 1997; 63 FR 26980, May 15, 1998; 66 FR 17358, Mar. 30, 2001] | (a) Definitions. For purposes of this section, the following definitions apply: (1) Health claim means any claim made on the label or in labeling of a food, including a dietary supplement, that expressly or by implication, including “third party” references, written statements (e.g., a brand name including a term such as “heart”), symbols (e.g., a heart symbol), or vignettes, characterizes the relationship of any substance to a disease or health-related condition. Implied health claims include those statements, symbols, vignettes, or other forms of communication that suggest, within the context in which they are presented, that a relationship exists between the presence or level of a substance in the food and a disease or health-related condition. (2) Substance means a specific food or component of food, regardless of whether the food is in conventional food form or a dietary supplement that includes vitamins, minerals, herbs, or other similar nutritional substances. (3) Nutritive value means a value in sustaining human existence by such processes as promoting growth, replacing loss of essential nutrients, or providing energy. (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. These levels are 13.0 grams (g) of fat, 4.0 g of saturated fat, 60 milligrams (mg) of cholesterol, or 480 mg of sodium, per reference amount customarily consumed, per label serving size, and, only for foods with reference amounts customarily consumed of 30 g or less or 2 tablespoons or less, per 50 g. For dehydrated foods that must have water added to them prior to typical consumption, the per 50-g criterion refers to the as prepared form. Any one of the levels, on a per reference amount customarily consumed, a per label serving size or, when applicable, a per 50 g basis, will disqualify a food from making a health claim unless an exception is provided in subpart E of this part, except that: (i) … | |||
| 21:21:2.0.1.1.2.1.1.14 | 21 | Food and Drugs | I | B | 101 | PART 101—FOOD LABELING | A | Subpart A—General Provisions | § 101.15 Food; prominence of required statements. | FDA | (a) A word, statement, or other information required by or under authority of the act to appear on the label may lack that prominence and conspicuousness required by section 403(f) of the act by reason (among other reasons) of: (1) The failure of such word, statement, or information to appear on the part or panel of the label which is presented or displayed under customary conditions of purchase; (2) The failure of such word, statement, or information to appear on two or more parts or panels of the label, each of which has sufficient space therefor, and each of which is so designed as to render it likely to be, under customary conditions of purchase, the part or panel displayed; (3) The failure of the label to extend over the area of the container or package available for such extension, so as to provide sufficient label space for the prominent placing of such word, statement, or information; (4) Insufficiency of label space (for the prominent placing of such word, statement, or information) resulting from the use of label space for any word, statement, design, or device which is not required by or under authority of the act to appear on the label; (5) Insufficiency of label space (for the prominent placing of such word, statement, or information) resulting from the use of label space to give materially greater conspicuousness to any other word, statement, or information, or to any design or device; or (6) Smallness or style of type in which such word, statement, or information appears, insufficient background contrast, obscuring designs or vignettes, or crowding with other written, printed, or graphic matter. (b) No exemption depending on insufficiency of label space, as prescribed in regulations promulgated under section 403 (e) or (i) of the act, shall apply if such insufficiency is caused by: (1) The use of label space for any word, statement, design, or device which is not required by or under authority of the act to appear on the label; (2) The use of label space to give greater conspicuousness to … | ||||
| 21:21:2.0.1.1.2.1.1.15 | 21 | Food and Drugs | I | B | 101 | PART 101—FOOD LABELING | A | Subpart A—General Provisions | § 101.17 Food labeling warning, notice, and safe handling statements. | FDA | [42 FR 14308, Mar. 15, 1977] | (a) Self-pressurized containers. (1) The label of a food packaged in a self-pressurized container and intended to be expelled from the package under pressure shall bear the following warning: WARNING—Avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120 °F. Keep out of reach of children. WARNING—Avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120 °F. Keep out of reach of children. (2) In the case of products intended for use by children, the phrase “except under adult supervision” may be added at the end of the last sentence in the warning required by paragraph (a)(1) of this section. (3) In the case of products packaged in glass containers, the word “break” may be substituted for the word “puncture” in the warning required by paragraph (a)(1) of this section. (4) The words “Avoid spraying in eyes” may be deleted from the warning required by paragraph (a)(1) of this section in the case of a product not expelled as a spray. (b) Self-pressurized containers with halocarbon or hydrocarbon propellants. (1) In addition to the warning required by paragraph (a) of this section, the label of a food packaged in a self-pressurized container in which the propellant consists in whole or in part of a halocarbon or a hydrocarbon shall bear the following warning: WARNING—Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal. WARNING—Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal. (2) The warning required by paragraph (b)(1) of this section is not required for the following products: (i) Products expelled in the form of a foam or cream, which contain less than 10 percent propellant in the container. (ii) Products in a container with a physical barrier that prevents escape of the propellant at the time of use. (iii) Products of a net quantity of con… | |||
| 21:21:2.0.1.1.2.1.1.16 | 21 | Food and Drugs | I | B | 101 | PART 101—FOOD LABELING | A | Subpart A—General Provisions | § 101.18 Misbranding of food. | FDA | (a) Among representations in the labeling of a food which render such food misbranded is a false or misleading representation with respect to another food or a drug, device, or cosmetic. (b) The labeling of a food which contains two or more ingredients may be misleading by reason (among other reasons) of the designation of such food in such labeling by a name which includes or suggests the name of one or more but not all such ingredients, even though the names of all such ingredients are stated elsewhere in the labeling. (c) Among representations in the labeling of a food which render such food misbranded is any representation that expresses or implies a geographical origin of the food or any ingredient of the food except when such representation is either: (1) A truthful representation of geographical origin. (2) A trademark or trade name provided that as applied to the article in question its use is not deceptively misdescriptive. A trademark or trade name composed in whole or in part of geographical words shall not be considered deceptively misdescriptive if it: (i) Has been so long and exclusively used by a manufacturer or distributor that it is generally understood by the consumer to mean the product of a particular manufacturer or distributor; or (ii) Is so arbitrary or fanciful that it is not generally understood by the consumer to suggest geographic origin. (3) A part of the name required by applicable Federal law or regulation. (4) A name whose market significance is generally understood by the consumer to connote a particular class, kind, type, or style of food rather than to indicate geographical origin. | ||||
| 21:21:2.0.1.1.2.1.1.2 | 21 | Food and Drugs | I | B | 101 | PART 101—FOOD LABELING | A | Subpart A—General Provisions | § 101.2 Information panel of package form food. | FDA | [42 FR 14308, Mar. 15, 1977, as amended at 42 FR 15673, Mar. 22, 1977; 42 FR 45905, Sept. 13, 1977; 42 FR 47191, Sept. 20, 1977; 44 FR 16006, Mar. 16, 1979; 49 FR 13339, Apr. 4, 1984; 53 FR 16068, May 5, 1988; 58 FR 44030, Aug. 18, 1993; 60 FR 17205, Apr. 5, 1995; 62 FR 43074, Aug. 12, 1997; 62 FR 49847, Sept. 23, 1997; 63 FR 14817, Mar. 27, 1998; 81 FR 59131, Aug. 29, 2016] | (a) The term information panel as it applies to packaged food means that part of the label immediately contiguous and to the right of the principal display panel as observed by an individual facing the principal display panel with the following exceptions: (1) If the part of the label immediately contiguous and to the right of the principal display panel is too small to accommodate the necessary information or is otherwise unusable label space, e.g., folded flaps or can ends, the panel immediately contiguous and to the right of this part of the label may be used. (2) If the package has one or more alternate principal display panels, the information panel is immediately contiguous and to the right of any principal display panel. (3) If the top of the container is the principal display panel and the package has no alternate principal display panel, the information panel is any panel adjacent to the principal display panel. (b) All information required to appear on the label of any package of food under §§ 101.4, 101.5, 101.8, 101.9, 101.13, 101.17, 101.36, subpart D of part 101, and part 105 of this chapter shall appear either on the principal display panel or on the information panel, unless otherwise specified by regulations in this chapter. (c) All information appearing on the principal display panel or the information panel pursuant to this section shall appear prominently and conspicuously, but in no case may the letters and/or numbers be less than one-sixteenth inch in height unless an exemption pursuant to paragraph (f) of this section is established. The requirements for conspicuousness and legibility shall include the specifications of §§ 101.7(h)(1) and (2) and 101.15. (1)(i) Soft drinks packaged in bottles manufactured before October 31, 1975 shall be exempt from the requirements prescribed by this section to the extent that information which is blown, lithographed, or formed onto the surface of the bottle is exempt from the size and placement requirements of this section. (ii) Soft drinks packa… | |||
| 21:21:2.0.1.1.2.1.1.3 | 21 | Food and Drugs | I | B | 101 | PART 101—FOOD LABELING | A | Subpart A—General Provisions | § 101.3 Identity labeling of food in packaged form. | FDA | [42 FR 14308, Mar. 15, 1977, as amended at 48 FR 10811, Mar. 15, 1983; 58 FR 2227, Jan. 6, 1993; 60 FR 67174, Dec. 28, 1995; 62 FR 49847, Sept. 23, 1997] | (a) The principal display panel of a food in package form shall bear as one of its principal features a statement of the identity of the commodity. (b) Such statement of identity shall be in terms of: (1) The name now or hereafter specified in or required by any applicable Federal law or regulation; or, in the absence thereof, (2) The common or usual name of the food; or, in the absence thereof, (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. (c) Where a food is marketed in various optional forms (whole, slices, diced, etc.), the particular form shall be considered to be a necessary part of the statement of identity and shall be declared in letters of a type size bearing a reasonable relation to the size of the letters forming the other components of the statement of identity; except that if the optional form is visible through the container or is depicted by an appropriate vignette, the particular form need not be included in the statement. This specification does not affect the required declarations of identity under definitions and standards for foods promulgated pursuant to section 401 of the act. (d) This statement of identity shall be presented in bold type on the principal display panel, shall be in a size reasonably related to the most prominent printed matter on such panel, and shall be in lines generally parallel to the base on which the package rests as it is designed to be displayed. (e) Under the provisions of section 403(c) of the Federal Food, Drug, and Cosmetic Act, a food shall be deemed to be misbranded if it is an imitation of another food unless its label bears, in type of uniform size and prominence, the word “imitation” and, immediately thereafter, the name of the food imitated. (1) A food shall be deemed to be an imitation and thus subject to the requirements of section 403(c) of the act if it is a substitute for and resembles another food but is nutritionally inferior to that food. (2) A f… | |||
| 21:21:2.0.1.1.2.1.1.4 | 21 | Food and Drugs | I | B | 101 | PART 101—FOOD LABELING | A | Subpart A—General Provisions | § 101.4 Food; designation of ingredients. | FDA | [42 FR 14308, Mar. 15, 1977, as amended at 43 FR 12858, Mar. 28, 1978; 43 FR 24519, June 6, 1978; 48 FR 8054, Feb. 25, 1983; 55 FR 17433, Apr. 25, 1990; 58 FR 2875, Jan. 6, 1993; 62 FR 49847, Sept. 23, 1997; 62 FR 64634, Dec. 8, 1997; 64 FR 50448, Sept. 17, 1999; 66 FR 17358, Mar. 30, 2001; 66 FR 66742, Dec. 27, 2001; 68 FR 15355, Mar. 31, 2003; 81 FR 5590, Feb. 3, 2016; 88 FR 17716, Mar. 24, 2023] | (a)(1) Ingredients required to be declared on the label or labeling of a food, including foods that comply with standards of identity, except those ingredients exempted by § 101.100, shall be listed by common or usual name in descending order of predominance by weight on either the principal display panel or the information panel in accordance with the provisions of § 101.2, except that ingredients in dietary supplements that are listed in the nutrition label in accordance with § 101.36 need not be repeated in the ingredient list. Paragraph (g) of this section describes the ingredient list on dietary supplement products. (2) The descending order of predominance requirements of paragraph (a)(1) of this section do not apply to ingredients present in amounts of 2 percent or less by weight when a listing of these ingredients is placed at the end of the ingredient statement following an appropriate quantifying statement, e.g., “Contains __ percent or less of ______” or “Less than __ percent of ______.” The blank percentage within the quantifying statement shall be filled in with a threshold level of 2 percent, or, if desired, 1.5 percent, 1.0 percent, or 0.5 percent, as appropriate. No ingredient to which the quantifying phrase applies may be present in an amount greater than the stated threshold. (b) The name of an ingredient shall be a specific name and not a collective (generic) name, except that: (1) Spices, flavorings, colorings and chemical preservatives shall be declared according to the provisions of § 101.22. (2) An ingredient which itself contains two or more ingredients and which has an established common or usual name, conforms to a standard established pursuant to the Meat Inspection or Poultry Products Inspection Acts by the U.S. Department of Agriculture, or conforms to a definition and standard of identity established pursuant to section 401 of the Federal Food, Drug, and Cosmetic Act, shall be designated in the statement of ingredients on the label of such food by either of the following alternati… | |||
| 21:21:2.0.1.1.2.1.1.5 | 21 | Food and Drugs | I | B | 101 | PART 101—FOOD LABELING | A | Subpart A—General Provisions | § 101.5 Food; name and place of business of manufacturer, packer, or distributor. | FDA | (a) The label of a food in packaged form shall specify conspicuously the name and place of business of the manufacturer, packer, or distributor. (b) The requirement for declaration of the name of the manufacturer, packer, or distributor shall be deemed to be satisfied, in the case of a corporation, only by the actual corporate name, which may be preceded or followed by the name of the particular division of the corporation. In the case of an individual, partnership, or association, the name under which the business is conducted shall be used. (c) Where the food is not manufactured by the person whose name appears on the label, the name shall be qualified by a phrase that reveals the connection such person has with such food; such as “Manufactured for ______”, “Distributed by ______”, or any other wording that expresses the facts. (d) The statement of the place of business shall include the street address, city, State, and ZIP code; however, the street address may be omitted if it is shown in a current city directory or telephone directory. The requirement for inclusion of the ZIP code shall apply only to consumer commodity labels developed or revised after the effective date of this section. In the case of nonconsumer packages, the ZIP code shall appear either on the label or the labeling (including invoice). (e) If a person manufactures, packs, or distributes a food at a place other than his principal place of business, the label may state the principal place of business in lieu of the actual place where such food was manufactured or packed or is to be distributed, unless such statement would be misleading. | ||||
| 21:21:2.0.1.1.2.1.1.6 | 21 | Food and Drugs | I | B | 101 | PART 101—FOOD LABELING | A | Subpart A—General Provisions | § 101.7 Declaration of net quantity of contents. | FDA | [42 FR 14308, Mar. 15, 1977, as amended at 42 FR 15673, Mar. 22, 1977. Redesignated at 81 FR 59131, Aug. 29, 2016] | (a) The principal display panel of a food in package form shall bear a declaration of the net quantity of contents. This shall be expressed in the terms of weight, measure, numerical count, or a combination of numerical count and weight or measure. 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. If there is a firmly established general consumer usage and trade custom of declaring the contents of a liquid by weight, or a solid, semisolid, or viscous product by fluid measure, it may be used. Whenever the Commissioner determines that an existing practice of declaring net quantity of contents by weight, measure, numerical count, or a combination in the case of a specific packaged food does not facilitate value comparisons by consumers and offers opportunity for consumer confusion, he will by regulation designate the appropriate term or terms to be used for such commodity. (b)(1) Statements of weight shall be in terms of avoirdupois pound and ounce. (2) Statements of fluid measure shall be in terms of the U.S. gallon of 231 cubic inches and quart, pint, and fluid ounce subdivisions thereof, and shall: (i) In the case of frozen food that is sold and consumed in a frozen state, express the volume at the frozen temperature. (ii) In the case of refrigerated food that is sold in the refrigerated state, express the volume at 40 °F (4 °C). (iii) In the case of other foods, express the volume at 68 °F (20 °C). (3) Statements of dry measure shall be in terms of the U.S. bushel of 2,150.42 cubic inches and peck, dry quart, and dry pint subdivisions thereof. (c) When the declaration of quantity of contents by numerical count does not give adequate information as to the quantity of food in the package, it shall be combined with such s… | |||
| 21:21:2.0.1.1.2.1.1.7 | 21 | Food and Drugs | I | B | 101 | PART 101—FOOD LABELING | A | Subpart A—General Provisions | § 101.8 Vending machines. | FDA | [79 FR 71291, Dec. 1, 2014, as amended at 84 FR 57610, Oct. 28, 2019] | (a) Definitions. The definitions of terms in section 201 of the Federal Food, Drug, and Cosmetic Act apply to such terms when used in this section. In addition, for the purposes of this section: Authorized official of a vending machine operator means an owner, operator, agent in charge, or any other person authorized by a vending machine operator who is not otherwise subject to section 403(q)(5)(H)(viii) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 343(q)(5)(H)(viii)), to register the vending machine operator with the Food and Drug Administration (“FDA”) for purposes of paragraph (d) of this section. Vending machine means a self-service machine that, upon insertion of a coin, paper currency, token, card, or key, or by optional manual operation, dispenses servings of food in bulk or in packages, or prepared by the machine, without the necessity of replenishing the machine between each vending operation. Vending machine operator means a person(s) or entity that controls or directs the function of the vending machine, including deciding which articles of food are sold from the machine or the placement of the articles of food within the vending machine, and is compensated for the control or direction of the function of the vending machine. (b) Articles of food not covered. Articles of food sold from a vending machine are not covered vending machine food if: (1) The prospective purchaser can view: (i) The calories, serving size, and servings per container listed in the Nutrition Facts label on the vending machine food without any obstruction. The Nutrition Facts label must be in the format required in § 101.9(c) and (d). The Nutrition Facts label must be in a size that permits the prospective purchaser to be able to easily read the nutrition information contained in the Nutrition Facts label on the article of food in the vending machine. Smaller formats allowed for Nutrition Facts for certain food labeling under FDA regulation at § 101.9 are not considered to be a size that a prospective purchas… | |||
| 21:21:2.0.1.1.2.1.1.8 | 21 | Food and Drugs | I | B | 101 | PART 101—FOOD LABELING | A | Subpart A—General Provisions | § 101.9 Nutrition labeling of food. | FDA | [58 FR 2175, Jan. 6, 1993] | (a) Nutrition information relating to food shall be provided for all products intended for human consumption and offered for sale unless an exemption is provided for the product in paragraph (j) of this section. (1) When food is in package form, the required nutrition labeling information shall appear on the label in the format specified in this section. (2) When food is not in package form, the required nutrition labeling information shall be displayed clearly at the point of purchase (e.g., on a counter card, sign, tag affixed to the product, or some other appropriate device). Alternatively, the required information may be placed in a booklet, looseleaf binder, or other appropriate format that is available at the point of purchase. (3) Solicitation of requests for nutrition information by a statement “For nutrition information write to ______________________ ” on the label or in the labeling or advertising for a food, or providing such information in a direct written reply to a solicited or unsolicited request, does not subject the label or the labeling of a food exempted under paragraph (j) of this section to the requirements of this section if the reply to the request conforms to the requirements of this section. (4) If any vitamin or mineral is added to a food so that a single serving provides 50 percent or more of the Reference Daily Intake (RDI) for the age group for which the product is intended, as specified in paragraph (c)(8)(iv) of this section, of any one of the added vitamins or minerals, unless such addition is permitted or required in other regulations, e.g., a standard of identity or nutritional quality guideline, or is otherwise exempted by the Commissioner, the food shall be considered a food for special dietary use within the meaning of § 105.3(a)(1)(iii) of this chapter. (b) Except as provided in § 101.9(h)(3), all nutrient and food component quantities shall be declared in relation to a serving as defined in this section. (1) The term serving or serving size means an amount of food… | |||
| 21:21:2.0.1.1.2.1.1.9 | 21 | Food and Drugs | I | B | 101 | PART 101—FOOD LABELING | A | Subpart A—General Provisions | § 101.10 Nutrition labeling of restaurant foods whose labels or labeling bear nutrient content claims or health claims. | FDA | [79 FR 71253, Dec. 1, 2014] | Nutrition labeling in accordance with § 101.9 shall be provided upon request for any restaurant food or meal for which a nutrient content claim (as defined in § 101.13 or in subpart D of this part) or a health claim (as defined in § 101.14 and permitted by a regulation in subpart E of this part) is made, except that information on the nutrient amounts that are the basis for the claim ( e.g., “low fat, this meal provides less than 10 grams of fat”) may serve as the functional equivalent of complete nutrition information as described in § 101.9. For the purposes of this section, restaurant food includes two categories of food. It includes food which is served in restaurants or other establishments in which food is served for immediate human consumption or which is sold for sale or use in such establishments. It also includes food which is processed and prepared primarily in a retail establishment, which is ready for human consumption, which is of the type described in the previous sentence, and which is offered for sale to consumers but not for immediate human consumption in such establishment and which is not offered for sale outside such establishment. For standard menu items that are offered for sale in covered establishments (as defined in § 101.11(a)), the information in the written nutrition information required by § 101.11(b)(2)(ii)(A) will serve to meet the requirements of this section. Nutrient levels may be determined by nutrient databases, cookbooks, or analyses or by other reasonable bases that provide assurance that the food or meal meets the nutrient requirements for the claim. Presentation of nutrition labeling may be in various forms, including those provided in § 101.45 and other reasonable means. | |||
| 21:21:2.0.1.1.2.2.1.1 | 21 | Food and Drugs | I | B | 101 | PART 101—FOOD LABELING | B | Subpart B—Specific Food Labeling Requirements | § 101.22 Foods; labeling of spices, flavorings, colorings and chemical preservatives. | FDA | [42 FR 14308, Mar. 15, 1977, as amended at 44 FR 3963, Jan. 19, 1979; 44 FR 37220, June 26, 1979; 54 FR 24891, June 12, 1989; 58 FR 2875, Jan. 6, 1993; 63 FR 14818, Mar. 27, 1998; 74 FR 216, Jan. 5, 2009] | (a)(1) The term artificial flavor or artificial flavoring means any substance, the function of which is to impart flavor, which is not derived from a spice, fruit or fruit juice, vegetable or vegetable juice, edible yeast, herb, bark, bud, root, leaf or similar plant material, meat, fish, poultry, eggs, dairy products, or fermentation products thereof. Artificial flavor includes the substances listed in §§ 172.515(b) and 182.60 of this chapter except where these are derived from natural sources. (2) The term spice means any aromatic vegetable substance in the whole, broken, or ground form, except for those substances which have been traditionally regarded as foods, such as onions, garlic and celery; whose significant function in food is seasoning rather than nutritional; that is true to name; and from which no portion of any volatile oil or other flavoring principle has been removed. Spices include the spices listed in § 182.10 and part 184 of this chapter, such as the following: Allspice, Anise, Basil, Bay leaves, Caraway seed, Cardamon, Celery seed, Chervil, Cinnamon, Cloves, Coriander, Cumin seed, Dill seed, Fennel seed, Fenugreek, Ginger, Horseradish, Mace, Marjoram, Mustard flour, Nutmeg, Oregano, Paprika, Parsley, Pepper, black; Pepper, white; Pepper, red; Rosemary, Saffron, Sage, Savory, Star aniseed, Tarragon, Thyme, Turmeric. Allspice, Anise, Basil, Bay leaves, Caraway seed, Cardamon, Celery seed, Chervil, Cinnamon, Cloves, Coriander, Cumin seed, Dill seed, Fennel seed, Fenugreek, Ginger, Horseradish, Mace, Marjoram, Mustard flour, Nutmeg, Oregano, Paprika, Parsley, Pepper, black; Pepper, white; Pepper, red; Rosemary, Saffron, Sage, Savory, Star aniseed, Tarragon, Thyme, Turmeric. Paprika, turmeric, and saffron or other spices which are also colors, shall be declared as “spice and coloring” unless declared by their common or usual name. (3) The term natural flavor or natural flavoring means the essential oil, oleoresin, essence or extractive, protein hydrolysate, distillate, or any product… | |||
| 21:21:2.0.1.1.2.2.1.2 | 21 | Food and Drugs | I | B | 101 | PART 101—FOOD LABELING | B | Subpart B—Specific Food Labeling Requirements | § 101.30 Percentage juice declaration for foods purporting to be beverages that contain fruit or vegetable juice. | FDA | [58 FR 2925, Jan. 6, 1993, as amended at 58 FR 44063, Aug. 18, 1993; 58 FR 49192, Sept. 22, 1993; 81 FR 33994, May 27, 2016; 81 FR 59131, Aug. 29, 2016] | (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. The beverage may be carbonated or noncarbonated, concentrated, full-strength, diluted, or contain no juice. For example, a soft drink (soda) that does not represent or suggest by its physical characteristics, name, labeling, ingredient statement, or advertising that it contains fruit or vegetable juice does not purport to contain juice and therefore does not require a percent juice declaration. (b)(1) If the beverage contains fruit or vegetable juice, the percentage shall be declared by the words “Contains __ percent (or %) ______ juice” or “__ percent (or %) juice,” or a similar phrase, with the first blank filled in with the percentage expressed as a whole number not greater than the actual percentage of the juice and the second blank (if used) filled in with the name of the particular fruit or vegetable (e.g., “Contains 50 percent apple juice” or “50 percent juice”). (2) If the beverage contains less than 1 percent juice, the total percentage juice shall be declared as “less than 1 percent juice” or “less than 1 percent ______ juice” with the blank filled in with the name of the particular fruit or vegetable. (3) If the beverage contains 100 percent juice and also contains non-juice ingredients that do not result in a diminution of the juice soluble solids or, in the case of expressed juice, in a change in the volume, when the 100 percent juice declaration appears on a panel of the label that does not also bear the ingredient … | |||
| 21:21:2.0.1.1.2.3.1.1 | 21 | Food and Drugs | I | B | 101 | PART 101—FOOD LABELING | C | Subpart C—Specific Nutrition Labeling Requirements and Guidelines | § 101.36 Nutrition labeling of dietary supplements. | FDA | [62 FR 49849, Sept. 23, 1997, as amended at 63 FR 30620, June 5, 1998; 66 FR 56035, Nov. 6, 2001; 71 FR 51726, Aug. 31, 2006; 71 FR 74791, Dec. 13, 2006; 81 FR 33994, May 27, 2016; 83 FR 65502, Dec. 21, 2018] | (a) The label of a dietary supplement that is offered for sale shall bear nutrition labeling in accordance with this regulation unless an exemption is provided for the product in paragraph (h) of this section. (b) The declaration of nutrition information on the label and in labeling shall contain the following information, using the subheadings and the format specified in paragraph (e) of this section. (1) Serving size. (i) The subheading “Serving Size” shall be placed under the heading “Supplement Facts” and aligned on the left side of the nutrition label. The serving size shall be determined in accordance with §§ 101.9(b) and 101.12(b), Table 2. Serving size for dietary supplements shall be expressed using a term that is appropriate for the form of the supplement, such as “tablets,” “capsules,” “packets,” or “teaspoonfuls.” (ii) The subheading “Servings Per Container” shall be placed under the subheading “Serving Size” and aligned on the left side of the nutrition label, except that this information need not be provided when it is stated in the net quantity of contents declaration. (2) Information on dietary ingredients that have a Reference Daily Intake (RDI) or a Daily Reference Value (DRV) as established in § 101.9(c) and their subcomponents (hereinafter referred to as “(b)(2)-dietary ingredients”). (i) The (b)(2)-dietary ingredients to be declared, that is, total calories, total fat, saturated fat, trans fat, cholesterol, sodium, total carbohydrate, dietary fiber, total sugars, added sugars, protein, vitamin D, calcium, iron, and potassium, shall be declared when they are present in a dietary supplement in quantitative amounts by weight that exceed the amount that can be declared as zero in nutrition labeling of foods in accordance with § 101.9(c). Calories from saturated fat, polyunsaturated fat, monounsaturated fat, soluble fiber, insoluble fiber, and sugar alcohol may be declared, but they shall be declared when a claim is made about them. Any (b)(2)-dietary ingredients that are not present, or… | |||
| 21:21:2.0.1.1.2.3.1.2 | 21 | Food and Drugs | I | B | 101 | PART 101—FOOD LABELING | C | Subpart C—Specific Nutrition Labeling Requirements and Guidelines | § 101.42 Nutrition labeling of raw fruit, vegetables, and fish. | FDA | (a) The Food and Drug Administration (FDA) urges food retailers to provide nutrition information, as provided in § 101.9(c), for raw fruit, vegetables, and fish at the point-of-purchase. If retailers choose to provide such information, they should do so in a manner that conforms to the guidelines in § 101.45. (b) In § 101.44, FDA has listed the 20 varieties of raw fruit, vegetables, and fish that are most frequently consumed during a year and to which the guidelines apply. (c) FDA has also defined in § 101.43, the circumstances that constitute substantial compliance by food retailers with the guidelines. (d) By May 8, 1993, FDA will issue a report on actions taken by food retailers to provide consumers with nutrition information for raw fruit, vegetables, and fish under the guidelines established in § 101.45. (1) The report will include a determination of whether there is substantial compliance, as defined in § 101.43, with the guidelines. (2) In evaluating substantial compliance, FDA will consider only the 20 varieties of raw fruit, vegetables, and fish most frequently consumed as identified in § 101.44. (e) If FDA finds that there is substantial compliance with the guidelines for the nutrition labeling of raw fruit and vegetables or of fish, the agency will so state in the report, and the guidelines will remain in effect. FDA will reevaluate the market place for substantial compliance every 2 years. (f) If FDA determines that there is not substantial compliance with the guidelines for raw fruit and vegetables or for raw fish, the agency will at that time issue proposed regulations requiring that any person who offers raw fruit and vegetables or fish to consumers provide, in a manner prescribed by regulations, the nutrition information required by § 101.9. Final regulations would have to be issued 6 months after issuance of proposed regulations, and they would become effective 6 months after the date of their promulgation. | ||||
| 21:21:2.0.1.1.2.3.1.3 | 21 | Food and Drugs | I | B | 101 | PART 101—FOOD LABELING | C | Subpart C—Specific Nutrition Labeling Requirements and Guidelines | § 101.43 Substantial compliance of food retailers with the guidelines for the voluntary nutrition labeling of raw fruit, vegetables, and fish. | FDA | [55 FR 60890, Nov. 27, 1991, as amended at 61 FR 42759, Aug. 16, 1996] | (a) The Food and Drug Administration (FDA) will judge a food retailer who sells raw agricultural commodities or raw fish to be in compliance with the guidelines in § 101.45 with respect to raw agricultural commodities if the retailer displays or provides nutrition labeling for at least 90 percent of the raw agricultural commodities listed in § 101.44 that it sells, and with respect to raw fish if the retailer displays or provides nutrition labeling for at least 90 percent of the types of raw fish listed in § 101.44 that it sells. To be in compliance, the nutrition labeling shall: (1) Be presented in the store or other type of establishment in a manner that is consistent with § 101.45(a)(1); (2) Be presented in content and format that are consistent with § 101.45 (a)(2), (a)(3), and (a)(4); and (3) Include data that have been provided by FDA in appendices C and D to part 101 of this chapter, except that the information on potassium is voluntary. (b) To determine whether there is substantial compliance by food retailers with the guidelines in § 101.45 for the voluntary nutrition labeling of raw fruit and vegetables and of raw fish, FDA will select a representative sample of 2,000 stores, allocated by store type and size, for raw fruit and vegetables and for raw fish. (c) FDA will find that there is substantial compliance with the guidelines in § 101.45 if it finds based on paragraph (a) of this section that at least 60 percent of all stores that are evaluated are in compliance. (d) FDA will evaluate substantial compliance separately for raw agricultural commodities and for raw fish. | |||
| 21:21:2.0.1.1.2.3.1.4 | 21 | Food and Drugs | I | B | 101 | PART 101—FOOD LABELING | C | Subpart C—Specific Nutrition Labeling Requirements and Guidelines | § 101.44 What are the 20 most frequently consumed raw fruits, vegetables, and fish in the United States? | FDA | [71 FR 42044, July 25, 2006] | (a) The 20 most frequently consumed raw fruits are: Apple, avocado (California), banana, cantaloupe, grapefruit, grapes, honeydew melon, kiwifruit, lemon, lime, nectarine, orange, peach, pear, pineapple, plums, strawberries, sweet cherries, tangerine, and watermelon. (b) The 20 most frequently consumed raw vegetables are: Asparagus, bell pepper, broccoli, carrot, cauliflower, celery, cucumber, green (snap) beans, green cabbage, green onion, iceberg lettuce, leaf lettuce, mushrooms, onion, potato, radishes, summer squash, sweet corn, sweet potato, and tomato. (c) The 20 most frequently consumed raw fish are: Blue crab, catfish, clams, cod, flounder/sole, haddock, halibut, lobster, ocean perch, orange roughy, oysters, pollock, rainbow trout, rockfish, salmon (Atlantic/coho/Chinook/sockeye, chum/pink), scallops, shrimp, swordfish, tilapia, and tuna. | |||
| 21:21:2.0.1.1.2.3.1.5 | 21 | Food and Drugs | I | B | 101 | PART 101—FOOD LABELING | C | Subpart C—Specific Nutrition Labeling Requirements and Guidelines | § 101.45 Guidelines for the voluntary nutrition labeling of raw fruits, vegetables, and fish. | FDA | [61 FR 42760, Aug. 16, 1996, as amended at 66 FR 56035, Nov. 6, 2001; 71 FR 42044, July 25, 2006; 88 FR 17718, Mar. 24, 2023] | (a) Nutrition labeling for raw fruits, vegetables, and fish listed in § 101.44 should be presented to the public in the following manner: (1) Nutrition labeling information should be displayed at the point of purchase by an appropriate means such as by a label affixed to the food or through labeling including shelf labels, signs, posters, brochures, notebooks, or leaflets that are readily available and in close proximity to the foods. The nutrition labeling information may also be supplemented by a video, live demonstration, or other media. (2) Serving sizes should be determined, and nutrients declared, in accordance with § 101.9 (b) and (c), respectively, except that the nutrition labeling data should be based on the raw edible portion for fruits and vegetables and on the cooked edible portion for fish. The methods used to cook fish should be those that do not add fat, breading, or seasoning (e.g., salt or spices). (3) When nutrition labeling information is provided for more than one raw fruit, vegetable, or fish on signs, posters, brochures, notebooks, or leaflets, it may be presented in charts with horizontal or vertical columns or as a compilation of individual nutrition labels. Nutrition labeling that is presented in a linear display (see § 101.9(j)(13)(ii)(A)( 2 )) will not be considered to be in compliance. The heading “Nutrition Facts” must be in a type size larger than all other print in the nutrition label. The required information (i.e., headings, serving sizes, list of nutrients, quantitative amounts by weight (except for vitamins and minerals), and percent of Daily Values (DV's) (except for sugars and protein) must be clearly presented and of sufficient type size and color contrast to be plainly legible, with numeric values for percent of DV highlighted in contrast to the quantitative amounts by weight and hairlines between all nutrients. (i) Declaration of the number of servings per container need not be included in the nutrition labeling of raw fruits, vegetables, and fish. (ii) Except for the… | |||
| 21:21:2.0.1.1.2.4.1.1 | 21 | Food and Drugs | I | B | 101 | PART 101—FOOD LABELING | D | Subpart D—Specific Requirements for Nutrient Content Claims | § 101.54 Nutrient content claims for “good source,” “high,” “more,” and “high potency.” | FDA | [58 FR 2413, Jan. 6, 1993; 58 FR 17342, Apr. 2, 1993, as amended at 59 FR 394, Jan. 4, 1994; 59 FR 15051, Mar. 31, 1994; 60 FR 17206, Apr. 5, 1995; 61 FR 11731, Mar. 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. 30, 2001] | (a) General requirements. Except as provided in paragraph (e) of this section, a claim about the level of a nutrient in a food in relation to the Reference Daily Intake (RDI) established for that nutrient in § 101.9(c)(8)(iv) or Daily Reference Value (DRV) established for that nutrient in § 101.9(c)(9), (excluding total carbohydrates) may only be made on the label or in labeling of the food if: (1) The claim uses one of the terms defined in this section in accordance with the definition for that term; (2) The claim is made in accordance with the general requirements for nutrient content claims in § 101.13; and (3) The food for which the claim is made is labeled in accordance with § 101.9, § 101.10, or § 101.36, as applicable. (b) “High” claims. (1) The terms “high,” “rich in,” or “excellent source of” may be used on the label and in the labeling of foods, except meal products as defined in § 101.13(l) and main dish products as defined in § 101.13(m), provided that the food contains 20 percent or more of the RDI or the DRV per reference amount customarily consumed. (2) The terms defined in paragraph (b)(1) of this section may be used on the label and in the labeling of meal products as defined in § 101.13(l) and main dish products as defined in § 101.13(m), provided that: (i) The product contains a food that meets the definition of “high” in paragraph (b)(1) of this section; and (ii) The label or labeling clearly identifies the food that is the subject of the claim (e.g., the serving of broccoli in this product is high in vitamin C). (c) “Good Source” claims. (1) The terms “good source,” “contains,” or “provides” may be used on the label and in the labeling of foods, except meal products as defined in § 101.13(l) and main dish products as defined in § 101.13(m), provided that the food contains 10 to 19 percent of the RDI or the DRV per reference amount customarily consumed. (2) The terms defined in paragraph (c)(1) of this section may be used on the label and in the labeling of meal products as defi… | |||
| 21:21:2.0.1.1.2.4.1.2 | 21 | Food and Drugs | I | B | 101 | PART 101—FOOD LABELING | D | Subpart D—Specific Requirements for Nutrient Content Claims | § 101.56 Nutrient content claims for “light” or “lite.” | FDA | [58 FR 2413, Jan. 6, 1993; 58 FR 17342, Apr. 2, 1993, as amended at 60 FR 17206, Apr. 5, 1995] | (a) General requirements. A claim using the term light or lite to describe a food may only be made on the label or in labeling of the food if: (1) The claim uses one of the terms defined in this section in accordance with the definition for that term; (2) The claim is made in accordance with the general requirements for nutrient content claims in § 101.13; and (3) The food is labeled in accordance with § 101.9 or § 101.10, where applicable. (b) “Light” claims. The terms “light” or “lite” may be used on the label or in the labeling of foods, except meal products as defined in § 101.13(l) and main dish products as defined in § 101.13(m), without further qualification, provided that: (1) If the food derives 50 percent or more of its calories from fat, its fat content is reduced by 50 percent or more per reference amount customarily consumed compared to an appropriate reference food as specified in § 101.13(j)(1); or (2) If the food derives less than 50 percent of its calories from fat: (i) The number of calories is reduced by at least one-third (33 1/3 percent) per reference amount customarily consumed compared to an appropriate reference food; or (ii) Its fat content is reduced by 50 percent or more per reference amount customarily consumed compared to the reference food that it resembles or for which it substitutes as specified in § 101.13(j)(1); and (3) As required in § 101.13(j)(2) for relative claims: (i) The identity of the reference food and the percent (or fraction) that the calories and the fat were reduced are declared in immediate proximity to the most prominent such claim, (e.g., “1/3 fewer calories and 50 percent less fat than our regular cheese cake”); (ii) Quantitative information comparing the level of calories and fat content in the product per labeled serving size with that of the reference food that it replaces (e.g., “lite cheesecake—200 calories, 4 grams (g) fat per serving; regular cheesecake—300 calories, 8 g fat per serving”) is declared adjacent to the most prominent cla… | |||
| 21:21:2.0.1.1.2.4.1.3 | 21 | Food and Drugs | I | B | 101 | PART 101—FOOD LABELING | D | Subpart D—Specific Requirements for Nutrient Content Claims | § 101.60 Nutrient content claims for the calorie content of foods. | FDA | [58 FR 2413, Jan. 6, 1993; 58 FR 17342, Apr. 2, 1993, as amended at 58 FR 44031, Aug. 18, 1993; 59 FR 394, Jan. 4, 1994; 60 FR 17206, Apr. 5, 1995; 62 FR 15342, Mar. 31, 1997; 62 FR 49881, Sept. 23, 1997] | (a) General requirements. A claim about the calorie or sugar content of a food may only be made on the label or in the labeling of a food if: (1) The claim uses one of the terms defined in this section in accordance with the definition for that term; (2) The claim is made in accordance with the general requirements for nutrient content claims in § 101.13; (3) The food for which the claim is made is labeled in accordance with § 101.9, § 101.10, or § 101.36, as applicable; and (4) For dietary supplements, claims regarding calories 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 except when an equivalent amount of a similar dietary supplement (e.g., another protein supplement) that the labeled food resembles and for which it substitutes, normally exceeds the definition for “low calorie” in § 101.60(b)(2). (b) Calorie content claims. (1) The terms “calorie free,” “free of calories,” “no calories,” “zero calories,” “without calories,” “trivial source of calories,” “negligible source of calories,” or “dietarily insignificant source of calories” may be used on the label or in the labeling of foods, provided that: (i) The food contains less than 5 calories per reference amount customarily consumed and per labeled serving. (ii) As required in § 101.13(e)(2), if the food meets this condition without the benefit of special processing, alteration, formulation, or reformulation to lower the caloric content, it is labeled to disclose that calories are not usually present in the food (e.g., “cider vinegar, a calorie free food”). (2) The terms “low calorie,” “few calories,” “contains a small amount of calories,” “low source of calories,” or “low in calories” may be used on the label or in labeling of foods, except meal products as defined in § 101.13(l) and main dish products as defined in § 101.13(m), provided that: (i)(A) The food has a reference amount customarily consumed greater than 30 grams (g) or greater than 2 tablespoons and does not… | |||
| 21:21:2.0.1.1.2.4.1.4 | 21 | Food and Drugs | I | B | 101 | PART 101—FOOD LABELING | D | Subpart D—Specific Requirements for Nutrient Content Claims | § 101.61 Nutrient content claims for the sodium content of foods. | FDA | [58 FR 2413, Jan. 6, 1993; 58 FR 17342, Apr. 2, 1993, as amended at 58 FR 44032, Aug. 18, 1993; 59 FR 394, Jan. 4, 1994; 60 FR 17206, Apr. 5, 1995] | (a) General requirements. 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 claim uses one of the terms defined in this section in accordance with the definition for that term; (2) The claim is made in accordance with the general requirements for nutrient content claims in § 101.13; and (3) The food for which the claim is made is labeled in accordance with § 101.9, § 101.10, or § 101.36, as applicable. (b) Sodium content claims. (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 (iii) As required in § 101.13(e)(2) if the food meets these conditions without the benefit of special processing, alteration, formulation, or reformulation to lower the sodium content, it is labeled to disclose that sodium is not usually present in the food (e.g., “leaf lettuce, a sodium free food”). (2) The terms “very low sodium,” or “very low in sodium,” may be used on the label or in labeling of foods, except meal products as defined in § 101.13(l) and main dish products as defined in § 101.13(m), provided that: (i)(A) The food has a reference amount customarily consumed greater than 30 grams (g) or g… | |||
| 21:21:2.0.1.1.2.4.1.5 | 21 | Food and Drugs | I | B | 101 | PART 101—FOOD LABELING | D | Subpart D—Specific Requirements for Nutrient Content Claims | § 101.62 Nutrient content claims for fat, fatty acid, and cholesterol content of foods. | FDA | [58 FR 2413, Jan. 6, 1993; 58 FR 17342, 17343, Apr. 2, 1993, as amended at 58 FR 44032, Aug. 18, 1993; 58 FR 60105, Nov. 15, 1993; 59 FR 394, Jan. 4, 1994; 60 FR 17207, Apr. 5, 1995; 61 FR 59001, Nov. 20, 1996; 63 FR 26980, May 15, 1998; 72 FR 1459, Jan. 12, 2007] | (a) General requirements. 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: (1) The claim uses one of the terms defined in this section in accordance with the definition for that term; (2) The claim is made in accordance with the general requirements for nutrient content claims in § 101.13; (3) The food for which the claim is made is labeled in accordance with § 101.9, § 101.10, or § 101.36, as applicable; and (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. (b) Fat content claims. (1) The terms “fat free,” “free of fat,” “no fat,” “zero fat,” “without fat,” “negligible source of fat,” or “dietarily insignificant source of fat” or, in the case of milk products, “skim” may be used on the label or in labeling of foods, provided that: (i) The food contains less than 0.5 gram (g) of fat per reference amount customarily consumed and per labeled serving or, in the case of a meal product or main dish product, less than 0.5 g of fat per labeled serving; and (ii) The food contains no added ingredient that is a fat or is generally understood by consumers to contain fat 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 fat,” “adds a negligible amount of fat,” or “adds a dietarily insignificant amount of fat;” and (iii) As required in § 101.13(e)(2), if the food meets these conditions without the benefit of special processing, alteration, formulation, or reformulation to lower fat content, it is labeled to disclose that fat is not usually present in the food (e.g., “broccoli, a fat free food”). (2) The terms “low fat,” “low in fat,” “contains a small amount of fat,” “low source of fat,” or “little fat” may be used on the label or in labeling of f… | |||
| 21:21:2.0.1.1.2.4.1.6 | 21 | Food and Drugs | I | B | 101 | PART 101—FOOD LABELING | D | Subpart D—Specific Requirements for Nutrient Content Claims | § 101.65 Implied nutrient content claims and related label statements. | FDA | [58 FR 2413, Jan. 6, 1993; 58 FR 17343, Apr. 2, 1993, as amended at 59 FR 394, Jan. 4, 1994; 59 FR 24249, May 10, 1994; 59 FR 50828, Oct. 6, 1994; 62 FR 49858, Sept. 23, 1997; 63 FR 14355, Mar. 25, 1998; 70 FR 56848, Sept. 29, 2005; 89 FR 106162, Dec. 27, 2024] | (a) General requirements. An implied nutrient content claim can only be made on the label and in labeling of the food if: (1) The claim uses one of the terms described in this section in accordance with the definition for that term; (2) The claim is made in accordance with the general requirements for nutrient content claims in § 101.13, with the exception of § 101.13(h) when the nutrient content claim is made in accordance with paragraph (d) of this section; and (3) The food for which the claim is made is labeled in accordance with § 101.9, § 101.10, or § 101.36, as applicable. (b) Label statements that are not implied claims. Certain label statements about the nature of a product are not nutrient content claims unless such statements are made in a context that would make them an implied claim under § 101.13(b)(2). The following types of label statements are generally not implied nutrient content claims and, as such, are not subject to the requirements of § 101.13 and this section: (1) A claim that a specific ingredient or food component is absent from a product, provided that the purpose of such claim is to facilitate avoidance of the substances because of food allergies (see § 105.62 of this chapter), food intolerance, religious beliefs, or dietary practices such as vegetarianism or other nonnutrition related reason, e.g., “100 percent milk free;” (2) A claim about a substance that is nonnutritive or that does not have a nutritive function, e.g., “contains no preservatives,” “no artificial colors;” (3) A claim about the presence of an ingredient that is perceived to add value to the product, e.g., “made with real butter,” “made with whole fruit,” or “contains honey,” except that claims about the presence of ingredients other than vitamins or minerals or that are represented as a source of vitamins and minerals are not allowed on labels or in labeling of dietary supplements of vitamins and minerals that are not in conventional food form. (4) A statement of identity for a food in which an ingredient … | |||
| 21:21:2.0.1.1.2.4.1.7 | 21 | Food and Drugs | I | B | 101 | PART 101—FOOD LABELING | D | Subpart D—Specific Requirements for Nutrient Content Claims | § 101.67 Use of nutrient content claims for butter. | FDA | [58 FR 2455, Jan. 6, 1993] | (a) Claims may be made to characterize the level of nutrients, including fat, in butter if: (1) The claim complies with the requirements of § 101.13 and with the requirements of the regulations in this subpart that define the particular nutrient content claim that is used and how it is to be presented. In determining whether a claim is appropriate, the calculation of the percent fat reduction in milkfat shall be based on the 80 percent milkfat requirement provided by the statutory standard for butter (21 U.S.C. 321a); (2) The product contains cream or milk, including milk constituents (including, but not limited to, whey, casein, modified whey, and salts of casein), or both, with or without added salt, with or without safe and suitable colorings, with or without nutrients added to comply with paragraph (a)(3) of this section, and with or without safe and suitable bacterial cultures. The product may contain safe and suitable ingredients to improve texture, prevent syneresis, add flavor, extend shelf life, improve appearance, and add sweetness. The product may contain water to replace milkfat although the amount of water in the product shall be less than the amount of cream, milk, or milk constituents; (3) The product is not nutritionally inferior, as defined in § 101.3(e)(4), to butter as produced under 21 U.S.C. 321a; and (4) If the product would violate 21 U.S.C. 321a but for the nutrient content claim that characterizes the level of nutrients, that claim shall be an explicit claim that is included as part of the common or usual name of the product. (b) Deviations from the ingredient provisions of 21 U.S.C. 321a must be the minimum necessary to achieve similar performance characteristics as butter as produced under 21 U.S.C. 321a, or the food will be deemed to be adulterated under section 402(b) of the act. The performance characteristics (e.g., physical properties, organoleptic characteristics, functional properties, shelf life) of the product shall be similar to butter as produced under 21 U.S.C. 321a. If… | |||
| 21:21:2.0.1.1.2.4.1.8 | 21 | Food and Drugs | I | B | 101 | PART 101—FOOD LABELING | D | Subpart D—Specific Requirements for Nutrient Content Claims | § 101.69 Petitions for nutrient content claims. | FDA | [58 FR 2413, Jan. 6, 1993; 58 FR 17343, Apr. 2, 1993, as amended at 58 FR 44033, Aug. 18, 1993; 62 FR 40598, July 29, 1997; 63 FR 26718, May 14, 1998; 63 FR 40024, July 27, 1998; 67 FR 9585, Mar. 4, 2002; 69 FR 16481, Mar. 30, 2004] | (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 (2) That are not exempted under section 403(r)(5)(A) through (r)(5)(C) of the act from the requirements for such claims in section 403(r)(2). (b) Petitions included in this section are: (1) Petitions for a new (heretofore unauthorized) nutrient content claim; (2) Petitions for a synonymous term (i.e., one that is consistent with a term defined by regulation) for characterizing the level of a nutrient; and (3) Petitions for the use of an implied claim in a brand name. (c) An original and one copy of the petition to be filed under the provisions of section 403(r)(4) of the act shall be submitted, or the petitioner may submit an original and a computer readable disk containing the petition. Contents of the disk should be in a standard format, such as ASCII format. Petitioners interested in submitting a disk should contact the Food and Drug Administration's (FDA) Center for Food Safety and Applied Nutrition for details. If any part of the material submitted is in a foreign language, it shall be accompanied by an accurate and complete English translation. The petition shall state the petitioner's post office address to which published notices as required by section 403 of the act may be sent. (d) Pertinent information may be incorporated in, and will be considered as part of, a petition on the basis of specific reference to such information submitted to and retained in the files of FDA. However, any reference to unpublished information furnished by a person other than the applicant will not be considered unless use of such information is authorized (with the understanding that such information may in whole or part be subject to release to the public) in a written statement signed by the person who submitted it. Any reference to publis… | |||
| 21:21:2.0.1.1.2.5.1.1 | 21 | Food and Drugs | I | B | 101 | PART 101—FOOD LABELING | E | § 101.70 Petitions for health claims. | FDA | [58 FR 2534, Jan. 6, 1993; 58 FR 17097, Apr. 1, 1993, as amended at 59 FR 425, Jan. 4, 1994; 62 FR 28232, May 22, 1997; 62 FR 40599, July 29, 1997; 63 FR 26719, May 14, 1998; 63 FR 40024, July 27, 1998; 66 FR 56035, Nov. 6, 2001] | (a) Any interested person may petition the Food and Drug Administration (FDA) to issue a regulation regarding a health claim. An original and one copy of the petition shall be submitted, or the petitioner may submit an original and a computer readable disk containing the petition. Contents of the disk should be in a standard format, such as ASCII format. (Petitioners interested in submitting a disk should contact the Center for Food Safety and Applied Nutrition for details.) If any part of the material submitted is in a foreign language, it shall be accompanied by an accurate and complete English translation. The petition shall state the petitioner's post office address to which any correspondence required by section 403 of the Federal Food, Drug, and Cosmetic Act may be sent. (b) Pertinent information may be incorporated in, and will be considered as part of, a petition on the basis of specific reference to such information submitted to and retained in the files of FDA. Such information may include any findings, along with the basis of the findings, of an outside panel with expertise in the subject area. Any reference to published information shall be accompanied by reprints, or easily readable copies of such information. (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. (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… | ||||
| 21:21:2.0.1.1.2.5.1.10 | 21 | Food and Drugs | I | B | 101 | PART 101—FOOD LABELING | E | § 101.79 Health claims: Folate and neural tube defects. | FDA | [61 FR 8779, Mar. 5, 1996; 61 FR 48529, Sept. 13, 1996, as amended at 65 FR 58918, Oct. 3, 2000] | (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. (2) Relationship. The available data show that diets adequate in folate may reduce the risk of neural tube defects. The strongest evidence for this relationship comes from an intervention study by the Medical Research Council of the United Kingdom that showed that women at risk of recurrence of a neural tube defect pregnancy who consumed a supplement containing 4 milligrams (mg)(4,000 micrograms (mcg)) folic acid daily before conception and continuing into early pregnancy had a reduced risk of having a child with a neural tube defect. (Products containing this level of folic acid are drugs). In addition, based on its review of a Hungarian intervention trial that reported periconceptional use of a multivitamin and multimineral preparation containing 800 mcg (0.8 mg) of folic acid, and its review of the observational studies that reported periconceptional use of multivitamins containing 0 to 1,000 mcg of folic acid, the Food and Drug Administration concluded that most of these studies had results consistent with the conclusion that folate, at levels attainable in usual diets, may reduce the risk of neural tube defects. (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 … | ||||
| 21:21:2.0.1.1.2.5.1.11 | 21 | Food and Drugs | I | B | 101 | PART 101—FOOD LABELING | E | § 101.80 Health claims: dietary noncariogenic carbohydrate sweeteners and dental caries. | FDA | [61 FR 43446, Aug. 23, 1996, as amended at 62 FR 63655, Dec. 2, 1997; 66 FR 66742, Dec. 27, 2001; 67 FR 71470, Dec. 2, 2002; 71 FR 15563, Mar. 29, 2006; 72 FR 52789, Sept. 17, 2007; 81 FR 5590, Feb. 3, 2016; 88 FR 17718, Mar. 24, 2023] | (a) Relationship between dietary carbohydrates and dental caries. (1) Dental caries, or tooth decay, is a disease caused by many factors. Both environmental and genetic factors can affect the development of dental caries. Risk factors include tooth enamel crystal structure and mineral content, plaque quantity and quality, saliva quantity and quality, individual immune response, types and physical characteristics of foods consumed, eating behaviors, presence of acid producing oral bacteria, and cultural influences. (2) The relationship between consumption of fermentable carbohydrates, i.e., dietary sugars and starches, and tooth decay is well established. Sucrose, also known as sugar, is one of the most, but not the only, cariogenic sugars in the diet. Bacteria found in the mouth are able to metabolize most dietary carbohydrates, producing acid and forming dental plaque. The more frequent and longer the exposure of teeth to dietary sugars and starches, the greater the risk for tooth decay. (3) Dental caries continues to affect a large proportion of Americans. Although there has been a decline in the prevalence of dental caries among children in the United States, the disease remains widespread throughout the population, imposing a substantial burden on Americans. Recent Federal government dietary guidelines recommend that Americans choose diets that are moderate in sugars and avoid excessive snacking. Frequent between-meal snacks that are high in sugars and starches may be more harmful to teeth than eating such foods at meals and then brushing. (4) Noncariogenic carbohydrate sweeteners, such as sugar alcohols, can be used to replace dietary sugars, such as sucrose and corn sweeteners, in foods such as chewing gums and certain confectioneries. Noncariogenic carbohydrate sweeteners are significantly less cariogenic than dietary sugars and other fermentable carbohydrates. (b) Significance of the relationship between noncariogenic carbohydrate sweeteners and dental caries. Noncariogenic carbohydrate sweeteners… | ||||
| 21:21:2.0.1.1.2.5.1.12 | 21 | Food and Drugs | I | B | 101 | PART 101—FOOD LABELING | E | § 101.81 Health claims: Soluble fiber from certain foods and risk of coronary heart disease (CHD). | FDA | [62 FR 3600, Jan. 23, 1997, as amended at 62 FR 15344, Mar. 31, 1997; 63 FR 8119, Feb. 18, 1998; 66 FR 66742, Dec. 27, 2001; 67 FR 61782, Oct. 2, 2002; 68 FR 15355, Mar. 31, 2003; 70 FR 40880, July 15, 2005; 70 FR 76162, Dec. 23, 2005; 73 FR 9947, Feb. 25, 2008; 73 FR 23953, May 1, 2008; 81 FR 5590, Feb. 3, 2016; 88 FR 17718, Mar. 24, 2023] | (a) Relationship between diets that are low in saturated fat and cholesterol and that include soluble fiber from certain foods and the risk of CHD. (1) Cardiovascular disease means diseases of the heart and circulatory system. Coronary heart disease (CHD) is one of the most common and serious forms of cardiovascular disease and refers to diseases of the heart muscle and supporting blood vessels. High blood total cholesterol and low density lipoprotein (LDL)-cholesterol levels are associated with increased risk of developing coronary heart disease. High CHD rates occur among people with high total cholesterol levels of 240 milligrams per deciliter (mg/dL) (6.21 (mmol/L)) or above and LDL-cholesterol levels of 160 mg/dL (4.13 mmol/L) or above. Borderline high risk total cholesterol levels range from 200 to 239 mg/dL (5.17 to 6.18 mmol/L) and 130 to 159 mg/dL (3.36 to 4.11 mmol/L) of LDL-cholesterol. The scientific evidence establishes that diets high in saturated fat and cholesterol are associated with increased levels of blood total- and LDL-cholesterol and, thus, with increased risk of CHD. (2) Populations with a low incidence of CHD tend to have relatively low blood total cholesterol and LDL-cholesterol levels. These populations also tend to have dietary patterns that are not only low in total fat, especially saturated fat and cholesterol, but are also relatively high in fiber-containing fruits, vegetables, and grain products, such as whole oat products. (3) Scientific evidence demonstrates that diets low in saturated fat and cholesterol may reduce the risk of CHD. Other evidence demonstrates that the addition of soluble fiber from certain foods to a diet that is low in saturated fat and cholesterol may also help to reduce the risk of CHD. (b) Significance of the relationship between diets that are low in saturated fat and cholesterol and that include soluble fiber from certain foods and the risk of CHD. (1) CHD is a major public health concern in the United States. It accounts for more deaths than any ot… | ||||
| 21:21:2.0.1.1.2.5.1.13 | 21 | Food and Drugs | I | B | 101 | PART 101—FOOD LABELING | E | § 101.82 Health claims: Soy protein and risk of coronary heart disease (CHD). | FDA | [64 FR 57732, Oct. 26, 1999] | (a) Relationship between diets that are low in saturated fat and cholesterol and that include soy protein and the risk of CHD. (1) Cardiovascular disease means diseases of the heart and circulatory system. CHD is one of the most common and serious forms of cardiovascular disease and refers to diseases of the heart muscle and supporting blood vessels. High blood total cholesterol and low density lipoprotein (LDL)-cholesterol levels are associated with increased risk of developing CHD. 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. Borderline high risk total cholesterol levels range from 200 to 239 mg/dL (5.17 to 6.18 mmol/L) and 130 to 159 mg/dL (3.36 to 4.11 mmol/L) of LDL-cholesterol. The scientific evidence establishes that diets high in saturated fat and cholesterol are associated with increased levels of blood total and LDL-cholesterol and, thus, with increased risk of CHD. (2) Populations with a low incidence of CHD tend to have relatively low blood total cholesterol and LDL-cholesterol levels. These populations also tend to have dietary patterns that are not only low in total fat, especially saturated fat and cholesterol, but are also relatively high in plant foods that contain dietary fiber and other components. (3) Scientific evidence demonstrates that diets low in saturated fat and cholesterol may reduce the risk of CHD. Other evidence demonstrates that the addition of soy protein to a diet that is low in saturated fat and cholesterol may also help to reduce the risk of CHD. (b) Significance of the relationship between diets that are low in saturated fat and cholesterol and that include soy protein and the risk of CHD. (1) CHD is a major public health concern in the United States. It accounts for more deaths than any other disease or group of diseases. Early management of risk factors for CHD is a major public health goal that ca… | ||||
| 21:21:2.0.1.1.2.5.1.14 | 21 | Food and Drugs | I | B | 101 | PART 101—FOOD LABELING | E | § 101.83 Health claims: plant sterol/stanol esters and risk of coronary heart disease (CHD). | FDA | [65 FR 54717, Sept. 8, 2000; 65 FR 70466, Nov. 24, 2000, as amended at 66 FR 66742, Dec. 27, 2001; 68 FR 15355, Mar. 31, 2003; 70 FR 41958, July 21, 2005; 88 FR 17718, Mar. 24, 2023] | (a) Relationship between diets that include plant sterol/stanol esters and the risk of CHD. (1) Cardiovascular disease means diseases of the heart and circulatory system. Coronary heart disease (CHD) is one of the most common and serious forms of cardiovascular disease and refers to diseases of the heart muscle and supporting blood vessels. High blood total cholesterol and low density lipoprotein (LDL) cholesterol levels are associated with increased risk of developing coronary heart disease. 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. Borderline high risk blood cholesterol levels range from 200 to 239 mg/dL (5.17 to 6.18 mmol/l) for total cholesterol, and 130 to 159 mg/dL (3.36 to 4.11 mmol/l) of LDL cholesterol. (2) Populations with a low incidence of CHD tend to have relatively low blood total cholesterol and LDL cholesterol levels. These populations also tend to have dietary patterns that are not only low in total fat, especially saturated fat and cholesterol, but are also relatively high in plant foods that contain dietary fiber and other components. (3) Scientific evidence demonstrates that diets that include plant sterol/stanol esters may reduce the risk of CHD. (b) Significance of the relationship between diets that include plant sterol/stanol esters and the risk of CHD. (1) CHD is a major public health concern in the United States. It accounts for more deaths than any other disease or group of diseases. Early management of risk factors for CHD is a major public health goal that can assist in reducing risk of CHD. High blood total and LDL cholesterol are major modifiable risk factors in the development of CHD. (2) The scientific evidence establishes that including plant sterol/stanol esters in the diet helps to lower blood total and LDL cholesterol levels. (c) Requirements —(1) General. All requirements set forth in § 101.… | ||||
| 21:21:2.0.1.1.2.5.1.2 | 21 | Food and Drugs | I | B | 101 | PART 101—FOOD LABELING | E | § 101.71 Health claims: claims not authorized. | FDA | [58 FR 2534, Jan. 6, 1993, as amended at 58 FR 2548, 2578, 2620, 2639, 2664, 2714, Jan. 6, 1993; 58 FR 17100, Apr. 1, 1993; 59 FR 437, Jan. 4, 1994; 65 FR 58918, Oct. 3, 2000] | Health claims not authorized for foods in conventional food form or for dietary supplements of vitamins, minerals, herbs, or other similar substances: (a) Dietary fiber and cardiovascular disease. (b) Zinc and immune function in the elderly. | ||||
| 21:21:2.0.1.1.2.5.1.3 | 21 | Food and Drugs | I | B | 101 | PART 101—FOOD LABELING | E | § 101.72 Health claims: calcium, vitamin D, and osteoporosis. | FDA | [73 FR 56486, Sept. 29, 2008] | (a) Relationship between calcium, vitamin D, and osteoporosis. 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. Peak bone mass is the total quantity of bone present at maturity, and experts believe that it has the greatest bearing on whether a person will be at risk of developing osteoporosis and related bone fractures later in life. Another factor that influences total bone mass and susceptibility to osteoporosis is the rate of bone loss after skeletal maturity. Vitamin D is required for normal absorption of calcium and to prevent the occurrence of high serum parathyroid hormone (PTH) concentration, which stimulates mobilization of calcium from the skeleton and can lower bone mass. Calcium, along with vitamin D and several other nutrients, is required for normal bone mineralization. While vitamin D is required for optimal bone mineralization, it is more effective when calcium intake is adequate. An adequate intake of calcium and vitamin D is thought to exert a positive effect during adolescence and early adulthood in optimizing the amount of bone that is laid down. However, the upper limit of peak bone mass is genetically determined. The mechanism through which adequate intakes of calcium and vitamin D and optimal peak bone mass reduce the risk of osteoporosis is thought to be as follows. All persons lose bone with age. Hence, those with higher bone mass at maturity take longer to reach the critically reduced mass at which bones can fracture easily. The rate of bone loss after skeletal maturity also influences the amount of bone present at old age and can influence an individual's risk of developing osteoporosis. Maintenance of adequate intakes of calcium and vitamin D later in life is thought to be important in reducing the rate of bone loss particularly in the elderly and in women during the first decade following menopause, but a significant protective effect is also seen amon… | ||||
| 21:21:2.0.1.1.2.5.1.4 | 21 | Food and Drugs | I | B | 101 | PART 101—FOOD LABELING | E | § 101.73 Health claims: dietary lipids and cancer. | FDA | [58 FR 2801, Jan. 6, 1993; 58 FR 17343, Apr. 2, 1993] | (a) Relationship between fat and cancer. (1) Cancer is a constellation of more than 100 different diseases, each characterized by the uncontrolled growth and spread of abnormal cells. Cancer has many causes and stages in its development. Both genetic and environmental risk factors may affect the risk of cancer. Risk factors include a family history of a specific type of cancer, cigarette smoking, alcohol consumption, overweight and obesity, ultraviolet or ionizing radiation, exposure to cancer-causing chemicals, and dietary factors. (2) Among dietary factors, the strongest positive association has been found between total fat intake and risk of some types of cancer. Based on the totality of the publicly available scientific evidence, there is significant scientific agreement among experts, qualified by training and experience to evaluate such evidence, that diets high in total fat are associated with an increased cancer risk. Research to date, although not conclusive, demonstrates that the total amount of fats, rather than any specific type of fat, is positively associated with cancer risk. The mechanism by which total fat affects cancer has not yet been established. (3) A question that has been the subject of considerable research is whether the effect of fat on cancer is site-specific. Neither human nor animal studies are consistent in the association of fat intake with specific cancer sites. (4) Another question that has been raised is whether the association of total fat intake to cancer risk is independently associated with energy intakes, or whether the association of fat with cancer risk is the result of the higher energy (caloric) intake normally associated with high fat intake. FDA has concluded that evidence from both animal and human studies indicates that total fat intake alone, independent of energy intake, is associated with cancer risk. (b) Significance of the relationship between fat intake and risk of cancer. (1) Cancer is ranked as a leading cause of death in the United States. The overa… | ||||
| 21:21:2.0.1.1.2.5.1.5 | 21 | Food and Drugs | I | B | 101 | PART 101—FOOD LABELING | E | § 101.74 Health claims: sodium and hypertension. | FDA | [58 FR 2836, Jan. 6, 1993; 58 FR 17100, Apr. 1, 1993] | (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) The scientific evidence establishes that diets high in sodium are associated with a high prevalence of hypertension or high blood pressure and with increases in blood pressure with age, and that diets low in sodium are associated with a low prevalence of hypertension or high blood pressure and with a low or no increase of blood pressure with age. (b) Significance of sodium in relation to high blood pressure. (1) High blood pressure is a public health concern primarily because it is a major risk factor for mortality from coronary heart disease and stroke. Early management of high blood pressure is a major public health goal that can assist in reducing mortality associated with coronary heart disease and stroke. There is a continuum of mortality risk that increases as blood pressures rise. Individuals with high blood pressure are at greatest risk, and individuals with moderately high, high normal, and normal blood pressure are at steadily decreasing risk. The scientific evidence indicates that reducing sodium intake lowers blood pressure and associated risks in many but not all hypertensive individuals. There is also evidence that reducing sodium intake lowers blood pressure and associated risks in many but not all normotensive individuals as well. (2) The populations at greatest risk for high blood pressure, and those most likely to benefit from sodium reduction, include those with family histories of high blood pressure, the elderly, males because they devel… | ||||
| 21:21:2.0.1.1.2.5.1.6 | 21 | Food and Drugs | I | B | 101 | PART 101—FOOD LABELING | E | § 101.75 Health claims: dietary saturated fat and cholesterol and risk of coronary heart disease. | FDA | [58 FR 2757, Jan. 6, 1993, as amended at 81 FR 91722, Dec. 19, 2016] | (a) Relationship between dietary saturated fat and cholesterol and risk of coronary heart disease. (1) Cardiovascular disease means diseases of the heart and circulatory system. Coronary heart disease is the most common and serious form of cardiovascular disease and refers to diseases of the heart muscle and supporting blood vessels. High blood total- and low density lipoprotein (LDL)- cholesterol levels are major modifiable risk factors in the development of coronary heart disease. High coronary heart disease rates occur among people with high blood cholesterol levels of 240 milligrams/decaliter (mg/dL) (6.21 millimoles per liter (mmol/L)) or above and LDL-cholesterol levels of 160 mg/dL (4.13 mmol/L) or above. Borderline high risk blood cholesterol levels range from 200 to 239 mg/dL (5.17 to 6.18 mmol/L) and 130 to 159 mg/dL (3.36 to 4.11 mmol/L) of LDL-cholesterol. Dietary lipids (fats) include fatty acids and cholesterol. Total fat, commonly referred to as fat, is composed of saturated fat (fatty acids containing no double bonds), and monounsaturated and polyunsaturated fat (fatty acids containing one or more double bonds). (2) The scientific evidence establishes that diets high in saturated fat and cholesterol are associated with increased levels of blood total- and LDL-cholesterol and, thus, with increased risk of coronary heart disease. Diets low in saturated fat and cholesterol are associated with decreased levels of blood total- and LDL-cholesterol, and thus, with decreased risk of developing coronary heart disease. (b) Significance of the relationship between dietary saturated fat and cholesterol and risk of coronary heart disease. (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. 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. There is a continuum of mortality risk from coron… | ||||
| 21:21:2.0.1.1.2.5.1.7 | 21 | Food and Drugs | I | B | 101 | PART 101—FOOD LABELING | E | § 101.76 Health claims: fiber-containing grain products, fruits, and vegetables and cancer. | FDA | [58 FR 2548, Jan. 6, 1993] | (a) Relationship between diets low in fat and high in fiber-containing grain products, fruits, and vegetables and cancer risk. (1) Cancer is a constellation of more than 100 different diseases, each characterized by the uncontrolled growth and spread of abnormal cells. Cancer has many causes and stages in its development. Both genetic and environmental risk factors may affect the risk of cancer. Risk factors include: A family history of a specific type of cancer, cigarette smoking, overweight and obesity, alcohol consumption, ultraviolet or ionizing radiation, exposure to cancer-causing chemicals, and dietary factors. (2) The scientific evidence establishes that diets low in fat and high in fiber-containing grain products, fruits, and vegetables are associated with a reduced risk of some types of cancer. Although the specific role of total dietary fiber, fiber components, and the multiple nutrients and other substances contained in these foods are not yet fully understood, many studies have shown that diets low in fat and high in fiber-containing foods are associated with reduced risk of some types of cancer. (b) Significance of the relationship between consumption of diets low in fat and high in fiber-containing grain products, fruits, and vegetables and risk of cancer. (1) Cancer is ranked as a leading cause of death in the United States. The overall economic costs of cancer, including direct health care costs and losses due to morbidity and mortality, are very high. (2) U.S. diets tend to be high in fat and low in grain products, fruits, and vegetables. Studies in various parts of the world indicate that populations who habitually consume a diet high in plant foods have lower risks of some cancers. These diets generally are low in fat and rich in many nutrients, including, but not limited to, dietary fiber. Current dietary guidelines from Federal government agencies and nationally recognized health professional organizations recommend decreased consumption of fats (less than 30 percent of calories), mai… | ||||
| 21:21:2.0.1.1.2.5.1.8 | 21 | Food and Drugs | I | B | 101 | PART 101—FOOD LABELING | E | § 101.77 Health claims: fruits, vegetables, and grain products that contain fiber, particularly soluble fiber, and risk of coronary heart disease. | FDA | [58 FR 2578, Jan. 6, 1993] | (a) Relationship between diets low in saturated fat and cholesterol and high in fruits, vegetables, and grain products that contain fiber, particularly soluble fiber, and risk of coronary heart disease. (1) Cardiovascular disease means diseases of the heart and circulatory system. Coronary heart disease is the most common and serious form of cardiovascular disease and refers to diseases of the heart muscle and supporting blood vessels. High blood total- and low density lipoprotein (LDL)- cholesterol levels are major modifiable risk factors in the development of coronary heart disease. High coronary heart disease rates occur among people with high blood cholesterol levels of 240 milligrams per deciliter (mg/dL) (6.21 (mmol/L)) or above and LDL-cholesterol levels of 160 mg/dL (4.13 mmol/L) or above. Borderline high risk blood cholesterol levels range from 200 to 239 mg/dL (5.17 to 6.18 mmol/L) and 130 to 159 mg/dL (3.36 to 4.11 mmol/L) of LDL-cholesterol. Dietary lipids (fats) include fatty acids and cholesterol. Total fat, commonly referred to as fat, is composed of saturated fat (fatty acids containing no double bonds), and monounsaturated and polyunsaturated fat (fatty acids containing one or more double bonds). (2) The scientific evidence establishes that diets high in saturated fat and cholesterol are associated with increased levels of blood total- and LDL-cholesterol and, thus, with increased risk of coronary heart disease. Diets low in saturated fat and cholesterol are associated with decreased levels of blood total- and LDL-cholesterol, and thus, with decreased risk of developing coronary heart disease. (3) Populations with relatively low blood cholesterol levels tend to have dietary patterns that are not only low in total fat, especially saturated fat and cholesterol, but are also relatively high in fruits, vegetables, and grain products. Although the specific roles of these plant foods are not yet fully understood, many studies have shown that diets high in plant foods are associated with reduced ris… | ||||
| 21:21:2.0.1.1.2.5.1.9 | 21 | Food and Drugs | I | B | 101 | PART 101—FOOD LABELING | E | § 101.78 Health claims: fruits and vegetables and cancer. | FDA | [58 FR 2639, Jan. 6, 1993] | (a) Relationship between substances in diets low in fat and high in fruits and vegetables and cancer risk. (1) Cancer is a constellation of more than 100 different diseases, each characterized by the uncontrolled growth and spread of abnormal cells. Cancer has many causes and stages in its development. Both genetic and environmental risk factors may affect the risk of cancer. Risk factors include a family history of a specific type of cancer, cigarette smoking, alcohol consumption, overweight and obesity, ultraviolet or ionizing radiation, exposure to cancer-causing chemicals, and dietary factors. (2) 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. These studies correlate diets rich in fruits and vegetables and nutrients from these diets, such as vitamin C, vitamin A, and dietary fiber, with reduced cancer risk. Persons consuming these diets frequently have high intakes of these nutrients. Currently, there is not scientific agreement as to whether the observed protective effects of fruits and vegetables against cancer are due to a combination of the nutrient components of diets rich in fruits and vegetables, including but not necessarily limited to dietary fiber, vitamin A (as beta-carotene) and vitamin C, to displacement of fat from such diets, or to intakes of other substances in these foods which are not nutrients but may be protective against cancer risk. (b) Significance of the relationship between consumption of diets low in fat and high in fruits and vegetables and risk of cancer. (1) Cancer is ranked as a leading cause of death in the United States. The overall economic costs of cancer, including direct health care costs and losses due to morbidity and mortality, are very high. (2) U.S. diets tend to be high in fat and low in fruits and vegetables. Studies in various parts of the world indicate that populations who hab… | ||||
| 21:21:2.0.1.1.2.6.1.1 | 21 | Food and Drugs | I | B | 101 | PART 101—FOOD LABELING | F | Subpart F—Specific Requirements for Descriptive Claims That Are Neither Nutrient Content Claims nor Health Claims | § 101.91 Gluten-free labeling of food. | FDA | [78 FR 47178, Aug. 5, 2013, as amended at 85 FR 49260, Aug. 13, 2020] | (a) Definitions. (1) The term “gluten-containing grain” means any one of the following grains or their crossbred hybrids (e.g., triticale, which is a cross between wheat and rye): (i) Wheat, including any species belonging to the genus Triticum; (ii) Rye, including any species belonging to the genus Secale; or (iii) Barley, including any species belonging to the genus Hordeum. (2) The term “gluten” means the proteins that naturally occur in a gluten-containing grain and that may cause adverse health effects in persons with celiac disease (e.g., prolamins and glutelins). (3) The labeling claim “gluten-free” means: (i) That the food bearing the claim in its labeling: (A) Does not contain any one of the following: ( 1 ) An ingredient that is a gluten-containing grain (e.g., spelt wheat); ( 2 ) An ingredient that is derived from a gluten-containing grain and that has not been processed to remove gluten (e.g., wheat flour); or ( 3 ) An ingredient that is derived from a gluten-containing grain and that has been processed to remove gluten (e.g., wheat starch), if the use of that ingredient results in the presence of 20 parts per million (ppm) or more gluten in the food (i.e., 20 milligrams (mg) or more gluten per kilogram (kg) of food); or (B) Inherently does not contain gluten; and (ii) Any unavoidable presence of gluten in the food bearing the claim in its labeling is below 20 ppm gluten (i.e., below 20 mg gluten per kg of food). (b) Requirements. (1) A food that bears the claim “gluten-free” in its labeling and fails to meet the requirements of paragraph (a)(3) of this section and, if applicable, paragraphs (c)(2) through (4) of this section will be deemed misbranded. (2) A food that bears the claim “no gluten,” “free of gluten,” or “without gluten” in its labeling and fails to meet the requirements of paragraph (a)(3) of this section and, if applicable, paragraphs (c)(2) through (4) of this section will be deemed misbranded. (3) A food that bears the term “wheat” in the ingredient list or in a… | |||
| 21:21:2.0.1.1.2.6.1.2 | 21 | Food and Drugs | I | B | 101 | PART 101—FOOD LABELING | F | Subpart F—Specific Requirements for Descriptive Claims That Are Neither Nutrient Content Claims nor Health Claims | § 101.93 Certain types of statements for dietary supplements. | FDA | [62 FR 49886, Sept. 23, 1997, as amended at 62 FR 49867, Sept. 23, 1997; 65 FR 1050, Jan. 6, 2000; 66 FR 17358, Mar. 30, 2001; 66 FR 56035, Nov. 6, 2001; 88 FR 17718, Mar. 24, 2023] | (a)(1) No later than 30 days after the first marketing of a dietary supplement that bears one of the statements listed in section 403(r)(6) or the Federal Food, Drug, and Cosmetic Act, the manufacturer, packer, or distributor of the dietary supplement shall notify the Office of Dietary Supplement Programs (HFS-810), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, that it has included such a statement on the label or in the labeling of its product. An original and two copies of this notification shall be submitted. (2) The notification shall include the following: (i) The name and address of the manufacturer, packer, or distributor of the dietary supplement that bears the statement; (ii) The text of the statement that is being made; (iii) The name of the dietary ingredient or supplement that is the subject of the statement, if not provided in the text of the statement; and (iv) The name of the dietary supplement (including brand name), if not provided in response to paragraph (a)(2)(iii) on whose label, or in whose labeling, the statement appears. (3) The notice shall be signed by a responsible individual or the person who can certify the accuracy of the information presented and contained in the notice. The individual shall certify that the information contained in the notice is complete and accurate, and that the notifying firm has substantiation that the statement is truthful and not misleading. (b) Disclaimer. The requirements in this section apply to the label or labeling of dietary supplements where the dietary supplement bears a statement that is provided for by section 403(r)(6) of the Federal Food, Drug, and Cosmetic Act (the act), and the manufacturer, packer, or distributor wishes to take advantage of the exemption to section 201(g)(1)(C) of the act that is provided by compliance with section 403(r)(6) of the act. (c) Text for disclaimer. (1) Where there is one statement, the disclaimer shall be placed in accordance with pa… | |||
| 21:21:2.0.1.1.2.6.1.3 | 21 | Food and Drugs | I | B | 101 | PART 101—FOOD LABELING | F | Subpart F—Specific Requirements for Descriptive Claims That Are Neither Nutrient Content Claims nor Health Claims | § 101.95 “Fresh,” “freshly frozen,” “fresh frozen,” “frozen fresh.” | FDA | [58 FR 2426, Jan. 6, 1993] | The terms defined in this section may be used on the label or in labeling of a food in conformity with the provisions of this section. The requirements of the section pertain to any use of the subject terms as described in paragraphs (a) and (b) of this section that expressly or implicitly refers to the food on labels or labeling, including use in a brand name and use as a sensory modifier. However, the use of the term “fresh” on labels or labeling is not subject to the requirements of paragraph (a) of this section if the term does not suggest or imply that a food is unprocessed or unpreserved. For example, the term “fresh” used to describe pasteurized whole milk is not subject to paragraph (a) of this section because the term does not imply that the food is unprocessed (consumers commonly understand that milk is nearly always pasteurized). However, the term “fresh” to describe pasta sauce that has been pasteurized or that contains pasteurized ingredients would be subject to paragraph (a) of this section because the term implies that the food is not processed or preserved. Uses of fresh not subject to this regulation will be governed by the provisions of 403(a) of the Federal Food, Drug, and Cosmetic Act (the act). (a) The term “fresh,” when used on the label or in labeling of a food in a manner that suggests or implies that the food is unprocessed, means that the food is in its raw state and has not been frozen or subjected to any form of thermal processing or any other form of preservation, except as provided in paragraph (c) of this section. (b) The terms “fresh frozen” and “frozen fresh,” when used on the label or in labeling of a food, mean that the food was quickly frozen while still fresh (i.e., the food had been recently harvested when frozen). Blanching of the food before freezing will not preclude use of the term “fresh frozen” to describe the food. “Quickly frozen” means frozen by a freezing system such as blast-freezing (sub-zero Fahrenheit temperature with fast moving air directed at the food) that… | |||
| 21:21:2.0.1.1.2.7.1.1 | 21 | Food and Drugs | I | B | 101 | PART 101—FOOD LABELING | G | Subpart G—Exemptions From Food Labeling Requirements | § 101.100 Food; exemptions from labeling. | FDA | [42 FR 14308, Mar. 15, 1977, as amended at 51 FR 25017, July 9, 1986; 58 FR 2188, 2876, Jan. 6, 1993; 66 FR 17358, Mar. 30, 2001; 87 FR 2546, Jan. 18, 2022] | (a) The following foods are exempt from compliance with the requirements of section 403(i)(2) of the act (requiring a declaration on the label of the common or usual name of each ingredient when the food is fabricated from two or more ingredients). (1) An assortment of different items of food, when variations in the items that make up different packages packed from such assortment normally occur in good packing practice and when such variations result in variations in the ingredients in different packages, with respect to any ingredient that is not common to all packages. Such exemption, however, shall be on the condition that the label shall bear, in conjunction with the names of such ingredients as are common to all packages, a statement (in terms that are as informative as practicable and that are not misleading) indicating by name other ingredients which may be present. (2) A food having been received in bulk containers at a retail establishment, if displayed to the purchaser with either: (i) The labeling of the bulk container plainly in view, provided ingredient information appears prominently and conspicuously in lettering of not less than one-fourth of an inch in height; or (ii) A counter card, sign, or other appropriate device bearing prominently and conspicuously, but in no case with lettering of less than one-fourth of an inch in height, the information required to be stated on the label pursuant to section 403(i)(2) of the Federal Food, Drug, and Cosmetic Act (the act). (3) Incidental additives that are present in a food at insignificant levels and do not have any technical or functional effect in that food. For the purposes of this paragraph (a)(3), incidental additives are: (i) Substances that have no technical or functional effect but are present in a food by reason of having been incorporated into the food as an ingredient of another food, in which the substance did have a functional or technical effect. (ii) Processing aids, which are as follows: ( a ) Substances that are added to a food d… | |||
| 21:21:2.0.1.1.2.7.1.2 | 21 | Food and Drugs | I | B | 101 | PART 101—FOOD LABELING | G | Subpart G—Exemptions From Food Labeling Requirements | § 101.108 Temporary exemptions for purposes of conducting authorized food labeling experiments. | FDA | [48 FR 15240, Apr. 8, 1983, as amended at 59 FR 14364, Mar. 28, 1994; 62 FR 15343, Mar. 31, 1997; 88 FR 17718, Mar. 24, 2023] | (a) The food industry is encouraged to experiment voluntarily, under controlled conditions and in collaboration with the Food and Drug Administration, with and other formats for presenting nutrition and other related food labeling information that is consistent with the current quantitative system in §§ 101.9 and 105.66 of this chapter. (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.; (4) The dates on which the experiment will begin and end and on which a written report of analysis of the experimental data will be submitted to FDA, together with a commitment not to continue the experiment beyond the proposed ending date without FDA approval; (5) The geographic area or areas in which the experiment is to be conducted; (6) The mechanism to measure the effectiveness of the experiment; (7) The method for conveying to consumers the required nutrition and other labeling information that is exempted from the label during the experiment; (8) The method that will be or has been used to determine the actual nutritional characteristics of foods for which a claim is made; and (9) A statement of the sections of the regulations for which an exemption is sought. (c) The written proposal should be sent to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500, between 9 a.m. and 4 p.m., Monday through Friday. The proposal should be clearly identified as a request for a temporary exemption for… |
Advanced export
JSON shape: default, array, newline-delimited, object
CREATE TABLE cfr_sections (
section_id TEXT PRIMARY KEY,
title_number INTEGER,
title_name TEXT,
chapter TEXT,
subchapter TEXT,
part_number TEXT,
part_name TEXT,
subpart TEXT,
subpart_name TEXT,
section_number TEXT,
section_heading TEXT,
agency TEXT,
authority TEXT,
source_citation TEXT,
amendment_citations TEXT,
full_text TEXT
);
CREATE INDEX idx_cfr_title ON cfr_sections(title_number);
CREATE INDEX idx_cfr_part ON cfr_sections(part_number);
CREATE INDEX idx_cfr_agency ON cfr_sections(agency);