cfr_sections
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10 rows where part_number = 701 and title_number = 21 sorted by section_id
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| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 21:21:7.0.1.2.11.1.1.1 | 21 | Food and Drugs | I | G | 701 | PART 701—COSMETIC LABELING | A | Subpart A—General Provisions | § 701.1 Misbranding. | FDA | (a) Among representations in labeling of a cosmetic which render such cosmetic misbranded is a false or misleading representation with respect to another cosmetic or a food, drug, or device. (b) The labeling of a cosmetic which contains two or more ingredients may be misleading by reason (among other reasons) of the designation of such cosmetic 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. | ||||
| 21:21:7.0.1.2.11.1.1.2 | 21 | Food and Drugs | I | G | 701 | PART 701—COSMETIC LABELING | A | Subpart A—General Provisions | § 701.2 Form of stating labeling requirements. | 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 602(c) 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; (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)(1) All words, statements, and other information required by or under authority of the Act to appear on the label or labeling shall appear thereon in the English language: Provided, however, That in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English, the predominant language may be substituted for Eng… | ||||
| 21:21:7.0.1.2.11.1.1.3 | 21 | Food and Drugs | I | G | 701 | PART 701—COSMETIC LABELING | A | Subpart A—General Provisions | § 701.3 Designation of ingredients. | FDA | [39 FR 10056, Mar. 15, 1974, as amended at 40 FR 8922, Mar. 3, 1975; 40 FR 18426, Apr. 28, 1975; 42 FR 4718, Jan. 25, 1977; 42 FR 15676, Mar. 22, 1977; 42 FR 24255, May 31, 1977; 42 FR 46516, Sept. 16, 1977; 42 FR 61257, Dec. 2, 1977; 45 FR 3577, Jan. 18, 1980; 47 FR 9397, Mar. 5, 1982; 54 FR 24900, June 12, 1989; 64 FR 13297, Mar. 17, 1999; 69 FR 18803, Apr. 9, 2004; 81 FR 49897, July 29, 2016] | (a) The label on each package of a cosmetic shall bear a declaration of the name of each ingredient in descending order of predominance, except that fragrance or flavor may be listed as fragrance or flavor. An ingredient which is both fragrance and flavor shall be designated by each of the functions it performs unless such ingredient is identified by name. No ingredient may be designated as fragrance or flavor unless it is within the meaning of such term as commonly understood by consumers. Where one or more ingredients is accepted by the Food and Drug Administration as exempt from public disclosure pursuant to the procedure established in § 720.8(a) of this chapter, in lieu of label declaration of identity the phrase “and other ingredients” may be used at the end of the ingredient declaration. (b) The declaration of ingredients shall appear with such prominence and conspicuousness as to render it likely to be read and understood by ordinary individuals under normal conditions of purchase. The declaration shall appear on any appropriate information panel in letters not less than 1/16 of an inch in height and without obscuring design, vignettes, or crowding. In the absence of sufficient space for such declaration on the package, or where the manufacturer or distributor wishes to use a decorative container, the declaration may appear on a firmly affixed tag, tape, or card. In those cases where there is insufficient space for such declaration on the package, and it is not practical to firmly affix a tag, tape, or card, the Commissioner may establish by regulation an acceptable alternate, e.g., a smaller type size. A petition requesting such a regulation as an amendment to this paragraph shall be submitted pursuant to part 10 of this chapter. (c) A cosmetic ingredient shall be identified in the declaration of ingredients by: (1) The name specified in § 701.30 as established by the Commissioner for that ingredient for the purpose of cosmetic ingredient labeling pursuant to paragraph (e) of this section; (2) In … | |||
| 21:21:7.0.1.2.11.1.1.4 | 21 | Food and Drugs | I | G | 701 | PART 701—COSMETIC LABELING | A | Subpart A—General Provisions | § 701.9 Exemptions from labeling requirements. | FDA | (a) Except as provided by paragraphs (b) and (c) of this section, a shipment or other delivery of a cosmetic which is, in accordance with the practice of the trade, to be processed, labeled, or repacked in substantial quantity at an establishment other than that where originally processed or packed, shall be exempt, during the time of introduction into and movement in interstate commerce and the time of holding in such establishment, from compliance with the labeling requirements of sections 601(a) and 602(b) of the act if: (1) The person who introduced such shipment or delivery into interstate commerce is the operator of the establishment where such cosmetic is to be processed, labeled, or repacked; or (2) In case such person is not such operator, such shipment or delivery is made to such establishment under a written agreement, signed by and containing the post office addresses of such person and such operator, and containing such specifications for the processing, labeling, or repacking, as the case may be, of such cosmetic in such establishment as will insure, if such specifications are followed, that such cosmetic will not be adulterated or misbranded within the meaning of the act upon completion of such processing, labeling, or repacking. Such person and such operator shall each keep a copy of such agreement until 2 years after the final shipment or delivery of such cosmetic from such establishment, and shall make such copies available for inspection at any reasonable hour to any officer or employee of the Department who requests them. (b) An exemption of a shipment or other delivery of a cosmetic under paragraph (a)(1) of this section shall, at the beginning of the act of removing such shipment or delivery, or any part thereof, from such establishment, become void ab initio if the cosmetic comprising such shipment, delivery, or part is adulterated or misbranded within the meaning of the act when so removed. (c) An exemption of a shipment or other delivery of a cosmetic under paragraph (a)(2) of this se… | ||||
| 21:21:7.0.1.2.11.2.1.1 | 21 | Food and Drugs | I | G | 701 | PART 701—COSMETIC LABELING | B | Subpart B—Package Form | § 701.10 Principal display panel. | FDA | The term principal display panel as it applies to cosmetics 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 designs, 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 of 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; and (c) In the case of any other shape of 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, the area shall consist of the entire top surface. In determining the area of the principal display panel, exclude tops, bottoms, flanges at the 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 … | ||||
| 21:21:7.0.1.2.11.2.1.2 | 21 | Food and Drugs | I | G | 701 | PART 701—COSMETIC LABELING | B | Subpart B—Package Form | § 701.11 Identity labeling. | FDA | (a) The principal display panel of a cosmetic 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 common or usual name of the cosmetic; or (2) An appropriately descriptive name or, when the nature of the cosmetic is obvious, a fanciful name understood by the public to identify such cosmetic; or (3) An appropriate illustration or vignette representing the intended cosmetic use. (c) The 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. | ||||
| 21:21:7.0.1.2.11.2.1.3 | 21 | Food and Drugs | I | G | 701 | PART 701—COSMETIC LABELING | B | Subpart B—Package Form | § 701.12 Name and place of business of manufacturer, packer, or distributor. | FDA | (a) The label of a cosmetic in package 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. Abbreviations for “Company,” “Incorporated,” etc., may be used and “The” may be omitted. In the case of an individual, partnership, or association, the name under which the business is conducted shall be used. (c) Where the cosmetic 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 cosmetic; 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 the invoice). (e) If a person manufactures, packs, or distributes a cosmetic 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 cosmetic was manufactured or packed or is to be distributed, unless such statement would be misleading. | ||||
| 21:21:7.0.1.2.11.2.1.4 | 21 | Food and Drugs | I | G | 701 | PART 701—COSMETIC LABELING | B | Subpart B—Package Form | § 701.13 Declaration of net quantity of contents. | FDA | (a) The label of a cosmetic in package form shall bear a declaration of the net quantity of contents. This shall be expressed in 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 cosmetic is liquid or in terms of weight if the cosmetic is solid, semisolid, or viscous, or a mixture of solid and liquid. If there is a firmly established, general consumer usage and trade custom of declaring the net quantity of a cosmetic by numerical count, linear measure, or measure of area, such respective term may be used. If there is a firmly established, general consumer usage and trade custom of declaring the contents of a liquid cosmetic by weight, or a solid, semisolid, or viscous cosmetic by fluid measure, it may be used. Whenever the Commissioner determines for a specific packaged cosmetic that an existing practice of declaring net quantity of contents by weight, measure, numerical count, or a combination of these does not facilitate value comparisons by consumers, he shall by regulation designate the appropriate term or terms to be used for such cosmetic. (b) Statements of weight shall be in terms of avoirdupois pound and ounce. 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 express the volume at 68 °F. (20 °C.). (c) When the declaration of quantity of contents by numerical count, linear measure, or measure of area does not give accurate information as to the quantity of cosmetic in the package, it shall be augmented by such statement of weight, measure, or size of the individual units or the total weight or measure of the cosmetic as will give such information. (d) The declaration may contain common or decimal fractions. A common fraction shall be in terms of halves, quarters, eighths, sixteenths, or thirty-seconds; except that if there exists a firmly established, general consumer usage and trade custom of emplo… | ||||
| 21:21:7.0.1.2.11.3.1.1 | 21 | Food and Drugs | I | G | 701 | PART 701—COSMETIC LABELING | C | Subpart C—Labeling of Specific Ingredients | § 701.20 Detergent substances, other than soap, intended for use in cleansing the body. | FDA | (a) In its definition of the term cosmetic, the Federal Food, Drug, and Cosmetic Act specifically excludes soap. The term soap is nowhere defined in the act. In administering the act, the Food and Drug Administration interprets the term “soap” to apply only to articles that meet the following conditions: (1) The bulk of the nonvolatile matter in the product consists of an alkali salt of fatty acids and the detergent properties of the article are due to the alkali-fatty acid compounds; and (2) The product is labeled, sold, and represented only as soap. (b) Products intended for cleansing the human body and which are not “soap” as set out in paragraph (a) of this section are “cosmetics,” and accordingly they are subject to the requirements of the act and the regulations thereunder. For example, such a product in bar form is subject to the requirement, among others, that it shall bear a label containing an accurate statement of the weight of the bar in avoirdupois pounds and ounces, this statement to be prominently and conspicuously displayed so as to be likely to be read under the customary conditions of purchase and use. | ||||
| 21:21:7.0.1.2.11.3.1.2 | 21 | Food and Drugs | I | G | 701 | PART 701—COSMETIC LABELING | C | Subpart C—Labeling of Specific Ingredients | § 701.30 Ingredient names established for cosmetic ingredient labeling. | FDA | [42 FR 24255, May 13, 1977, as amended at 45 FR 3577, Jan. 18, 1980] | The Commissioner establishes the following names for the purpose of cosmetic ingredient labeling pursuant to paragraph (e) of § 701.3: |
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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);