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General Specifications and General Restrictions for Provisional Color Additives for Use in Foods, Drugs, and Cosmetics
21 CFR Part 81 establishes general specifications and restrictions for provisional color additives used in foods, drugs, and cosmetics under the Color Additive Amendments of 1960. The regulation lists provisionally approved color additives, requires progress reports, and prohibits their use in eye-area products. It also documents termination of provisional listings for specific colors due to safety concerns, including Ext. D&C Yellow Nos. 9 and 10 (due to β-naphthylamine contamination) and FD&C Red No. 1 (due to demonstrated toxicity in animal feeding studies).
General Enforcement Regulations
General enforcement regulations under the Federal Food, Drug, and Cosmetic Act establishing that FDA regulations apply to causing prohibited acts, defining key terms like labeling and label, and clarifying the agency's statutory authorities for food, drug, and cosmetic regulation including provisions on package labeling and net quantity declarations.
Color Additives
21 CFR Part 70 establishes federal regulations governing color additives used in foods, drugs, and cosmetics under the Federal Food, Drug, and Cosmetic Act. The regulation defines color additives as dyes, pigments, or synthetic substances capable of imparting color when added to food, drugs, cosmetics, or the human body, and clarifies exemptions for natural food ingredients and substances where color is incidental to primary function. The FDA's Color Certification Branch administers certification procedures for regulated color additives.
General Administrative Rulings and Decisions
21 CFR Part 2 establishes FDA administrative procedures for declaring imminent hazards to public health and conducting examination and investigation samples of foods, drugs, and cosmetics. An imminent hazard exists when evidence shows a product poses significant health threat requiring immediate correction. FDA officers collecting official samples must gather at least twice the estimated quantity needed for analysis, with exceptions for limited availability, cost exceeding $150, or samples from importers or labeled manufacturers. The regulation governs sample handling, preservation, and evidentiary retention for enforcement actions under the Federal Food, Drug, and Cosmetic Act.
Listing of Certified Provisionally Listed Colors and Specifications
21 CFR Part 82 establishes specifications and certification requirements for provisionally listed coal-tar colors used in food, drugs, and cosmetics. The regulation defines key terms including alumina, blanc fixe, and gloss white, and sets permissible limits for impurities such as lead, arsenic, and heavy metals in straight colors and certifiable mixtures. It outlines requirements for batch composition, diluent safety, and certification procedures for color products intended for food, drug, and cosmetic applications.
Color Additive Petitions
21 CFR Part 71 establishes the petition process for proposing color additives for use in foods, drugs, cosmetics, or human body coloring. Petitioners must submit detailed information including the additive's chemical identity, composition, physical and chemical properties, production methods, and safety data. Petitions require specification of intended uses, proposed conditions of use, and supporting toxicological and analytical data to demonstrate safety and suitability for FDA approval.
Enforcement Policy
FDA enforcement policy governing regulatory actions under the Federal Food, Drug, and Cosmetic Act. Establishes procedures for recalls, corrections, and voluntary removals of violative products including foods, drugs, devices, cosmetics, biologics, and tobacco. Defines recall classifications based on health hazard severity and clarifies distinctions between recalls, market withdrawals, and stock recoveries.
Cosmetic Product Warning Statements
21 CFR Part 740 establishes requirements for warning statements on cosmetic product labels. Manufacturers must display warnings whenever necessary to prevent health hazards, with statements appearing prominently in bold type on contrasting backgrounds (minimum 1/16 inch height). Specific warnings are mandated for products with unsubstantiated safety claims and for self-pressurized containers, including precautions against eye contact, puncture, incineration, and high temperature exposure.
Voluntary Registration of Cosmetic Product Establishments
21 CFR Part 710 establishes a voluntary registration program for cosmetic product establishments in the US. Manufacturers and packagers of cosmetic products must register with the FDA within 30 days of beginning operations using Form FD-2511, providing establishment name, address, business trading names, and business type. Registration is not required for beauty shops, retailers, physicians, hospitals, research facilities, or other exempt entities. No registration fee applies, and registration does not indicate FDA approval.
Voluntary Filing of Cosmetic Product Ingredient Composition Statements
21 CFR Part 720 establishes a voluntary program for manufacturers, packers, and distributors of cosmetic products to file ingredient composition statements with the FDA on Form FDA 2512. Filings must occur within 180 days of the rule's effective date for existing products, or within 60 days of commercial distribution for new products. The filing requires disclosure of product name, manufacturer details, brand name, cosmetic category, and complete ingredient listings, with information made available to poison control centers and licensed physicians for safety and medical purposes.
General
21 CFR Part 700 establishes general provisions and definitions for cosmetic products under the Federal Food, Drug, and Cosmetic Act. Key definitions include cosmetic product, ingredients, flavors, fragrances, proprietary ingredients, and manufacturing/packaging processes. The regulation defines commercial distribution thresholds (>$1,000 annual gross sales), establishes requirements for ingredient chemical descriptions, and outlines procedures for reporting allergic reactions and bodily injuries associated with cosmetic use.
Cosmetic Labeling
21 CFR Part 701 establishes labeling requirements for cosmetic products, including prohibitions on misbranding, specifications for ingredient declaration in descending order of predominance, and standards for label prominence and conspicuousness. Requirements address language, visibility, and accurate ingredient representation to prevent consumer deception.