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Civil Money Penalties Hearings
21 CFR Part 17 establishes procedures for FDA administrative hearings on civil money penalties for violations of the Federal Food, Drug, and Cosmetic Act and Public Health Service Act. Penalties apply to violations involving prescription drug marketing, medical devices, pesticide residues, clinical trials, direct-to-consumer drug advertising, biologics, electronic products, mammography standards, vaccine record falsification, and tobacco products.
Standards of Conduct and Conflicts of Interest
21 CFR Part 19 establishes standards of conduct and conflict-of-interest regulations for FDA employees. It incorporates Department standards from 45 CFR Part 73, applies the Congressional Code of Ethics for Government Service, and establishes a permanent Conflict of Interest Review Board to review conflict matters referred by management or appealed by affected employees.
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.
Organization
21 CFR Part 5 Subpart M establishes the organizational structure and contact information for FDA offices, including headquarters location, Chief Counsel office, Dockets Management Staff, Freedom of Information Staff, and Press Relations Staff offices.
Institutional Review Boards
21 CFR Part 56 establishes standards for Institutional Review Boards (IRBs) that oversee clinical investigations of FDA-regulated products including drugs, medical devices, biological products, foods, dietary supplements, and electronic products. The regulation defines the composition, operation, and responsibilities of IRBs to protect the rights and welfare of human research subjects.
Electronic Records; Electronic Signatures
21 CFR Part 11 establishes FDA criteria for electronic records and signatures to be considered trustworthy, reliable, and equivalent to paper records. The regulation applies to electronic records created, modified, maintained, or transmitted under FDA regulations and those submitted under the Federal Food, Drug, and Cosmetic Act and Public Health Service Act. Electronic signatures meeting these requirements are treated as equivalent to handwritten signatures unless specifically excepted. Electronic records may replace paper records unless paper is required, and computer systems must be subject to FDA inspection.
Nutritional Quality Guidelines for Foods
21 CFR Part 104 establishes nutritional quality guidelines for foods, prescribing minimum nutrient levels for food classes. Products complying with guidelines may use a government-approved statement on labeling. The regulation prohibits misleading claims about nutritional differences and requires prominent declarations when nutrients are added at inappropriate levels or in excess of guideline maximums. It establishes uniform fortification principles to maintain desirable nutritional quality in the food supply while preventing random fortification that could cause nutrient imbalances.
Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food
21 CFR Part 117 establishes current good manufacturing practice (CGMP), hazard analysis, and risk-based preventive controls requirements for human food manufacturing, processing, packing, and holding facilities in the US. The regulation defines applicability, key food safety terms (including critical control points, allergen cross-contact, environmental pathogens), and compliance obligations under the Federal Food, Drug, and Cosmetic Act to prevent adulteration and contamination.
Regulation of Combination Products
21 CFR Part 4 establishes current good manufacturing practice (CGMP) requirements for combination products, which are products containing two or more constituent parts (drugs, devices, or biological products). The regulation clarifies how CGMP rules apply to both co-packaged and single-entity combination products, defines key terms, and outlines the regulatory framework for designing and implementing CGMP operating systems at manufacturing facilities.
Public Hearing Before a Public Advisory Committee
This regulation (21 CFR Part 14) establishes procedures for public hearings before FDA advisory committees. It applies when the FDA Commissioner determines it is in the public interest, or when required by statute for specific matters including electronic product radiation safety, color additives, prescription and over-the-counter drugs, medical devices, and device manufacturing standards. The rule defines advisory committees, distinguishes between standing and ad hoc committees, and specifies when groups do not qualify as advisory committees.
Patent Term Restoration
This regulation establishes FDA procedures for reviewing patent term restoration applications under 35 U.S.C. 156 for patents related to drugs, medical devices, food additives, and color additives. It defines the FDA's role in determining patent eligibility, calculating regulatory review periods, and adjudicating due diligence challenges through informal hearings.
Hazard Analysis and Critical Control Point (HACCP) Systems
21 CFR Part 120 establishes mandatory Hazard Analysis and Critical Control Point (HACCP) systems for juice processing. The regulation requires all juice sold or used as a beverage ingredient to be processed according to HACCP requirements, with applicability phased in for small and very small businesses between 2002 and 2004. The rule defines key terms including critical control points, critical limits, food hazards, and control measures to prevent biological, chemical, and physical contamination risks.
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.
Product Jurisdiction
21 CFR Part 3 establishes FDA procedures for determining which internal agency component has primary jurisdiction over premarket review of combination products containing any mixture of drugs, devices, and biologics. It implements the Safe Medical Devices Act and modernization amendments to streamline oversight by eliminating the need for multiple FDA component approvals on a single product.
Public Information
21 CFR Part 20 establishes FDA procedures for public disclosure of agency records and governs employee testimony. It requires FDA employees to decline testimony unless authorized by the Commissioner, allows written requests for testimony to be evaluated based on public interest, and mandates that record requests follow established procedures under the regulation's subparts addressing confidentiality, trade secrets, and privacy protections.
Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements
21 CFR Part 111 establishes Current Good Manufacturing Practice (CGMP) requirements for dietary supplement manufacturers, packagers, labelers, and distributors in the US. The regulation applies to all entities manufacturing or importing dietary supplements, with exemptions for retail-only storage. Key definitions include batch/lot identification, component specifications, in-process materials, and microorganism standards to ensure product identity, purity, strength, and composition.
Common or Usual Name for Nonstandardized Foods
This FDA regulation establishes requirements for the common or usual names of nonstandardized foods. Names must accurately describe the basic nature and characterizing properties of foods in simple, direct terms and be uniform across identical products. When characterizing ingredients materially affect price or consumer perception, their percentage must be declared on the principal display panel in specified font sizes and format. Presence or absence of key ingredients must also be disclosed when it could mislead consumers about the product's composition.
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.
Production, Storage, and Transportation of Shell Eggs
21 CFR Part 118 establishes production, storage, and transportation requirements for shell eggs from farms with 3,000 or more laying hens. Covered producers must implement biosecurity programs to prevent Salmonella Enteritidis contamination, maintain proper refrigeration, conduct flock testing, and comply with registration requirements unless eggs receive approved antimicrobial treatment. Requirements apply to farms, shell egg processing facilities, and transporters handling eggs for the table market.
Environmental Impact Considerations
21 CFR Part 25 establishes FDA procedures for implementing the National Environmental Policy Act (NEPA), requiring environmental impact assessments for major Federal actions related to FDA-regulated products including drugs, biologics, and medical devices. The regulation defines key NEPA terms and establishes supplemental procedures consistent with FDA's authority under the Federal Food, Drug, and Cosmetic Act and Public Health Service Act.
Regulatory Hearing Before the Food and Drug Administration
21 CFR Part 16 establishes procedures for regulatory hearings before the FDA when the Commissioner considers regulatory actions affecting drugs, devices, food, cosmetics, and tobacco products. Hearings are available under specific statutory provisions including premarket approval withdrawals, device bans, mandatory recalls, investigational device exemptions, and tobacco product orders. The procedures apply when the Commissioner discretionarily offers a hearing or when statutory provisions mandate one, but exclude informal presentations and certain admission refusals.
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.
Food Labeling
21 CFR Part 101 establishes federal requirements for food labeling on packaged products. It defines the principal display panel as the most prominently displayed label surface and specifies its measurement for rectangular, cylindrical, and irregularly shaped containers. The information panel must appear immediately contiguous to the principal display panel and contain required disclosures in conspicuous, legible text of at least one-sixteenth inch height. These provisions ensure consumers can readily access mandatory nutritional and ingredient information at retail.
Emergency Permit Control
21 CFR Part 108 establishes emergency permit control procedures for food manufacturers, processors, and packers. The FDA Commissioner may issue temporary emergency permits when a facility fails to meet mandatory conditions of applicable food safety regulations. The rule specifies procedures for permit determination, including notification, objection filing within 3 working days, expedited hearings for imminent health hazards, and permit revocation once compliance is demonstrated. Permits remain valid only as long as necessary to protect public health.
Financial Disclosure by Clinical Investigators
FDA regulation requiring disclosure of financial interests and compensation arrangements between clinical investigators and study sponsors for drugs and medical devices. Investigators must disclose equity interests, proprietary interests in tested products, and compensation affected by study outcomes to minimize potential bias in clinical data submitted for FDA marketing applications.
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.
Current Good Manufacturing Practice in Manufacturing, Packing, or Holding Human Food
21 CFR Part 110 establishes current good manufacturing practice (CGMP) standards for manufacturing, packing, and holding human food. The regulation defines key terms including acid foods, critical control points, food-contact surfaces, microorganisms, pests, sanitization, and quality control operations. It sets mandatory requirements (indicated by "shall") and advisory procedures to prevent food adulteration and ensure food safety through proper manufacturing and sanitation practices.
Shell Eggs
21 CFR Part 115 establishes refrigeration requirements for shell eggs held for retail distribution in the United States. Shell eggs must be promptly placed under refrigeration and maintained at or below 7.2°C (45°F) while held at retail establishments, with exemptions for eggs processed to destroy viable Salmonella. The regulation empowers FDA to order diversion or destruction of non-compliant eggs and allows states and localities to assist in enforcement through inspections and administrative remedies.
Foods for Special Dietary Use
21 CFR Part 105 establishes regulatory requirements for foods marketed for special dietary uses, including those for medical conditions, specific age groups, and fortified products. The regulation defines labeling requirements for hypoallergenic foods, infant foods, and weight-management foods, mandating clear ingredient disclosure, allergen source identification, and processing information where applicable.
Unavoidable Contaminants in Food for Human Consumption and Food-Packaging Material
21 CFR Part 109 establishes the regulatory framework for unavoidable contaminants in food and food-packaging materials. It defines naturally occurring versus added poisonous or deleterious substances, and authorizes the FDA to establish tolerances, regulatory limits, and action levels for contaminants. The regulation distinguishes between substances controlled as food additives under section 409 of the Federal Food, Drug, and Cosmetic Act and those managed through tolerance or action level mechanisms, with EPA typically controlling pesticide residues.
Formal Evidentiary Public Hearing
This FDA regulation (21 CFR Part 12) establishes procedural rules for formal evidentiary public hearings before the FDA Commissioner. It covers initiation of proceedings for issuing, amending, or revoking regulations and orders related to food additives, color additives, drugs, medical devices, and biologics. The regulation specifies timelines for submitting petitions, objections, and hearing requests (typically 30 days), notification requirements, and incorporation of the Equal Access to Justice Act procedures for expense reimbursement.
Color Additive Certification
21 CFR Part 80 establishes the FDA's color additive certification procedures and fee schedules. Manufacturers must submit certification requests with prescribed samples and fees ($0.45/lb minimum $288 for straight colors; tiered fees for repacks). Requests require duplicate submission, responsible officer signature, and advance deposit option. The regulation governs batch certification, foreign manufacturer requirements, and refund procedures for advance deposits.
Acidified Foods
21 CFR Part 114 establishes current good manufacturing practice requirements for acidified foods—low-acid foods to which acids are added to achieve a finished pH of 4.6 or below. Processors must employ quality control procedures and employ supervisory personnel trained in food handling, pH controls, and acidification. The regulation defines key terms including acidified foods, scheduled processes, and water activity, and exempts certain products like carbonated beverages, jams, and refrigerated foods from coverage.
Infant Formula
21 CFR Part 107 establishes labeling requirements, nutrient standards, and exemption criteria for infant formula under the Federal Food, Drug, and Cosmetic Act. Manufacturers must comply with nutrient content specifications, labeling formats declaring calories and specific nutrients (vitamins, minerals, biotin, choline, inositol), and special provisions for exempt formulas designed for infants with inborn errors of metabolism or low birth weight. Non-compliance renders formulas misbranded or adulterated.
Administrative Practices and Procedures
21 CFR Part 10 establishes administrative practices and procedures governing petitions, hearings, and administrative proceedings conducted by the FDA under the Federal Food, Drug, and Cosmetic Act and related laws. It defines key terms such as administrative action, administrative file, ex parte communication, and participant, and clarifies the applicability and scope of FDA administrative proceedings and related regulatory sections.
Infant Formula Requirements Pertaining to Current Good Manufacturing Practice, Quality Control Procedures, Quality Factors, Records and Reports, and Notifications
21 CFR Part 106 establishes current good manufacturing practice (cGMP), quality control, and quality factor requirements for infant formula manufacturers under the Federal Food, Drug, and Cosmetic Act. Manufacturers must comply with processing standards, quality factors, and record-keeping procedures; non-compliance renders formula adulterated. The regulation mandates manufacturer registration, submission, and notification to the FDA.
Public Hearing Before the Commissioner
This regulation establishes procedures for public hearings before the FDA Commissioner. It applies when the Commissioner determines it is in the public interest to hold a hearing, when an act or regulation specifically provides for one, or when a person waives a formal evidentiary hearing and requests one instead. The Commissioner must publish notice in the Federal Register detailing the hearing's purpose, subject matter, date, time, and location. Participants must file notices of participation with specified information, and the Commissioner determines time allocations for presentations.
Public Hearing Before a Public Board of Inquiry
This regulation establishes procedures for public hearings before a Public Board of Inquiry under FDA jurisdiction. It defines the scope of when such boards are established, requires Federal Register notice of hearings with specified information, and sets qualifications and nomination procedures for board members, who must be free from conflicts of interest and possess relevant medical, technical, or scientific expertise.
General
This regulation establishes procedures for states and political subdivisions to petition the FDA for exemption from federal food labeling and composition preemption under the Federal Food, Drug, and Cosmetic Act. States may request exemptions if their requirements do not conflict with federal law, do not unduly burden interstate commerce, and address specific information needs not met by federal requirements. Petitions must demonstrate state authority, preemption applicability, and that requirements differ from federal standards.
Listing of Color Additives Subject to Certification
21 CFR Part 74 establishes regulations for certified color additives used in food, including dietary supplements. The regulation specifies identity requirements, purity specifications, permissible uses, and labeling standards for FD&C Blue No. 1 and FD&C Blue No. 2. These synthetic dyes must meet strict composition and contamination limits for volatile matter, impurities, heavy metals (chromium, manganese, arsenic, lead), and total color content, and all batches require certification per 21 CFR Part 80.
Protection of Human Subjects
21 CFR Part 50 establishes requirements for the protection of human subjects in clinical investigations regulated by the FDA. It applies to investigations involving drugs, biological products, medical devices, food additives, dietary supplements, and related products submitted for FDA approval. The regulation defines the scope of coverage, applicable regulatory sections, and key definitions for research and marketing permit applications across multiple FDA-regulated product categories.
Listing of Color Additives Exempt from Certification
21 CFR Part 73 establishes permitted color additives exempt from FDA certification for food use, including diluents in color additive mixtures. It specifies GRAS substances and approved diluents for general food coloring, marking food supplements and produce, and coating shell eggs, with detailed specifications for substances like annatto extract including limits on arsenic and lead contamination.
Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption
21 CFR Part 112 establishes standards for growing, harvesting, packing, and holding of produce for human consumption. It covers raw agricultural commodities including fruits, vegetables, and nuts grown domestically or imported into the US, with specific exemptions for produce rarely consumed raw, farm-direct consumption, and items undergoing commercial processing that reduces microorganisms of public health significance.
Good Laboratory Practice for Nonclinical Laboratory Studies
21 CFR Part 58 establishes Good Laboratory Practice (GLP) standards for nonclinical laboratory studies supporting FDA applications for regulated products including drugs, medical devices, biologics, food and color additives, and electronic products. The regulation ensures quality and integrity of safety data submitted under the Federal Food, Drug, and Cosmetic Act and Public Health Service Act by defining requirements for test articles, control articles, study scope, and application types covered.
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).
Thermally Processed Low-Acid Foods Packaged in Hermetically Sealed Containers
21 CFR Part 113 establishes regulatory requirements for thermally processed low-acid foods packaged in hermetically sealed containers. The regulation defines key concepts including commercial sterility, aseptic processing, critical factors, and equipment specifications to ensure microorganisms capable of reproducing under normal storage conditions are eliminated, protecting public health and maintaining product safety in shelf-stable food manufacturing.
Dissemination of Information on Unapproved/New Uses for Marketed Drugs, Biologics, and Devices
21 CFR Part 99 establishes requirements for manufacturers disseminating information about unapproved or new uses of FDA-approved drugs, biologics, and devices to healthcare practitioners, pharmacy benefit managers, health insurers, group health plans, and government agencies. The regulation defines key terms including health care practitioners, manufacturers, and new uses, and specifies that unsolicited requests from healthcare providers are exempted from these dissemination requirements.
Dietary Supplements That Present a Significant or Unreasonable Risk
This regulation designates dietary supplements containing ephedrine alkaloids as adulterated products under the Federal Food, Drug, and Cosmetic Act because they present an unreasonable risk of illness or injury under recommended or ordinary conditions of use.
Protection of Privacy
21 CFR Part 21 implements the Privacy Act of 1974 by establishing procedures for the FDA to manage, protect, and control access to records about individuals maintained in Privacy Act Record Systems. The regulation defines scope, exemptions, and key terms; limits disclosure to the individuals who are subjects of records, their legal representatives, or those with consent; and excludes certain records such as those anticipated for litigation and personnel records managed by the Division of Human Resources Management.