Showing 351–400 of 648 regulations
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.
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.
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.
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.
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.
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.
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
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Canned Vegetables
21 CFR Part 155 establishes standards for canned vegetables, including procedures for determining drained weight, quality compliance, fill of container, and sampling/acceptance criteria. The regulation defines lot compliance based on defect limits, establishes sampling plans and acceptance numbers, and specifies color measurement standards using Munsell color discs for products like tomato concentrates.
Food Standards: General
21 CFR Part 130 establishes general provisions for food standards under the Federal Food, Drug, and Cosmetic Act. It defines key terms, procedures for establishing food standards through formal petition and public hearing processes, and FDA's review framework for Codex Alimentarius standards. All standardized foods must comply with ingredient listing requirements, use only safe and suitable ingredients, and cannot be adulterated or misbranded regardless of compliance with specific food definitions.
Canned Fruits
21 CFR Part 145 establishes federal standards of identity and quality for canned fruits. It defines key ingredients and processing terms including corn sirup, glucose sirup, invert sugar sirup, fruit juice, and packing media. The regulation specifies compositional requirements, density measurement procedures, and labeling standards to ensure safety and consistency in canned fruit products.
Guidelines for State Licensing of Wholesale Prescription Drug Distributors
This regulation establishes minimum standards and conditions for state licensing of wholesale prescription drug distributors operating in interstate commerce, implementing the Prescription Drug Marketing Act of 1987. It defines key terms including prescription drugs, wholesale distribution, wholesale distributors, and health care entities, while specifying exemptions from wholesale distribution requirements such as intracompany sales, emergency transfers, drug samples, and certain inter-entity transactions.
Indirect Food Substances Affirmed as Generally Recognized as Safe
21 CFR Part 186 establishes the regulatory framework for indirect food substances affirmed as Generally Recognized as Safe (GRAS) by the FDA. These substances migrate into food from food-contact surfaces such as packaging and containers, and must comply with specified purity standards and current good manufacturing practices. Use is limited to indirect food contact and is prohibited where it may deceive consumers or violate the Federal Food, Drug, and Cosmetic Act.
Substances Prohibited from Use in Human Food
21 CFR Part 189 prohibits specified substances from use in human food due to public health risks or insufficient safety data. It establishes rules for prohibited cattle materials, including specified risk materials (brain, spinal cord, eyes), small intestine, material from nonambulatory disabled cattle, and mechanically separated beef. Certain tallow and derivatives are permitted if they meet purity standards. The FDA may modify the prohibited list based on new scientific evidence.
Substances Generally Recognized as Safe
21 CFR Part 182 establishes FDA regulations for substances generally recognized as safe (GRAS) for use in food. The regulation defines GRAS status, outlines good manufacturing practice requirements including quantity restrictions and food-grade purity standards, and lists approved food ingredients such as spices, essential oils, natural extractives, and synthetic flavoring substances that may be used in accordance with the established guidelines.
Vegetable Juices
21 CFR Part 156 establishes standards for vegetable juices, defining quality and composition metrics including color strength (measured by Munsell color disc comparison), tomato soluble solids content (determined by refractive index), and salt content (sodium chloride). The regulation specifies sampling and acceptance procedures to determine compliance with quality and fill standards for lots of canned vegetable juice products.
Food Additive Petitions
21 CFR Part 171 establishes procedural requirements for petitions requesting approval of food additives under section 409(b) of the Federal Food, Drug, and Cosmetic Act. Petitioners must submit detailed information on the additive's chemical identity, composition, manufacturing process, analytical controls, stability data, and safety assessments to the FDA's Office of Food Additive Safety. Submissions must be in triplicate (or quadruplicate for meat/poultry uses) with English translations of foreign materials and supporting documentation.
Indirect Food Additives: Adjuvants, Production Aids, and Sanitizers
21 CFR Part 178 establishes regulations for indirect food additives used as adjuvants, production aids, and sanitizers. It permits hydrogen peroxide solution (max 35% by weight) to sterilize food-contact polymeric surfaces with residue limits not exceeding 0.5 ppm, and allows sanitizing solutions containing hypochlorite compounds on food-processing equipment and utensils, subject to adequate drainage before food contact.
Margarine
21 CFR Part 166 establishes labeling requirements for margarine and oleomargarine products. Manufacturers must display the word "margarine" or "oleomargarine" prominently on all package panels in type at least as large as any other label text, meeting specific height, area, and boldness criteria. Products must comply with identity standards and include full ingredient statements. Requirements apply to both colored and uncolored margarine sold in interstate commerce.
Eggs and Egg Products
21 CFR Part 160 establishes standards of identity and composition for eggs and egg products, including dried eggs and frozen eggs. Dried eggs must contain at least 95% egg solids and be free of viable Salmonella, with optional glucose removal via enzyme or yeast procedures and anticaking agents (silicon dioxide ≤1% or sodium silicoaluminate <2%). Frozen eggs must similarly be Salmonella-free and may contain monosodium or monopotassium phosphate (≤0.5% by weight). All ingredients must be labeled.
Sweeteners and Table Sirups
21 CFR Part 168 establishes standardized specifications for sweeteners and table syrups, including dextrose anhydrous, dextrose monohydrate, and glucose syrup. Requirements cover minimum solids content, reducing sugar content, sulfated ash limits, and sulfur dioxide content, with testing methods referenced from AOAC official methods.
Dietary Supplements
21 CFR Part 190 establishes premarket notification requirements for dietary supplements containing new dietary ingredients not previously present in the food supply. Manufacturers or distributors must submit safety information to FDA at least 75 days before introducing such products to interstate commerce, including ingredient identification, usage conditions, safety history, and published evidence supporting safety conclusions. FDA acknowledges receipt and assigns a filing date; the product cannot be marketed during the 75-day review period unless FDA determines no safety concern exists.
Indirect Food Additives: Polymers
21 CFR Part 177 establishes safety standards for acrylic and modified acrylic plastics used in food contact applications. The regulation permits semirigid and rigid acrylic polymers as articles or components in contact with food, provided they contain at least 50% polymer units from specified acrylic or methacrylic monomers. Optional additives include GRAS substances and approved compounds; specific monomers and copolymers are listed, with restrictions on minor monomers for repeated-use articles only.
Requirement for Authorized Dispensers and Pharmacies to Distribute a Side Effects Statement
21 CFR Part 209 requires authorized dispensers and pharmacies to distribute a standardized side effects statement with each dispensed prescription drug product approved under FDA section 505. The statement directs consumers to call their doctor about side effects and report adverse events to FDA at 1-800-FDA-1088. Distribution must occur with new and refill prescriptions via sticker, vial cap, separate paper, consumer medication information, or FDA-approved Medication Guide, using clear type no smaller than 6-10 points depending on format.
Frozen Vegetables
21 CFR Part 158 establishes standards for frozen vegetables, specifically defining identity, size specifications, and labeling requirements. Frozen peas must be prepared from Pisum sativum L., blanched, drained, and frozen to −18 °C or lower. Standards address acceptable quality levels, defect criteria, size grading (minimum 80% by weight of declared size), and mandatory label declarations including product name, freezing method, flavoring, and condiments.
Cacao Products
21 CFR Part 163 establishes standards for cacao products, including specifications for cacao nibs. The regulation prescribes analytical methods for determining shell and fat content, defines cacao nibs as shelled cacao beans with maximum 1.75% shell content, permits optional alkali processing and neutralizing agents within specified limits, and requires labeling statements identifying processing methods used.
Bakery Products
21 CFR Part 136 establishes federal standards for bakery products, particularly bread, rolls, and buns. It defines product categories by weight post-cooling, specifies mandatory and optional ingredients (flour, yeast, water, milk, eggs, sweeteners, etc.), sets minimum total solids content at 62%, and limits certain additives like monocalcium phosphate and carrageenan. All ingredients must be safe and suitable for consumption.
Indirect Food Additives: Paper and Paperboard Components
21 CFR Part 176 establishes safety standards for indirect food additives used as components in paper and paperboard intended for food contact. The regulation permits specific substances—including acrylamide-acrylic acid resins, alkyl ketene dimers, anti-offset agents, chelating agents, and chromium complexes—for use in paper manufacturing under defined conditions and concentration limits to prevent chemical migration into food while maintaining packaging performance.
Food Additives Permitted for Direct Addition to Food for Human Consumption
21 CFR Part 172 establishes regulations for food additives permitted for direct addition to human food. The regulation prescribes general provisions requiring additives be used only in quantities necessary to achieve their intended effect and meet food-grade standards. Subpart B details specific approvals, including anoxomer (CAS 60837-57-2), a polymeric antioxidant permitted for use in fats and oils up to 5,000 ppm, subject to defined purity, molecular weight, and heavy metal specifications.
Mitigation Strategies to Protect Food Against Intentional Adulteration
21 CFR Part 121 establishes mitigation strategies to protect food against intentional adulteration. It applies to domestic and foreign food facilities that manufacture, process, pack, or hold food for U.S. consumption and are required to register under the Federal Food, Drug, and Cosmetic Act. The rule defines key terms including actionable process steps, food defense, contaminants (biological, chemical, physical, or radiological agents), and verification/monitoring requirements to ensure mitigation strategies operate as intended.