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Food Additives Permitted in Food or in Contact with Food on an Interim Basis Pending Additional Study
21 CFR Part 180 establishes the regulatory framework for interim approval of food additives and food-contact substances when new safety or functionality concerns arise but evidence does not conclusively prove harm. Interim regulations permit continued use during study periods, subject to specified limitations, mandatory progress reporting every six months, and compliance with good laboratory practice standards. The FDA may revoke interim approvals if adequate studies are not initiated within 60 days or if interim results indicate health hazards.
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.
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.
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.
Processing and Bottling of Bottled Drinking Water
21 CFR Part 129 establishes current good manufacturing practice requirements for processing and bottling of bottled drinking water. The regulation mandates that facilities use approved water sources, maintain sanitary conditions throughout processing, bottling, holding, and shipping, and implement controls ensuring product safety. Key requirements include plant construction standards with separated bottling rooms, proper ventilation, enclosed container washing areas, and use of nontoxic materials for water-contact surfaces.
Canned Fruit Juices
21 CFR Part 146 establishes federal standards for canned fruit juices, including definitions of ingredients (corn syrup, dextrose, glucose syrup, invert sugar, refined sugar) and compliance procedures. It specifies sampling and acceptance criteria for quality and container fill, with detailed lot definitions and defective unit classifications. The regulation includes specific identity standards for lemon juice requiring mechanical extraction from mature lemons with minimum soluble solids content.
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: General
21 CFR Part 174 establishes general regulatory provisions for indirect food additives—substances used in food-contact articles such as packaging and processing equipment. It defines good manufacturing practice requirements, including limits on additive migration into food and purity standards for components. The regulation permits use of substances generally recognized as safe, those with prior approval, and those meeting negligible migration thresholds, provided they comply with all applicable Federal Food, Drug, and Cosmetic Act provisions.
Macaroni and Noodle Products
21 CFR Part 139 establishes standards of identity and labeling requirements for macaroni and noodle products. It defines macaroni, spaghetti, and vermicelli based on shape and diameter, specifies permitted optional ingredients including egg white, disodium phosphate, seasonings, salt, gum gluten, and glyceryl monostearate with quantitative limits, and requires labeling statements disclosing optional ingredients used in the finished product.
Secondary Direct Food Additives Permitted in Food for Human Consumption
21 CFR Part 173 establishes permitted secondary direct food additives for human consumption, including polymer substances and adjuvants. The regulation specifies acrylate-acrylamide resins, modified polyacrylamide resins, and ion-exchange membranes as safe food processing additives with defined usage limits and residual monomer restrictions. Acrylamide-based resins are approved as flocculents in sugar juice clarification and scale control, while ion-exchange membranes are permitted for juice processing and pH adjustment.
Cereal Flours and Related Products
21 CFR Part 137 establishes standardized requirements for cereal flours and related products. The regulation defines wheat flour specifications including granulation standards (≥98% passing 212 µm sieve), ash and protein limits, moisture content (≤15%), and permitted optional ingredients such as dough conditioners (ascorbic acid up to 200 ppm) and bleaching agents (chlorine, benzoyl peroxide, azodicarbonamide, etc.). All ingredients must be labeled per FDA requirements, with specific declarations required for bleached flour and enzyme additions.
Food Additives
21 CFR Part 170 establishes regulatory definitions and general provisions governing food additives under the Federal Food, Drug, and Cosmetic Act. A food additive is any substance not exempted by law whose intended use may result in it becoming a component of food or affecting food characteristics, including substances in food contact articles and packaging materials. The regulation defines key terms including food contact substances, common use in food, and safety standards requiring reasonable certainty of harmlessness under conditions of intended use, determined through scientific procedures or general recognition of safety.
Fish and Fishery Products
21 CFR Part 123 establishes food safety regulations for fish and fishery products, defining key terms and concepts including critical control points, critical limits, food safety hazards, and preventive measures. The regulation applies to processors engaged in commercial handling, preparation, manufacturing, and preservation of fish and molluscan shellfish intended for human consumption, but exempts harvesting, on-vessel preparation, and retail establishments.
Fish and Shellfish
21 CFR Part 161 establishes standards of identity and labeling requirements for fish and shellfish products, particularly oysters. The regulation specifies that canned oysters must be labeled with accurate total weight declarations and sets detailed processing standards for raw, shucked oysters, including water contact time limits (max 30 minutes), draining procedures, and packing requirements to ensure product quality and consumer safety.
Beverages
21 CFR Part 165 establishes standards for beverages, particularly bottled water. It defines key terms such as lot, sample, and analytical unit for quality testing purposes. Bottled water is defined as water sealed in containers with no added ingredients except optional safe antimicrobial agents and fluoride. The regulation specifies nomenclature for different water types including artesian, ground, mineral, and purified water, with specific chemical and source requirements for each category.
Fruit Butters, Jellies, Preserves, and Related Products
21 CFR Part 150 establishes standards of identity for fruit butters, jellies, preserves, and related products. Fruit butters must be smooth, semisolid foods made from specified fruit ingredients with optional additions such as sweeteners, spices, flavorings, salt, acidifying agents, juice, preservatives, antifoaming agents, and pectin. The mixture must contain at least five parts fruit ingredient to two parts sweetener by weight, with a minimum soluble solids content of 43 percent as determined by refractometer analysis.
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.
Irradiation in the Production, Processing and Handling of Food
21 CFR Part 179 establishes safety standards for using ionizing radiation sources in food production, processing, and inspection. Approved sources include X-ray tubes (≤500 kVp), sealed isotope units (americium-241, cesium-137, cobalt-60, iodine-125, krypton-85, radium-226, strontium-90), californium-252 for moisture measurement, and machine sources up to 10 MeV. Facilities must comply with current good manufacturing practices, apply minimum effective doses not exceeding specified limits (10 grays for standard sources, 2 milligrays for californium-252), use scheduled processes, and ensure packaging compliance.
Milk and Cream
21 CFR Part 131 establishes standards of identity and labeling requirements for milk and cream products in the US. The regulation defines milk as lacteal secretion from healthy cows with minimum 8.25% milk solids not fat and 3.25% milkfat, requiring pasteurization or ultra-pasteurization for beverage use. Cream must contain at least 18% milkfat. The standards specify optional vitamin A and D fortification, permitted ingredients including fruit flavoring and stabilizers, and analytical methods for verifying composition, with detailed nomenclature and labeling 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.
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 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.
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.
Antidiarrheal Drug Products for Over-the-Counter Human Use
This regulation establishes standards for over-the-counter antidiarrheal drug products for oral use. It defines antidiarrheal drugs as those treating diarrhea symptoms and identifies bismuth subsalicylate and kaolin as approved active ingredients. The regulation mandates specific labeling requirements including use statements, warnings about contraindications (bloody/black stool, fever, mucus in stool, ulcers, bleeding disorders), and special warnings for bismuth subsalicylate products including Reye's syndrome caution and salicylate allergy alerts.
Miscellaneous Internal Drug Products for Over-the-Counter Human Use
21 CFR Part 357 establishes regulatory standards for over-the-counter anthelmintic drug products for oral administration. The regulation specifies that pyrantel pamoate is the approved active ingredient for treating pinworm infections. It defines labeling requirements including product identity, indications, warnings about potential side effects and contraindications (pregnancy, liver disease), dosage instructions based on body weight, and mandatory consumer package insert information covering pinworm identification, symptoms, life cycle, and transmission prevention.
Antacid Products for Over-the-Counter (OTC) Human Use
21 CFR Part 331 establishes standards for over-the-counter antacid products suitable for oral administration. It specifies permitted active ingredients (aluminum, magnesium, calcium, bismuth, bicarbonate, citrate, phosphate, and potassium compounds), minimum acid-neutralizing capacity requirements (5 meq), dosage limits by age group where applicable, and ingredient contribution thresholds (minimum 25% of total capacity). Products must comply with general OTC drug conditions under 21 CFR 330.1.
Miscellaneous External Drug Products for Over-the-Counter Human Use
FDA regulation 21 CFR Part 358 establishes requirements for over-the-counter wart remover drug products. Approved active ingredients are salicylic acid at specified concentrations in plaster or collodion-like vehicles. The regulation mandates labeling requirements including indications for common and plantar warts, warnings against use on irritated skin, diabetics, and certain wart types, and storage/application directions. Products must comply with general OTC drug standards and misbranding prohibitions.
Current Good Manufacturing Practice for Medicated Feeds
21 CFR Part 225 establishes current good manufacturing practice (CGMP) standards for medicated feeds to ensure drug safety, identity, strength, quality, and purity. The regulation applies to all facilities and equipment used in medicated feed production, requires qualified personnel with adequate training and supervision, and mandates proper building construction, maintenance, and sanitation to prevent contamination and pest infestation.
Common or Usual Names for Nonstandardized Animal Foods
21 CFR Part 502 establishes requirements for common or usual names of nonstandardized animal foods. Manufacturers must use simple, accurate names that identify the food's basic nature and characterizing properties. Percentage declarations of key ingredients and statements about ingredient presence or absence are required when they materially affect price, consumer acceptance, or could otherwise mislead consumers. Font size and placement requirements apply to percentage and presence/absence declarations on product labels.
New Animal Drugs
21 CFR Part 510 establishes regulatory definitions and general provisions for new animal drugs under the Federal Food, Drug, and Cosmetic Act. A new animal drug is defined as any drug intended for animals other than humans that is not generally recognized as safe and effective by qualified experts, or has been investigated for safety and effectiveness but not materially used. Newness can arise from new active substances, new combinations, new proportions, new animal species, new therapeutic uses, or new dosages and administration methods.
Unavoidable Contaminants in Animal Food and Food-Packaging Material
21 CFR Part 509 establishes the regulatory framework for managing unavoidable contaminants in animal 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 specifies procedures for setting contamination thresholds at which food is deemed adulterated and requires public notice and comment for action level changes.
Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals
This regulation establishes current good manufacturing practice (CGMP), hazard analysis, and risk-based preventive controls for animal food facilities in the US. It defines applicability criteria, prohibits operation of non-compliant animal food manufacturing facilities, and establishes requirements for hazard analysis and preventive controls. Facilities manufacturing both human and animal food may comply with human food standards instead if requirements are met.
Animal Food Labeling
This regulation establishes labeling requirements for packaged animal food, defining the principal display panel as the most visible label area and specifying its measurement for different container shapes. It requires all mandatory label information to appear prominently on either the principal display panel or information panel (positioned to its right), with minimum type size of 1/16 inch for legibility and conspicuousness.
Anticaries Drug Products for Over-the-Counter Human Use
FDA regulation 21 CFR Part 355 establishes standards for over-the-counter anticaries drug products for topical use on teeth. The regulation defines allowable active ingredients (primarily sodium fluoride), dosage forms (dentifrices, treatment rinses, preventive gels), and fluoride concentrations to prevent dental cavities. Products meeting these requirements are recognized as safe and effective.
Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use
21 CFR Part 341 establishes safety and efficacy standards for over-the-counter cold, cough, allergy, bronchodilator, and antiasthmatic drug products in oral, inhalant, or topical forms. It defines product categories, lists approved active ingredients (including antihistamines, antitussives, and bronchodilators), and sets conditions for marketing these products without misbranding.
Topical Antimicrobial Drug Products for Over-the-Counter Human Use
This regulation establishes standards for over-the-counter topical antimicrobial first aid antibiotic drug products, specifying approved active ingredients (bacitracin, neomycin sulfate, chlortetracycline hydrochloride, tetracycline hydrochloride, polymyxin B sulfate) and their permitted concentrations in ointment, cream, aerosol, and powder forms, as well as allowed combinations of these ingredients for treating minor cuts, scrapes, and burns.
General
21 CFR Part 500 establishes administrative rulings on food and animal drug manufacturing. It requires thermally processed low-acid foods in hermetically sealed containers to comply with processing and emergency permit regulations. Anthelmintic drugs for animals must include labeling directing users to consult veterinarians for parasitism diagnosis and treatment. Timed-release animal drugs are classified as new animal drugs requiring FDA approval or index listing to ensure safe and effective ingredient release rates.
Qualifying Pathogens
21 CFR Part 317 defines 'qualifying pathogens' under the Federal Food, Drug, and Cosmetic Act—microorganisms posing serious public health threats for which expedited drug development pathways apply. The regulation lists 21 qualifying pathogens including Mycobacterium tuberculosis, Staphylococcus aureus, and Streptococcus pneumoniae.
New Animal Drugs for Use in Animal Feeds
21 CFR Part 558 establishes regulatory framework for new animal drugs approved for use in animal feeds. It defines two drug categories based on withdrawal period requirements, and three medicated feed types (A, B, C) with specific manufacturing standards, nutrient composition requirements, and concentration limits. Type A articles are drug-only components; Type B feeds contain ≥25% nutrients for further feed manufacturing; Type C feeds are complete or supplemental feeds for direct animal consumption.
Food Additives
21 CFR Part 570 establishes regulatory definitions and provisions governing food additives under the Federal Food, Drug, and Cosmetic Act. It defines food additives as substances not exempted that become food components or affect food characteristics, including packaging materials with migration potential. The regulation outlines safety standards, requiring reasonable certainty of harmlessness based on scientific procedures, and addresses general recognition of safety, cumulative dietary effects, and prior sanctions.
Tolerances for Residues of New Animal Drugs in Food
21 CFR Part 556 establishes tolerances for residues of new animal drugs in food. The regulation requires applicants to submit proposed tolerances when seeking approval of new animal drugs for food-producing animals. Tolerances are set based on acceptable daily intake (ADI) and acute reference dose (ARfD) to ensure consumer safety, with residue limits codified for approved and conditionally approved drugs.
Medicated Feed Mill License
21 CFR Part 515 establishes the licensing requirements for medicated feed mills manufacturing animal feeds containing new animal drugs. Applicants must submit Form FDA 3448 with facility details, FDA registration number, responsible personnel information, and certifications confirming compliance with good manufacturing practices, applicable drug regulations, and record-keeping requirements. The FDA Center for Veterinary Medicine reviews applications within 90 days, and supplemental applications are required for ownership or address changes.
Food Additive Petitions
21 CFR Part 571 establishes the procedure for submitting food additive petitions to the FDA under the Federal Food, Drug, and Cosmetic Act. Petitioners must submit applications in triplicate with detailed information on the food additive's chemical identity, composition, manufacturing methods, analytical controls, stability data, and proposed uses. The regulation specifies content requirements including physical/chemical/biological properties, specifications, impurities, and manufacturing details for each entity involved in production.
Control of Communicable Diseases
21 CFR Part 1240 establishes FDA regulations for controlling communicable diseases through sanitation and quarantine measures. The regulation defines key terms including communicable diseases, contamination, conveyances, garbage, incubation periods, and milk/milk products. It specifies requirements for interstate traffic involving conveyances and persons, and sets minimum heat treatment standards (boiling for 30+ minutes) for garbage in food-handling establishments including houses, restaurants, hotels, and kitchens.
Intramammary Dosage Form New Animal Drugs
21 CFR Part 526 establishes regulations for intramammary dosage form new animal drugs used in lactating and dry dairy cattle. The regulation specifies approved formulations of amoxicillin, ceftiofur, and cephapirin benzathine for treating bovine mastitis, including dosing amounts, indications, milk and meat withdrawal periods, and restrictions on veterinary-only use and extralabel application.
Regulations Under the Federal Import Milk Act
21 CFR Part 1210 establishes regulatory requirements for imported milk and cream under the Federal Import Milk Act. It defines milk, cream, and related dairy products; specifies pasteurization standards (minimum 143°F for 30 minutes or 161°F for 15 seconds); and requires dairy farms and processing plants to undergo sanitary inspections scoring at least 50 out of 100 points and be available for examination by authorized agents. The rules apply to all milk and cream offered for import into the continental United States.
Substances Prohibited from Use in Animal Food or Feed
21 CFR Part 589 establishes prohibitions on substances in animal food and feed that present potential health risks or lack adequate safety data. The regulation prohibits gentian violet in all animal feed and propylene glycol in cat food, and restricts mammalian proteins in ruminant feed to prevent disease transmission. Violations render animal feed adulterated under the Federal Food, Drug, and Cosmetic Act.