If you are thinking about opening a food business, there are many regulatory requirements that yous volition need to meet. Some of these requirements apply to all food businesses, and some are specific to the particular food product, such as low-acid canned food, seafood, or juice.

This information provides a cursory overview of regulatory requirements that chronicle to starting a food business. In improver to the Food and Drug Administration's (FDA'due south) requirements, your food business volition be subject to other federal, state, and local requirements. These will vary depending on the your product and the type of facility y'all operate. If yous are planning to operate a food concern, you may want to discuss your specific product and facility with the FDA Commune Function and the state and local regulatory agencies that have jurisdiction. These discussions will help yous identify what country and local regulations must be met related to operating a food business concern.

On this page:

  • Food Businesses Bailiwick to FDA Regulation
  • Home-Based Businesses
  • Food Facility Registration
  • Nutrient Imports
  • Prior Find
  • Recordkeeping
  • Good Manufacturing Practise Requirements
  • Hazard Analysis & Critical Command Points (HACCP)
  • Nutrient Additives
  • Food Contact Substances
  • Labeling
  • Reporting
  • Preventive Controls
  • Inspections
  • Dietary Supplements
  • Boosted Information
    • Responsibility of a Food Facility
    • Specific Nutrient Production Requirements
  • Resources

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Food Businesses Field of study to FDA Regulation

FDA regulates all foods and food ingredients introduced into or offered for auction in interstate commerce, with the exception of meat, poultry, and certain candy egg products regulated by the U.Southward. Section of Agriculture (USDA).

The Center for Food Safety and Practical Nutrition (CFSAN), works with FDA field offices to ensure that the nations' food supply (except meat, poultry and some egg products, which are regulated by USDA) is prophylactic, sanitary, wholesome, and honestly labeled and that cosmetic products are safe and properly labeled.

Examples of Nutrient businesses Non regulated past FDA:

  • Retail food establishments (i.eastward. grocery stores, restaurants, cafeterias, and food trucks), which are regulated by state and local governments.
  • Farmers markets

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Home-Based Business

If you lot are starting a home-based food business, you volition demand to sympathize the regulations of FDA and your state and local health department. Local and canton wellness agencies inspect food service and food retail establishments, provide technical aid to food facilities and educate consumers about nutrient rubber.

Under federal regulations at Championship 21, Lawmaking of Federal Regulations (CFR), section 1.227 (21 CFR i.227), a private residence is not a "facility" and thus, is not required to exist registered with FDA.

A individual residence must run across customary expectations for a private home and does not otherwise include commercial facilities in which a person as well happens to reside. Thus, a individual residence (domestic or foreign) that meets customary expectations for a individual residence that is also used to manufacture, process, pack, or hold food need non be registered.

Be sure to advisedly review the regulations to understand how they use to your unique gear up of circumstances.

Requirements governing what FDA regulates:

  • What Does FDA Regulate?
  • Federal Food, Drug, and Corrective Act (FFD&C Act)
  • Title 21 of the Code of Federal Regulations (21 CFR)
  • Public Health Service Act (several provisions of this act provide FDA with of import statutory authorisation, such every bit the say-so to issue regulations for the control of catching diseases)
  • Laws Enforced by FDA

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Food Facility Registration

Facilities that manufacture, process, pack, or agree food that is intended for human or brute consumption in the United States must annals with FDA before beginning these activities. The registration requirement applies to any facility that conducts these activities, unless a facility is specifically exempt under 21 CFR 1.226. For instance, farms, retail nutrient establishments, and restaurants are exempt from food facility registration requirements.

For a full list of exempted facilities delight visit the links below.

Facility Registration:

  • Registration of Food Facilities
  • Guidance for Industry: What You Need to Know Nigh Registration of Food Facilities; Minor Entity Compliance Guide
  • Guidance for Industry: Questions and Answers Regarding Food Facility Registration (Sixth Edition)

Requirements governing food facility registration:

  • Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act)
  • 21 CFR department one.225
  • Nutrient Rubber Modernization Deed (FSMA)
  • Food Defense Guidance Documents & Regulatory Information

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Food Imports

Nutrient imported into the United states must meet the same laws and regulations as nutrient produced in the U.s.a.. It must exist safe and contain no prohibited ingredients, and all labeling and packaging must be informative and true, with the labeling information in English (or Spanish in Puerto Rico).

All imported food is considered to be interstate commerce.

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Prior Notice

Every bit of Dec 12, 2003, FDA must be notified in accelerate of whatsoever shipments of nutrient for humans and other animals that are imported into the U.S., unless the food is exempt from Prior Notice.

Prior Notice of imported food shipments provide FDA with an opportunity to, review and evaluate data earlier a food product arrives in the U.S., audit and intercept contaminated food products

  • Prior Observe of Imported Foods
  • What You lot Demand to Know nearly Prior Notice of Imported Nutrient Shipments

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Recordkeeping

Food manufacturers, processors, packers, transporters, distributors, receivers, holders, and importers are required to institute, maintain, and make bachelor to FDA upon request certain records that will let the agency to identify all food products handled by the facility.

For instance, if your business organisation is required to register under the Bioterrorism Human activity and makes cookie dough that is later on baked and packaged by another facility, your records must include the names and addresses of the facilities from which y'all get your ingredients, plus the names and addresses of the facilities where yous send your dough to be baked and packaged. This is also known as "one up, i down" in the distribution chain.

Depending on the type of food concern you operate, your food business may take to keep records in addition to those required under the Bioterrorism Act and to make them available to FDA. You may desire to consult Title 21 of the Code of Federal Regulations to determine what records are required for a specific type of facility and operation. Requirements may vary depending on the food commodity and the blazon of food processing in your business.

Requirements governing recordkeeping:

  • Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act)
  • 21 CFR Function 1, Subpart J
  • Food Safety Modernization Act

Resources:

  • Establishment and Maintenance of Records
  • Records and Records Admission nether the Food Safety Modernization Act (FSMA)

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Expert Manufacturing Practice Requirements

Current Adept Manufacturing Practice (cGMP) regulations require that food offered for auction or introduced into interstate commerce be produced nether safe and sanitary conditions.

Sure nutrient commodities have additional requirements because of inherent hazards, item attributes, or specific manufacturing processes. For case, certain egg producers must follow the Egg Rubber Final Rule in guild to reduce the spread of Salmonella Enteritidis, a known pathogen of eggs.

Requirements governing cGMP:

  • 21 CFR Part 117

Resources:

  • Skilful Manufacturing Practices (GMPs) for the 21st Century - Food Processing
  • Commodity Specific Information (Eggs, Milk, Seafood, and more)
  • Bad Bug Book (Second Edition)

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Labeling

Food manufacturers are responsible for developing labels (including diet information) that meet legal food labeling requirements. All labeling of FDA-regulated food products must exist true and not misleading. Proper labeling, including diet labeling and labeling for the major food allergens, is required for most prepared foods.

Note: The labels of nutrient products sold in U.S. interstate commerce must be in English language. However, foods distributed solely in Puerto Rico may acquit labels in Castilian instead of English. Encounter Compliance Policy Guide Sec. 562.750 Labeling of Food Articles Distributed Solely in Puerto Rico.

Requirements governing the labeling of foods:

  • Federal Food, Drug, and Cosmetic Act (FFD&C Act)
  • Off-white Packaging and Labeling Act
  • Nutrition Labeling and Education Deed
  • Food Allergen labeling and Consumer Protection Human action of 2004
  • FDA's regulations on nutrient labeling - 21 CFR 101

Resources:

  • Nutrient Labeling and Nutrition Overview
  • Nutrient Labeling Guide
  • Food Allergens Labeling Information
  • Small Business Nutrition Labeling Exemption
  • Labeling & Nutrition Guidance Documents & Regulatory Information - Topic–Specific Labeling Information

Developing Labels:

  • Manufacturers may choose to rent a commercial laboratory to perform analyses of foods to make up one's mind nutrient content. FDA cannot recommend whatever detail laboratory.
  • The U.s. Department of Agriculture's Food Nutrient Database tin can be used to develop appropriate nutrient information for products. This information may be used in conjunction with food product recipes to calculate diet information required for nutrient labels.
  • FDA's Nutrition Labeling Manual provides technical instructions to manufacturers nearly how to develop and apply nutrition databases for food products.

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Reporting

Registered facilities must report when there is a reasonable probability that the use of, or exposure to, an article of nutrient will cause serious adverse health consequences or death to humans or animals. Information is bachelor about how to study these situations to FDA'due south Reportable Food Registry.

FDA allows conventional food manufacturers, processors, packers, transporters, distributors, receivers, holders, and importers to forward reports of serious adverse events in connection with their products to FDA by filing Course 3500.

FDA requires reporting of serious adverse events involving dietary supplements. See Dietary Supplements - Reporting an Agin Event and Guidance for Manufacture: Questions and Answers Regarding Agin Event Reporting and Recordkeeping for Dietary Supplements as Required past the Dietary Supplement and Nonprescription Drug Consumer Protection Deed for additional data.

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Preventive Controls

The FDA Food Condom Modernization Deed (FSMA), signed into law in January 2011, enables FDA to focus more on preventing food safety bug rather than relying primarily on reacting to problems after they occur. Run into Preventive Standards Under the Food Safety Modernization Act for more data.

Unless specifically exempted by FSMA, the owner, operator, or amanuensis in accuse of a facility will be required to:

  • Evaluate the hazards that could affect food manufactured, candy, packed, or held by the facility;
  • Place and implement preventive controls to significantly minimize or prevent the occurrence of such hazards;
  • Provide assurances that such food is not adulterated under section 402 or misbranded under section 403(w) of the Federal Food, Drug, and Cosmetic Deed;
  • Monitor the performance of those controls; and
  • Routinely maintain records of this monitoring.

Note: FDA is currently developing proposed regulations to implement requirements under the FSMA. Information near FSMA implementation is posted on the FDA website. Y'all can sign up for FSMA updates to receive updates on implementation and progress via east-postal service.

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Inspections

Investigators with FDA'south Office of Regulatory Affairs (ORA) inspect FDA-regulated facilities. Alternatively, FDA may arrange for land regulatory officials to comport inspections on behalf of the agency. ORA offices are located throughout the country. A list of local ORA offices provides a point of contact for manufacturers and distributors located inside each jurisdiction. State regulatory agencies tin provide information well-nigh their state and local agencies' contacts, requirements, and inspections.

FDA inspects food facilities on a varying schedule based upon the risk level of the product, time elapsed since previous inspection, and compliance history, as well every bit other factors. For instance, infant formula facilities are inspected annually.

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Dietary Supplements

FDA regulates both finished dietary supplement products and dietary supplement ingredients. Dietary supplements are regulated under a different prepare of regulations than those roofing "conventional" foods and drug products.

Dietary supplements are regulated under the Dietary Supplement Health and Education Human activity of 1994 (DSHEA). However, dietary supplement manufacturers and distributors are not required to obtain blessing from FDA earlier marketing dietary supplements. Before a firm markets a dietary supplement, the firm is responsible for ensuring that the products it manufactures or distributes are safe; any claims made about the products are not simulated or misleading; and that the products comply with the Federal Food, Drug, and Corrective Human action and FDA regulations in all other respects.

Resources:

  • Dietary Supplements Guidance Documents & Regulatory Information
  • Dietary Supplement Labeling Guide
  • National Institutes of Health, Office of Dietary Supplements

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Additional Information

Responsibility of a Food Facility

Nether provisions of the Federal Food, Drug, and Corrective Deed (FFD&C Deed), and FDA's implementing regulations found in Title 21 of the Code of Federal Regulations, nutrient manufacturers, processors, and distributors are responsible for ensuring that their products that are intended for distribution in U.Southward. interstate commerce are prophylactic, sanitary, and labeled co-ordinate to federal requirements.

Specific Nutrient Product Requirements

Sure foods, such as depression-acid canned foods, milk, eggs, juices, seafood, and infant formula, take boosted product-specific regulatory requirements to ensure that they are healthful and gratuitous of contamination.

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Resources

  • Minor Business Guide to FDA
  • Is It Really FDA Approved
  • Local Health Departmentdisclaimer icon: Delight speak with your local health section to determine if y'all will be required to meet state and local laws.
  • Advert: The Federal Trade Commission (FTC) primarily regulates advertising. See Advertising FAQs: A Guide for Small Business for additional data on advertizement regulations.
  • Business organisation Development: The U.S. Small Business Administration (SBA) tin assist you with developing a business organization plan for your food or drinkable visitor.

The information provided on this webpage is an informal advice that is not intended to exist guidance. FDA's good guidance practices, its policies and procedures for developing, issuing, and using guidance documents, are gear up along in 21 CFR 10.115.

CFSAN's intent in posting this information is to provide an overview of the discipline matter, with links to more detailed information such as federal laws, regulations, guidance documents, and other federal agency websites. Additional data almost state and local laws, regulations, requirements, and guidance may be available from land and local agencies and resources.

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