How To Get Fda Approval For Food

If you are thinking about opening a food business, there are many regulatory requirements that you will 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 relate to starting a food business. In addition to the Food and Drug Administration's (FDA's) requirements, your food business will be subject to other federal, state, and local requirements. These will vary depending on the your product and the type of facility you operate. If you are planning to operate a food business, you may want to discuss your specific product and facility with the FDA District Office and the state and local regulatory agencies that have jurisdiction. These discussions will help you identify what state and local regulations must be met related to operating a food business.

On this page:

Food Businesses Subject to FDA Regulation
Home-Based Businesses
Food Facility Registration
Food Imports
Prior Notice
Recordkeeping
Good Manufacturing Practice Requirements
Hazard Analysis & Critical Control Points (HACCP)
Food Additives
Food Contact Substances
Labeling
Reporting
Preventive Controls
Inspections
Dietary Supplements
Additional Information
- Responsibility of a Food Facility
- Specific Food Product Requirements
Resources

Food Businesses Subject to FDA Regulation

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

The Center for Food Safety and Applied 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 safe, sanitary, wholesome, and honestly labeled and that cosmetic products are safe and properly labeled.

Examples of Food businesses NOT regulated by FDA:

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

Home-Based Business

If you are starting a home-based food business, you will need to understand the regulations of FDA and your state and local health department. Local and county health agencies inspect food service and food retail establishments, provide technical assistance to food facilities and educate consumers about food safety.

Under federal regulations at Title 21, Code of Federal Regulations (CFR), section 1.227 (21 CFR 1.227), a private residence is not a "facility" and thus, is not required to be registered with FDA.

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

Be sure to carefully review the regulations to understand how they apply to your unique set of circumstances.

Requirements governing what FDA regulates:

What Does FDA Regulate?
Federal Food, Drug, and Cosmetic 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 important statutory authority, such as the authority to issue regulations for the control of communicable diseases)
Laws Enforced by FDA

Food Facility Registration

Facilities that manufacture, process, pack, or hold food that is intended for human or animal consumption in the United States must register 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 example, farms, retail food establishments, and restaurants are exempt from food facility registration requirements.

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

Facility Registration:

Registration of Food Facilities
Guidance for Industry: What You Need to Know About Registration of Food Facilities; Small 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 section 1.225
Food Safety Modernization Act (FSMA)
Food Defense Guidance Documents & Regulatory Information

Food Imports

Food imported into the United States must meet the same laws and regulations as food produced in the United States. It must be safe and contain no prohibited ingredients, and all labeling and packaging must be informative and truthful, with the labeling information in English (or Spanish in Puerto Rico).

All imported food is considered to be interstate commerce.

Prior Notice

As of December 12, 2003, FDA must be notified in advance of any shipments of food 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 information before a food product arrives in the U.S., inspect and intercept contaminated food products

Prior Notice of Imported Foods
What You Need to Know about Prior Notice of Imported Food Shipments

Recordkeeping

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

For instance, if your business is required to register under the Bioterrorism Act and makes cookie dough that is subsequently baked and packaged by another facility, your records must include the names and addresses of the facilities from which you get your ingredients, plus the names and addresses of the facilities where you send your dough to be baked and packaged. This is also known as "one up, one down" in the distribution chain.

Depending on the type of food business you operate, your food business may have to keep records in addition to those required under the Bioterrorism Act and to make them available to FDA. You may want 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 type of food processing in your business.

Requirements governing recordkeeping:

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

Resources:

Establishment and Maintenance of Records
Records and Records Access under the Food Safety Modernization Act (FSMA)

Good Manufacturing Practice Requirements

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

Certain food commodities have additional requirements because of inherent hazards, particular attributes, or specific manufacturing processes. For instance, certain egg producers must follow the Egg Safety Final Rule in order to reduce the spread of Salmonella Enteritidis, a known pathogen of eggs.

Requirements governing cGMP:

21 CFR Part 117

Resources:

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

Labeling

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

Note: The labels of food products sold in U.S. interstate commerce must be in English. However, foods distributed solely in Puerto Rico may bear labels in Spanish instead of English. See 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)
Fair Packaging and Labeling Act
Nutrition Labeling and Education Act
Food Allergen labeling and Consumer Protection Act of 2004
FDA's regulations on food labeling - 21 CFR 101

Resources:

Food Labeling and Nutrition Overview
Food 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 hire a commercial laboratory to perform analyses of foods to determine nutrient content. FDA cannot recommend any particular laboratory.
The United States Department of Agriculture's Food Nutrient Database can be used to develop appropriate nutrient information for products. This information may be used in conjunction with food product recipes to calculate nutrition information required for food labels.
FDA's Nutrition Labeling Manual provides technical instructions to manufacturers about how to develop and use nutrition databases for food products.

Reporting

Registered facilities must report when there is a reasonable probability that the use of, or exposure to, an article of food will cause serious adverse health consequences or death to humans or animals. Information is available about how to report these situations to FDA's 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 Form 3500.

FDA requires reporting of serious adverse events involving dietary supplements. See Dietary Supplements - Reporting an Adverse Event and Guidance for Industry: Questions and Answers Regarding Adverse Event Reporting and Recordkeeping for Dietary Supplements as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act for additional information.

Preventive Controls

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

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

Evaluate the hazards that could affect food manufactured, processed, packed, or held by the facility;
Identify 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 Act;
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 about FSMA implementation is posted on the FDA website. You can sign up for FSMA updates to receive updates on implementation and progress via e-mail.

Inspections

Investigators with FDA's Office of Regulatory Affairs (ORA) inspect FDA-regulated facilities. Alternatively, FDA may arrange for state regulatory officials to conduct 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 within each jurisdiction. State regulatory agencies can provide information about 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 as other factors. For instance, infant formula facilities are inspected annually.

Dietary Supplements

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

Dietary supplements are regulated under the Dietary Supplement Health and Education Act of 1994 (DSHEA). However, dietary supplement manufacturers and distributors are not required to obtain approval from FDA before 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 false or misleading; and that the products comply with the Federal Food, Drug, and Cosmetic Act 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

Additional Information

Responsibility of a Food Facility

Under provisions of the Federal Food, Drug, and Cosmetic Act (FFD&C Act), and FDA's implementing regulations found in Title 21 of the Code of Federal Regulations, food manufacturers, processors, and distributors are responsible for ensuring that their products that are intended for distribution in U.S. interstate commerce are safe, sanitary, and labeled according to federal requirements.

Specific Food Product Requirements

Certain foods, such as low-acid canned foods, milk, eggs, juices, seafood, and infant formula, have additional product-specific regulatory requirements to ensure that they are healthful and free of contamination.

Resources

Small Business Guide to FDA
Is It Really FDA Approved
Local Health Department: Please speak with your local health department to determine if you will be required to meet state and local laws.
Advertising: The Federal Trade Commission (FTC) primarily regulates advertising. See Advertising FAQs: A Guide for Small Business for additional information on advertising regulations.
Business Development: The U.S. Small Business Administration (SBA) can assist you with developing a business plan for your food or beverage company.

The information provided on this webpage is an informal communication that is not intended to be guidance. FDA's good guidance practices, its policies and procedures for developing, issuing, and using guidance documents, are set forth in 21 CFR 10.115.

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