The Federal Food, Drug and Cosmetic Act (FDCA) (21 U.S.C. § 350d) requires that all facilities that hold, pack, manufacture or produce food (but not meat, poultry, or egg products) for animal or human consumption in the U.S. must register with the U.S. Food and Drug Administration (FDA) prior to beginning manufacturing/processing, packing, or holding food. Facilities that fail to register face civil suit and/or criminal prosecution. The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 added the registration requirement to assist FDA response in case of bioterrorism attack or other food-related emergency.
Registration is only required once. However, if information about the facility changes, the facility must submit a registration update within 60 days of the change. If the facility is relocated, the existing registration must be cancelled and a new registration submitted. If the facility goes out of business or changes ownership, the facility must submit a registration cancellation within 60 days. Cancellations are irreversible.
FDA has published a helpful, 16-page guide on facility registration titled What You Need to Know About Registration of Food Facilities.1 The Guide explains who must register (including exemptions), and how to register.
Facilities Exempted From Registration (21 C.F.R. § 1.226)
Many types of direct farm businesses are exempt from registration requirements. Farms, retail facilities, restaurants, nonprofit food facilities, fishing vessels, and operations regulated exclusively by USDA (e.g., meat, poultry, egg products) throughout the entire facility are exempt from the registration requirement.
Whether a direct farm business qualifies for an exception to the registration requirement depends on the definitions set forth in FDA regulations:
Farm (21 C.F.R. § 1.227(b)(3)): a facility in one general physical location devoted to the growing and harvesting of crops, the raising of animals (including seafood), or both. Washing, trimming of outer leaves of, and cooling produce are considered part of harvesting. The term “farm” includes:
Facilities that pack or hold food, provided that all food used in such activities is grown, raised, or consumed on that farm or another farm under the same ownership; and,
Facilities that manufacture/process food, provided that all food used in such activities is consumed on that farm or another farm under the same ownership.
Restaurant (21 C.F.R. § 1.227(b)(10)): a facility that prepares and sells food directly to consumers for immediate consumption. “Restaurant” does not include facilities that provide food to interstate conveyances, central kitchens, and other similar facilities that do not prepare and serve food directly to consumers.
Entities in which food is provided to humans, such as cafeterias, lunchrooms, cafes, bistros, fast food establishments, food stands, saloons, taverns, bars, lounges, catering facilities, hospital kitchens, day care kitchens, and nursing home kitchens are restaurants; and,
Pet shelters, kennels, and veterinary facilities in which food is provided to animals are restaurants.
Retail Food Establishment (21 C.F.R. § 1.227(b)(11)): an establishment that sells food products directly to consumers as its primary function. A retail food establishment may manufacture/process, pack, or hold food if the establishment's primary function is to sell from that establishment food, including food that it manufactures/processes, packs, or holds, directly to consumers. A retail food establishment's primary function is to sell food directly to consumers if the annual monetary value of sales of food products directly to consumers exceeds the annual monetary value of sales of food products to all other buyers. The term “consumers” does not include businesses. A “retail food establishment” includes grocery stores, convenience stores, and vending machine locations.
Many questions arise about whether a facility qualifies for an exemption under these definitions. FDA considers some facilities "mixed-type" that require registration. For example, a maple syrup operation that harvests maple sap and then heats the maple sap into syrup for sale to a distributor or grocery store is an example of mixed-type facility that requires registration, because even though taking sap from a tree is harvesting, heating sap into syrup is considered processing. The facility would not qualify for the retail food establishment exception because the final product is not sold directly to consumers. The FDA has published guidance containing a long list of questions and answers regarding whether an exception to registration applies.
Also, the following flowcharts, created and designed by the website authors, can be used to determine whether the facility is exempted from registration:
Does your facility qualify for the "retail food establishment" exemption?
If you are uncertain whether your facility must register, you can contact the FDA help line at 1-800-216-7331.
How to Register and Update A Registration
FDA maintains a web page containing step-by-step instructions on how to register online. In order to register electronically, the user must first create an account with the FDA. FDA has a web-based tutorial on how to create an account.
Registration can also be done through the mail, fax or cd-rom by downloading Form 3537. Instructions for filing out the form can be found here.
For information on how to update a registration, click here.
How to Cancel a Registration
FDA maintains a web page containing step-by-step instructions on how to cancel a registration online. Form 3537a is used for cancelling a registration.
1 Click here for the file on the FDA's website.
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