Who Must Register With FDA as a Food Facility, and Who Is Exempt
Last updated 13 October 2026. Based on 21 CFR Part 1, Subpart H, as published on eCFR (current as of 8 October 2026).
If your facility manufactures or processes, packs or holds food for consumption in the United States, you must register it with FDA unless one of the exemptions in 21 CFR 1.226 applies. Foreign facilities must also name a U.S. agent. Registering does not mean FDA has approved your facility or products, and FDA does not issue registration certificates.
That is the short answer. The rest of this guide helps you work out which side of the line your own site sits on: farm or facility, exempt or not. It is written for foreign food, tea, spice, dietary supplement and pet food producers who are not sure they need food facility registration (FFR) at all. If you already know you must register, our step-by-step registration guide covers the filing itself.
The basic rule (21 CFR 1.225)
Under 21 CFR 1.225, the owner, operator or agent in charge of a domestic or foreign facility that manufactures/processes, packs or holds food for consumption in the U.S. must register it, unless a 1.226 exemption applies. You can authorize someone else to register on your behalf.
Two definitions in 21 CFR 1.227 decide how wide that rule is.
What counts as "food". For registration purposes, food is broader than most exporters expect. It includes:
dietary supplements and dietary ingredients
animal feed, including pet food
beverages, including alcoholic beverages, and bottled water
raw agricultural commodities (RACs) used as food
food ingredients and food additives
What counts as a "facility". A facility is any establishment, structure or structures under one ownership at one general physical location. A private residence is not a facility, and neither are the transport vehicles of a carrier.
The 7 exemptions in 21 CFR 1.226
# | Exempt from registration | Key condition |
|---|---|---|
(a) | Foreign facility whose food is further processed abroad | Another facility outside the U.S. further manufactures/processes (including packaging) the food before export. Not exempt if the later facility only adds labeling or does something similarly minimal. |
(b) | Farms | Must fit the farm definition in 1.227 (see below). |
(c) | Retail food establishments | Direct-to-consumer sales must be worth more than sales to all other buyers. |
(d) | Restaurants | Prepares and sells food directly to consumers for immediate consumption. |
(e) | Nonprofit food establishments | Prepares or serves food directly to consumers; must be a 501(c)(3) charity. |
(f) | Fishing vessels | Only harvesting and transporting fish, plus heading, eviscerating or freezing solely to hold the fish on board. |
(g) | USDA-only facilities | The whole facility is regulated exclusively by USDA under the meat, poultry or egg products inspection acts. |
If none of these fits your site exactly, plan on registering.
The foreign facility rule: when another overseas plant processes your food
The first exemption is the one that matters most to many exporters. A foreign facility does not need to register if its food goes to another facility outside the U.S. that further manufactures, processes or packages it before it is exported.
Worked example. A spice grinder in country A sells bulk ground spice to a blender and packer in country B. The plant in country B blends it with other spices, packs it into retail jars and exports it to the U.S. The country A grinder is exempt; the country B plant must register.
The catch. If the country B plant only puts labels on the jars, or does something similarly minimal, the exemption does not apply. Then both plants must register. Relabeling is not enough to shift the obligation downstream.
Farms: primary production vs secondary activities farms
Farms are exempt under 1.226(b), but only if they fit the farm definition in 1.227. There are two kinds.
Primary production farm. An operation under one management in one general (not necessarily contiguous) location, devoted to growing and harvesting crops, raising animals, or both. It may also:
pack and hold raw agricultural commodities
dry or dehydrate RACs to create a distinct commodity (for example, grapes into raisins), and package and label them, as long as there is no additional manufacturing or processing such as slicing
apply a ripening treatment
package and label RACs
Secondary activities farm. An operation that is not on a primary production farm and that harvests (for example, hulling or shelling), packs and/or holds RACs, provided the primary production farm(s) that grow the majority of those RACs own, or jointly own, a majority interest in it.
Where harvesting ends. Harvesting covers steps such as cutting, trimming, cooling, sifting, threshing and washing RACs. It does not include turning a RAC into a processed food. Manufacturing and processing, by contrast, include cutting, drying to create a distinct commodity, grinding, milling, mixing, packaging and labeling. Once a farm does processing beyond what its definition allows, it needs to register (see mixed-type facilities below).
Tea and matcha: farm, or facility?
Tea sits right on the line, so the exact steps matter. Here is how FDA's rules apply:
Drying whole tea leaves and packing them, with no chopping, grinding or other further processing, falls within the farm definition. The farm definition in 1.227 allows drying a crop into a distinct commodity with packaging and labeling, and FDA's own example in 21 CFR 117.5 treats dried intact herbs the same way.
Chopping, grinding (for example, into matcha powder) or blending is additional processing. 21 CFR 117.5 names "chopped or ground dried herbs (including tea)" and drying chopped tea as processing. A site that does these steps must register, even if it sits on the farm. That makes it a farm mixed-type facility.
Check your exact process. FDA's rules do not name every tea step, such as steaming, rolling, withering or oxidizing. If your process includes steps beyond drying and packing whole leaf, review them against the rules before you decide you do not need to register.
Exporting Japanese tea? Our guide to Japan food facility renewal and matcha exporters covers the practical side.
Mixed-type facilities
A mixed-type facility does some activities that are exempt and some that require registration. The most common case is a farm that also does activities outside the farm definition, such as grinding, mixing or packing other operations' finished foods. Under 1.227 that is a "farm mixed-type facility", and it must register. The exempt farm activities do not cancel out the registrable ones.
Retail, restaurants, nonprofits, fishing vessels, USDA-only plants
These exemptions are real, but they rarely help an exporter.
Retail food establishments. A retail food establishment's main job is selling food directly to consumers: direct-to-consumer sales must be worth more than sales to all other buyers. Businesses are not consumers. Exporters who sell to importers, distributors or marketplaces generally don't qualify.
Restaurants prepare and sell food directly to consumers for immediate consumption. Nonprofit food establishments must be 501(c)(3) charities that prepare or serve food directly to consumers.
Fishing vessels are exempt only while they limit themselves to harvesting, transporting and the basic on-board steps listed in the table above.
USDA-only plants are exempt only when the whole facility is regulated exclusively by USDA. A plant that also handles FDA-regulated food is not covered.
Dietary supplements and pet food
Both count as food for registration. FDA's definition of food in 1.227 includes dietary supplements, dietary ingredients and animal feed, including pet food. A facility that makes, packs or holds them for the U.S. registers like any other food facility, unless an exemption applies. For animal food, see our page on pet food FDA compliance.
If you must register: U.S. agent and the 2026 renewal
Name a U.S. agent. Under 21 CFR 1.232, a foreign facility must list a U.S. agent (name, address, phone and email) and an emergency contact. The U.S. agent must live or keep a place of business in the U.S. and be physically present there; a mailbox or answering service does not count. The agent is FDA's communications link and the default emergency contact. Under 21 CFR 1.231, FDA will not confirm a foreign registration or issue a registration number until the U.S. agent confirms they agreed to serve. See our U.S. agent for foreign food facilities service.
Register on time, then renew. Under 21 CFR 1.230, a new facility registers before it starts manufacturing/processing, packing or holding food for the U.S. After that, you renew every other year between 1 October and 31 December of each even-numbered year. 2026 is a renewal year, so the current window closes 31 December 2026.
Not sure where you stand? You can check whether your facility is registered, or let us handle it through our FDA food facility registration service.
FAQ
Does a foreign food facility have to register with FDA?
Yes, if it manufactures/processes, packs or holds food for U.S. consumption, unless a 21 CFR 1.226 exemption applies. The main foreign-only exemption covers food that another facility outside the U.S. further processes or packages before export, as long as that's more than just labeling. Foreign facilities must also name a U.S. agent.
Are farms exempt from FDA food facility registration?
Farms are exempt under 21 CFR 1.226(b). A farm can grow, harvest, pack and hold raw crops and do limited processing such as drying a crop into a distinct commodity and packing it. If it goes beyond the farm definition, it's a farm mixed-type facility and must register.
Does a tea farm need FDA registration?
It depends on the steps. Drying whole tea leaves and packing them, with no chopping or grinding, falls within the farm definition. Chopping, grinding (e.g. into matcha powder) or blending is additional processing. A site doing that must register, even if it's on the farm.
Do dietary supplement and pet food makers need to register?
Yes. FDA's definition of food includes dietary supplements, dietary ingredients and animal feed including pet food. Facilities that make, pack or hold them for the U.S. register like any other food facility unless an exemption applies.
If I sell to U.S. importers, am I a "retail food establishment"?
No. That exemption applies only when direct-to-consumer food sales are worth more than sales to all other buyers, and businesses don't count as consumers. Exporters selling to importers, distributors or marketplaces generally don't qualify.
Does a foreign facility need a U.S. agent?
Yes. The registration must list a U.S. agent who lives or keeps a place of business in the U.S. and is physically present (not a mailbox or answering service). FDA won't confirm the registration until the agent confirms.
When do I renew FDA food facility registration?
Every other year, between 1 October and 31 December of each even-numbered year. The current window ends 31 December 2026. New facilities register before they start handling food for the U.S.
Not sure if your facility is exempt?Axentra Compliance files and updates food facility registrations for foreign food, supplement and pet food facilities. Flat $249 per facility per year with a 2-year price lock, including FFR filing, updates and U.S. Agent takeover. Registering does not mean FDA has approved your facility or products, and FDA does not issue registration certificates. |
Axentra Compliance, 1209 Mountain Road Pl NE, STE 7912, Albuquerque, NM 87110 · +1 505-358-4858 · WhatsApp +1 201-736-9569 · info@axentracompliance.com
Sources
eCFR, 21 CFR Part 1, Subpart H (current as of 8 October 2026): Subpart H, 1.225, 1.226, 1.227, 1.230, 1.231, 1.232
eCFR, 21 CFR 117.5 (exemptions; tea and dried herb examples)
FDA, Questions and Answers Regarding Food Facility Registration (Seventh Edition)
This article is general information, not legal advice. Whether an exemption applies depends on your exact activities.
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