Glossary: Regulatory Bodies and Registrations

The agencies that regulate a food operation and the registrations and designations that decide which rules apply to it — defined plainly and traced to their source.

~4 min

Before you can sell, you have to know who regulates you and what you owe them. These are the agencies, registrations, and designations that decide which body of food-safety and labeling law your operation falls under — and the ones a small producer runs into first.

The two federal agencies

FDA — The U.S. Food and Drug Administration, which regulates most of the packaged food supply — nearly everything except meat, poultry, and processed egg products. If you make sauces, baked goods, snacks, beverages, or blends, FDA sets the rules you register under and label to. Its oversight runs mostly on records and periodic inspection, not an inspector standing on your line (FDA's food program).
USDA / FSIS — The U.S. Department of Agriculture's Food Safety and Inspection Service, which regulates meat, poultry, and processed egg products under a separate and stricter regime, including a federal inspector present while you produce. Which agency owns you turns on the product, and some items — certain meat-containing foods, for one — fall under USDA even when the rest of your line is FDA.

Registering your facility

Food Facility Registration — The registration most facilities that manufacture, process, pack, or hold food for U.S. consumption must file with FDA before they operate. It carries no fee and must be renewed every two years, during October 1 to December 31 of each even-numbered year; miss that window and FDA treats the registration as expired (FDA's biennial renewal guide, checked July 2026).
DUNS — The Data Universal Numbering System number, a unique nine-digit identifier assigned at no cost by Dun & Bradstreet. Since the end of 2022, FDA will not accept a facility registration or renewal without one, so it is a hard prerequisite for the step above rather than an optional extra (checked July 2026).

Exemptions and the foods that break them

Cottage Food Exemption — The carve-out that lets you make and sell certain low-risk foods out of a home kitchen without a full commercial license. There is no federal cottage-food rule: it is written state by state, and the sales caps, the foods allowed, where you may sell, and the labeling all differ and change. Your own state's statute and its agriculture or health agency are the only authority — never assume another state's limits are yours (the National Agricultural Law Center tracks the states for orientation, not as law).
TCS Food — Time/Temperature Control for Safety food: anything that needs refrigeration or hot-holding to keep pathogens or toxins from developing — fresh meat, dairy, cooked vegetables, cut melon, most things that spoil. The term bites at the cottage line, because most states allow only non-TCS, shelf-stable foods from a home kitchen; as of 2026 a small but growing number permit some TCS items, so confirm your own state (FDA Food Code, checked July 2026).

Thermally processed and canned foods

Process Authority — A qualified expert — a person or lab with the scientific competence, often credentialed through a Better Process Control School — who establishes and validates the safe process for a thermally processed food. For an acidified or low-acid canned product you cannot set your own cook and pH targets by feel; a process authority has to establish them (21 CFR 108.25).
Scheduled Process — The specific, validated process you commit to for a given product and container: the time, temperature, pH, and other controls chosen to make it safe — commercially sterile, or acidified below the danger line. For acidified and low-acid canned foods a process authority establishes it, you file it with FDA, and every batch must run to at least that process (21 CFR 113.3).
Acidified and Low-Acid Canned Food — Two shelf-stable categories FDA regulates tightly because a mistake can let Clostridium botulinum grow. Low-acid canned foods have a finished pH above 4.6 and water activity above 0.85 in a hermetically sealed container (21 CFR 113); acidified foods are low-acid foods brought to pH 4.6 or below by adding acid — pickles, some salsas (21 CFR 114). Both demand a filed scheduled process and a separate FDA process-filing on top of your facility registration.

The label as a legal document

Misbranding — FDA's legal term for a food whose labeling is false or misleading, or that omits something the law requires — the ingredient list, an accurate net-quantity statement, the nutrition panel, an allergen declaration (21 U.S.C. 343). A perfectly safe product is still illegal to sell if it is misbranded, which is why the label is a legal document, not packaging art.
Statement of Identity — The common or usual name of the food, shown prominently on the front of the package in bold type (21 CFR 101.3). It tells the buyer what the product actually is; a clever brand name does not stand in for it. Bury it or get it wrong and the product is misbranded.
Nutrition Facts Panel — The standardized panel of calories, nutrients, and serving information most packaged foods must carry (21 CFR 101.9). The catch first-timers miss: the rounding is nutrient-specific — calories to the nearest 5 up to 50 and the nearest 10 above it, fat to the nearest half-gram under 5 grams, and so on — so a panel built from correct data is still misbranded if the increments are wrong (checked July 2026).
"Contains" statement — The optional line placed right after the ingredient list that names the major allergens present — "Contains: milk, wheat, sesame." Under the Food Allergen Labeling and Consumer Protection Act you may declare allergens inside the ingredient list or in this separate statement, but if you use a "Contains" line it must name every major allergen in the product, or it fails even when the ingredient list is complete. There are nine major allergens, since sesame joined on January 1, 2023 (verified July 2026).

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The two federal agencies

FDA — The U.S. Food and Drug Administration, which regulates most of the packaged food supply — nearly everything except meat, poultry, and processed egg products. If you make sauces, baked goods, snacks, beverages, or blends, FDA sets the rules you register under and label to. Its oversight runs mostly on records and periodic inspection, not an inspector standing on your line (FDA's food program).

USDA / FSIS — The U.S. Department of Agriculture's Food Safety and Inspection Service, which regulates meat, poultry, and processed egg products under a separate and stricter regime, including a federal inspector present while you produce. Which agency owns you turns on the product, and some items — certain meat-containing foods, for one — fall under USDA even when the rest of your line is FDA.

Registering your facility

Food Facility Registration — The registration most facilities that manufacture, process, pack, or hold food for U.S. consumption must file with FDA before they operate. It carries no fee and must be renewed every two years, during October 1 to December 31 of each even-numbered year; miss that window and FDA treats the registration as expired (FDA's biennial renewal guide, checked July 2026).

DUNS — The Data Universal Numbering System number, a unique nine-digit identifier assigned at no cost by Dun & Bradstreet. Since the end of 2022, FDA will not accept a facility registration or renewal without one, so it is a hard prerequisite for the step above rather than an optional extra (checked July 2026).

Exemptions and the foods that break them

Cottage Food Exemption — The carve-out that lets you make and sell certain low-risk foods out of a home kitchen without a full commercial license. There is no federal cottage-food rule: it is written state by state, and the sales caps, the foods allowed, where you may sell, and the labeling all differ and change. Your own state's statute and its agriculture or health agency are the only authority — never assume another state's limits are yours (the National Agricultural Law Center tracks the states for orientation, not as law).

TCS Food — Time/Temperature Control for Safety food: anything that needs refrigeration or hot-holding to keep pathogens or toxins from developing — fresh meat, dairy, cooked vegetables, cut melon, most things that spoil. The term bites at the cottage line, because most states allow only non-TCS, shelf-stable foods from a home kitchen; as of 2026 a small but growing number permit some TCS items, so confirm your own state (FDA Food Code, checked July 2026).

Thermally processed and canned foods

Process Authority — A qualified expert — a person or lab with the scientific competence, often credentialed through a Better Process Control School — who establishes and validates the safe process for a thermally processed food. For an acidified or low-acid canned product you cannot set your own cook and pH targets by feel; a process authority has to establish them (21 CFR 108.25).

Scheduled Process — The specific, validated process you commit to for a given product and container: the time, temperature, pH, and other controls chosen to make it safe — commercially sterile, or acidified below the danger line. For acidified and low-acid canned foods a process authority establishes it, you file it with FDA, and every batch must run to at least that process (21 CFR 113.3).

Acidified and Low-Acid Canned Food — Two shelf-stable categories FDA regulates tightly because a mistake can let Clostridium botulinum grow. Low-acid canned foods have a finished pH above 4.6 and water activity above 0.85 in a hermetically sealed container (21 CFR 113); acidified foods are low-acid foods brought to pH 4.6 or below by adding acid — pickles, some salsas (21 CFR 114). Both demand a filed scheduled process and a separate FDA process-filing on top of your facility registration.

The label as a legal document

Misbranding — FDA's legal term for a food whose labeling is false or misleading, or that omits something the law requires — the ingredient list, an accurate net-quantity statement, the nutrition panel, an allergen declaration (21 U.S.C. 343). A perfectly safe product is still illegal to sell if it is misbranded, which is why the label is a legal document, not packaging art.

Statement of Identity — The common or usual name of the food, shown prominently on the front of the package in bold type (21 CFR 101.3). It tells the buyer what the product actually is; a clever brand name does not stand in for it. Bury it or get it wrong and the product is misbranded.

Nutrition Facts Panel — The standardized panel of calories, nutrients, and serving information most packaged foods must carry (21 CFR 101.9). The catch first-timers miss: the rounding is nutrient-specific — calories to the nearest 5 up to 50 and the nearest 10 above it, fat to the nearest half-gram under 5 grams, and so on — so a panel built from correct data is still misbranded if the increments are wrong (checked July 2026).

"Contains" statement — The optional line placed right after the ingredient list that names the major allergens present — "Contains: milk, wheat, sesame." Under the Food Allergen Labeling and Consumer Protection Act you may declare allergens inside the ingredient list or in this separate statement, but if you use a "Contains" line it must name every major allergen in the product, or it fails even when the ingredient list is complete. There are nine major allergens, since sesame joined on January 1, 2023 (verified July 2026).