If you are thinking about starting an animal food business, you may have questions about what regulatory requirements would apply to your business. In addition to the Food and Drug Administration's (FDA's) requirements, your food business may have to comply with other federal, state, and local requirements. Some requirements apply to all animal food businesses, and some are specific to the type of animal food you are handling or making (for example, whether you are making medicated feed or have to register with FDA as a food facility).
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If you are planning to start an animal food business, there are several steps you need to take before marketing your product in the United States, such as:
- Submitting the appropriate registration, licensing, and notification information to the FDA;
- Complying with all FDA food safety regulations for the type of activities you are conducting and the type of animal food you are marketing;
- Ensuring any ingredients and additives are safe and suitable for their use, and have the appropriate regulatory status or approvals needed to legally market the animal food; Complying with labeling and marketing requirements; and
- Complying with applicable state and local animal food regulatory requirements.
In addition to operating in the United States, some businesses may be interested in importing or exporting animal food products.
The chart, below, gives you a snapshot of the requirements based on the three most common animal food business scenarios: in-home businesses, on-farm businesses, and commercial businesses. The chart is divided into three sections:
- Requirements that apply to all animal food businesses,
- Requirements that apply to animal food businesses that must register with FDA, and
- Requirements that apply to specific animal food business activities, such as importing or exporting animal food or ingredients.
Each requirement is hyperlinked to its corresponding section on this page, so you can easily find the information you need as you start your business. If you need more information, you can find the FDA’s Center for Veterinary Medicine (CVM) email and phone contact information at the bottom of the page.
Which requirements apply to my animal food business?
Requirements that Apply if You’re Required to Register as a Food Facility Description Qualified Facility Attestation If you are a very small business you must submit a qualified facility attestation to be exempt from certain requirements of the Preventive Controls for Animal Food during your initial food facility registration and subsequent biennial renewal. Preventive Controls for Animal Food Requirements for manufacturing, processing, packing, and holding animal food under current good manufacturing practice (CGMP) and a food safety plan for all businesses that must register as a food facility. Reportable Food Registry Requirements for when registered food facilities must notify FDA that a food (including animal food) may cause serious adverse health consequences (e.g., illness, injury), or death to humans or animals. Certain Activities with Additional Requirements Activity applies to: Medicated Feed Mill Licensing and CGMPs Businesses and farms manufacturing, processing, packing, or holding medicated feed. Veterinary Feed Directives Veterinarians, clients (animal caretakers), manufacturers, and distributors authorizing, manufacturing, distributing, or using medicated feed with a veterinary feed directive (VFD) marketing status. Low Acid Canned Food Regulations Businesses manufacturing shelf stable low-acid foods in hermetically sealed container, such as pet food in a can or an airtight pouch. Sanitary Transportation of Animal Food Businesses involved in the transportation of animal food, such as shippers, receivers, loaders, and carriers who transport food in the United States by motor or rail vehicle. Bovine Spongiform Encephalopathy Businesses that are handling animal food for ruminants, such as cows, sheep, and goats, or handling brain and spinal cord tissue from cattle 30 months of age or over intended for food for any species. Import/Export of Animal Food Businesses importing animal food into the United States or exporting animal food from the United States.
Requirements that Apply to All Food Businesses
Adulteration
All animal food must meet the requirements in the Federal Food, Drug, and Cosmetic Act (FD&C Act), which prohibits the adulteration of animal food. Common reasons an animal food may be considered adulterated include:
- If it contains a contaminant, such as bacteria, toxins, or physical objects (e.g., glass or metal) which may harm human or animal health;
- If is not suitable for animal food, for example because it has gone bad (e.g., rotted);
- If it is something that is not safe for animals to eat, for example because it has been labeled “not for animal food use,” or because it contains an unsafe ingredient; and
- If it was not handled in a way to keep it safe for animals to eat.
You can find the full legal definition of adulterated food in the U.S. Code (21 U.S.C. 342 codifies the adulteration provisions in section 402 of the FD&C Act) and information about contaminants in animal food on the FDA website.
What is the difference between the FD&C Act and the United States Code (U.S.C.)?
When Congress passes and the President signs a law, they publish it as an “Act.” The Federal Food, Drug, and Cosmetic (FD&C) Act is the foundational law that establishes FDA regulation of certain products and businesses. Congress makes changes to the law by amending it. For example, the Food Safety Modernization Act (FSMA) amends the FD&C Act by adding in new requirements.
The Office of the Law Revision Counsel compiles these Acts and amendments to the law, organizing them by subject, into something called the United States Code (U.S.C.). The U.S.C. contains only the current enacted law. As a result, you may see a reference to Section 402 of the FD&C Act, which is the section on food adulteration, or you might see a reference 21 U.S.C. 342, which is the same information as compiled into the U.S.C. FDA has a helpful explanation about the FD&C Act and U.S.C. at: Federal Food, Drug, and Cosmetic Act (FD&C Act).
Ingredients and Additives
Under the FD&C Act, anything that’s added to or becomes part of an animal food, directly or indirectly, must either be approved as a food additive or it must be considered Generally Recognized as Safe (GRAS) for that use. Approved food additives and ingredients that are GRAS are limited to specific uses. Some ingredients may be safe when used one way, but not safe when used in other ways. For example, xylitol is an artificial sweetener that is an approved food additive for use in human foods, but can be extremely toxic to dogs, and therefore not acceptable for use in dog food.
In addition to federal regulations, the Official Publication of the Association of American Feed Control Officials (AAFCO) contains a list of animal food ingredients and their definitions, a list of approved animal food additives, and a list of ingredients that are considered GRAS for specific uses. Many of the ingredients in the AAFCO Official Publication, however, are not approved food additives and may not meet the criteria needed to be recognized as GRAS for those uses. FDA recognizes the list of ingredients in the Official Publication for their marketing and sale in the U.S. under an exercise of enforcement discretion provided there are no safety concerns with the listed ingredients.
You can find more information about animal food ingredients and additives and how FDA regulates them on the Ingredients and Additives webpage.
Labeling and Marketing
Labeling for animal foods marketed in the United States must comply with current federal and state regulations. The FD&C Act defines "labeling" as all labels and other written, printed, or graphic matter upon any article or any of its containers or wrappers, or accompanying such articles. Labeling can include promotional websites, promotional brochures, promotional pamphlets, testimonials, product information sheets, books, etc.
Labels must comply with animal food labeling requirements listed in 21 CFR part 501, which requires the label to include:
- A statement of identity (the name of the food) and, when needed, what the product is used for;
- An ingredient statement listing ingredients by their common or usual name, in descending order of predominance by weight, meaning that the ingredient that weighs the most is listed first and the ingredient that weighs the least is listed last;
- The name and address of manufacturer, packer, or distributor;
- A net quantity statement, which provides the amount of food in the container or package. It must be expressed in weight, measure, or numeric count. Generally, if the food is solid, semisolid or viscous, it should be expressed in terms of weight (pounds and ounces). If the food is a liquid, it should be expressed in fluid measure (e.g., fl oz);
- The label must be in English. If the label is in a foreign language, it must include an English translation; and
- Warning and/or caution statements, when applicable.
Medicated feed has additional federal labeling requirements. When a Type A medicated article is approved by FDA, the company that makes the article is required to create a model “Blue Bird Label” to guide manufacturers of medicated animal feeds when preparing final printed feed labels. Information from that Blue Bird Label must appear on any medicated feeds made with that Type A medicated article. You can find more information about medicated feed labels on our Blue Bird Labels webpage.
Labeling must also comply with the Federal Food, Drug, and Cosmetic Act's misbranding provisions. In general, a product is misbranded if it does not have required information on the labeling or if it is false or misleading. A label is false or misleading if it contains information that is not true or could confuse consumers, such as implying that an animal food has more of a beneficial ingredient than what is actually included in the animal food.
For state labeling requirements, the best source of information is AAFCO. To promote uniform labeling requirements across all U.S. states and territories, AAFCO developed a set of “Model Regulations for Pet Food and Specialty Pet Food,” which can be found in AAFCO’s Official Publication. Since the AAFCO “Model Regulations” are consistent with Federal requirements, they are a useful resource for information on the regulation of pet food.
You can find more information about animal food regulation (including pet food), marketing, and labeling on FDA’s website.
State Regulations
In addition to meeting federal requirements, your animal food business may also have to follow certain state regulatory requirements. The AAFCO webpage has detailed information about your state’s regulatory requirements for animal food. You can find other useful resources for animal food businesses on their Industry webpage. Additional information about starting a pet food business and state requirements can be found on AAFCO’s The Business of Pet Food site.
Food Facility Registration Requirement & Qualified Facility Attestation
If your company manufactures, processes, packs, or stores an animal food in the United States, you must register as a food facility, unless an exemption applies to your business. The below webpages will help you determine if you must register as a food facility and if so, how to complete a food facility registration and get your unique facility identifier.
Some animal food businesses meet the definition of a “qualified facility,” typically because they are very small businesses. A qualified facility is generally a business that, because of its very small size, is required to meet only modified requirements under the FDA Food Safety Modernization Act (FSMA) Preventive Controls for Animal Food (PCAF) regulation. These businesses must “attest,” or affirm, to FDA that they are qualified facilities on their food facility registrations.
CVM’s website has more information about how to determine whether your business is a qualified facility, current inflation adjusted cut offs for qualified facilities, and answers to frequently asked questions.
Animal Food Receipt and Distribution Record Requirements
If you manufacture, process, pack, transport, distribute, receive, hold, or import animal food in the United States, you must keep records of the receipt and distribution of animal food, unless an exemption applies to your business.
If you are a business that manufactures, processes, packs, or holds the animal food (not for transportation), you must establish and maintain the records for all food you receive and distribute. Generally, these requirements include records that establish:
- The name and contact information of the business that you received animal food from or distributed animal food to;
- A description of the type of animal food (e.g., type of animal food, brand name and variety)
- Date you received or distributed the animal food;
- A lot code or other identifier (to the extent this information exists);
- The quantity and how the animal food was packaged;
- The name of the business and contact information of the transporter (including incoming ingredients and distributed animal food); and
- Information to identify the specific source of each ingredient used to make every lot of finished product.
Transporters of animal food also are required to maintain records that establish information regarding the transportation of the food.
For animal food, receipt and distribution records must be retained for a period of 1 year.
Requirements that Apply if You’re Required to Register as a Food Facility
Preventive Controls for Animal Food (PCAF)
The FSMA Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Food for Animals regulation in 21 CFR part 507 is commonly referred to as the PCAF regulation or part 507. The PCAF regulation has two primary parts, the current good manufacturing practice (CGMP) requirements and the hazard analysis and risk-based preventive controls (PC) requirements. The PCAF regulation also addresses related personnel, training, and recordkeeping requirements (See 21 CFR part 507, subparts A and F). The PCAF requirements apply to all facilities that must register with the FDA unless they fall under an exemption. There are also exemptions, or modified requirements for warehouses or other businesses that only store packaged animal food that is not exposed to the environment.
Reportable Food Registry (RFR) Requirements
If your animal food business is required to register as a food facility, you are required to file a report with FDA’s Reportable Food Registry (RFR) whenever you have an instance of a “reportable food.” A “reportable food” is a food for which 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. For example, this could be an animal food that is contaminated with something that would cause the animal eating it to get sick, such as disease-causing bacteria, or the food could contain something that would harm the animal, like pieces of plastic that could pose a choking hazard. Reportable food also includes animal food that could cause people to get sick, either from handling the animal food or from consuming milk, meat, eggs, or other animal products from the animal that ate the animal food. If you have a reportable food, you must file a report as soon as possible, but no later than 24 hours after you have identified that the animal food is a “reportable food.”
The Reportable Food Registry webpage has detailed information about these requirements.
Certain Activities with Additional Requirements
Medicated Feed Mill Licensing and CGMPs
Medicated Feed Mill Licensing and Drug Establishment Registration
If you are an animal food business that manufactures or processes medicated feeds, you may need an FDA-approved medicated feed mill license and drug establishment registration if you make the following types of feed:
- medicated feed using Category II, Type A medicated articles (21 CFR 558.4(a));
- all free-choice medicated feeds that contain a Category II drug (21 CFR 510.455(f));
- free-choice medicated feeds that contain a Category I drug and use a proprietary formula and/or specifications (21 CFR 510.455(f));
- all liquid medicated feeds that contain a Category II drug (21 CFR 558.5(g)(1)); and
- liquid medicated feeds that contain a Category I drug and use a proprietary formula and/or specifications (21 CFR 558.5(g)(2)).
If you use drugs from Categories I
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