Pet food companies come in a vast spectrum of animal nutrition expertise. Some companies break into the market because of current capitalization from another industry. In contrast, others began small and built their reputation over years of R&D. Again, and the best manufacturers aren’t always the ones who charge an arm and a leg for their bags of cat food or dog food.
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There are affordable brands that are wholly supported by sound veterinary science. If you’re interested in asking a company about their methods, you can always call them first and ask the representative to tell you about their R&D efforts and what their brand is about.
They should be able to give you at least an overview of their pet food. It’s never about the marketing and consistently about what’s been going on in their production line and research efforts.
Does the manufacturer have at least one full-time nutrition on board? Ideally, the nutritionist should have a doctorate in animal nutrition. In addition, this person should ideally be board-certified by the American College of Veterinary Nutrition. Suppose you’re buying from a manufacturer in another country. In that case, the same criteria apply—that persons should have had extensive training in animal nutrition and should be board-certified by the equivalent institution in the originating country.
Having a knowledgeable and responsible nutritionist differs from purchasing a recipe from an animal nutritionist. These two are not equivalent, and you should be wary of any claims that sound shady.
Now, if the manufacturer does not have a full-time, board-certified, doctorate degree-holding animal nutritionist on board, then who formulates the cat food or dog food? Who decides the ratios and the source of the carbohydrates, fats, proteins, etc.? The animal nutrition expert should have equivalent or more training (as stated previously). Pet food manufacturers shouldn’t be skimping on the qualifications of the professionals who formulate their products.
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).
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:
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:
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.
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:
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).
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 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:
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.
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.
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.
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:
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.
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.
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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.
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:
If you use drugs from Categories I and II in a combination drug product, the Category II requirements apply to the entire combination drug product (21 CFR 558.4(e)). You need a medicated feed mill license and drug establishment registration to make the combination drug product from a Type A medicated article.
Whether or not you are required to have a feed mill license and drug establishment registration determines what Medicated Feed Mill Current Good Manufacturing Practice requirements in 21 CFR part 225 apply at your facility.
CVM’s Medicated Feeds webpage has more information and resources on medicated feed mill licensing and drug establishment registration, including the forms and instructions for submitting a medicated feed mill application and a link to drug establishment registration information.
If you are a distributor of medicated feeds containing veterinary feed directive (VFD) drugs, you must send a one-time notification to FDA (21 CFR 558.6(c)(5)). A VFD drug is intended for use in animal feeds. VFD drugs can only be used under the professional supervision of a licensed veterinarian. CVM’s website has information about what you must include in the notification and how and where to submit it.
To view the current VFD Distributor Notification List, which lists the names and addresses of businesses that distribute VFD medicated feeds, visit the Medicated Feeds section of the Animal Drugs @ FDA home page. You can view the list as a PDF or as an Excel spreadsheet. You can sort the Excel spreadsheet by distributor name or state. FDA updates the lists when new notifications are processed.
In addition to the notification, you must also follow the VFD requirements. These requirements cover authorizations from veterinarians to use VFD feed, manufacturers and distributors who manufacture and distribute VFD feed, and clients or animal producers who use VFD feed. The regulation includes general requirements in 21 CFR 558.6(a) that apply to all three roles, as well as more specific requirements for authorizing veterinarians in 21 CFR 558.6(b) and for VFD distributors in 21 CFR 558.6(c). You can find more information about these requirements on CVM’s webpage:
If your animal food business thermally processes low-acid foods packaged in hermetically sealed (airtight) containers, commonly called low-acid canned foods (LACF), you must follow the LACF requirements. Although some airtight containers (like pouches or trays) used to thermally process low-acid foods are not considered cans, we continue to use the term “low-acid canned foods” and its abbreviation (LACF) as a shorthand description. If your business makes these types of products, you must register your business as a Food Canning Establishment and file scheduled processes with FDA for each product you make. A scheduled process is the process you select as adequate under the conditions of manufacture for a given product to achieve commercial sterility. This process may be in excess of that necessary to ensure destruction of microorganisms of public health significance, and shall be at least equivalent to the process established by a competent processing authority to achieve commercial sterility (21 CFR 113.3(r)).
FDA’s website contains more information about LACF requirements and acidified requirements. Note that the information on this page covers both LACF requirements and acidified food requirements. LACF requirements apply to both human and animal food, but acidified requirements apply only to human food.
The Sanitary Transportation of Human and Animal Food (ST) regulation in 21 CFR part 1, subpart O, explains the steps that shippers, loaders, motor or railroad carriers, and receivers must take to ensure the safety of food during transport. Ways that food can become unsafe during transport include:
The regulation is broken down into sections including General Provisions, Vehicles and Transportation Equipment, Transportation Operations, Training, Records, and Waivers. The Sanitary & Transportation Guidance Documents & Regulatory Information webpage has links to the different regulations and guidance documents you need.
If your animal food business handles “prohibited materials,” which are materials that could cause the spread of BSE disease through animal food, then you must follow the BSE requirements for handling these materials as part of your business.
Prohibited materials include, but are not limited to, ruminant (e.g., cattle, sheep, and goat) meat and bone meal, organs, and offal. The most common prohibited material found in animal food is meat and bone meal that comes from cattle. You can find more information about prohibited materials on CVM’s Bovine Spongiform Encephalopathy (BSE) webpage.
Prohibited materials are commonly handled at businesses such as renderers, protein blenders, commercial animal feed manufacturers, distributors (including retailers), transporters of animal feed and animal food ingredients, and on-farm animal feed mixers. Although ruminant feeders are unlikely to handle prohibited materials, it is important they are aware of the requirements and know what to avoid. The regulations (21 CFR 589.2000) define several of these business types.
There are two FDA regulations that focus on preventing the spread of BSE through animal food.
The “Animal Proteins Prohibited from Use in Animal Feeds” regulation in 21 CFR 589.2000 was created to prevent BSE from spreading through animal food. This regulation prohibits using certain tissues from mammals in animal food for ruminants (e.g., cattle, sheep, goats). You can find more information about this regulation on CVM’s ruminant feed inspections webpage.
The “Cattle Materials Prohibited in Animal Food/Feed (CMPAF)” regulation in 21 CFR 589.2001 prohibits using the brains and spinal cords from cattle 30 months of age and older in any animal food, including all types of livestock and poultry feed and pet food. The regulation is age-specific because cattle in this age range are at the highest risk for BSE. In BSE-infected cattle, the brain and spinal cord contain most (about 85%) of the infectious materials that could cause the spread of BSE. This regulation is intended to remove these tissues from the animal food chain entirely, thus greatly reducing the potential for inadvertent cross-contamination. Removing these tissues from the animal food chain prevents cross-contamination or accidental or intentional misfeeding. The regulation mainly applies to renderers and slaughter facilities because it focuses on removing the brains and spinal cords from animal carcasses, which is an activity typically performed at these facilities.
You can find CVM BSE Guidances, the Feed Ban Enhancement, and other requirements for BSE on the CVM BSE webpage.
General FDA Imports Information
Imported animal food, including medicated feed products, must meet the requirements of The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act). This law requires animal food producing facilities to register with FDA and to file "prior notice" for each shipment of imported food before it arrives at a U.S. port of entry. The FDA website has more detailed information about facility registration and prior notice requirements.
If you have questions, or you need help with registering your facility or with filing prior notice, please contact the FDA’s Industry Systems Help Desk experts Monday to Friday from 7:30 am to 11:00 pm EST
In addition to FDA requirements, you may need to satisfy U.S. Customs and Border Protection (CBP) requirements. You can find CBP’s requirements on the U.S. Customs and Border Protection website.
FDA can examine shipments of regulated products whenever they are offered for entry at a U.S. Port of Entry. FDA will detain products that violate FDA law and regulations. Products that cannot be brought into compliance with the law will be refused. Refused products must be exported or destroyed under CBP supervision. Even if FDA did not examine a regulated product at the time of entry, the product must still comply with U.S. laws and regulations when it is in the U.S.
The following FDA webpages have more detailed information about importing products into the U.S.:
Foreign Supplier Verification Program (FSVP)
The Foreign Supplier Verification Program (FSVP) regulation in 21 CFR part 1, subpart L, applies to U.S. importers of human and animal food. Under the FSVP, an importer is the U.S. owner or consignee of a food offered for import into the United States. If there is no U.S. owner or consignee, the importer is the U.S. agent or representative of the food’s foreign owner or consignee at the time of entry, as confirmed in a signed statement of intent. You can find more information about whether the FSVP regulation applies to you on the Am I Subject to FSVP? fact sheet.
Importers of animal food must have an FSVP in place. The FSVP requires importers to verify that the processes and procedures their foreign suppliers are using to make animal food give the same level of public health protection that the PCAF regulation does and ensures that the supplier’s animal food is not adulterated. Importers must:
You can find more information about the FSVP rule, including information on compliance dates, on the FDA FSMA Final Rule on Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals webpage.
Some animal food businesses will export their animal food to other countries. You can find more information about the requirements for exporting animal food, including the types of export certificates an animal food business can request on CVM’s Exporting—Animal Feed and Animal Drugs webpage.
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