Institute for Food Laws and Regulations

 Scott Haskell teaches the online course “Animal Health, World Trade, and Food Safety” for Michigan State University’s Institute for Food Laws and Regulations. The course is offered each year in the fall semester.

The Food Safety Modernization Act (FSMA) continues to be a substantial improvement to domestic pet food safety. Pet food production in many instances can be more challenging than human food due to the type of ingredients that may be incorporated into the manufacturing of pet foods (for instance raw diets). Innovative industry efforts to incorporate a wide array of new products and bi-products into animal feed have in many instances increased food safety risk that challenges the acceptable boundaries of FSMA required cGMPs (current Good manufacturing practices) designed to manage these risks. FSMA compliance is a strong recognition that pet food must be manufactured as though human consumption may in many instances occur.

But what about pet food labeling requirements not necessarily specified by the FSMA? Labeling is an important piece of this puzzle assuring safety within the product. The United States Food and Drug Administration (FDA) labeling requirements are currently regulated at two important levels: FDCA and the CVM. Under the Federal Food, Drug and Cosmetic Act (FFDCA, FDCA or the FD&C Act), the FDA has legal jurisdiction over all animal feeds within interstate commerce (e.g., domestic and imported pet foods, feed supplements, treats, edible chews).  The FD&C Act requires that all animal foods must be safe to consume, they must be produced/manufactured under sanitary conditions (including foreign produced feeds and feed products), may contain no harmful substances, and must be truthfully labelled. These regulations are published in the Code of Federal Regulations (CFR).

The FD&C Act defines food as "articles used for food or drink for man or other animals..." 21 USC § 321(f). “Any article that is intended to be used as an animal food ingredient, to become part of an ingredient or food, or added to an animal's drinking water is considered a ‘food’ and thus, is subject to regulation.” The FDA's Center for Food Safety and Applied Nutrition holds the responsibility for the regulation of human food products. Additionally, the FDA's Center for Veterinary Medicine (CVM) is responsible for the regulation of animal food products.

FSMA amended the FD&C Act to include the requirement that all pet food manufacturers establish preventive controls and follow cGMPs. The CVM ensures that all ingredients and additives are safe to consume. These ingredients must have a proper function within the specified food and they must also enforce basic animal feed labeling requirements. These feed labeling requirements include: manufacturers/distributors name, address and contact information, ingredient declaration, statement of identity, and net content statement.

The FD&C Act is extremely important for pet food as it sets forth the legal requirements for "foods" and labeling. These requirements are found within FDCA sections 402 and 403. FDCA Section 403(f) states that a food is misbranded "if any word, statement, or other information required by or under authority of this act to appear on the label or labeling is not prominently placed thereon with such conspicuousness and in such terms as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.” Failure to meet these FDCA requirements can result in an animal food product being deemed adulterated or misbranded and removed from production and/or sales. “‘Adulteration’ means food packaged or held under unsanitary conditions, food or ingredients that are filthy or decomposed, and food that contains any poisonous or deleterious substance, or other contaminant. A food may be considered misbranded if its labeling is false or misleading in any way or fails to include required information.” (FDCA)

FDA regulations require proper product identification, a net quantity statement, manufacturer/distributor legal name and place of business, potential allergens specified on the label, net weight and appropriate ingredient listing for the product. Ingredients must be specified in descending order (e.g., from highest to lowest), based on product weight. These ingredient definitions are extremely important because animal foods and their ingredients must be truthfully and correctly labeled when they enter domestic commerce. Additionally, many state governments regulate animal feed labeling requirements beyond federal standards.

As for food additives, the Dietary Supplement and Health Education Act (DSHEA) of 1994, exempts many substances from regulation considering them drugs or food additives if the intended product meets the definition of a dietary supplement. However, for animal feeds, the FDA’s assessment of this law is that it does not apply to animal food. The term "dietary supplement" has no regulatory classification for animal feed. These “supplements” are considered either “new animal drugs” or “foods". This classification depends on the intended use of the product. The regulatory status of these products is determined by the CVM. (A listing of the approved animal food additives can be found in 21 CFR 573. https://www.govinfo.gov/app/collection/cfr/ or https://www.ecfr.gov/cgi-bin/ECFR?page=browse).

In lieu of or in conjunction with the FDA, many states have utilized recommended pet food labeling regulations associated with the Association of American Feed Control Officials (AAFCO). The AAFCO at times can be more specific than the FDA requirements hence the reason many states utilize these specifications. These AAFCO rules tend to augment and in fact complement the existing FDA regulations. They cover many aspects of pet food labeling which are not covered by federal mandate. For instance, AAFCO also covers the product name, feeding directions, specified calorie requirements for specific pets as a calorie statement, the guaranteed analysis, and in most instances a nutritional adequacy statement.

AAFCO is a private organization (not a government agency), and all AAFCO members must be federal or state government officials. They do an outstanding job helping to manage the appropriate labeling of animal feeds. Importantly, the laws and/or regulations developed by AAFCO are not directly enforceable by the organization. One of AAFCO’s strengths is that it provides a professional forum where industry associations and partners, state/federal officials, and consumer groups can meet to address animal food issues/concerns/problems and develop the necessary industry guidance. It should be noted that guidance is just that, and is not the rule of law.

AAFCO determines nutrient standards for pet food to substantiate ‘nutritional adequacy’, specifies ingredient names and defines product ingredients. Additionally, AAFCO continues to be the accepted industry norm for standardized feed testing methodology, definitions of ingredients, and pet food labelling requirements.

The FDA through FSMA and the FD&C Act helps regulate animal food labeling through cooperation with AAFCO and state and local partners. To be effective, they utilize a variety of methods and mechanisms (e.g., memoranda of understanding, laws and regulations, cooperative agreements, guidance directives, recommendations and partnerships). The FDA has many responsibilities for regulating safe animal feed products but manufacturers and producers in many instances have the final responsibility. Most do an excellent job!

Veterinary professionals and pet parents definitely need assurance that the products they feed are nutritious and have the ingredients that are specified on the affixed label. As such, the pet food label is a mandatory information source. If there is a question about a specific product, contact the manufacturer or ask an appropriate regulatory agency. So, let’s review these requirements and hopefully agree upon their necessity to protect both the pet/consumer and industry. We will discuss this in the next IFLR blog.

Disclaimer.

References

FDA Product Regulation https://www.fda.gov/animal-veterinary/animal-food-feeds/product-regulation

Food Additive Petitions for Animal Food https://www.fda.gov/animal-veterinary/development-approval-process/food-additive-petitions-animal-food

Pet Food Labels – General https://www.fda.gov/animal-veterinary/animal-health-literacy/pet-food-labels-general

Sub Chapter 660 - 699 Animal Feed https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/manual-compliance-policy-guides/chapter-6-veterinary-medicine

Guidance for Industry: Voluntary Labeling Indicating Whether Foods Have or Have Not Been Derived from Genetically Engineered Plants https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-voluntary-labeling-indicating-whether-foods-have-or-have-not-been-derived

Federal Food, Drug, and Cosmetic Act (FD&C Act) https://www.fda.gov/regulatory-information/laws-enforced-fda/federal-food-drug-and-cosmetic-act-fdc-act