By Johnny Braddy, DVM, MPH, Dipl. ACVPM, EAS Independent Consultant.
(This Issue of the Month article is an abbreviated version of a White Paper published on the EAS website.).
To help ensure that the nation’s food supply is safe, Congress amended the Food Drug & Cosmetic Act (FD&C) by passing the FDA Food Safety Modernization Act (FSMA) in 2011. FSMA aims to ensure the U.S. food supply is safe by shifting the focus to preventing contamination of the food supply, rather than responding to it. The law applies to human food as well as to food for animals, including pets. FDA finalized seven foundational rules to implement FSMA, recognizing that ensuring the safety of the food supply is a shared responsibility among many different stakeholders in the global supply chain for both human and animal food. The FSMA rules are designed to make clear specific actions that must be taken at each point in the supply chain to prevent contamination, and to ensure the safety of human and animal foods.
Animal Food Facilities Responsibilities Under FSMA
The FDA’s FSMA Preventive Controls Rules apply to all facilities required to register with the FDA as a food facility, unless covered by an exemption. FSMA requires animal food facilities to prepare and implement a written food safety plan (Subpart C, 21 CFR 117.126), which includes a hazard analysis to identify and evaluate food safety hazards that are potentially associated with the animal food, and to take steps, when necessary, to identify and implement preventive controls to provide assurance that any hazards requiring a preventive control will be significantly minimized or prevented, and the food manufactured, processed, packed, or held for consumption in the United States will not be adulterated under section 402 of the Act, or misbranded under section 403 of the Act. For a complete overview of additional requirements that should be included in the written food safety plan, please review Subpart C, 21 CFR 117.126.
Besides having to follow the requirements under FSMA, registered animal food facilities must also comply with current good manufacturing practices (unless an exemption applies). These practices provide baseline standards for manufacturing, processing, packing, and holding animal food to ensure it is safe for animals to eat.
Animal Food Safety Challenges
Foodborne Hazards (Biological, Chemical, and Physical Contaminants)
Food fed to animals may contain various biological, chemical, or physical contaminants. They may be naturally occurring (e.g., mycotoxins, bacteria) or accidently or intentionally introduced during the manufacturing process. The Center for Veterinary Medicine (CVM) continually monitors animal food, including pet food, through its Animal Feed Contaminants Program. In addition, CVM may issue assignments to monitor a specific industry, product, or contaminant, and may also prohibit any detectable amount of a contaminant or establish a regulatory limit for the contaminant. Information on assignments and regulatory limits can be found on the individual contaminant webpage.
Substances Prohibited from Use in Animal Food or Feed
The substances listed in 21 CFR Part 589 are prohibited from use in animal food or feed by the Food and Drug Administration because of a determination that they present a potential risk to public health or have not been shown by adequate scientific data to be safe for use in such food or feed. Use of any of these substances in violation of this part causes the animal food or feed to be adulterated and in violation of the Act. Subpart B of this part includes only a partial list of substances prohibited from use in animal food or feed, and thus is not a complete list of substances that may not lawfully be used in such animal food or feed. The specific substances prohibited from use in animal food or feed include:
- Gentian violet (sec. 589.1000)
- Propylene glycol in or on cat food (sec. 589.1001)
- Animal proteins prohibited in ruminant feed (sec. 589.2000)
- Cattle materials prohibited in animal food or feed (sec. 589.2001)
In 1958, in response to public concern about the increased use of chemicals in food and food processing, Congress amended the FD&C Act to require FDA’s review and approval of food additives before they can be marketed. A food additive is any substance that directly or indirectly becomes a component of a food or that affects a food’s characteristics. One exception to this definition is that a substance that is generally recognized as safe (GRAS) by qualified experts for a specific use in food is not considered a food additive and don’t need to be reviewed and approved by FDA before being marketed.
To be legally marketed, a food additive must have an approved food additive petition. Substances that by their intended use, may become components of animal feed or pet food either directly or indirectly, that may otherwise affect the characteristics of the animal feed or pet food are “food additives” (21 CFR Parts 570, 571, and 573). Food additives are illegal unless they are the subject of a prior approval (sanction) or a regulation for their safe use. Food additive regulations are based on data submitted in the form of a food additive petition. Food for either people or animals that contains an unapproved food additive is unsafe and adulterated according to the FD&C Act. Food additive petitions (FAP) pertaining to animal feed ingredients should be submitted to the FDA, Center for Veterinary Medicine (CVM), Division of Animal Feeds.
Animal supplements have no federal definition, though FDA’s Center for Veterinary Medicine has used an informal process for dealing with pet supplements. In 1996, FDA determined that the Dietary Supplement Health and Education Act (DSHEA) did not apply to products for use in animals, and at least one court case has upheld the agency’s thinking. Therefore, products marketed as dietary supplements for animals do not fall under DSHEA and FDA does not recognize them as a special category. Rather, the agency regulates these products as either food for animals or animal drugs, depending on their intended use:
- The Act defines food as “articles used for food or drink for man or other animals.” Therefore, 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 subject to regulation; and
- The FDA defines a drug, in part, as “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals.” Refer to section 201(g) of the FD&C Act.
As stated above, the FD&C Act defines the term drug to include articles intended for use in the treatment, or prevention of disease in man or other animals. However, most complete pet food diets intended to meet an animal’s nutritional needs and to treat or prevent a disease are not approved animal drugs, and without such approval, FDA considers them to be “unapproved animal drugs.” FDA considers an unapproved animal drug to be a drug that is intended for use in animals and meets the definition of “new animal drug” in the FD&C Act, but does not have legal marketing status…meaning FDA has not approved, conditionally approved, or indexed the drug.
In April 2016, FDA finalized a Compliance Policy Guide that outlines the agency’s current thinking about pet food products that are formulated as a complete diet. Under the FD&C Act, FDA can regulate them as drugs, food, or both. The Compliance Policy Guide explains the factors that FDA will consider when determining whether to take regulatory action against a company that may be illegally selling complete pet food diets intended to treat or prevent a disease. FDA thinks these products should be available to pet owners only through veterinarians, or through retail stores, or Internet sellers under the direction of a veterinarian. A veterinarian’s involvement is important because these products are formulated for specific health needs and may not be suitable for all pets.
Regulatory Agency Responsibilities
The FD&C defines food and drugs as articles intended for man or other animals. A safe animal food and feed supply helps ensure healthy animals and people. The Center for Veterinary Medicine (CVM) monitors and establishes standards for animal feed contaminants, including those in pet food, approves safe food additives for animal food use, and manages the FDA’s medicated feed and pet food programs.