1. Can pet food contain residues of pentobarbital?
No. FDA considers pet food containing pentobarbital residues to be adulterated under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and will act to remove it from the market. Pentobarbital residues are not affected by rendering or canning temperatures and pressures (such as heat treatments capable of killing pathogenic organisms), and therefore we do not allow the use of animals euthanized with a chemical substance such as pentobarbital in the manufacture of pet foods. There is currently no set tolerance for pentobarbital in pet food and detection of its presence renders the product adulterated.
Below are links to examples of actions and recalls due to pentobarbital contamination:
2/16/18: FDA Alerts Pet Owners About Potential Pentobarbital Contamination in Canned Dog Food Manufactured by The J.M. Smucker Company, Including Certain Gravy Train, Kibbles ‘N Bits, Ol’ Roy, and Skippy Products
Yes. We believe that the new requirements that the Food Safety Modernization Act (FSMA) places on food manufacturers will help prevent this kind of contamination. FSMA requires certain animal food facilities to create and implement a food safety plan, including an analysis of potential hazards and determining if there are hazards requiring preventive controls to reduce or eliminate those safety hazards. FDA published a draft guidance identifying residues of pentobarbital as an example of a known or reasonably foreseeable hazard that would require a preventive control (see, Draft Guidance for Industry #245, “Hazard Analysis and Risk-Based Preventive Controls for Food for Animals”).
In general, pet food manufacturers are responsible for taking appropriate steps to ensure that the food they produce is safe and properly labeled. One way that a manufacturer can do this is by taking steps to verify the identity and safety of the ingredients they receive from their suppliers. There are several different players connected to the issue of pentobarbital in animal food, including livestock producers, horse owners, veterinarians, renderers, haulers, and animal food manufacturers, and each has a role in preventing pet food contamination from pentobarbital residues. FDA has engaged with many of these stakeholders to communicate that no level of pentobarbital in pet food is acceptable and the agency is encouraging them to work together to fully investigate the issue and determine appropriate solutions. We will continue to follow up on complaints received, positive samples, and/or violative inspections.
The Director of FDA’s Center for Veterinary Medicine recently spoke about pet food contamination in general and mentioned pentobarbital. FDA believes that the increased focus through FSMA on hazard identification and preventive controls will raise awareness of contaminants such as pentobarbital, and lead manufacturers and ingredient suppliers to put the necessary safeguards in place.
Yes. Under the FD&C Act, food that is made from a diseased animal or an animal that died other than by slaughter is adulterated. However, federal agencies have discretion to enforce laws and FDA takes action based on scientific review and risk. We received a Citizen Petition (Docket No. FDA-2016-P-3578) requesting that we reconsider our policy. When we finish our review and respond to that petition, we intend to update this page to reflect that response.
It is important to remember that regardless of any enforcement discretion policy, the agency can and will act when necessary to protect public health.
Yes. Pathogenic bacteria (e.g., Salmonella or Listeria monocytogenes) are considered adulterants in both human and animal food. Although many animals consuming this food may not become sick themselves, they can become carriers and expose their human family members to pathogenic bacteria. This is especially problematic with young children, the elderly, or people who are immunocompromised. For example, in March 2018, two children became ill with a strain of Salmonella that matched the strain found in samples of the raw pet food that was fed to the family dog.
Due to competing priorities and resource limitations, government agencies cannot act against every violation of the law. The same is true of FDA’s enforcement of the Federal Food, Drug, and Cosmetic Act. The use of enforcement discretion allows FDA to concentrate on the most egregious violations and the ones that present the highest risk to animal and human health.