Since 2016, there have been more than 30 recalls of raw pet foods due to the potential or presence of microbiological contamination, primarily Salmonella and Listeria monocytogenes (Lm), at least 25 of which occurred in 2018. With two additional FDA alerts already published in 2019, the agency has been issuing consumer cautions to “avoid the dangers of raw pet food.” In the January 23 alert, FDA states, “Without an effective control, such as cooking, raw pet food is more likely than other types of pet food to contain pathogens such as Salmonella and L. mono. Refrigeration or freezing does not kill the bacteria. Pet owners who choose to feed raw pet food should be aware of the risks associated with these products.” That risk awareness phrase links to a January 9 advisory on the risks, which, in turn, links to a 2018 advisory with further discussion on the dangers of raw pet food. With such consumer alerts and advisories being published, my view is that FDA has developed a zero tolerance for pathogens in raw meat fed to pets. This was most visible in the 2018 warning issued to Darwin’s Natural Pet Products which had issued five recalls in less than two years for raw pet foods due to Salmonella, Lm or E. coli contamination. With contamination detected by FDA through whole genome sequencing (WGS) after multiple consumer complaints and the death of a kitten, the manufacturer was given 15 days to detail the corrective actions it had taken along with steps taken to prevent any recurrence or similar violation. FDA’s contention about raw pet food that contains pathogens is that it is not only dangerous to the pet, but because pet food is handled by humans who are feeding their pets, it has the potential to expose them to foodborne illness as well. But, just as with raw milk producers, raw pet food manufacturers continue to tout the benefits to pets of raw food. As recently as February 25, 2019, Darwin’s updated its “Benefits of Raw” web page, equating raw to the “ancestral diet” of dogs and cats, and as “real food” having “No preservatives. No high-pressure processing.” But it is just such an intervention as high-pressure processing (HPP) that I would see FDA as requiring to ensure the safety of pet food – for both pets and humans. And I could see this effectively destroying the raw pet food industry unless they adopt such an intervention. In fact, as FDA specifically stated in the warning letter to Darwin, “Unlike other human and pet foods which are heat-treated or are intended to be cooked, raw pet food has the potential to pose a significant risk to human and animal health because raw pet food is produced with minimal processing and is intended to be handled by humans and fed to animals without cooking, which would kill potentially harmful pathogens. It is therefore essential that your firm has a food safety system in place to prevent and control contamination of your products and facility.” FDA further advises that such a system may include cleaning and sanitizing, product testing, environmental controls, root cause investigation and corrective action and “a kill step to destroy microorganism contamination.” The issue is not new. In fact, the FDA Center for Veterinary Medicine (CVM) conducted a two-year study from October 2010 through July 2012 in which it screened more than 1,000 samples of pet food for bacteria that can cause foodborne illnesses. The study showed that, compared to other types of pet food tested, raw pet food was more likely to be contaminated with disease-causing bacteria. Of the 196 raw pet foods tested, 15 were positive for Salmonella and 32 for Lm. Comparatively a total of 866 other types were tested, of which only one was positive for Salmonella and none for Lm. Not only does the study conclude that there is a potential health risk for the pets eating the raw food, but also, “Owners who feed their pet a raw diet may have a higher risk of getting infected with Salmonella and Listeria monocytogenes.” While this is not a new study, the number of recalls of raw pet foods for pathogenic contamination has increased so significantly in the last year, I have no doubts that FDA is increasing its oversight, inspections, and investigations into these foods. Indeed, I feel that FDA is “on a mission” to put the raw pet food companies that do not have very solid preventive controls out of business. Pets have always been important to their owners, but today’s pets are seen as one of the family – which is exactly the reason owners are seeking natural, healthy foods for these family members. But when natural (e.g., raw) may equate to deadly for both the pets and their owners rather than healthy, it’s time to set more stringent standards and regulations. Certain raw pet food companies have embraced HPP, while others have not, feeling that HPP is somehow processing the raw food to the point that it will be rejected by consumers – clearly those that are using HPP don’t feel the same way. If the last couple of years is anything to go by, FDA will continue a public health mission to test and require recalls of raw pet foods that contain pathogens. Given that raw meat will always carry the risk of pathogens, then the answer to my title question of “Is Selling Raw Pet Food Compatible with Current FDA Regulatory Strategy?” is a clear No! About The Acheson Group (TAG) Led by Former FDA Associate Commissioner for Foods Dr. David Acheson, TAG is a food safety consulting group that provides guidance and expertise worldwide for companies throughout the food supply chain. With in-depth industry knowledge combined with real-world experience, TAG’s team of food safety experts help companies more effectively mitigate risk, improve operational efficiencies, and ensure regulatory and standards compliance. www.AchesonGroup.com