Lystn, manufacturer of raw pet food brand Answers Pet Food, filed a lawsuit in Colorado federal court to challenge the legality of U.S. Food and Drug Administration enforcement of zero-tolerance Salmonella standards, alleging it is beyond the agency’s powers granted by Congress.
The raw pet food company’s lawsuit named the U.S. Food and Drug Administration, the U.S. Department of Health and Human Services, the Colorado Department of Agriculture and three individuals in that state agency as defendants.
The raw pet food manufacturer alleges that the federal policy of zero-tolerance for Salmonella is only a guideline or recommendation, yet results in consequences as if it were law. Lystn also claims scientific evidence does not support that zero-tolerance policy for the pathogen.
“The FDA’s Compliance Policy itself plainly states – and its local and state partners will plainly admit— that this zero-tolerance tolerance policy should be viewed only as a recommendation…,” wrote lawyers for Lystn in legal documents. “It is a ‘recommendation’ the FDA – through AAFCO, compels state regulatory agencies to enforce in exchange for a piece of roughly US$11,100,000.00 in FDA funding.”
History of Lystn raw pet food FDA warnings
In January, the United States Food and Drug Administration (FDA) warned pet owners that Lystn’s A+ Answers Straight Beef Formula for Dogs, lot 2018 20/08 20, tested positive for Salmonella. However, Lystn refuted the warning in a press release.
Anne Norris, FDA health communications specialist, responded to Lystn’s allegations in a previous article, prior to the filing of Lystn's lawsuit:
“A sample of Answers Straight Beef Formula 4lb. Pounder for Dogs UPC 856554002072 lot code 2018 02/08 20 was collected and tested by Nebraska Department of Agriculture (NDA) on December 10, 2018, and was found to be contaminated with Salmonella.
“The firm initiated a recall of this lot of pet food in the state of Nebraska, however, the FDA recommended a nationwide recall of this lot and an accompanying press release to notify the public of the associated health hazards.
“The firm’s negative samples do not negate the positive results found by NDA.”
“FDA expert scientists from the Office of Regulatory Science have reviewed the NDA data packet and chain of custody. They have concluded that the analysis was performed correctly, and that the results demonstrate that the product is contaminated with Salmonella.
“The firm tested four additional samples from this lot of pet food, and received negative results however, due to the nature of how bacteria grows, there is no expectation that the Salmonella will be equally distributed throughout the entire lot of pet food. Therefore, the firm’s negative samples do not negate the positive results found by NDA.
“Because the firm had not determined to implement a recall of this contaminated product on a national level, in the interest of protecting public health, FDA issued its own public notification.”
A+ Answers Pet Food maker perspective on FDA Salmonella warning
In a press release, Lystn alleged that there were errors in the FDA’s notice:
(1) The Best Use By Date (BUBD) is incorrectly listed as 20/08 20. The correct BUBD is 02/08 20.
(2) The statement that Lystn has recalled the affected lot in Nebraska is not correct. Lystn stopped further distribution of the lot in question working with Lystn’s distributor, retail stores and the Nebraska Department of Agriculture who reported the follow-up that the product was removed from retail store shelves.
(3) Lystn has not implemented a nationwide recall because the product was only tested by the State of Nebraska and Lystn for which the test results were contradictory addressed below, and not tested by the FDA.
The FDA Notice comments that the reason why the FDA issued this warning is because it (the product in question) represents a serious threat to human and animal health and is adulterated under the Federal Food, Drug, and Cosmetic Act (FD&C Act). It is important to note that neither Lystn nor any government agency has received any report of animal or human illness. Neither the State of Nebraska nor the FDA quantified the alleged finding of Salmonella which is just one factor for consideration when defining adulterated food under the FD&C Act. The FDA uses a Compliance Policy Guide which contains Nonbinding Recommendations of a “zero tolerance” of Salmonella for enforcement. In contrast to human consumed products inspected by the USDA, a certain percentage of Salmonella is allowed (some of the same sourcing Lystn buys as ingredients for its pet food).
For just some of the reasons stated below, Lystn disagrees with the FDA zero-tolerance policy, based upon our understanding of science and the FD&C Act.
One random test by the Nebraska Department of Agriculture was sampled 12/10/18 and revealed the presence of Salmonella in the Straight Beef Formula 4lb. Pounder for Dogs. Lystn requested a split sample of the product in question and while a confirmation of Salmonella was detected on the initial sample supplied by Nebraska, there was insufficient quantity to run all the quantitative tests. Lystn requested and received a subsequent larger quantity and all 4 samples tested negative for the presence of Salmonella. It is Lystn’s belief (as well as our science advisors) that the initial sample sent from Nebraska may have been cross contaminated in the lab, transport or elsewhere and should not be considered a representative sample. Even if Salmonella was present in the initial sample, equally important was that the quantification of Lactic Acid Bacteria in the subsequent samples was significant in quantity (greater than Log 7) confirming that our fermentation process was working and therefore evaluated as a safe product by Lystn’s team of scientists and advisors.
Because Salmonella is prevalent throughout much of the food chain and in our environment, Lystn formulates ANSWERS Pet Food products using what is referred to as “Hurdle Technology”. One step of Lystn’s Hurdle Technology uses natural competitive inhibition through fermentation by inoculating products, which favors growth of desirable (good) bacteria but inhibits the growth of pathogens (bad bacteria). This avoids destroying the benefits of good bacteria needed in the gut of the pets ingesting ANSWERS pet food and continues to protect the pets post ingestion and the household environment from potential pathogens, according to the company.
Lystn’s labeling conspicuously identifies the products as being in the raw state and states – “For Pet Use Only: Not for human consumption. This product has not been pasteurized and may contain harmful bacteria.” The labeling also contains – “Safe Handling Instructions: Keep raw meat separate from other foods. Wash working surfaces, utensils, hands and any other items that come in contact with raw meat with hot soapy water.“
Lystn states that the company advised the FDA of Lystn’s third-party test results and science-based evaluation that the food is safe and not a public health risk, in accordance with the assessment of an independent “Ph.D. science expert” in concurrence with Lystn’s science team. Nevertheless, the FDA proceeded to issue this Warning Notice without further consultation with Lystn.