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Fleetwood, PA, July 8, 2019. – Lystn, LLC d.b.a./ANSWERS™ Pet Food, announced today that the company has filed a Declaratory Judgment Complaint and is seeking Injunctive Relief against the Food and Drug Administration (FDA), in the United States Colorado District Court. The complaint challenges the lawfulness of the FDA’s actions, with cooperation provided by various members of the Association of American Feed Control Officials (AAFCO), by adopting a nationwide, zero tolerance standard for Salmonella in pet food that is noncompliant with federal law, unsupported by science, and beyond the FDA’s scope of power as delegated by Congress.
While the United States Department of Agriculture (U.S.D.A) permits allowable quantities of Salmonella in human food, the FDA who regulates pet food, rather than following federal law as set forth by the federal Food, Drug and Cosmetic Act (FD&C ACT), has instead adopted an unsustainable, zero tolerance standard for Salmonella presence in pet food, based on a “Non-Binding” Compliance Policy Guide (CPG). FDA guidance policies do not establish legally enforceable responsibilities, yet the adopted, supposedly nonbinding CPG has the FDA taking enforcement actions against manufacturers and imposes obligations upon the manufacturer creating legal consequences flowing from it.
The FD&C Act defines when a product is adulterated. It requires in addition to several other steps a suspected harmful substance be quantified, and a Health Hazard Evaluation be performed to determine if the product ordinarily renders it injurious to health. Currently the FDA does not follow the law for the more than 2,500 strains of Salmonella, most of which do not cause illness, but does quantify other contaminants such as aflatoxin in dry pet food, creating allowable tolerances. The Food Safety Modernization Act (FSMA) grants the FDA authority to mandate a recall, but only after following the FD&C Act.
ANSWERS™ approach to food safety and controlling pathogens is unique. In lieu of using high heat, high pressure or irradiation that denatures proteins, ANSWERS™ employs fermentation, Hurdle Technology and other proprietary processes, to preserve the integrity of the food, controlling pathogens and potential pathogens by either eliminating them, reducing them or inhibiting growth whereby good bacteria can survive and out compete harmful bacteria.
Keith A. Hill, President of Lystn, LLC, stated, “ANSWERS™ Pet Food would be the first party to initiate a recall if there was any indication of one of their products being a likely health risk to either pets or their owners, but when the science proves otherwise as provided by federal law, a manufacturer should not be coerced based on administrative policy view in contrast to the law.”
A report published in 2007, “FDA Science and Mission at Risk”, cited the FDA couldn’t fulfill its mission due to such issues as: a weak scientific organizational base and structure, with insufficient capacity and capability, and an inadequate information technology infrastructure. Using the CPG is easy and inexpensive to quote, but expensive for the public to present meaningful science to challenge these guides and deprives persons their due process and right to participate in regulation. As a result, the FDA, AAFCO and participating states are deciding what the public can and should feed their pets based on administrative policy views, not science or the law – taking away the public’s freedom of food choice.
Also addressed in the complaint, is the alleged extensive FDA regulatory abuse. ANSWERS™ asserts the FDA is unlawfully targeting the raw pet food industry, seeking to eradicate true, raw food from the marketplace through discriminatory and selective behavior. The FDA has been open in their bias against the raw pet food industry, despite the fact that the majority of reported illnesses occur in cooked and heavily processed food.
This press release by Lystn, LLC d.b.a./ANSWERS Pet Food is in response to the January 14, 2019 Food Drug and Administration Warning Notice: “FDA Cautions Pet Owners Not to Feed One Lot of A+ Answers Straight Beef Formula for Dogs Due to Salmonella”.
Before addressing the history and investigation behind the events leading up to the FDA’s posting of this Notice, please allow Lystn to correct a number of 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) Just one reason Lystn has not implemented a nationwide recall is 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. For additional information on our response to the FDA and Lystn’s position on these and other raw pet food industry issues, please visit our website. Additional information is forthcoming through continued updates.
Because Salmonella is prevalent throughout much of the food chain and in our environment, Lystn formulates ANSWERS Pet Food products to protect the pets and their owners from potential harmful bacteria using what is referred to as “Hurdle Technology”. One step of Lystn’s Hurdle Technology uses natural competitive inhibition through fermentation by inoculating our 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.
One (1) 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.
Lystn’s Hurdle Technology and labeling addresses the concerns expressed by the FDA regarding product exposure and handling risks to children and immune compromised individuals, in that the good bacteria from the fermentation process continues to compete with bad bacteria, regardless of manner of exposure. 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.“
We advised the FDA of Lystn’s extensive 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.
Many of our distributors, customers, and retailers alike understand Lystn’s use of competitive inhibition through the process of fermentation to protect our foods from pathogens. But, if after presenting our customers with our views, if a customer is uncomfortable with an ANSWERS’ product, they may return it (or any unused portion) to the place of purchase for a full refund. The Straight Beef Formula 4lb. Pounder for Dogs product comes in a cardboard milk carton box marked with lot code 2018 and a Best Use By Date (BUBD) of 02/08 20 sticker on the carton. The above referenced lot number and BUBD Lystn product was distributed at various times from 8/17/18 to 9/14/18 and sold through retail stores within the United States.
ANSWERS Pet Food continues to be at the forefront as a leader in transparency and is committed to keeping you informed. We are in the process of creating a page on our website for the web and social media for our customers to go see the latest information concerning state and federal regulatory matters applicable to ANSWERS Pet Food and the raw pet food industry. To learn more about ANSWERS, our unique process, and the raw pet food industry, please visit our website at www.answerspetfood.com.
The above comments and observations by Lystn are the current view and understanding of Lystn and not intended to be a statement of law nor contain all details that may apply. Thank you for time and understanding.
Lystn, LLC, Manufacturer of Answers Pet Food
Roxanne Stone, VP of Quality Assurance/Quality Control (801) 707-2175 or rstone@answerspetfood.com
