ANSWERS Pet Food Response to FDA Advisory Re: Voluntarily Withdrawals of Certain Limited Lots of Beef and Chicken Dog Foods Due to Potential Salmonella and Listeria
FOR IMMEDIATE RELEASE: September 24, 2024
Answers Pet Food Withdrawal and Contact: info@answerspetfood.com
This communication from Lystn, LLC d.b.a./ANSWERS Pet Food of Fleetwood, PA (“ANSWERS”), is in response to the September 23, 2024 posted FDA Advisory: Do Not Feed Certain Answers Pet Food for Dogs Due to Salmonella and Listeria monocytogenes. ANSWERS prides itself on being transparent, and, therefore, wants to clarify statements made by the FDA not explained in the Advisory.
- The FDA reported that they collected and tested unopened retail samples of products after receiving three consumer complaints of illnesses in dogs that ate products from this lot. This is a misrepresentation of the facts. ANSWERS requested information on the reported complaints, and the limited information provided by the FDA was that one (1) consumer filed a series of three (3) complaints. When ANSWERS additionally requested supporting documentation, the FDA would not discuss the complaints further, and said ANSWERS would have to file a Freedom of Information Act (FOIA) request to learn more of the complaints.
- ANSWERS internal investigation found no research tying the alleged health problems reportedly suffered by the dogs in the complaint to the consumption of pet food alleged to contain pathogens. These lots of our products were distributed to many other end-users with no reported health complaints. ANSWERS is unaware of any confirmed illnesses in humans or animals directly tied to and caused by the implicated product lots referenced in the September 23, 2024 FDA Advisory.
- The FDA reported that they recommended that ANSWERS Pet Food recall these products. They state that to date, the company has not initiated an adequate recall of the affected products. The FDA, CVM and their staff are not following the requirements of the applicable federal law, the Food, Drug & Cosmetic Act (FD&C Act), for the determination if a food is adulterated. You may be aware that in 2019, ANSWERS Pet Food sought a court Declaratory Judgement against the FDA using nonbinding Compliance Policy Guides (CPG) to determine if a manufacturer is in violation of the Food, Drug & Cosmetic Act (FD&C Act) regarding adulterated food in lieu of completing a number of steps required by the law, including, but not limited to:
- Determining if the alleged pathogen was from an additive substance or not,
- Quantification of the alleged pathogen,
- Quality of the alleged pathogen (serotype), and
- Completing a Health Hazard Evaluation (HHE)
The above additional data required to be collected and investigated is to be used to determine if the quantity of such substance in a product defines it as adulterated and injurious to health. The courts have determined that it is unlawful to use a nonbinding zero tolerance Compliance Policy Guide to alone determine if a product is violative. The FDA is using the non-binding Compliance Policy Guides (CPG) to determine legal compliance by regulated industries with the FD&C Act.
From time-to-time pathogens appear in all types of pet food products and some may be harmful to pets and/or humans. The FDA does not follow the requirements of the FD&C Act; therefore, it is unknown if the questionable products violate the law. It is not even known if the alleged pathogenetic substance is an added substance or not, and in the case where a substance is not an added substance, under the FD&C Act such food shall not be considered adulterated under this clause if the quantity of such substance in such foods does not ordinarily render it injurious to health.
The FDA never quantified the substance nor provided to ANSWERS a required Health Hazard Evaluation (HHE). The law requires that the FDA must provide the HHE to the applicable manufacturer when a food recall is required, and/or the CVM assigns a classification and publicly posts the recall in the weekly FDA Enforcement Report. Within FDA communications provided to ANSWERS, they state “Upon determination by the FDA Center for Veterinary Medicine (CVM) that an action meets the definition of a recall, the Agency assigns a classification and publicly posts the recall in the weekly FDA Enforcement Report in accordance with 21 CFR 7.50.” Under FDA published information on Enforcement Reports it states, “Once FDA completes the hazard assessment, the Enforcement Report entry will be updated with the recall classification.” Since the FDA has not determined if a product is adulterated, a recall is not applicable because by FDA’s own definition of a recall is when a product is removed from the market because it violates FDA laws.
ANSWERS requested that all required data, documentation, and process required by the law be followed including the HHE in determining the appropriate action regarding the products. The FDA required an answer regarding the disposition of the implicated products within 24 hours of Answers receiving and discussing the laboratory Reports of Sample Analysis. The 24-hour period did not allow ANSWERS adequate time to follow our recall determination strategy, including but not limited to obtaining split samples and independent test results as well as more detailed data of FDA test results and conducting a Health Hazard Evaluation. ANSWERS uses Hurdle Technology including fermented ingredients, and we inoculate our products using protective cultures specifically to help mitigate pathogenic bacterium, so quantification of pathogens and Lactic Acid Bacteria (LABs), and a Health Hazard Evaluation are critical to ANSWERS decision making.
Even though the FDA did not follow the requirements of the FD&C ACT, and did not complete a HHE, the FDA reported that they would issue an advisory unless ANSWERS initiated a recall under 21 CFR 7.46 with an adequate press release using FDA language, which ANSWERS disagrees with.
Regardless, ANSWERS informed the FDA that we would honor our commitment to notify the public and withdraw the implicated product lots from the market. A manufacturer may decide on its own and under any circumstances to remove from sale any of its products. ANSWERS moved forward with the voluntary withdrawal as intended, notifying distributors, retailers, and the public, prior to the FDA releasing their Public Advisory. In the meantime, ANSWERS will continue investigating this FDA report with further data collection, testing and analysis as our number one priority is to bring healthy, safe, truly raw pet food products to market. ANSWERS stands by the safety of our food, and the unique and innovative way we protect our food with fermentation, probiotics and protective cultures that mitigate pathogens from growing. To learn more, ANSWERS has developed an educational video, “Answers Food-Safety” that can be viewed at https://www.answerspetfood.com/food-safety/, on our social media platforms, or accessed in the footer located on our website at www.answerspetfood.com.
