- Delivery Method:
- Overnight Delivery
- Animal & Veterinary
Recipient NameGary T. Tashjian
- Arrow Reliance Inc.
350 Treck Drive
Tukwila, WA 98188
- Issuing Office:
- Division of Human and Animal Food Operations West VI
February 16, 2023
In reply, refer to CMS 644947
Dear Mr. Tashjian:
The U.S. Food and Drug Administration (FDA) collected samples of your Darwin’s Natural Selections Antibiotic & Grain-Free Chicken Recipe for Cats and Darwin’s Natural Selections Antibiotic & Grain-Free Turkey Recipe for Cats in response to a consumer complaint received about your products causing illness in the customer’s kittens. FDA laboratory analysis revealed these products to be contaminated with Salmonella. Further, during a follow-up inspection of your manufacturing facility, located at 350 Treck Drive, Tukwila, Washington, from August 23, 2022, through September 30, 2022, FDA collected an additional sample of your Natural Selections Antibiotic & Grain-Free Chicken Recipe for Cats. FDA laboratory analysis revealed this product was also contaminated with Salmonella. Based on the analytical results, FDA considers the product lots sampled to be adulterated in that they bear or contain a poisonous or deleterious substance which may render them injurious to health.1 Furthermore, you are using the unapproved/unsafe animal food additive peroxyacetic acid. Use of an unsafe food additive causes a food to be adulterated.2 The introduction or delivery for introduction into interstate commerce of an adulterated food is a prohibited act.3 Additionally, the doing of any act to a food after shipment of the food and/or its components in interstate commerce and while the food is held for sale (whether or not the first sale) that results in the food being adulterated or misbranded is prohibited.4 You may find the FD&C Act and FDA’s regulations through links on FDA’s homepage at www.fda.gov.
At the close of the inspection, you were issued a Form FDA 483, Inspectional Observations (FDA 483). We received your response emailed by your Director of Quality on October 14, 2022, and address your response below, in relation to each of the noted violations.
Adulterated Animal Food
On July 13, 2022, prior to the inspection of your facility, FDA collected and analyzed unopened samples of your Natural Selections Antibiotic & Grain-Free Chicken Recipe for Cats, lot 9116, and Natural Selections Antibiotic & Grain-Free Turkey Recipe for Cats, lot 9121, (FDA samples 1179788 and 1179789, respectively) from one of your customers after receiving a complaint from the customer that three kittens developed diarrhea after consuming the food. The complainant also provided documentation that a stool sample from one of the kittens tested positive for Salmonella spp.
FDA laboratory analysis of the sampled pet food products revealed the presence of Salmonella kentucky and Salmonella typhimurium in FDA sample 1179788, and Salmonella typhimurium in FDA sample 1179789.5 Additionally, during the inspection of your facility, FDA collected a sample of your Natural Selections Antibiotic & Grain-Free Chicken Recipe for Cats, lot 9306 (FDA sample 1168289), and FDA laboratory analysis revealed the presence of Salmonella typhimurium.
The Salmonella found in the three lots of pet food described above causes them to be adulterated within the meaning of section 402(a)(1) of the FD&C Act [21 U.S.C. § 342(a)(1)] because the Salmonella may render the food injurious to health. Salmonella is a pathogenic bacterium that can cause serious and sometimes fatal infections in both humans and animals. Pets like dogs and cats are prone to Salmonella infections from eating contaminated pet foods and humans are prone to Salmonella infections from handling contaminated pet foods or having contact with infected pets or their feces. Infections can be especially serious in young children, elderly people, and others with weakened immune systems.
Evaluation of your response:
In your response, you stated you dispute the FDA Investigators’ observation that the pet food samples contained a poisonous or deleterious substance that may render the food injurious to health, as well as the observation’s relevance. You asserted that FDA has not presented any evidence to demonstrate Salmonella typhimurium is poisonous or deleterious to the intended consumer (i.e., cats) or that it is an “added substance;” therefore, you feel it is incumbent on FDA to demonstrate the Salmonella is present in a quantity that makes it “ordinarily injurious” to the intended consumer.
FDA is responsible for protecting the public (human and animal) health by ensuring, among other things, the safety of the nation’s food supply. The association between human illness or outbreaks of salmonellosis and Salmonella-contaminated pet foods is well established.6 Association with pet illness has also been shown.7 Thus, FDA considers a pet food to be adulterated if it is contaminated with Salmonella, regardless of the quantity or Salmonella serotype; however, Salmonella typhimurium is one of the most common serotypes that causes human infection.8 You have been previously informed of the FDA’s position regarding Salmonella in pet food on other occasions, including in a Warning Letter issued to your firm on April 2, 2018, and in teleconferences between FDA and your firm dated March 2, 2018, and February 13, 2019.
Your response is inadequate in that it did not address corrective actions that you have taken or plan to take in response to the FDA laboratory findings of Salmonella in your products, including steps to prevent the recurrence of Salmonella in your pet food.
During the inspection, you informed our Investigators that no product from Natural Selections Chicken Recipe for Cats, lot 9306, had been distributed to customers. You again stated that none of this lot had been distributed when we shared whole genome sequencing results with you during a teleconference on October 6, 2022. We requested during this teleconference that you notify FDA of any disposition decision that is made with respect to your Natural Selections Chicken Recipe for Cats, lot 9306. We have not received any information regarding your decision; therefore, we reiterate our request at this time.
Use of Peroxyacetic Acid (PAA)
FDA inspected your facility in June 2021, and subsequently sent you a letter dated August 27, 2021, documenting our concerns with your use of PAA as a pathogen mitigation step to reduce E. coli O157:H7 and Salmonella spp. in your raw pet food products. In our letter, we explained that any substances that may become part of your pet food, such as PAA, must be used as described in an animal food additive regulation, be generally recognized as safe (GRAS) for the intended use as defined by the FD&C Act, or should be otherwise not objectionable for use in animal food due to a definition in the AAFCO Official Publication.
During the current inspection, FDA Investigators noted you continue to use PAA as a pathogen mitigation step and you have increased your PAA concentration from (b)(4) ppm to (b)(4) ppm on the advice of your PAA supplier and a third-party laboratory. There is no food additive regulation in 21 CFR Part 573 for the use of PAA in animal food, and PAA is not listed in 21 CFR Part 582 or 584 as a substance that is GRAS for the intended use. Furthermore, FDA is not aware of any data demonstrating that PAA is GRAS for any use in animal food. Under section 409(a) of the FD&C Act [21 U.S.C. § 348(a)(2)], an unapproved food additive is unsafe and food containing an unsafe food additive is deemed to be adulterated.9
Although peroxyacids are permitted for use on certain meat products intended for human food as an antimicrobial secondary direct food additive under 21 CFR 173.370, the permitted uses allow for a maximum PAA concentration of 220 ppm. Additionally, the directions for use outlined on the label of the PAA product you use allow for a maximum concentration of 220 ppm of PAA on a ready-to-eat (cooked) human food. Your production process involves adding a quantity of (b)(4) ppm PAA into your pet food. We are concerned that we have been unable to find scientific data indicating that PAA at that level is safe for dogs and cats to consume. It is your responsibility to ensure your pet foods are safe before marketing them.
Food Facility Registration
FDA has determined that your facility is subject to the registration requirement in the FD&C Act10 and its implementing regulations.11 Our records indicate that as of the date of this letter your facility is not registered with FDA.
In consideration as to whether your facility meets an exemption from the food facility registration requirement, we reviewed the definition of a “retail food establishment” in 21 CFR 1.227. A “retail food establishment” sells food products from that establishment directly to consumers as its primary function. The term “retail food establishment” includes facilities that manufacture, process, pack, or hold food if the establishment’s primary function is to sell from that establishment food, including food that it manufactures, processes, packs, or holds, directly to consumers. Your Director of Quality informed FDA’s Investigators that the majority of your product (approximately (b)(4) percent) is shipped directly to consumers from third-party warehouses rather than from your facility. Thus, your manufacturing facility is not a retail food establishment as defined in 21 CFR 1.227.
Food facility registration guidance is available online at www.fda.gov/food/guidanceregulation-food-and-dietary-supplements/registration-food-facilities-and-other-submissions. Registration may be accomplished online at www.access.fda.gov.
This letter is not intended to be an all-inclusive statement of violations that may exist at your facility or in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law and FDA regulations.
This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may lead to legal action including, without limitation, seizure and injunction.
Additionally, please note the following:
1. Because your firm is subject to the food facility registration requirement, you are also subject to the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food for Animals regulations found in 21 CFR Part 507. Future inspections will assess your compliance with these regulations. For more information about FDA’s current thinking on the requirements of 21 CFR Part 507, see:
- Guidance for Industry #235, Current Good Manufacturing Practice Requirements for Food for Animals, at: www.fda.gov/media/97464/download.
- Guidance for Industry #245, Hazard Analysis and Risk-Based Preventive Controls for Food for Animals, at: www.fda.gov/media/110477/download.
- Draft Guidance for Industry #246, Hazard Analysis and Risk-Based Preventive Controls for Food for Animals: Supply Chain Program, at: www.fda.gov/media/113923/download.
2. During the inspection, you provided documentation of a study performed by a third-party facility in support of your application of (b)(4) ppm PAA to your products, entitled “Efficacy [of] Peroxyacetic Acid Interventions for Raw Materials Used in Pet Food Production,” dated August 23, 2022. This study “evaluated inoculated raw materials with surrogate organisms for E. coli O157:H7 and Salmonella before the application of (b)(4) ppm PAA and compared it to finished pet foods made from raw materials treated with (b)(4) ppm PAA.” We offer the following comments:
- The study demonstrated an approximate (b)(4) reduction in E. coli bacteria following application of PAA; however, it did not demonstrate an ability to fully eliminate pathogens in your products.
- Additionally, though a (b)(4) reduction in E. coli was demonstrated by the study, given a higher starting level of contamination in your raw ingredients than was present in your study, a two-log reduction may not ensure a pathogen-free final product.
- We also noted a limitation of the study you provided is that no other manufacturing was conducted on the same day as the study was performed, as may occur under normal operating conditions.
3. With regard to your use of (b)(4) ppm PAA to address pathogens in your raw pet food:
- For information relating to GRAS substances and FDA’s GRAS Notification Program, we recommend reviewing the information and various linked resources located on FDA’s website at www.fda.gov/animal-veterinary/animal-food-feeds/generally-recognized-safe-gras-notification-program.
- An alternative option is to consider submitting an animal food additive petition as explained in FDA’s Guidance for Industry #221, Recommendations for Preparation and Submission of Animal Food Additive Petitions, www.fda.gov/media/86905/download.
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to address any violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective actions within fifteen (15) working days, state the reason for the delay and the time frame within which you will complete the correction. If you believe that you have complied with the FD&C Act and FDA regulations, include your reasoning and any supporting information for our consideration.
Your written response should be sent to U.S. Food and Drug Administration, 22215 26th Avenue SE, Suite 210, Bothell, Washington 98021, to the attention of Mark Babbitt, Compliance Officer. If you have questions, you may contact Compliance Officer Babbitt at (509) 353-2136 extension 107, or by email at firstname.lastname@example.org.
Miriam R. Burbach
Program Division Director
Office of Human and Animal Food Operations
West – Division 6
1 See section 402(a)(1) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) [21 U.S.C. § 342(a)(1)]
2 See section 402(a)(2)(C)(i) of the FD&C Act [21 U.S.C. § 342(a)(2)(C)(i)]
3 See section 301(a) of the FD&C Act [21 U.S.C. § 331(a)]
4 See section 301(k) of the FD&C Act [21 U.S.C. § 331(k)]
5 On August 5, 2022, FDA issued a press release cautioning pet owners about these two lots of pet food (www.fda.gov/animalveterinary/outbreaks-and-advisories/fda-cautions-pet-owners-not-feed-certain-lots-darwins-natural-pet-products-due-salmonella)
6 For example, see the Centers for Disease Control and Prevention information on past Salmonella outbreaks related to pet food: www.cdc.gov/salmonella/pet-treats-07-19/index.html (pig ear dog treats), www.cdc.gov/salmonella/dog-food-05-12/index.html (dry dog food), www.cdc.gov/salmonella/2007/pet-food-9-4-2007.html (dry dog food).
7 www.cdc.gov/healthypets/keeping-pets-and-people-healthy/pet-food-safety.html; www.avma.org/resources-tools/avmapolicies/raw-or-undercooked-animal-source-protein-cat-and-dog-diets
9 See section 402(a)(2)(C)(i) of the FD&C Act [21 U.S.C. § 342(a)(2)(C)(i)]
10 See section 415 of the FD&C Act [21 U.S.C. § 350d]
11 See 21 CFR Part 1, Subpart H