Tag: FDA Warning Letter

FDA gives Darwin’s pet food owners 15 days to clear up issues

Adulterated pet food, dead kitten, use of unapproved additive spur FDA warning letter

The FDA issued a formal warning letter to Arrow Reliance Inc. doing business as Darwin’s Natural Pet Products, citing pathogen problems at a production plant and saying scientific evidence shows the company’s cleaning solution is ineffective.

Darwin’s is a manufacturer of raw pet foods and is based in Tukwila, WA.

The April 2 warning letter from the Food and Drug Administration cites a history of consumer complaints and product recalls leading to the agency’s analysis of several Darwin’s products. Laboratory tests detected Salmonella, Listeria monocytogenes and E. coli O128 in one or more samples of the pet foods.

Foods under FDA jurisdiction, including pet foods, are deemed to be adulterated if they bear or contain a poisonous or deleterious substance that may render them injurious to health, according to the Federal Food, Drug, and Cosmetic Act (the Act). Introduction of an adulterated food into interstate commerce is a prosecutable violation of the Act.

Federal officials also found two Darwin’s products were also contaminated with Listeria innocua. Although it is not considered a pathogen in terms of human health, the warning letter underscored that the presence of Listeria innocua is an indicator that Listeria monocytogenes would be capable of surviving and growing in the product.

One of the consumer complaints that triggered the FDA investigation was lodged by the owner of a kitten that died as a result of a “severe systemic Salmonella infection” after being fed Darwin’s Natural Selections Duck Meals for Cats. 

Salmonella was isolated from the dead kitten’s liver and from an unopened raw pet food package. Whole Genome Sequencing (WGS) analysis, often referred to as genetic fingerprinting, confirmed that the Salmonella recovered from the dead kitten and from the pet food sample were identical.

FDA also performed WGS analysis on Salmonella recovered from various other Darwin’s samples. The identical Salmonella strain was found in two different products manufactured two weeks apart and containing two different meat sources. 

The presence of the identical Salmonella in these two products, according to the warning letter, suggests pathogen contamination in Darwin’s manufacturing facility.

In the letter, FDA also expressed its concern regarding Darwin’s use of a bacteriophage product to control pathogens in the raw pet foods, citing a lack of scientifically based validation of the controls and a change in the company’s protocol for applying the bacteriophage to the products.

The agency noted that the bacteriophage product is not “generally recognized as safe” (GRAS) nor is it the subject of a regulation describing additives permitted in animal foods.

The company was given 15 business days to reply to the warning letter, with a description of the steps taken to correct the violations and prevent these or similar violations from occurring in the future. 

This story first appeared in Food Safety News and is reposted here with permission.

Evanger’s proposes donating recalled pet food. FDA says ‘no’

The United States Food and Drug Administration (FDA) has vetoed a proposal by Evanger’s Dog and Cat Food Co. to donate recalled pet food to animal shelters after conducting random spot-checks for pentobarbital.

The proposal was revealed in a June 29, 2017 Warning Letter issued by FDA, and released on its website Tuesday morning (July 4, 2017) under the agency’s standing policy to post recent Warning Letters on a weekly basis.

The letter addressed to Holly N. Sher and Joel A. Sher, President and Vice President, respectively, notifies them that FDA found “…serious violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act) and its implementing regulations” during an investigation that included supplier traceback, facility inspection, and analysis of samples collected by FDA.

In its response to the Evanger’s proposal to donate recalled pet food, FDA said that finding the contents of individual cans of food from recalled lots to be negative for pentobarbital would not provide “…sufficient assurance that the remaining units are not adulterated.”

After stating that FDA’s own testing confirmed the pentobarbital contamination not to be homogeneous throughout an entire lot, the agency declined Evanger’s proposal and recommended destruction of all remaining recalled product.

The Warning Letter is the most recent development in an investigation of Evanger’s that began in early January with the reported illness of five dogs in a single household and the death of one of the dogs. Lab tests conducted on the gastric contents of the dead dog and on the remains of Evanger’s Hunk of Beef au Jus canned dog food that had been fed to all five of the animals, revealed the presence of a ‘large quantity’ of pentobarbital in both samples.

FDA opened its investigation immediately upon becoming aware of the incident. A team of inspectors began an on-site inspection of Evanger’s manufacturing facility in Wheeling, Illinois on January 10, 2017.

On February 14, 2017, the inspection team furnished Evanger’s management with a Form 483, listing a series of Inspectional Observations, including:

• Pentobarbital found in a sample of Evanger’s Hand Packed Hunk of Beef au Jus, 12 oz. can (Lot #1816E06HB13)
• Pentobarbital found in a sample of Against the Grain brand Grain Free Pulled Beef with Gravy Dinner for Dogs, 12 oz. can (Lot #2415E01ATB12; BEST DEC 2019)
• Condensate dripping throughout the facility, including into open cans in-process and onto totes of raw meat
• Pitted, cracked and damaged floors
• Peeling paint, mold throughout the facility and a live ‘fly-like insect’ in the hand-packing area during processing
• Inadequate temperature controls

In addition to the two pentobarbital-positive samples cited in the February 14th Form 483, FDA has found pentobarbital in the following five production lots of Evanger’s dog food:

• Braised Beef Chunks, lot code 2016E08BBW11 Best Aug 2020.
• Hunk of Beef Au Jus, lot code 1816E14HBC18 Best June 2020.
• Hunk of Beef Au Jus, lot code 1816E02HB12 Best June 2020.
• Hunk of Beef Au Jus, lot code 1316E23HB09 Best Jan 2020.
• Hunk of Beef Au Jus, lot code 1816E03HB17 Best June 2020.

On March 3, 2017, Evanger’s voluntarily recalled all cans of Evanger’s Braised Beef Chuncks, Evanger’s Hunk of Beef Au Jus and Against the Grain Pulled Beef with Gravy manufactured between December 2015 and January 2017.

In correspondence dated 2/4/2017, 2/21/2017, 4/4/2017, 5/18/2017 and 5/23/2017, Evanger’s addressed FDA’s Inspectional Observations, and proposed a series of corrective actions. In addition to the proposed donation of recalled product, the following actions, listed in the Warning Letter, are those FDA found to be inadequate or unacceptable.

Evanger’s discontinued doing business with the meat supplier alleged by the company to be the source of the adulterated meat.

Evanger’s was unable to supply any documentation or evidence that the indicated supplier was the only one who supplied the contaminated raw materials. Therefore, FDA was unable to evaluate whether or not this was an adequate response.

Evanger’s suggested that if pentobarbital were to be present in any of its ground loaf products, it would be “…well within the range that FDA had previously deemed not to be a health or safety concern in pet foods.”

FDA disagrees that grinding would dilute any pentobarbital to safe levels, and points out that there is zero tolerance for pentobarbital in pet food.

Evanger’s proposed random pentobarbital tests of finished products prior to shipment as a way to ensure that raw materials are not adulterated.

FDA considers this to be an inadequate and unreliable way to ensure the safety of the finished product. FDA’s own testing has demonstrated pentobarbital contamination is not uniformly distributed throughout all cans in a production lot. Also, the agency disagrees that finished product testing can mitigate the risk of pentobarbital in the raw material.

Evanger’s now requires new and current suppliers to provide letters of guarantee for their products.

FDA points out that a letter of guarantee may not provide adequate assurance of product safety, and recommends conducting site audits and/or reviews of supplier procedures in addition to the letter of guarantee.

As is customary, the Warning Letter concludes with a requirement that Evanger’s must furnish a written reply within fifteen working days, spelling out the steps it has taken or will take to correct the violations and prevent them from occurring again.

The complete text of the Warning Letter can be found on the FDA website.

This article first appeared in Food Safety News and is reposted here with permission.