Tag: FDA

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.

Darwin’s pet food owner knew of pathogens in production plant

The producer of Darwin’s brand raw pet foods knew about Salmonella in its plant, fielded more than 300 consumer complaints about sick or dead pets, and racked up a laundry list of food safety violations in 2017, according to government inspectors.

Investigators from the U.S. Food and Drug Administration and the Washington State Department of Agriculture (WSDA) identified numerous problems at Arrow Reliance Inc., doing business as Darwin’s Natural Pet Products. They undertook the December 2017 inspection in response to an ongoing pattern of product recalls and a consumer complaint received in October 2017.

Gary Tashjian, president and owner of Darwin’s, told the inspectors his company hadn’t received any specific complaints regarding Salmonella, E. coli or Listeria, according to a draft report from the inspectors. He said if consumers complained of pets’ illnesses, they would have to provide Darwin’s with test results from a veterinarian before the company would test its retained samples of implicated products. Only if the retained sample also tested positive would Darwin’s initiate a recall Tashjian told inspectors.

This week Darwin’s issued its fifth product recall since October 2016 after the Food and Drug Administration found Salmonella in four of its products. One of those products also was contaminated with E. coli O128.

According to the draft inspection report, obtained from WSDA by Food Safety News through a public records request, a review of the pet food company’s own records revealed much of the information that shows Darwin’s owners were aware of the pathogen problems.

Darwin did not have a written sanitation plan at the time of the inspection, according to the draft report.

The company was performing in-house pathogen testing that included screening for Salmonella. Darwin’s logs showed the company found Salmonella on the handle of a hand cart and the wheel of a garbage can that were on the processing floor in September. There was no documentation of a repeat test after the contaminated items were cleaned.

Similarly, an Aug. 24, 2017, log entry documented failure of the trench drain by the grinder. Again, there was no mention of corrective action.

Thermometer verification logs also showed several failures, with no corrective action documented.

Inspectors reported that Darwin’s maintains a record of customer complaints. During the period from Jan. 5, 2017, through Dec. 5, 2017, the company logged 332 complaint entries, including complaints of foreign material, spoiled and leaking packages, and pet illnesses and deaths.

More than one-third of the complaints — 36 percent — related to sickness. Ten percent were for foreign objects, including metal, plastic, rubber bands, produce bands and ties, hairnet material, and a pebble.

In addition to reporting on Darwin’s records, investigators recorded the following general “objectionable” conditions:

  • Failure to conduct operations under cGMPs (current Good Manufacturing Practices);
  • Raw materials were not thawed under conditions that would minimize the potential for growth of undesirable pathogens;
  • Animal food contact surfaces not made of appropriate materials or maintained to protect animal food from becoming contaminated; and
  • Equipment and utensils not used appropriately to avoid adulteration of animal food with contaminants.

Inspectors also cited the following specifics in their report:

  • A mallet with raw meat material on it was on a rack used to store sanitized equipment in the sanitizing room;
  • 4-wheeled hand cart with two shelves covered with wet cardboard containing raw meat. Cart was touching a food preparation surface. Buckets used to carry and mix micro ingredients and phage preparation stored on the cart. Cart handle was broken and surface appeared to not be cleanable;
  • Dirty tool from processing floor placed on top of sanitized yellow pallet;
  • Food preparation table grooved and not cleanable;
  • Flashing between wall and floor and behind prep table was damaged and contained meat debris;
  • Employee observed breaking down dirty cardboard boxes with gloved hands and returning to processing floor without changing gloves or sanitizing;
  • Freezer box “B” had bloody and rusted metal racks; bloody floors and boxes storing frozen meat; organic material behind racks;
  • Cooler box “A” had bloody boxes of meat and vegetables stored on metal racks and pallets with organic material behind racks;
  • Cardboard boxes containing raw meat were observed leaking and dripping blood onto boxes stored below and onto adjacent boxes, pallets and metal racks;
  • Wooden pallets and metal racks not maintained or designed to be cleaned in a manner that protects ingredients against contamination;
  • Fork lift was observed moving from the receiving/loading dock, over the packing floor, through Box A and into the raw product prepping room;
  • Employees were wearing dirty boots in sanitation room and on process floor;
  • Damaged wall in preparation room;
  • Cement floor under hoses chipped and broken away. An approximately 12-inch x 12-inch hole was observed in first layer of cement;
  • Employee pocket knife observed on food contact service;
  • Door stops and upright pillar stops pitted and rusted;
  • Slider door between prep room and temping room rusted and dirty; and
  • Recycled wooden pallets noted in processing area at end of packing line.

FDA advice to consumers
People who think they might have become ill due to exposure to contaminated raw pet food or the feces of pets that have eaten contaminated raw pet food should talk to their health care providers.

Contact your health care provider if you have diarrhea that lasts for more than three days, or is accompanied by high fever, blood in the stool, or so much vomiting that you cannot keep liquids down and you pass very little urine.

People who think their pets have become ill after consuming contaminated raw pet food should contact their veterinarians. Veterinarians who wish to have dogs tested for Salmonella may do so through the Vet-LIRN Network if the pet is from a household with a person infected with Salmonella.

The FDA encourages consumers to report complaints about this and other pet food products electronically through the Safety Reporting Portal or by calling their state’s FDA Consumer Complaint Coordinators.

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

Regulators’ hands were tied on pet food issues observed in 2016

Federal and state inspectors observed numerous problems with manufacturing processes during a 2016 visit to the Tukwila, WA, manufacturing facility of Arrow Reliance Inc., doing business as Darwin’s Natural Pet Products.

The regulators’ ability to take action was limited because the company was not yet required to comply with current Good Manufacturing Practices (CGMP) under the Food Safety Modernization Act (FSMA), according to a report by the Washington State Department of Agriculture (WSDA) and obtained by Food Safety News through a Public Records Request.

State inspectors worked with federal inspectors from the Food and Drug Administration on the case. However, without documentation of product adulteration, they could not act.

There are several ways FDA is able to support a finding of adulteration of an animal food under the Food, Drugs and Cosmetics Act (FD&C), according to a spokesperson for FDA, including demonstration of a “poisonous or deleterious substance” in a particular food, demonstration that the food was prepared under insanitary conditions, or demonstration that the food is unfit, based on scientific test results, available scientific literature and expert opinion.

The 2016 FDA/WSDA joint inspection was triggered by a consumer complaint of foreign objects, specifically plastic, metal and bone shards, in multiple packages of Darwin Natural Selections premium dog food.

According to information Food Safety News obtained from WSDA, the consumer contacted the Illinois Department of Agriculture (IDOA) and FDA after having lodged several complaints with the company without having obtained a satisfactory response.

Illinois officials forwarded the complaint to WSDA on June 8, 2016.

FDA and WSDA inspected Darwin’s manufacturing plant over a period of four days, June 22-30, 2016.

During the June 22 and 23 visits to the plant, inspectors observed that a metal detector was not working consistently, and the company did not maintain a maintenance/calibration log for the metal detector.

Inspectors also observed liquid leaking from boxed meat products that were stored on wooden pallets in the cooler.

During the inspection, samples of two products were collected by the WSDA inspector for pathogen analysis. The WSDA detected Salmonella agona in a sample of Darwin’s Natural Selection Duck with Organic Vegetables, Meals for Dogs, Lot code 3077, manufactured on June 22.

On July 29, 2016, Darwin officials agreed to destroy and dispose of the contaminated product. No recall was considered necessary, as none of the product had been shipped to customers.

The 2016 report referring to “numerous GMP-type issues” is consistent with information obtained by Food Safety News from an individual who was employed by Darwin in 2015.

Speaking under conditions of anonymity, the former employee described a reluctance on the part of company management to engage in developing and implementing food safety programs, including a sanitation program, environmental swabbing and HACCP.

As of May 31, 2017, Darwin still did not have a written Food Safety Plan, according to WSDA.

A spokesman for the company told Food Safety News on Monday that the firm is “actively updating” its Food Safety Plan in advance of this year’s Sept. 17 deadline for compliance with FSMA.

The company also has replaced the wooden pallets in its warehouse with plastic pallets, is calibrating its metal detectors “regularly” and is continuously testing its packaging materials, according to the spokesperson.

Darwin’s former employee alleges the company’s consumer complaint log did not reflect all of the complaints received, including items such as animals passing bones; plastic material in the products; and sick animals.

The company’s spokesman told Food Safety News that Darwin’s customer service staff addresses customer concerns on a “case-by-case basis.” He did not reply when asked whether Darwin conducts any routine microbiological testing of its ingredients or finished products prior to shipment.

Situations that were serious enough to warrant a product recall were ignored by management, according to the former Darwin employee, who says the company would only initiate a recall if a customer’s veterinarian documented beyond doubt the existence of a contaminant.

A review of product recalls initiated by the company since the 2016 inspection showed that each one resulted from a consumer complaint lodged with the company and/or with FDA, according to the following information provided by FDA.

  • Recall initiated October. 17, 2016 – Darwin received a customer complaint that a dog became ill after consuming one of their products. In response, the firm tested several products and found that they were contaminated with Listeria monocytogenes. Darwin recalled the three products found to be contaminated.
  • Recall initiated Aug. 9, 2017 – Darwin received a customer complaint that a kitten became ill and died after consuming the raw cat food Natural Selections brand frozen raw Duck Meals for Cats Lot #38277. A necropsy was performed on the dead kitten. The veterinary lab submitted animal tissues and product for culture and Salmonella was found. Independently, Darwin submitted a sample of the implicated pet food to a contract lab. The product was recalled after the contract lab reported finding Salmonella in the pet food sample.
  • Recall initiated Oct. 4, 2017 – A dog owner reported to FDA that her dog became ill after consuming a variety of Darwin’s Natural Selections Raw Dog Foods, particularly the beef variety. FDA collected four samples of these foods, and two of the four samples were preliminarily positive for Salmonella. One additional sample was preliminarily positive for both Salmonella and Listeria monocytogenes. Darwin recalled all three products.
  • Recall initiated Feb. 10, 2018 – FDA received a consumer complaint in which a pet owner described ongoing sickness in her dog while feeding Darwin’s raw pet food products. FDA collected three intact samples from the pet owner, and found that two tested positive for Salmonella. Darwin recalled the two Salmonella-positive products.

Foodborne pathogens such as Salmonella and Listeria monocytogenes can cause serious, and sometimes fatal, infections in pets and the people who handle their food. Bowls, utensils, surfaces such as counters and floors, and peoples’ hands or clothing can harbor the dangerous bacteria.

Regarding the apparent increase in Salmonella contamination problems during the past six months, the company spokesman said at the time of the most recent recall, “… over 99 percent of the product had already been consumed by pets, but less than 1 percent of our customers had any issues. Of these, most were relatively minor conditions such as diarrhea.”

When asked what additional information Darwin wished to share with pet owners, the company spokesman said, “Our number one priority is providing pets with meals that are healthy and safe.”

“Our customers know that feeding raw is a very healthy way for pets to eat,” he added, “and we are committed to continuously improving all aspects of our products to make them the healthiest alternative for pets.”

Darwin uses a bacteriophage (phage) antimicrobial treatment in its manufacturing process, and claims to have conducted validation tests that showed the process to have reduced pathogens, including Salmonella, to non-detectable levels.

However, a 2017 review article published in the Journal of Microbiology and Biotechnology referred to several attempts to apply phages to Salmonella control in meats and poultry. Those efforts left, in general, 10 percent of Salmonella alive. Also, phage treatment was most effective when used in combination with other control methods, according to the authors of the review article.

FDA’s investigation of the “pattern of contamination” in Darwin’s pet foods is ongoing. The agency reminds consumers that pets may carry Salmonella without displaying symptoms of illness, and can pass the infection to humans without the animals being visibly ill.

The FDA encourages consumers to report complaints about this and other pet food products electronically through the Safety Reporting Portal or by calling their state’s FDA Consumer Complaint Coordinators.

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