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FDA inspection report labels Evanger’s pet food adulterated

2017-02-20 foodsafetynews

Tag: FDA Evanger’s pet food

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The U.S. Food and Drug Administration Friday released the results of a month-long investigation of Evanger’s Dog & Cat Food Co., its production facility in Wheeling, IL, and the Nutripack LLC, facility in Markham, IL.

Nutripack is owned by Brett Sher, son of Joel and Holly Sher, who own Evanger’s. Joel Sher is listed as manager of the Nutripack operation. The two facilities are located about 50 miles apart.

The FDA investigation was initiated when five dogs in one household developed symptoms of barbiturate poisoning after eating Evanger’s Hand Packed Hunk of Beef au Jus.

Four of the five dogs required veterinary ICU hospitalization, and one of those four dogs died. According to a spokesperson from FDA, the agency has received several additional complaints associated with pets that have been fed Evanger’s dog food.

Some of those complaints are of a general nature, however, some complainants report symptoms possibly associated with pentobarbital toxicity. FDA has briefed its Consumer Complaint Coordinators on the Evanger’s situation and urges pet owners and veterinarians to report any concerns via the agency’s How To Report A Pet Food Complaint web page. The agency is especially interested in cases wher pets received a veterinary work-up and their owners still have cans of food available for testing by FDA.

The Inspectional Observations report, FDA Form 483, confirms that Evanger’s Hand Packed Hunk of Beef au Jus in 12-ounce cans with the code 1816E06HB13, and Against the Grain brand Grain Free Pulled Beef with Gravy Dinner for Dogs in 12-ounce cans with the code 2415E01ATB12 BEST DEC 2019 both contained the barbiturate drug pentobarbital.

Tests carried out by USDA confirmed that the meat used in the canned pet foods was beef. According to FDA’s report, the agency “…was unable to determine from available records whether any other Evanger’s or Against the Grain products made with beef contain any of the beef that went into the recalled products.”

Pentobarbital, a controlled substance, is used as a chemical euthanasia agent by veterinarians and pet shelters.

FDA report shows numerous problems at production plants
According to the Federal Food, Drug and Cosmetic Act, a food “… shall be deemed to be adulterated if it bears or contains any added poisonous or added deleterious substance that is unsafe…” A food also is considered to be adulterated under the Act “… if it has been prepared, packed, or held under insanitary conditions wherby it may have become contaminated with filth, or wherby it may have been rendered injurious to health.”  The list of violations and deficiencies found during the recent inspection visits fall under both of these definitions:

Condensate dripping directly into open cans of in-process foods at both plants;

Birds flying through the warehouse, resting in rafters, and feeding on spilled pet food on the concrete floor in Markham;

Pitted, cracked and damaged floors causing pooled water in areas wher food is exposed at both plants;

Peeling paint and mold on walls, including areas wher food is exposed in Wheeling;

Open sanitary sewer within 25 feet of food storage trailers and one food processing trailer in Wheeling;

Lack of operating refrigerated storage facilities or other means of controlling temperature exposure of raw meats during thawing, storage and processing in Wheeling;

Lack of ambient temperature control during hand packing operations in Wheeling; and

Employees observed cutting raw chicken parts on untreated wooden building construction lumber in Markham.

Evanger’s previous violations
This is not Evanger’s first brush with FDA, nor is this the first time that an inspection has turned up instances of insanitary conditions, poor temperature control, and deficiencies in plant construction and design. A summary of results from an inspection completed on Dec.5, 2011, included the following observations:

Construction of plant does not allow floors, walls, and ceilings to be adequately cleaned and kept clean and kept in good repair;

Inadequate screening or other protection against pests;

Failure to provide running water at a suitable temperature for employee sanitary facilities;

Failure to manufacture and store foods under conditions and controls necessary to minimize the potential for growth of microorganisms;

Failure to thaw frozen raw materials in a manner that prevents them and other ingredients from becoming adulterated;;

Deficiencies in plant construction and design prevent the taking of precautions to protect food, food-contact surfaces, and food-packaging materials from contamination with filth

Instruments used for measuring conditions that control or prevent the growth of undesirable microorganisms are not accurate;

Plumbing is source of contamination to water supply;

Inadequate lighting in food examination, storage and processing areas; and

Food-contact surfaces not cleaned frequently enough to protect against contamination.

A subsequent inspection, completed in November 2012 revealed that some of the issues still lingered, and new ones were documented, including:

Failure to mark each hermetically sealed container of low-acid processed food with an identifying code that is permanently visible to the naked eye;

Failure to properly store equipment and remove litter and waste that may constitute an attractant, breeding place, or harborage area for pests, within the immediate vicinity of the plant buildings or structures; and

Failure to install bleeders so that the operator can observe that they are functioning properly (bleeders are part of the retorts – equipment that cooks the food inside the sealed cans).

Evanger’s has long advertised that all of its suppliers of meat products are “USDA approved.” During the most recent inspection, FDA found evidence to the contrary. Specifically, the investigation team found a bill of lading from Evanger’s supplier of beef that listed “Inedible Hand Deboned Beef – For Pet Food Use Only. Not Fit For Human Consumption.”

FDA has established that the supplier in question does not have a “grant of inspection” from USDA. The meat from this supplier does not bear the USDA inspection mark. The meat does not, under any circumstances, qualify as human-grade, a term that Evanger’s has used to describe its meat ingredients since at least June 2003.

Evanger’s practice could result in allegations of false or deceptive advertising, and require the pet food makers to deal with the Federal Trade Commission.

Actions consumers can take on their own

The Federal Trade Commission (FTC) is tasked with the enforcement of the nation’s truth-in-advertising laws.

“The FTC looks especially closely at advertising claims that can affect consumers’ health or their pocketbooks – claims about food, over-the-counter drugs, dietary supplements, alcohol, and tobacco and on conduct related to high-tech products and the Internet,” according to the FTC website. The FTC has several remedies at its disposal, including filing actions in federal court to stop perpetration of scams and to obtain compensation for victims.

FTC and FDA cooperation in bringing companies making false claims to heel is common, especially against those who market phony supplements and medical devices. In addition to that work, and that of USDA, there are some actions consumers can take on their own, including:

1. Return any and all recalled product to the place of purchase, or directly to the manufacturer.

2. Consider switching to a different brand of pet food.

3. If you believe that your pet has been made ill as a result of consuming Evanger’s or any other pet food, please visit the FDA web page: How to Report a Pet Food Complaint.

4. If your pet has been examined by a veterinarian who believes that an illness may be food related, urge your veterinarian to report the incident via the federal Safety Reporting Portal.

5. If you purchased an Evanger’s meat-based food on the understanding that all of the meat in the company’s products is sourced from “USDA approved” suppliers, you can file a formal complaint of false advertising on the Federal Trade Commission website.

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