FDA Inspection Report Labels Evanger’s Products Adulterated

The U.S. Food and Drug Administration (FDA)  last Friday (Feb. 17) released the results of a month-long investigation of Evanger’s Dog and Cat Food Company’s 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 approximately 50 miles apart.

 

The investigation was initiated when five dogs in one household developed symptoms of barbiturate poisoning after eating a snack that included 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 feeding of Evanger’s dog food.

Some of those complaints are of a general nature; however, some complainants report symptoms possibly associated with phenobarbital 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 where the dog received a veterinary work-up and the 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, Net Wt 12 oz and coded 1816E06HB13, and Against the Grain brand Grain Free Pulled Beef with Gravy Dinner for Dogs Net Wt 12 oz and coded 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 News Release, 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.

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 whereby it may have become contaminated with filth, or whereby it may have been rendered injurious to health.”  The list of violations and deficiencies found during the recent inspections visits fall under both of these definitions:

• Condensate dripping directly into open cans of in-process foods (Wheeling and Markham)
• Birds flying through the warehouse, resting in rafters, and feeding on spilled pet food on the concrete floor (Markham)
• Pitted, cracked and damaged floors causing pooled water in areas where food is exposed (Wheeling and Markham)
• Peeling paint and mold on walls, including areas where food is exposed (Wheeling)
• Open sanitary sewer within 25 feet of food storage trailers and one food processing trailer (Wheeling)
• Lack of operating refrigerated storage facilities or other means of controlling temperature exposure of raw meats during thawing, storage and processing (Wheeling)
• Lack of ambient temperature control during hand packing operations (Wheeling)
• Employees observed cutting raw chicken parts on untreated wooden building construction lumber (Markham)

Joel Sher, vice president and co-owner of Evanger’s Dog & Cat Food Co. Inc., describes the company’s products during a trade show.

Pet owners may remember that 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 December 5, 2011 and retrieved from FDA’s on-line archive, included the following observations (among others):

• 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
• Food-contact surfaces not cleaned frequently enough to protect against contamination
• A subsequent inspection, completed in November 2012 (also retrieved from FDA’s on-line archive), revealed that some of these same issues still lingered, and were joined by a few new ones, such as:
• 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
• 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 boasted that all of its suppliers of meat products are ‘USDA Approved.’ During the course of its just-completed 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. This 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 another federal agency.

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. According to the Commission’s website, “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.” FTC has several remedies at its disposal, including filing actions in federal district 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 their 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 until Evanger’s is once more in compliance with the Federal Food, Drug and Cosmetics Act and all of its associated regulations.

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 webpage ‘How to Report a Pet Food Complaint’ at:

http://ift.tt/2liQNTI.

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 at:

http://ift.tt/PpHXCa.

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, consider filing a formal complaint of false advertising against Evanger’s on the Federal Trade Commission website at:

http://ift.tt/1aMuZSh.

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from Food Recalls – Food Safety News http://ift.tt/2liThl2