FDA Inspection Report Labels Evanger’s Products Adulterated

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Reveals use of meat “not for human consumption” despite Evanger’s marketing claims.

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 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)

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: https://www.fda.gov/AnimalVeterinary/SafetyHealth/ReportaProblem/ucm182403.htm.
  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: https://www.safetyreporting.hhs.gov.
  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: https://www.ftccomplaintassistant.gov/#&panel1-1.

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

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Recalls and Alerts: February 16 – 18, 2017

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Here is today’s list of food safety recalls, product withdrawals, allergy alerts and miscellaneous compliance issues. The live links will take you directly to the official recall notices and company news releases that contain detailed information for each recall and alert.

If you would like to receive automatic email alerts for all new articles posted on eFoodAlert, please submit your request using the sidebar link.

United States

Allergy Alert: Chapis Spice & Tea (Los Angeles, CA) recalls various Chapis brand Bread Crumbs due to possible presence of undeclared wheat, milk, eggs, tree nuts or soybean. Please refer to the recall notice for a detailed list of affected products, all of which were distributed through retail stores in Los Angeles and adjacent cities in Los Angeles County.

Allergy Alert: Licata Enterprises (Huntington Beach, CA) recalls The Supreme One/Theravits 100 multiple vitamin (all lots) due to undeclared fish oils and other labelling issues. The recalled products were distributed in Southern California, Ohio and Pennsylvania through health food stores, and also sold in Wyoming, Virginia, Utah, Idaho, Washington, Oregon and Texas.

Allergy Alert: Ditos (Anchorage, Alaska) recalls Heart Plastic Platter Strawberries w/ Dip with Chocolate Frosting 32oz, and Heart Plastic Platter Mixed Fruit w/ Dip with Chocolate Frosting 40oz (Use by dates: 02/14/2017, 02/15/2017, 02/16/2017, 02/19/2017) due to undeclared soy and/or milk. The product was sold at seven Walmart stores in Debarr, Dimond, Eagle River, Fairbanks, Kenai, Midtown, and Wasilla.

Allergy Alert: Price Chopper recalls Market 32 Elegant Dessert Apple Crumb Tart (5.5 oz) due to undeclared milk.

Food Safety Recall: Biery Cheese Company recalls various specialty Longhorn Colby cheeses due to potential contamination with Listeria monocytogenes. The recalled products were distributed between November 11, 2016 and January 4, 2017 to distribution centers in Georgia, Indiana and Pennsylvania. Please refer to the recall notice for a detailed list of products.

Food Safety Recall: Saputo Inc. recalls certain Great Midwest brand Applewood Smoked Gouda cheese (Sell by MAY 22 17) and Dutchmark brand Pasteurized Processed Smoked Gouda cheese (Best when used by 11-18-17) that may have been contaminated with Listeria monocytogenes.

Food Safety Recall: Sargento Foods Inc. (Plymouth, WI) expands its earlier recall to include additional products and production dates due to potential contamination with Listeria monocytogenes that originated from the facility of its supplier, Deutsch Kase Haus, LLC. Sargento also has terminated its relationship with the supplier. Please refer to the recall notice for a complete list of affected products.

Food Safety Recall: Dutch Valley Food Distributors, Schlabach Branch, recalls various cheeses and cheese-containing items due to potential contamination with Listeria monocytogenes. Please refer to the recall notice for a complete list of affected items.

Food Safety Recall: Hallmark Management Services, Inc. (Columbus, OH) expands its February 2, 2017 recall to include approximately 11.25 pounds of additional Chicken Tikka Masala that was produced without the benefit of inspection. Please refer to the recall notice for additional details.

Food Safety Recall: Papa John’s Salads & Produce recalls Colby Cheese Half Moon, Colby Jack Cheese Half Moon, Monterey Jack Cheese Half Moon and Pepper Jack Half Moon (Use by dates for all products: 1/10/17 through 5/9/17), because the products contain cheese that may be contaminated with Listeria monocytogenes. The recalled products were sold in Fry’s and Smith’s stores.

Food Safety Recall: Index Fresh recalls Index Fresh Avocados (UPC 76101-40154; Pack date 2/13/17; 4ct. bag) because the product may be contaminated with Listeria monocytogenes. The recalled avocados were sold in Ralphs stores.

Food Safety Recall: Meijer recalls Ham Sub on Artisan White Baguette (UPC 7-13733-76499-5; various expiration dates from 11/2/2016 through 12/30/2016) because the product contains cheese that may be contaminated with Listeria monocytogenes.

Food Safety Recall: GraceKennedy Foods recalls La Fe Papa Criolla Yellow Potatoes (14 oz; All date codes) due to the presence of Listeria monocytogenes. The recalled product was sold at Stop & Shop stores.

Food Safety Notice: The South Carolina Department of Health and Environmental Control (DHEC) has closed some shellfish harvesting beds in Beaufort County due to a sewer overflow.

Food Safety Notice: Oregon has closed recreational and commercial mussel harvesting from Cape Arago, south of Coos Bay, to the California border, due to elevated levels of paralytic shellfish toxins. Coastal scallops are not affected when only the adductor muscle is eaten.

Canada

Allergy Alert: Figues et Romarin (Blainville, QC) recalls Minestrone Soup (500 mL and 1 L sizes) due to undeclared wheat.

Europe

Allergy Alert (UK): Poundstretcher recalls Chocolate Crème Oreos (176g; pkg of 4; Best before April, May, July and August 2017) due to undeclared wheat and milk.

Allergy Alert (Northern Ireland): Heatons recalls a consignment of Toblerones (100g; Best before 8 September 2017; Batch code 00Y4062333) due to undeclared egg.

Food Safety Recall: Morrisons recalls Ready to Eat Peppered Beef Slices (150g; Use by 21 February 2017) because Listeria monocytogenes was found in the product.

 

Some supermarket chains post recall notices on their web sites for the convenience of customers. To see whether a recalled food was carried by your favorite supermarket, follow the live link to the supermarket’s recall website.

*The Kroger umbrella encompasses numerous supermarket, marketplace and convenience store chains
**Includes Safeway, Vons, Pavilions, Dominick’s, Genuardi’s, Randalls, Tom Thumb, Carrs and Pak N’ Save.

FDA Confirms Pentobarbital in Dog Food

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Pet owners warned to avoid certain Evanger’s and Against the Grain dog food

Against the Grain

Against the Grain

FDA is advising pet owners and pet caretakers not to feed their pets with certain lots of Evanger’s and Against the Grain dog food after confirming the presence of the euthanasia agent pentobarbital in both products.

Following discussions with FDA, Evanger’s announced a voluntary recall on February 3, 2017 of  five lots of its 12-ounce Hunk of Beef canned dog food, all with an expiration date of June 2020: 1816E03HB, 1816E04HB, 1816E06HB, 1816E07HB, and 1816E13HB. On February 9th, Against the Grain voluntarily recalled lot #2415E01ATB12 BEST DEC 2019 of its Grain Free Pulled Beef with Gravy dog food after the agency detected pentobarbital that product. The Pulled Beef with Gravy was manufactured in the same facilities as Evanger’s products and using beef from the same supplier.

Evanger's Hunks of BeefIn addition to the presence of pentobarbital, FDA reports a bill of lading from Evanger’s supplier of ‘Inedible Hand Deboned Beef – For Pet Food Use Only. Not Fit for Human Consumption’. This is despite Evanger’s claim that the beef in its Hunk of Beef product came from a ‘USDA approved’ supplier. FDA also has determined that the supplier’s facility does NOT have a grant of inspection from USDA’s Food Safety and Inspection Service. The meat from the supplier does not bear a USDA inspection mark and would not be considered human grade. Lab testing by USDA-FSIS of Evanger’s Hunk of Beef confirmed that the meat in the product was beef.

Other issues cited in a preliminary investigation report (FDA Form 483) released today by FDA include evidence of unsanitary conditions, inadequate refrigeration, improper storage, and inadequate control of ambient temperature during hand-packing operations at Evanger’s Wheeling, IL facility and unsanitary conditions and ‘avian activity’ at its Markham, IL manufacturing location.

FDA’s investigation is ongoing and will include examination of the suppliers of beef to Evanger’s and Against the Grain to determine the source of the pentobarbital. The agency is also coordinating with USDA to address possible areas of shared jurisdiction.

Consumers with cans of the recalled product should refer to the Evanger’s and Against the Grain recall notices for information on returning the product.

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