FDA Inspection Report Labels Evanger’s Products Adulterated

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.

FDA Confirms Pentobarbital in Dog Food

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.

Recalls and Alerts: February 12 – 15, 2017

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.

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United States

Allergy Alert: Cousins Products LLC (Madisonville, LA) recalls Creole Tomato Dressing (16 oz.; Best by 05/18/18; Lot #0001118) because the product may contain undeclared milk.

Allergy Alert: Legendary Baking (Denver, CO) expands its earlier recall of Private Selection Salted Caramel Chocolate Almond Pie (34-oz pkgs; Lot #CH17025) to include additional distribution information. The recalled product, which contains undeclared almonds and eggs, was distributed in were distributed in Kroger, Fry’s, and Smith’s retail stores in AL, AZ, GA, IL, IN, KY, MI, NM, OH, SC, TN, and WV, and in Fred Meyer, King Soopers, and City Market retail stores in CO, ID, NM, OR, UT, WA, and WY.

Allergy Alert: Century Packing Corp. (Las Piedras, PR) recalls approx. 999,419 pounds of thermally processed, commercially sterile, chicken sausage products because the products contain undeclared monosodium glutamate. The recalled items were produced from Jan. 1, 2015 through Feb. 13, 2017 and were shipped for retail and institutional use in Florida and Puerto Rico. Please refer to the recall notice for a detailed list.

Food Safety Recall: Albertsons Companies recalls Signature Café Southwest Style Salad (10.5 oz. clear, clamshell container; Est. No. P-34013 or P-34733; UPC 21130 06978; various Use By dates) due to potential contamination with Listeria monocytogenes. The recall was initiated in cooperation with Sargento Foods Inc. and affects salads sold in Albertsons, Safeway, Vons, Pavilions, Tom Thumb, Randalls and Pak ‘N Save stores in California, Louisiana, Nevada, Oregon, Texas and Washington. Please refer to the recall notice for the affected Use By dates by store and state.

Food Safety Recall: Sara Lee Deli recalls Sara Lee® Sliced Monterey Jack Cheese with Jalapeno Peppers (Item number 40205, Product Lot #A319349610, USE BY JUN-12-17) and Sara Lee® Sliced Colby Jack Cheese (Item Number 40208, Product Lot #A319348610, USE BY JUN-11-17) due to possible contamination with Listeria monocytogenes. The recalled products were distributed to food retailers in Alabama, California, Louisiana, Michigan, Pennsylvania and Texas.

Food Safety Recall: MDS Foods Inc. (Massilion, OH) recalls multiple products some of which were found to be contaminated with the bacteria Listeria monocytogenes and other products which may have the potential to be contaminated with the bacteria. Please refer to the recall notice for a detailed list of products.

Food Safety Recall: Del Monte Fresh Produce recalls Del Monte Pizza Style Portabella Mushrooms, 2-count (8 oz.; Sell by 2/16/2017; UPC 717524-72471), Traditional Gourmet Portabella Mushrooms, 2-count (8 oz.; Sell by 2/16/2017; UPC 717524-72470) and Stuffed Mushrooms, 6-count (7 oz.; Sell By 2/16/2017; UPC 717524-72469) because the product may be contaminated with Listeria monocytogenes. The recalled items were sold in Dillon (first item only) and Kroger (all three items) stores.

Food Safety Recall: Choice Farms LLC recalls stuffed mushrooms because the mushrooms may contain a cheese component which a third party supplier advised has the potential to be contaminated with Listeria monocytogenes. The recalled items were sold on February 10, 2017 at six Kroger stores in Texas and one Dillon store in Wichita, KS. Please refer to the recall notice for additional details.

Food Safety Recall: Country Fresh recalls various cooking and snacking products (Best if used by dates between 1/19/17 through 2/17/17) that contain recalled Sargento-branded cheeses, because the products may be contaminated with Listeria monocytogenes. The recalled products were supplied to retailers in Alabama, Florida, Georgia, Kentucky, Louisiana, Maryland, Mississippi, North Carolina, South Carolina, Tennessee, Texas, and Virginia under the Country Fresh and store brand labels. Please refer to the recall notice for details.

Food Safety Recall: Guggisberg Cheese, Inc. recalls various Colby-type cheeses and sizes manufactured by Guggisberg Cheese, Inc. and by Deutsch Kase Haus, LLC under the Guggisberg label. The recalled products may be contaminated with Listeria monocytogenes. Please refer to the recall notice for a complete list of affected products.

Food Safety Recall: Veggie Noodle Co. (Austin, TX) recalls Butternut Spirals (10.7 oz; UPC 852287006059; Enjoy by date of February 23, 2017) because routine product testing detected Listeria monocytogenes. The recalled product was supplied to Whole Foods Markets and othe retailers in Illinois, Indiana, Iowa, Michigan, Minnesota, Missouri, Nebraska, Ohio and Wisconsin.

Food Safety Alert: FDA warns US consumers who may have purchased PC Organics brand baby food pouches not to eat or serve these products, as they have been recalled due to the potential presence of dangerous bacteria. Please refer to the FDA notice for complete details.

Pet Food Safety Recall: Against The Grain Pet Food recalls Against the Grain Pulled Beef with Gravy Dinner for Dogs (12 oz. can; Exp. December 2019; Lot #2415E01ATB12) due to the potential presence of pentobarbital. The recalled product was manufactured in 2015 and distributed to independent pet retail stores in Washington and Maryland.

Pet Food Safety Recall: Blue Buffalo recalls Blue Buffalo Homestyle Recipe Healthy Weight, Chicken Dinner with Garden Vegetables, 12.5 ounce can, dog food (Best By August 3, 2019) due to the possible presence of aluminum in the product.

Pet Food Safety Recall (reported by Mollie Morrissette of PoisonedPets.com and Susan Thixton of Truth About Pet food): Triumph Pet Food recalls Triumph’s Ocean Fish Formula Cat Food (13.2 oz. cans; Production date August 3, 2016) due to possible contamination with pieces of metal.

Canada

Allergy Alert: Super Marché Etop Inc. (IGA) in Montreal recalls Imitation Crab Salad due to undeclared sesame seeds.

Allergy Alert: Metro Plus (Montreal) recalls Squid Cooked On Site and Salmon Rillette due to undeclared allergens. Please refer to the recall notice for complete details.

Outbreak Alert Update: Public Health Agency of Canada advises the public that an additional 19 cases of gastrointestinal illnesses (Norovirus) linked to raw/undercooked oysters, bringing the total number of cases to 221 in three provinces.

Food Spoilage Recall: Kraft Heinz Canada recalls Heinz brand Apple Juice from Concentrate (1 L; Code VJ6F22 2017 DE 14) due to mold contamination. The recalled product was distributed to retailers in Alberta, Manitoba, New Brunswick, Newfoundland and Labrador, Ontario and Quebec.

Food Spoilage Recall: Choy Foong International Trading Co. Inc. recalls Wufuyuan brand Color Tapioca Pearls (250g; Code 171212) and Tapioca Pearl Taro Flavor New Sago (250g; Code 171212) due to mold contamination. The recalled products were supplied to retailers in Ontario and Quebec.

Europe

Food Safety Recall (France): Fromagerie Le Pic recalls Petite Rouelle Cendrée cheese wheels (Lot #0401.14; Best before 15/02/2017) due to contamination with Listeria monocytogenes. According to the RASFF notification service, the recalled product may also have been exported to Germany and the United Kingdom.

Food Safety Recall (Germany): Backhaus Nahrstedt recalls Dinkel-Aktiv-Brot due to the risk of injury from the presence of pieces of foreign material in the active spelt bread.

Food Safety Recall (Germany): Güven-Al Großhandel GmbH recalls Sweet Halvah with Pistachios (350g; Expiry 23.11.2017) due to the presence of aflatoxin in excess of permitted levels.

Food Safety Recall (Luxembourg): Auchan Luxembourg recalls Auchan brand Stevia powdered sweetener (Best before 02/18; Lot #L 6055) due to the possible presence of particles of glass.

Asia, Africa and the Pacific Islands

Outbreak Alert (Hong Kong): The Centre for Health Protection is investigating an outbreak of acute gastroenteritis involving 28 students and 4 staff members in a primary school in Sham Shui Po.

Allergy Alert (Israel): Vanilla Sticks recalls Parve Chocolate Dot, Parve Jupiter and Parve Praline cakes due to possible presence of undeclared dairy ingredients.

Allergy Alert (Israel): Royalty Zack Little Switzerland Ltd. advises that Mars Food Industries Netherlands and Mars Food Industries England products contain some undeclared allergens. Please refer to the recall notice for full details and a list of affected items.

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.