FDA’s Negligence, Our Nightmare
After the 2007 recall, the Office of U.S. Inspector General scolded the FDA for its lack of protocol handling the deadliest pet food recall in history; Congress demanded FDA improve the safety of pet food Almost six years later, evidence shows the situation at FDA has gotten worse. Everything from violations of the Bioterrorism Act to allowing falsely documented imports into the U.S. marketplace. This is a nightmare.
In March 2007, Menu Foods announced a recall that ultimately grew to include hundreds of different pet foods. Some estimates run as high as 350,000 dogs and cats died or suffered serious kidney damage. The Office of U.S. Inspector General found the FDA did not properly investigate critical records (proper procedure) at the very beginning of the recall investigation; the delay caused poisoned pet food to remain on store shelves for almost four weeks, killing countless thousands more pets.
At about the same time the FDA was fumbling the 2007 pet food recall investigation, the agency began receiving reports of sick and dying pets believed to be linked to jerky treats imported from China. The jerky treat complaints – sick and dying dogs – continued to flood into the FDA for more than five years. The agency’s stance, 2007: ‘We are investigating’; 2008: ‘We are still investigating’; 2009: ‘We are still investigating’; 2010: ‘We are still investigating’; 2011: ‘We are still investigating’; and 2012: ‘We are still investigating’.
Finally in early 2013, the New York Department of Agriculture (not the FDA) announced testing had found residues of illegal antibiotics in numerous jerky treats imported from China; two of the largest importers (Purina’s Waggin Train and Delmonte’s Milo’s Kitchen) withdrew their Chinese jerky treats from market or issued a recall. A small handful of other brand names imported from China followed shortly after.
Neglect: Bioterrorism Act of 2002
From the FDA website “Fact Sheet on FDA’s New Food Terrorism Regulation – Registration of Food Facilities” it explains that “The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act)…takes steps to protect the public from a threatened or actual terrorist attack on the U.S. food supply.” The Bioterrorism Act “requires domestic and foreign facilities that manufacture/process, pack, or hold food for human or animal consumption in the United States to register with the FDA.” Included in the requirement for registration is “Animal feeds and pet food”.
Enter into evidence of neglect quotes from three (of five) FDA inspection reports of Chinese jerky treat manufacturing facilities. These inspection took place in April 2012 “as follow-up to complaints received by FDA’s Center for Veterinary Medicine (CVM) relating to sick and dying dogs following the consumption of imported chicken jerky treats (CJT).”
Inspection report of Shandong Petswell: (bold added)
“In preparation for the Shandong Petswell inspection, a query of FDA’s Food Facility Registration database (RURLS) found that Shandong Petswell had not registered with FDA in accordance with the Bioterrorism Act of 2002.”
Inspection report of Jinan Uniwell: (bold added)
“A check of the FURLS database found that Jinan Welcome Food Co. Ltd rather than Jinan Uniwell had registered with FDA in accordance with the Bioterrorism Act of 2002. …the food facility should identify Jinan Uniwell as the true manufacturer.”
Inspection report of Gambol Pet Products: (bold added)
“Gambol Pet Products has registered with FDA in accordance with the Bioterrorism Act of 2002 although the firm’s food facility registration was in need of updating to reflect the firm’s true operations at the time of inspection.”
These three quotes highlight a serious lapse of security for U.S. consumers. Three of five Chinese manufacturers of jerky treats that the FDA had linked to complaints of “sick and dying dogs”, were in violation of the U.S. Bioterrorism Act of 2002. One jerky treat manufacturer, Shandong Petswell, had been allowed to ship product into the U.S. for five years without ever registering with FDA – as required by the Bioterrorism Act.
What happens if a facility doesn’t register as required?
Quoting the FDA website (bold added): “Failure of a domestic or foreign facility to register, update required elements, or cancel its registration in accordance with this regulation is a prohibited act under the Federal Food, Drug, and Cosmetic Act. The Federal government can bring a civil action to ask a Federal court to enjoin persons who commit a prohibited act, or it can bring a criminal action in Federal court to prosecute persons who are responsible for the commission of a prohibited act. If a foreign facility is required to register but fails to do so, food from that foreign facility that is offered for import into the U.S. is subject to being held within the port of entry for the article unless otherwise directed by FDA or the Bureau of Customs and Border Protection (CBP).”
The FDA had authority to stop the imports from these three Chinese companies from day one, but did nothing. The FDA had full knowledge that jerky treats imported from three companies in violation of the Bioterrorism Act were linked to pet illness and death, but they did nothing.
Review of evidence of neglect part one:
• For more than five years the FDA received complaints of sick and dying pets relating to jerky treats manufactured in three (of five) Chinese facilities that were in violation of the U.S. Bioterrorism Act of 2002. One facility that was allowed to ship product into the U.S. for more than five years had never registered with FDA as required by the Bioterrorism Act.
• Because of this federal violation, the FDA had the authority to deny entry into the U.S. the treats from these three facilities from the very beginning…but the FDA did nothing.
Neglect: Import Documentation
Enter into evidence of neglect the FDA inspection report from April 2012 of Gambol Pet Products in Liaocheng, China. Gambol Pet Products was one of five Chinese jerky treat manufacturers FDA inspected in April 2012. This Chinese plant was linked to pet illness or death complaints received by the FDA during the previous five years.
Quoting the FDA inspection report of Gambol Pet Products (bold added): “A review of FDA’s Online reporting Analysis Decision Support System (ORADSS) database prior to the inspection found no lines of entry into the U.S. for product shipped by the firm after June 2008. The inspection found the firm’s products were exported to the U.S. under an unrelated Chinese broker/shipper’s food facility registration (FFR) number prior to January 2012. Since January 2012 the firm’s products have been exported to the U.S. under the FFR number of a related Chinese shipper/broker, (blacked out). The firm’s owner was informed that shipping records should identify the FFR number for the true manufacturer of these products rather than using the registration number of the shipper/broker and identifying the shipper/broker as the manufacturer. A review of the ORADSS database on 5-13-12 continued to find no lines of entry into the U.S. for Gambol Pet Products; however, shipments of pet products have entered the U.S. under the FFR number for (blacked out) identified as a manufacturer.”
The above paragraph (quoting the FDA inspection report of Gambol Pet Products) is highlighting another serious lapse of security for U.S. consumers; FDA and U.S. Customs allowing imports with falsified or improper documentation into the U.S.
Import documentation – as quoted above (and as was explained to Gambol Pet Products in April 2012) – is required to list the food facility registration number. U.S. consumer safety is the foundation of this import requirement. Should a U.S. citizen or pet become harmed by a product from a foreign country, it is of vital importance to allow investigators prompt access to manufacturer records.
As the FDA inspection report stated, Gambol Pet Products’ jerky treats were imported into the U.S. using a shipping company registration number instead of the required manufacturer registration number. Even though Gambol Pet Products received a warning directly from FDA in April 2012 that export/import data was incorrect, the company continued to ship jerky treats into the U.S. listing the shipping registration number as manufacturer throughout 2012 (shipper Shandong Burton Industry Group instead of manufacturer Gambol Pet Products). This Chinese jerky treat manufacturer ignored U.S. import/export regulations and the FDA April 2012 warning; they continued to ship jerky treats into the U.S. for the remainder of 2012 using the exact same shipper information (instead of required manufacturer information) on import documents.
Import records show that in October 2012 alone (see References 1 for Bill of Lading numbers), twelve shipments of “pet chews” were welcomed into the U.S. from “Shandong Burton Industry Group” – the shipper used by Gambol Pet Products. Six months after FDA warned this Chinese pet treat manufacturer to stop using the shipper identification on import documents, the company sent more than 420,000 pounds of pet chews to the U.S. – using false documentation. The FDA or U.S. Customs did nothing to stop these imported products with false documentation from reaching store shelves. Each pound was accepted into the U.S. without question.
The Consignee of these 420,000 pounds of jerky treats during October 2012 – allowed into the U.S. marketplace with false import documentation was Waggin Train LLC.
It should be noted that Waggin Train could have (perhaps should have) taken issue to the false import documents on their own. Waggin Train could have requested their supplier – Gambol Pet Products – use the legal manufacturer name/number on shipping documents (Gambol Pet Products) instead of allowing the shipper name/number (Shandong Burton Industry Group). But it doesn’t appear Waggin Train took such action.
Review of evidence of neglect part two:
• FDA has/had access to a database accessing all records of imports into the U.S. The FDA could have checked this database as early as 2008 to learn that Gambol Pet Products, Liaocheng, China was exporting pet treats into the U.S. using false documentation. False documentation gave FDA the authority to stop the treats from entering the U.S. market.
• The FDA is on record as of April 2012 (inspection report) stating they had full knowledge of the false documentation. The FDA continued to allow imports of jerky treats into the U.S. from Gambol Pet Products with false documentation throughout 2012. The FDA had authority to stop the jerky treats from entering the U.S. at any given time on the basis of false import documentation…but the FDA did nothing.
• According to import documents, Waggin Train was the Consignee for more than 420,000 pounds of jerky treats in October 2012. Each pound was accepted into the U.S. and accepted by Waggin Train with false import documentation.
Even More Neglect
Two additional Chinese jerky treat plants inspected by FDA in April 2012 was Shandong Honva Food Co. Ltd and Yantai Aska Foods, Ltd. FDA inspection reports state the inspections were performed because the Center for Veterinary Medicine (CVM) division of FDA had received complaints of pet illness or death related to treats manufactured at these Chinese facilities.
Shandong Honva Food Co. Ltd
The FDA inspection report states Shandong Honva Food Co., Ltd “manufactures jerky pet treat products.” A search of import records of Shandong Honva Food Co. Ltd found the Consignee of “dog treats – chicken jerky” to be “Del Monte Corporation”; Del Monte is the parent company of Milo’s Kitchen dog treats. Milo’s Kitchen recalled their chicken jerky and chicken grillers treats on January 9, 2013 after the New York Department of Agriculture found illegal “residual antibiotics” in the treats.
Further investigation of import records found that the same Chinese manufacturer of recalled Milo’s Kitchen jerky treats, the same manufacturer of treats found to contain illegal residual antibiotics – Shandong Honva Food Co., Ltd – also shipped “pet chews dog/pet jerky” to “Arthur Dogswell, LLC”. Arthur Dogswell, LLC is the parent company of Dogswell pet treats.
A total of 274,000 pounds of “pet chews” were shipped between September 2012 and December 2012, another 60,000 pounds of “pet chews” were shipped in January 2013 from Shandong Honva Food Co., Ltd to Arthur Dogswell, LLC. Bill of Lading numbers see References 2.
There has been no recall or jerky treat withdrawal from Dogswell; treats remain on store shelves today.
And import records found the same Chinese manufacturer of recalled Milo’s Kitchen jerky treats, the same manufacturer of treats found to contain illegal residual antibiotics – Shandong Honva Food Co., Ltd – also shipped “dog chews” and “pet chews” to “United Pet Group Inc.” United Pet Group Inc. is the parent company of Dingo dog treats.
A total of 80,000 pounds of dog/pet chews were shipped between March 2012 and May 2012 from Shandong Honva Food Co., Ltd to United Pet Group Inc. Bill of Lading numbers see References 3.
There has been no recall or jerky treat withdrawal from United Pet Group/Dingo; treats remain on store shelves today.
Page 33 of the FDA inspection report of the Shandong Honva Food Co., Ltd provides a list of “Exhibits” collected during the April inspection. Number 5/5a states the FDA was provided with a “List of firm’s products exported to the U.S. with translation (3 pages).” In other words, the FDA has known the names of all the U.S. private label companies that Shandong Honva Food sold jerky treats to – the same manufacturer of recalled Milo’s Kitchen. Again, the New York Department of Agriculture found illegal drug residues in treats made by this Chinese manufacturer. FDA went on record in April 2012 as having full knowledge of all U.S. private label brands made by this company, yet the FDA has not issued a warning to pet food consumers providing all the brand names of treats that could contain illegal drug residues.
Review of evidence of neglect part three:
• Treats manufactured by Shandong Honva Food Co, Liaocheng, China were found to contain residues of illegal antibiotics by the NY Department of Agriculture in January 2013. This Chinese jerky treat facility manufactured the recalled Milo’s Kitchen jerky treats. No other jerky treat withdrawal or recall has taken place from companies that imported from this same Chinese manufacturer. Including no recall from Dogswell or United Pet Group/Dingo.
• The FDA is on record as of April 2012 to have been provided with a complete list of all U.S. private label brands manufactured by Shandong Honva Food. The FDA has not issued a warning alerting the public to the risk of illegal antibiotic drug residues in numerous private label treats made by this Chinese manufacturer.
Yantai Aska Foods Co., Ltd
The FDA inspection report states Yantai Aska Foods Co, Ltd manufactures jerky treat products including “chicken jerky, duck jerky, vegetable or fruit chews with chicken wrap, chews with duck wrap, and miscellaneous other jerky products.”
A search of import records of Yantai Aska Foods Co., Ltd found the Consignee of “pet treats” as The Hartz Mountain Corporation. Hartz withdrew their jerky treats from store shelves on January 26, 2013 “because they contain trace amounts of unapproved antibiotic residue.” Records indicate that between January 2012 and May 2012 The Hartz Mountain Corporation received more than 550,000 pounds of “pet treats” from Yantai Aska Foods. Bill of Lading numbers see References 4.
During 2012 Yantai Aska Foods – the same Chinese manufacturer of recalled Hartz Mountain treats, the same manufacturer of treats found to contain illegal residual antibiotics, also shipped “pet treats” to:
“Vintage World, Inc.” References 5,
“Shanghai Adam & Co., Ltd. (U.S.A.)” References 6,
“Sales Marketing Professionals Inc. D”, References 7,
“Pets Pacifica, Inc.”, References 8,
“Pettrapport”, parent company of Beefeaters, References 9 and
“Pet Ventures, Inc.”, parent company of Pet ‘n Shape References 10.
A total of 2,328,441 pounds of “pet treats” were exported into the U.S. during 2012 from Yantai Aska Foods to the above importers. As you can see, it is difficult to know what U.S. private label brands Vintage World or Shanghai Adam & Co (and others) represents. Import records were often found to contain broker or alias information instead of private label brand information.
Page 43 and 44 of the FDA inspection report of the Yantai Aska Foods provides a list of “Exhibits” collected during the April inspection. Exhibits include the labels of various jerky products manufactured by this Chinese company and a seven page “Product list.” In other words, the FDA has known the names of all the private label companies that Yantai Aska Foods – the same manufacturer as recalled Hartz Mountain treats – sold jerky treats to since April 2012. As reminder, the Hartz Mountain Company found illegal drug residues in treats made by this Chinese manufacturer, however no recall or withdrawal of numerous other private label brands – made at the same facility – has occurred. The FDA has not issued a warning to pet food consumers providing all the brand names of treats that could contain illegal drug residues manufactured at this Chinese company.
Review of evidence of neglect part four:
• Treats manufactured by Yantai Aska Foods, Yantai, China were found to contain residues of illegal antibiotics by the Hartz Mountain Company; this led to the recall of Hartz products purchased from this Chinese supplier. No other jerky treat withdrawal or recall has taken place from companies that imported from this manufacturer. More than 2 million pounds imported by six private label brands or alias consignees remain on store shelves.
• The FDA is on record as of April 2012 to have been provided with a complete list of all U.S. private label brands manufactured by Yantai Aska Foods. The FDA has not issued a warning alerting the public to the risk of illegal antibiotic drug residues in numerous private label treats made by this Chinese manufacturer.
Import searches for Jinan Uniwell Pet Food Co, Ltd (one of the five Chinese plants inspected by FDA in April 2012) and Shandong Petswell Food Co., Ltd (one of the five Chinese plants inspected by FDA in April 2012) found no results; no records indicating either of these Chinese jerky treat manufacturers shipped products into the U.S. during 2012. Yet the FDA inspection reports stated “The inspection of this pet treat manufacturer was conducted…as follow-up to complaints received by FDA’s Center for Veterinary Medicine (CVM) relating to sick and dying dogs following the consumption of imported chicken jerky treats.”
We know that these companies did indeed import jerky treats into the U.S. and that their treats did indeed link to sick and dying dogs. But import records show nothing for either company. This more than likely means, both of these companies have exported jerky treats to the U.S. (for years) using false import documentation.
Review of evidence of neglect part five:
• Jinan Uniwell Pet Food Co., Jinan, China and Shandong Petswell Food Co., Liaocheng, China shipped jerky treats into the U.S. the FDA acknowledged were related to sick and dying dogs. Yet there are no import records for 2012 for either of these companies. It is assumed all of the imports were accepted into the U.S. with false documentation.
• FDA has/had access to a database accessing all records of imports into the U.S. The FDA could have checked this database as early as 2007 to learn that Jinan Uniwell Pet Food and Shandong Petswell Food was exporting pet treats into the U.S. using false documentation. The FDA had authority to stop the jerky treats from entering the U.S. at any given time on the basis of false import documentation…but the FDA did nothing.
More than five years of pet death and illness.
More than five years of violation of the Bioterrorism Act.
More than five years of false import documentation.
What is it going to take? What is it going to take for FDA to properly protect pet food/human food consumers? I hate to think of the answer to that question.
For those that wish you alert their representatives in Congress to the dangerous neglect by the FDA, I provide you with the following example letter.
I am writing to alert you to the serious lapse of U.S. security allowed by the Food and Drug Administration.
Of significant concern, please be aware that some of the Chinese jerky pet treat manufacturers – whose products were recently recalled, were never registered with the FDA as required by the Bioterrorism Act of 2002 or had improper registration information. One company in particular, Shandong Petswell Food Co., Liaocheng, China had shipped pet treats into U.S. ports for five years and never registered with FDA as required by the Bioterrorism Act.
In April 2012, the FDA inspected the Chinese jerky treat manufacturing plants and the agency warned several that import/export documents were not in proper (required) order. However throughout all of 2012, the FDA continued to allow these companies to import their products using false documentation, even after issuing a warning.
Jerky pet treats from three Chinese manufacturing facilities have tested to contain illegal antibiotic drug residues, yet the FDA has not warned the public or forced recall of dozens of private label brands made at these same Chinese facilities.
This is a dangerous situation not only for our pets but for U.S. citizens as well. Please assure me you will address these issues with FDA and require the agency to correct this negligence immediately. For full documentation of FDA neglect, you can read the story here: http://truthaboutpetfood2.com/fdas-neglect-our-nightmare
To locate and contact your Representatives in Congress, click here.
Wishing you and your pet(s) the best,
What’s in Your Pet’s Food?
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Cooking for pets made easy, Dinner PAWsible
1. Gambol Pet Products/ Shandong Burton Industry Group Bill of Lading numbers from October 2012: MAEU558624398, MAEU558624392, MAEU558624394, MAEU558624389, MAEU558624393, MAEU558624397, MAEU558624395, MAEU558624396, MAEU558624400, MAEU558624399, MAEU558624390, MAEU558624391.
2. Shandong Honva Food Co., Ltd , Arthur Dogswell LLC, Dogswell, Bill of Lading numbers: UPSPNJHY12110626, UPSPNJHY12090620, UPSPNJHY12100624, UPSPNJHY12120630, UPSPNJHY12100622, UPSPNJHY12120629, UPSPNJHY12090619, UPSPNJHY12110625, UPSPNJHY12090621, UPSPNJHY12120628, UPSPNJHY12100623.
3. Shandong Honva Food Co., Ltd to United Pet Group Inc., Bill of Lading numbers: PIFWSHA12040009, PIFWSHA12021251, PIFWSHA12022023.
4. Yantai Aska Foods, Hartz Mountain Corporation, Bill of Lading numbers: EGLV141100194340, EGLV141100194358. EGLV141100198396, EGLV141100201401, EGLV141100204396, EGLV141100204400, EGLV141100204418, EGLV141200005140, EGLV141200018225, EGLV141200018225, EGLV141200018225, EGLV141200038510,
5. Yantai Aska Foods, Vintage World Inc., Bill of Lading numbers: EDMLSYQD1208023, EDMLSYQD1202028, EDMLSYQD1203004, EDMLSYQD1201011. EDMLSYQD1201012, EDMLSYQD1202027.
6. Yantai Aska Foods, Shanghai Adam & Co., Ltd. (U.S.A.), Bill of Lading numbers: EDMLSYQD1201006, EDMLSYQD1201007, EDMLSYQD1201013, EDMLSYQD1201014, EDMLSYQD1201020, EDMLSYQD1202009, EDMLSYQD1202015, EDMLSYQD1202026, EDMLSYQD1204001, EDMLSYQD1112045, EDMLSYQD1201015, EDMLSYQD1201021, EDMLSYQD1201022, EDMLSYQD1202007, EDMLSYQD1202008, EDMLSYQD1202021, EDMLSYQD1203003, EDMLSYQD1203018, EDMLSYQD1203017, EDMLSYQD1203005, EDMLSYQD1202034, EDMLSYQD1203013, EDMLSYQD1203014, EDMLSYQD1203026, EDMLSYQD1203032, EDMLSYQD1203035, EDMLSYQD1203044, EDMLSYQD1204002, EDMLSYQD1203019, EDMLSYQD1201005.
7. Yantai Aska Foods, Sales Marketing Professionals Inc. D, Bill of Lading numbers: EDMLSYQD1203036.
8. Yantai Aska Foods, Pets Pacifica, Inc., Bill of Lading numbers: NYKS2393068330, NYKS2393078880.
9. Yantai Aska Foods, Pettrapport, Bill of Lading numbers: BANQTSN0195305, AMAWE120449076, AMAWE120449074, AMAWE120449451, BANQTSN0196236, BANQTSN0196238, BANQTSN0194482, AMAWE120349007, AMAWE120349005, AMAWE120349330, AMAWE120249341, BANQTSN0198303, AMAWE120349249, AMAWE120349247, AMAWE120349248, AMAWE120449078, BANQTSN0200514, BANQTSN0196147, BANQTSN0201436, BANQTSN0199200, BANQTSN0201700.
10. Yantai Aska Foods, Pet Ventures, Inc., Bill of Lading numbers: MAEU556095624, ULGIULGI31203022.