Valley Proteins receives FDA Warning Letter one year after pentobarbital found

Valley Proteins, Inc., a renderer located in Winchester, Virginia, was issued a Warning Letter from the US Food and Drug Administration (FDA) on November 18, 2019, one year almost to the day after FDA found pentobarbital in a sample of the company’s “animal fat product.”

The Warning Letter cited several violations of the Federal Food, Drug and Cosmetic Act revealed during the course of FDA inspections carried out in February 2019 and April 2019.

The animal fat product was adulterated due to the presence of pentobarbital

According to the Warning Letter, FDA advised Valley Proteins on December 18, 2018 that the agency had found pentobarbital in a sample of the Company’s animal fat product.

Despite the requirements spelled out in the Company’s formal Recall Plan, Valley Proteins “…did not take immediate action to notify customers or recall the product…”

On four separate occasions in February and in April 2019, FDA inquired as to whether the Company planned to recall the contaminated product. Valley Proteins declined to initiate a recall and refused to supply FDA with requested information regarding the amount of potentially affected product that was distributed by the Company before it learned of the pentobarbital contamination.

In response to FDA’s finding, Valley Proteins asserted that pentobarbital is an “unavoidable contaminant not known to present a health hazard,” an assertion strongly refuted by FDA in its Warning Letter, which included the following statement:

“Adulteration of animal food with pentobarbital is not unavoidable. It is your responsibility to prevent adulteration of animal food with unsafe new animal drugs by ensuring that you are not receiving ingredients from your suppliers that contain unsafe new animal drugs or by developing methods to ensure that materials you receive containing unsafe new animal drugs are segregated and not used for animal food.”

The animal fat product was adulterated due to Animal Food Hazard Analysis and Risk-Based Preventive Controls (PC) violations

Specifically, Valley Proteins did not “…identify and evaluate hazards that may be specific to the source of [the] raw material, which included carcasses of animals euthanized with pentobarbital” in that the Company’s Hazard Analysis “…did not list Pentobarbital as a known and reasonably foreseeable hazard.”

Valley Proteins began cleaning operations and started testing for pentobarbital in January 2019. However, it did not provide FDA with any indications as to how it planned to account for adulterated product that was distributed prior to starting its cleaning and testing program.

In fact, the Company continues to assert that it has no legal requirement to recall any products due to pentobarbital contamination.

In an update to its Hazard Analysis documentation, the Company states that it will no longer accept or process “dead stock” (i.e., euthanized animals). However, in a letter to its customers, the Company indicates that it “…will accept euthanized animals for collection and disposal, but chemically euthanized animals will not be rendered.”

FDA has requested, but has not yet received, information as to how Valley Proteins proposes to collect and dispose of euthanized animals.

Microbial hazards

FDA also highlighted concerns regarding the Company’s process control to prevent microbial hazards.

Specifically,
1. Bills of Lading for some products should have – but did not – including the statement, “not processed to control microbial hazards.”
2. The Company’s process controls lacked adequate parameters for controlling some microbial hazards, including Salmonella, E. coli and Listeria monocytogenes.
3. The process control parameters provided to FDA by the Company did not match the parameters as determined in the scientific study presented to validate those process controls.

Where did the adulterated animal fat go?

According to a spokesperson for FDA, the Company claims that none of the adulterated animal fat was distributed to pet food manufacturers. However, the firm did not provide any documentation to support its assertion.

The Warning Letter describes the adulterated sample as having been taken from a finished fat tank “…used to store animal fat distributed for use in animal food.” This could refer to food for livestock, including poultry, cattle, etc.

FDA is at risk of becoming a paper tiger

Setting aside the specific violations cited in this Warning Letter, Valley Proteins is just the latest in a string of companies that has refused an FDA request for a product recall, for documentation, or for some other aspect of cooperation in an investigation.

In recent months, we have seen at least two other instances of non-cooperation, even in the face of a direct risk to the health of consumers or their companion animals.

Lystn, LLC (Answers Pet Food) initiated a lawsuit against FDA, the US Department of Health and Human Services, and the Colorado Department of Agriculture, among others, rather than agree to a recall of its contaminated raw pet food products.
FDA was forced to take the extreme step of suspending facility registration of Topway Enterprises Inc. (a Texas-based seafood producer), citing “…an unwillingness and disregard by the company to cease operations and correct severe violations at their facility.”

These two examples are only the tip of the iceberg. It is not uncommon for company officials to decline FDA inspectors access to consumer complaint records, product formulations, and other information that inspectors often need to conduct their oversight. It is not unknown for a company to deny an inspector permission to document observations by photography, and later dispute the accuracy of the inspector’s written observations.

FDA’s remedies in the face of non-cooperation are limited. In theory, FDA is empowered under existing law to demand full access to these records. In practice, however, there is little an FDA inspector can do to enforce the agency’s authority other than by suspending the inspection and applying for a court order.

Similarly, FDA’s mandatory recall authority is a clumsy and slow instrument of last resort. The mandatory notification and appeal process would render moot an eventual mandatory recall of a perishable product. FDA’s best tool is to issue a Public Health Alert, warning consumers of the hazard posed by the offending firm’s products.

It’s time for a more assertive FDA stance

A driver caught for speeding is obliged by law to produce relevant documentation (driver license, vehicle registration and proof or insurance) upon request. Declining such a request lands the driver in even hotter water than before. Nor can the driver fight the charge by claiming that a speed limit is arbitrary and thus may be ignored.

Perhaps it’s time for FDA to arm its inspectors with the appropriate warrant or court order at the start of an inspection, especially in the case of a company with a history of prior non-cooperation.

Perhaps it’s time for an amendment to the Food Safety Modernization Act. One that will grant FDA the authority to suspend a company’s operations in the event of non-cooperation with a lawful inspection.

Evanger’s pentobarbital recalls. A peek behind the curtain.

On February 3, 2017, Evanger’s Dog & Cat Food Co. announced a recall of specific production lots of its Hunk of Beef au Jus canned dog food after pentobarbital was confirmed in samples of the product.

One month later, the company expanded its recall to include every batch of Hunk of Beef, Braised Beef and Against the Grain Pulled Beef canned dog foods manufactured between December 2015 and January 2017.

FDA categorized the recalls as Class I.

A Class I recall represents “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”

More than two years later, these Class I recalls are still listed as “Ongoing” by FDA.

A series of email exchanges between Evanger’s, its attorneys, its consultants and FDA staff, released in response to a Freedom of Information Act request, offer a glimpse into the prickly relationship between Evanger’s and FDA.

The story began on December 31, 2016 when Nikki Mael gave her five dogs a New Year’s Eve ‘treat’, consisting of most of the contents of a can of Evanger’s Hunk of Beef au Jus dog food. Within 15 minutes, the dogs began to behave oddly, exhibiting acute neurological symptoms. The pet owner rushed her dogs to an emergency veterinary clinic, where one of the dogs died.

Lab tests conducted on stomach contents retrieved during necropsy of the dead dog revealed the presence of a large amount of pentobarbital, a drug used to euthanize animals. The same drug was found in the residue of food remaining in the can from which the five dogs were fed.

FDA, alerted by the veterinarian, launched its investigation into the incident, including an inspection of Evanger’s production facilities that began on January 10, 2017.

According to a February 4th email from Evanger’s to FDA, the agency first advised Evanger’s of the results of the necropsy on January 27th.

Evanger’s management protested FDA’s handling of the incident. In a series of emails, the company questioned FDA’s determination that pentobarbital was an adulterant, and cautioned the agency not to put too much credence in consumer complaints.

The company’s outside consultant had this to say in an email addressed to Joel Sher, Vice-President of Evanger’s, dated February 4, 2017.

I am dismayed by CVM’s determination. Low levels of Pentobarbital have positive uses in treating seizures and insomnia, both in humans and animals. Those who made the decision are obviously unaware of FDA’s 1998 study that found Pentobarbital in almost 50% of the dry dog foods tested and made a determination at that time that residues of Pentobarbital were acceptable.

Evanger’s consultant made reference to a 1986 fraudulent complaint targeting Gerber’s baby food before summarized the company’s thoughts regarding consumer complaints in the following words, taken from an email dated February 17, 2017.

Complaints cannot be trusted! Once a complaint hits the press unscrupulous people will line up complaining hoping for a payout. Back in 1986 FDA did not have the Office of Criminal Investigations to conduct follow-ups at complainants to interrogate them to determine if their complaints were legitimate or not. Today FDA does have that ability and, perhaps, some of the complaints against Evanger’s and Against the Grain should be investigated further by FDA. I would really caution FDA about coming out with a press statement about receiving ‘many’ complaints against these products unless a comprehensive analysis of the complaint is done first.

In a March 3rd email, Evanger’s attorney expressed concern about FDA’s press releases, and asked the agency to give Evanger’s the opportunity to ‘address the issues’ prior to issuing a new public alert, as follows:

Please recall I represent Evanger’s. On its behalf, I’d like to request that the FDA communicate to and work with Evanger’s after the completion of any investigation or the discovery of any new information or questions so that, prior to any new press release from the FDA, Evanger’s is given the opportunity to address the issues. As I am sure you are aware, an FDA press release has significant impact in the market; this is obviously the FDA’s intended effect with the goal of protecting the public. This is indeed the goal the FDA and Evanger’s share.

Later in the same email, the attorney wrote,

It is for this reason that we ask that, Evanger’s be given the opportunity to address new questions, issues or concerns before the FDA issues an independent release. If this is not possible, I believe Evanger’s would be entitled to know why so as to preclude even the appearance of arbitrary or capricious action.

On June 29, 2017, FDA issued a formal Warning Letter to Evanger’s, listing the various violations of the Federal Food, Drug & Cosmetics Act documented during the agency’s January inspection of the company’s facilities.

On July 9, 2017, a “concerned consumer” sent the following email to FDA.

Dear Mr. Lyons,

I am responding, to the letter that your office sent to Evanger’s Dog And Cat Food Company, dated June 29, 2019. The reason is the FDA has made false Allegations against Evanger’s in the following way: [redacted by FDA].

The anti seizure medication contained 30 mg of phenobarbital not 15 mg. The medication has since been recalled by a company called Truxton because of mislabeling. [redacted by FDA]

Again the FDA jumped the gun when Evanger’s got blamed for the dogs deaths.

[redacted by FDA]

5. The FDA came charging in like a bull, and the FDA failed to ask about the medical history of the dogs. The phenobarbital that you found came from a labor dispute between the meat supplier and its employee.

Before you make any more false and misleading information about Evanger’s, you need to check your facts. As you have caused thousands of dogs to lose a perfectly safe free meal. Please correct your letter and investigate the new facts in this case. Thank you [redacted by FDA]

Ps. Let me also make it clear I am just a concerned consumer writing this letter by myself.

In October 2017, the company and FDA were still in correspondence regarding the destruction of the recalled products. An October 18, 2017 email from FDA to Evanger’s attorney provides a window into some of the ongoing issues.

As you may know, FDA initiated an inspection at the Evanger’s Markham, IL facility on Tuesday, October 10, 2017 (and is still currently in progress). According to our investigators, the firm has approximately only [redacted by FDA] pallets of recalled product in their possession at this location. The amount of recalled product originally inventoried at the firm in February 2017 by FDA was approximately [redacted by FDA] pallets of product. The firm stated they are destroying the product by discarding approximately [redacted by FDA] at a time into their regular trash bin and covering the product in trash; the trash is then collected per their regularly scheduled pickup. The firm has not provided any documentation or evidence that the product was destroyed; however, Chelsea Sher stated on the second day of the inspection that some of the product has been disposed of at a landfill with documentation. Documentation of the landfill destruction has not been provided to the investigators either. According the investigators the firm is also not rendering the product unsalvageable when the product is thrown into the trash.

Relations between FDA and the companies it regulates can be difficult. Fortunately, not every recall situation is fraught with the controversy and confrontation that characterized the interaction between Evanger’s and FDA.

A final note: All of the excerpts quoted above are ‘as written’ except for the indicated redactions by FDA. No attempt was made to abridge the content or correct any errors of fact, spelling or grammar.

JBS knowingly distributed pentobarbital-adulterated products

This story by Phyllis Entis first appeared in Food Safety News and is reposted here with permission.

JBS Souderton Inc. continued to distribute pentobarbital-adulterated products to customers even after receiving formal notification of pentobarbital contamination, according to a warning letter issued on April 23 by the Food and Drug Administration.

The warning letter to JBS Souderton Inc., which does business as MOPAC, was sent more than one year after pentobarbital was first discovered in beef tallow from the company’s Souderton, PA, facility.

Pentobarbital is a barbiturate used by veterinarians to euthanize animals, including companion animals, horses and cattle. According to the FDA, pet foods containing even a trace amount of pentobarbital are considered adulterated. It is against federal law to release “adulterated” products into the stream of commerce.

JBS was the supplier of beef tallow to Big Heart Pet Brands Inc. and to Champion PetFoods, among others.

Big Heart is a wholly owned subsidiary of The J.M. Smucker Company Inc. Champion is a Canadian pet food company whose U.S. production facility is in Auburn, KY. It manufactures Acana and Orijen brands of dry dog food.

In February 2018, a media outlet reported having found pentobarbital in several samples of Gravy Train canned, wet dog food. Smucker initiated a product withdrawal of the implicated products pending the outcome of its internal investigation.

Concurrently, FDA alerted pet owners about the possible presence of pentobarbital in the several dog food brands, including Gravy Train, Kibbles ’N Bits, Ol’ Roy and Skippy.

Smucker converted its withdrawal into a full-blown recall once company officials had confirmation of the presence of pentobarbital in its finished product and in samples of beef tallow supplied by JBS.

As part of its investigation into the Big Heart, FDA and the Pennsylvania Department of Agriculture conducted a joint inspection of JBS beginning March 13, 2018.

According to the warning letter, FDA found pentobarbital in four out of nine samples collected at the JBS facility. Upon further analysis, three of the samples were found to contain pentobarbital at levels ranging from 61.8 +/-19 to 277 +/-70 nanograms per gram (ng/g), well above the minimum detection concentration of 4 ng/g.

The four pentobarbital-contaminated products were delivered to customers from November 2017 through March 2018.

Samples collected from JBS and from its customers’ facilities and analyzed by Pennsylvania officials found levels of pentobarbital as high as 680 ng/g.

The list of Inspectional “Observations” in the FDA’s Form 483, provided to JBS management on Oct. 17, 2018, contained two items:

JBS did not visually verify loads of raw materials with what the hauler stated that they brought in. This led to tallow, manufactured at [the JBS] facility, to be adulterated with pentobarbital.
JBS did not have an effective system for evaluating incoming raw materials to ensure that these ingredients are suitable for use in human products and animal feeds.

JBS officials informed the FDA on April 17, 2018, that the company had completed cleaning all of its conveyances, conduits, cookers and centrifuges, and some of its storage tanks to remove any pentobarbital-contaminated product. In a May 30, 2018, letter, JBS management indicated the company would complete the cleaning process within an additional 30 days.

The company officials also reported having identified and talked with all of its suppliers that may have presented a risk for entry of euthanized animals into the rendering plant, and obtained a guarantee from each supplier that they would not provide euthanized animals. JBS also indicated it would continue to conduct random tests of tallow products for pentobarbital.

On July 27, 2018, the FDA took a follow-up sample from one of the JBS storage tanks. Upon analysis, the sample was found to contain trace amounts of pentobarbital.

On Aug. 8, 2018, the FDA inquired what actions JBS planned to take in response to the pentobarbital finding.

The company declined to recall the product. Instead, JBS offered to ask animal food producing customers that received animal food products to remove any products deemed positive for pentobarbital and to have their tanks cleaned.

JBS described its product withdrawals and attempted withdrawals of pentobarbital-contaminated product from its customers in a Nov. 26, 2018, letter to the FDA.

In its warning letter, the FDA noted that it was unable to asses the effectiveness of the corrective actions in the absence of a voluntary recall or other documentation demonstrating all contaminated products were removed from the marketplace.

As reported by Food Safety News in November 2018, Champion PetFoods retrieved pet foods the contaminated tallow from its third-party distributors. The company declined to initiate a retail-level recall, even though some of the product had reached the store/consumer level. The refusal was based on laboratory test results on retained samples of those finished products that did not reveal pentobarbital.

JBS was given fifteen working days to notify the FDA in writing of the specific steps it has taken to correct the violations listed in the warning letter, or to provide a time frame within which the corrections will be completed.