Exclusive: FDA CVM responds to TCR questions following Midwestern warning letter

Editor’s Note

Last week, TCR posed detailed questions to FDA Center for Veterinary Medicine (CVM) Director Dr. Steven Solomon following the Agency’s announcement that it had issued a Warning Letter to Midwestern Pet Foods, Inc., the manufacturer responsible for a series of recalls beginning in late December due to high levels of aflatoxin contamination that occurred earlier this year.

Every question we put to Dr. Solomon was answered thoroughly and promptly through his team. Most public officials, regulators, corporations, or institutions we cover are likely to provide boilerplate answers. Because that’s anything but the case with Dr. Solomon and his colleagues, we are publishing the exchange in full, including our follow-up questions and the responses.

[UPDATE: In January 2022, TCR followed up on these inquiries and filed new Freedom of Information Act requests Eight months later, FDA CVM has still not responded to repeated folllow-ups.  The division would only offer an anonymous email contending that the information we requested, updated case numbers of canine DCM, were “not relevant.”]

The top part of the exchange has the follow-up questions. The original questions, which CVM answered within approximately 24 hours of our query, are farther down.

We will, of course, continue to follow up with CVM, along with the many parties involved in the Midwestern aflatoxin recalls, including dog owners, state regulators, veterinarians contributing research to the investigation, insurance companies, and attorneys.

Finally, as these questions focused on larger policy and procedural issues, we think it’s worth highlighting CVM’s response to our question about policies regarding members of the public who wish to review cases of DCM submitted to the FDA and why they are currently being told to submit Freedom of Information requests:

Regarding DCM reports submitted to the FDA, these case documents include extensive medical records and require redaction to protect personal information of pet owners. CVM is in the process of preparing these documents for posting, and we appreciate your patience while we review and redact thousands upon thousands of pages and make them 508-compliant so they are accessible to everyone.

TCR will continue to press CVM for a timetable on when we can expect the documents to be published and any additional status updates.

From: Norris, Anne

Sent: Tuesday, August 24, 2021 4:14 PM

To: Emily Brill

Cc: Solomon, Steven M

Subject: RE: [EXTERNAL] RE: Your inquiry

Hi Emily,

Here are the responses to your two questions.

Depending on the facts of the particular situation, the FDA may take actions such as holding a regulatory meeting with Firm X, issuing a public safety notice, suspending Firm X’s food facility registration, issuing a mandatory recall order, refusing import shipments of Firm X’s food, or initiating an injunction or seizure action. This is not an exhaustive list and the FDA tailors any response to the specific situation.

When FDA receives or anticipates receiving multiple requests for the same document, we try to post it in the appropriate electronic reading room. While some these requests are for FDA Form 483s, there are many other types of documents. Unfortunately, redacting documents and making them 508-compliant (a legal requirement for documents posted on federal websites), is a time-intensive and labor-intensive process. To put things into perspective, last fiscal year, the FDA issued approximately 2,800 FDA Form 483s. The FDA has to prioritize its resources to post the documents that are of greatest and widest interest to the public. However, as you are aware, these documents are available upon request.

In the case of Midwestern Pet Foods, the 483s were issued by FDA’s Office of Regulatory Affairs (ORA), not the Center for Veterinary Medicine (CVM). In response to demand, ORA posted the FDA Form 483 for the Chickasha, OK facility in their reading room on April 19, 2021. Regarding DCM reports submitted to the FDA, these case documents include extensive medical records and require redaction to protect personal information of pet owners. CVM is in the process of preparing these documents for posting, and we appreciate your patience while we review and redact thousands upon thousands of pages and make them 508-compliant so they are accessible to everyone.

Hopefully this clears some things up for you. I’ll contact you about the sunblock question separately.

Thanks!

Anne

From: Norris, Anne

Sent: Monday, August 23, 2021 1:07 PM

To: Emily Brill <emily@thecaninereview.com>

Cc: Solomon, Steven M

Subject: RE: [EXTERNAL] RE: Your inquiry Hi Emily,

I’m trying to see if we can get further clarification on the answers – checking with legal on the enforcement question and FOI staff about the 483 question.

Thanks, Anne

From: Emily Brill

Sent: Monday, August 23, 2021 5:18 AM

To: Norris, Anne

Cc: Solomon, Steven M

Subject: RE: [EXTERNAL] RE: Your inquiry

Good morning. Hope you both had a good weekend and thanks so much for the prompt and thorough answers. Just two final questions below.

I do need to copy Dr. Solomon here to be sure that he had the opportunity to review because I am going to attribute the answers to Dr. Solomon answering through FDA spokeswoman Anne Norris (the questions are very CVM-specific; our focus is CVM, not any firm).

Hoping you can be more precise in your final answer You stated: “As stated in the corporate warning letter, FDA has requested a description of the specific steps the company has taken to correct any violations. FDA conducts follow-up inspections after issuing warning letters to verify that a firm has taken any appropriate actions needed to bring their facility into compliance. If the Agency’s follow-up reveals that a firm has failed to promptly make needed corrections or has failed to sustain those corrections, FDA may take additional actions.”

 If the Agency’s follow-up after a warning letter reveals that Firm X has failed to make corrections or sustain those corrections, please list out the specific possibilities with respect to “additional actions” the Agency may take. What are the actions FDA may take?

Finally, can you say why, despite clear public interest in Form 483’s on firms involved in major pet food recalls, reports to FDA of suspected DCM cases, etc. CVM requires FOIA requests to obtain these important and public Why? Dr. Solomon, why not direct CVM to be proactive about making documents available on your website where there is strong news interest? Why do I have veterinarians asking me to help them obtain documents from the FDA through FOIA requests? Why does a veterinarian need to know about FOIA? Similarly, why was I required to file a FOIA request to obtain the 483 on Midwestern? At the time, the recall was a leading national news story, obviously of interest to the public– so why does CVM not publish these documents? 

Thank you again,

Emily

From: Norris, Anne

Sent: Friday, August 20, 2021 5:38 PM

To: Emily Brill

Cc: Emily Brill

Subject: RE: [EXTERNAL] RE: Your inquiry

Hi Emily,

Answers below. Hope this helps. You can attribute to FDA, an FDA spokesperson, or to me.

Thanks, Anne

Do you have a policies and procedures guide and, if so, is there a document that contains the actual timeline or flow chart that determines the response of your agency when organizations and manufacturers do not correct deficiencies identified in Form 483? I understand that you cannot speak specifically about one company. I am asking to be pointed to the document or documents on which your agency bases its actions under the circumstances I’ve described.

Please see the Regulatory Procedures Manual (RPM), which is a reference manual that provides internal procedures and related information to be used by FDA employees who process certain regulatory and enforcement matters in support of the Agency’s public health mission.

We obtained an FDA Form 483 inspection report of the facility in Chickasha, Oklahoma through FOIA based on inspections of through February 2021. The report notes that the company’s preventive controls “failed to adequately control the hazard of aflatoxin in your firm’s finished pet food products as evidenced by the following deficiencies…” The report goes on to list alarming concentration levels of aflatoxin in food samples taken from “multiple sources in Missouri.”

Can you explain why the firm is now receiving another letter (as opposed to “product seizure and/or injunction”) since you’ve already issued a Form 483 this year?

An investigator issues an FDA Form 483 to firm management at the conclusion of an inspection when the investigator has observed conditions that in their judgment may constitute violations of the Federal Food, Drug, and Cosmetic (FD&C) Act and related Acts. As noted on the FDA Form 483 (see the boxed text immediately above the observations), these observations do not represent a final agency determination regarding compliance, but are written documentation of observations the investigator brought to the attention of firm management during a meeting at the conclusion of the inspection so they can be promptly addressed. For more information on FDA Form 483s, see FDA Form 483 Frequently AskedQuestions.

The FDA Form 483 you reference is only for the Chickasha, Okla., facility, while the warning letter issued covers the entire corporation and takes into account inspections performed and FDA Form 483s issued at the corporation’s other three facilities.

Warning letters may be based on observations made by investigator(s) when they inspect the firm and on other evidence collected. Warning letters, including corporate-wide warning letters, are advisory actions and are intended to give firms an opportunity to take voluntary and prompt corrective action to address any violations of the FD&C Act. Warning letters inform the firm of FDA’s position on a matter but do not commit the Agency to taking enforcement action. Firms often come into compliance after receiving a warning letter. For more information on warning letters, see FDA’s RPM, Chapter 4.

What makes a corporate-wide warning letter different from a standard warning letter is the scope; while a warning letter is typically focused on one facility, a corporate-wide warning letter is about all of a corporation’s facilities and points to systemic observations across their facilities.

 

I want to afford you the opportunity to respond to the suggestion that CVM’s warning letter, arriving eight months after the first recall, is coming a day late and a dollar short. Do you have any response?

The issuance of this corporate-wide warning letter is neither the beginning nor the end of our investigation of Midwestern Pet Foods, Inc. What it represents is a publicly acknowledgeable milestone in an investigation that has been progressing since the aflatoxin issue was initially brought to our attention in late December 2020.

The FDA has been conducting an investigation into Midwestern Pet Foods, Inc.’s four facilities that involves inspections, sample collection, testing, traceback, interviews, and more to understand the full extent of the animal food safety issues. Now that FDA and state regulatory partners have completed their inspections, the Agency has issued a corporate- wide warning letter citing concerns regarding evidence of significant violations of the law observed at its facilities and in connection with its products.

As described in the corporate-wide warning letter, FDA first became aware of reports of illness associated with Midwestern’s SPORTMiX brand of dog food on December 29, 2020 and started an inspection of the firm’s Chickasha, Okla., manufacturing facility two days later. At that time, Midwestern had already initiated a recall of the SPORTMiX products that had elevated levels of aflatoxin. Samples of other formulations and lots of SPORTMiX collected by FDA and the Office of the Texas State Chemist also tested positive for high levels of aflatoxin. On January 11, 2021, Midwestern expanded its pet food recall to include all products at risk of containing aflatoxin.

Because we wanted to define the scope and extent of the animal food safety concerns across the corporation and its manufacturing facilities, FDA also initiated inspections at Midwestern’s facilities in New York, Indiana and Illinois. In the course of our inspection of the Midwestern plant in Illinois, we discovered additional problems unrelated to aflatoxin, which led the firm to recall additional dry dog and cat food products because they had the potential to be contaminated with Salmonella.

The last of the four inspections concluded on April 16, 2021, and FDA immediately began the process of examining and compiling evidence from the multiple inspections into a corporate- wide warning letter.

Because the firm had voluntarily recalled the pet foods that had the potential to be contaminated with Salmonella or aflatoxin, because investigators provided initial feedback to the firm about their inspectional observations (FDA Form 483s), and because the Agency did not have evidence that violative Midwestern-manufactured product was currently in the marketplace, the FDA did not initiate a product seizure or injunction case.

However, because the conditions observed during the inspections indicated significant problems, the Agency took the step of issuing a corporate-wide warning letter.

Can you also cite any example at all of CVM taking the step of “legal action,  including product seizure and/or injunction”  without any criminal charges?

An example of an injunction related to a veterinary product is action taken against Bio Health Solutions, LLC for its product RenAvast, an unapproved animal drug. The press release is available here.

Injunctions have been regularly filed against dairy farms that have introduced food containing illegal drug residues into the U.S. food supply. A list of such actions is available here: https://www.fda.gov/animal-veterinary/compliance-enforcement/injunctions. Note that FDA/CVM cannot pursue judicial actions on its own; the U.S. Department of Justice brings injunction cases in court on FDA’s behalf.

U.S. Department of Justice brings injunction cases in court on FDA’s behalf.

FDA initiates civil actions like seizures and injunctions for different reasons than criminal actions. Civil actions are brought to protect the public from harmful products under FDA’s jurisdiction. Criminal actions are brought to punish culpable parties for wrongful action and discourage the behavior. Given the different goals and legal requirements for each, there are different procedures that FDA follows to initiate each type of case. Please see Chapter 6 of FDA’s Regulatory Procedures Manual for FDA’s policies about pursuing seizures, injunctions, and prosecution of criminal matters.

Depending on the nature of the violation, it is the FDA’s general practice to give individuals and firms an opportunity to take voluntary and prompt corrective action before it initiates a judicial action. In some cases, however, judicial action is necessary to protect public health. As noted above, all judicial action must be pursued by FDA through the U.S. Department of Justice.

 

You say that FDA “has requested a written response from the company within 15 working days stating the specific steps they have taken to correct any violations. Failure to adequately address any violations promptly may result in legal action, including product seizure and/or injunction.” Why only a written response? Why, at this point, would inspectors not simply start showing up every several days? Please explain to my readers.

As stated in the corporate warning letter, FDA has requested a description of the specific steps the company has taken to correct any violations.

FDA conducts follow-up inspections after issuing warning letters to verify that a firm has taken any appropriate actions needed to bring their facility into compliance. If the Agency’s follow-up reveals that a firm has failed to promptly make needed corrections or has failed to sustain those corrections, FDA may take additional actions.

From: Emily Brill <emily@thecaninereview.com>

Sent: Friday, August 20, 2021 2:41 PM

To: Norris, Anne

Subject: Re: [EXTERNAL] RE: Your inquiry

From: Emily Brill <emily@thecaninereview.com>

Sent: Thursday, August 19, 2021 12:30 PM

To: Norris, Anne

Subject: Re: [EXTERNAL] RE: Your inquiry

CAUTION: This email originated from outside of the organization. Do not click links or open attachments unless you recognize the sender and know the content is safe.

Hi! I am in back to back appts I will be available I’m 45 min ish but no laptop . How late can u connect? Would 5 be too late ?

Sent from my iPhone

On Aug 19, 2021, at 11:25 AM, Norris, Anne wrote:

Hi Emily,

Do you have a moment to chat? We have responses to your questions moving through clearance, but thought a little context (on background, of course) might make the wait a little more tolerable… or at least understandable. Saw your story posted, so if you’d rather just hang tight and wait for the written responses, that’s totally fine.

Thanks,

Anne

Anne Norris

(she/her)

Strategic Initiatives 

Office of the Director

Center for Veterinary Medicine

U.S. Food & Drug Administration

From: Emily Brill <emily@thecaninereview.com>

Sent: Wednesday, August 18, 2021 6:13 PM

To: DeLancey, Siobhan; Emily Brill

Cc: Norris, Anne

Subject: [EXTERNAL] RE: Your inquiry

CAUTION: This email originated from outside of the organization. Do not click links or open attachments unless you recognize the sender and know the content is safe.

Hi Siobhan,

Thanks very much. Appreciate the response. I will follow up with Anne tomorrow morning if I don’t hear from her first. Thanks again.

From: DeLancey, Siobhan

Sent: Wednesday, August 18, 2021 5:21 PM

To: Emily Brill

Cc: Norris, Anne

Subject: Your inquiry

Hi Emily,

Dr. Solomon let me know you had emailed him directly with several questions on a short deadline. Anne is out today but will follow up with you tomorrow.

In the meantime, you can peruse the Regulatory Procedures Manual and our Compliance & Enforcement page, which provides many of the resources you asked about. You’ll find descriptions of the differences between FDA Form 483 and warning letters particularly helpful,

We’ll get back to you on your specific questions. Best,

Siobhan DeLancey, RVT, MPH

(She/Her/Hers)

Senior Advisor for Strategic Communications Center for Veterinary Medicine

U.S. Food and Drug Administration