Uncovering DOJ’s ‘capacity’ in dietary supplement prosecutions: Gov’t transparencyUncovering DOJ’s ‘capacity’ in dietary supplement prosecutions: Gov’t transparency

Over the summer, a trial lawyer with the U.S. Department of Justice spoke at a dietary supplement event in New York City.

Patrick Runkle, assistant director of DOJ’s Consumer Protection Branch, shared the feds are “litigating supplement cases every day of the week, and so we are at capacity in terms of the amount of cases we can take.”

How does DOJ define “capacity,” or put more simply, how many cases is DOJ litigating in this area, where are the cases being brought in the U.S. and what specific issues are involved? I have tried — thus far in vain — to get these answers, focusing on criminal cases and leveraging the Freedom of Information Act (FOIA).

On July 15, 2024, I filed a FOIA request with the U.S. Food and Drug Administration. I surmised FDA would have records of pending criminal cases since the agency is principally responsible for regulating dietary supplement products and its Office of Criminal Investigations looks into such crimes as adulterating products with active pharmaceutical ingredients like sildenafil, also known as Viagra.

DOJ — not FDA — files criminal charges in the federal district courts through grand jury indictments, for example, and is responsible for prosecuting the cases. But again, FDA is the regulator of dietary supplement products, and the agency plays an instrumental role in civil and criminal investigations that are ultimately referred to DOJ for federal court actions.

Related:DOJ faces ‘capacity’ litigating dietary supplement cases

I requested, in part, “a list of all active and publicly filed criminal cases in the U.S. (including indictments and information counts) investigated by the FDA Office of Criminal Investigations against individuals and/or companies selling products marketed as dietary supplements and referred to the U.S. Department of Justice for prosecution.”

My FOIA request excluded cases that have been closed, in which, for instance, the defendants have been acquitted or found guilty and sentenced. I requested the names of the parties, case number in Pacer — which provides electronic access to federal court records — and the U.S. District Court where each case is pending.

As the holidays were approaching, I could not recall receiving a substantive response to my FOIA request (and some additional, unrelated FOIA inquiries to FDA), so I reached out to Sarah Kotler, director of FDA’s Division of Headquarters Freedom of Information. Kotler emailed me an attachment dated Aug. 23, 2024, in which FDA responded that it was “unable to locate any records responsive” to my request, following a “diligent search” of its files by the “Office of Regulatory Affairs (ORA), Office of Criminal Investigations (OCI).”

I followed up with Kotler, writing in an email that I was “thoroughly perplexed how FDA could find no ‘responsive records.’” My request was reopened, though my hope to obtain the criminal records — and report on them in our publication, SupplySide Supplement Journal — was short-lived.

On Dec. 13, OCI again confirmed it had no records responsive to my request.

“OCI does not maintain ‘a list’ containing the data elements you requested, e.g. names of parties, case numbers, or case status,” Kotler wrote to me. “OCI also does not track the specific data points you requested within the systems used to manage their records, so is not able to extract responsive data from OCI databases. Lastly, the FOIA does not require OCI staff to conduct research or create records in order to respond to your FOIA request.”

Kotler also advised me that the information I requested may be available through Pacer, or I could submit a FOIA request with DOJ. I was further advised I have the right to appeal FDA’s “no records” determination.

My initial reaction to her email was what you would expect from a scribe: nausea and infuriation. OCI’s response, the cynic in me concluded, was the U.S. government stonewalling me again in my efforts to simply obtain public records and report on them, the most elementary of duties as a journalist.

But I was willing to stand corrected. Perhaps, FDA really didn’t possess the records or “list” of criminal cases that I asked for in my FOIA request. On Dec. 19, I filed a FOIA request with the Justice Department, requesting the same criminal records. I’ll let you know what DOJ says — if and when I hear back.

I also emailed Patrick Runkle, the DOJ attorney who spoke June 25 at an event hosted by the American Conference Institute (ACI) and Council for Responsible Nutrition (CRN). Runkle said at the time that bringing cases in the dietary supplement sphere is challenging and often involves “deep science,” underscoring the need for clarity.

“My pitch on this topic is essentially that clarity helps everybody,” Runkle said. “These are very hard cases to prove.”

In a Dec. 22 email, I forwarded my DOJ FOIA request to Runkle and advised him that I’d “appreciate any assistance” he could provide and added in part, “It would seem that either or both FDA and DOJ are the best sources of the requested information since FDA and DOJ are the entities that investigate and prosecute these cases.”

I haven’t heard from him.

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Meanwhile, I was curious what attorneys well versed in FDA regulations and the dietary supplement industry thought of my FOIA request and FDA’s response to it.

“Recall that under FOIA, you can request and may be entitled to ‘records,’ — existing documents,” said Washington, D.C.-based attorney Stuart Pape, chair of the FDA practice at the law firm Polsinelli and who previously served in FDA’s Office of Chief Counsel. “Your request can be read (and seems to have been read) as requesting something— a ‘list’ — that apparently doesn’t exist. If that’s true, and I don’t doubt that it is, FDA has no obligation to create a list for you.”

The lawyer seemed to sympathize with my plight, however, adding in a follow-up email that he too was “perplexed that this information isn’t readily available.”

Kevin Bell, a partner with Arnall Golden Gregory LLP and co-chair of the dietary supplements industry team, has sued FDA twice on behalf of the Natural Products Association (NPA), including a lawsuit pending in the nation’s capital regarding the legality of NMN-containing dietary supplements.

Asked for comment on FDA’s response to me, Bell said, “I don’t believe them. For a federal agency to state that they do not know what actions they are taking in court and investigations is absurd. They have the information.”

In a FY24 budget request to Congress for $7.2 billion, FDA disclosed that in FY21, its dietary supplement compliance activity resulted in 111 warning letters, 1,299 import refusals, three filed injunctions, one seizure and 22 criminal convictions. Apparently, FDA is capable of tracking criminal convictions but does not track pending criminal cases.

NPA President and CEO Dan Fabricant described FDA’s response to my FOIA request as “shameful, especially with all the requests for new authorities in the past few years.”

As many readers are aware, FDA has requested authority to require that all dietary supplement products are listed with FDA. FDA has also requested that Congress clarify its authorities over products marketed as dietary supplements.

“If the left hand doesn’t know what the right hand is doing, what are we doing telling tall tales about what’s needed and what’s not when clearly the house isn’t in order,” asked Fabricant, who oversaw FDA’s Division of Dietary Supplement Programs from 2011 until 2014.

Jack Wenik is a member of the law firm Epstein Becker & Green P.C. and has represented dietary supplement clients in civil and criminal cases. He concluded that I directed my FOIA request to the wrong entity.

“Dietary supplement enforcement is a small sidebar of the FDA, and it does not surprise me that their record keeping is minimal,” he said. “Criminal and civil dietary supplement enforcement is handled by the Consumer Protection Branch of the Civil Division of the U.S. Department of Justice.”

Wenik believed I would receive “a more meaningful response” from DOJ’s Consumer Protection Branch.

Another way to get the information, the lawyer suggested, was to download all of the Consumer Protection Branch’s press releases as he believed “virtually every case that’s prosecuted” is announced in a news release. Setting aside whether all relevant prosecutions against dietary supplement defendants across the U.S. are announced in a release, how many years back must I go to capture all the pending criminal cases?

Some criminal cases may linger in the courts for several years. Wenik is one of the attorneys representing Hi-Tech Pharmaceuticals and its executives in a pending criminal matter that dates back to 2017 and is set for trial in July 2025.

For many years, attorney Rick Collins has defended clients accused of selling steroids and committing other crimes in the dietary supplement industry. He wasn’t so forgiving of FDA as Wenik, saying he couldn’t come up with a “good reason that would explain FDA-OCI’s inability to provide the information” that I requested.

“If they really can’t easily locate any internal records concerning the publicly filed dietary supplement investigations initiated by their own agents, that’s a systems failure,” said Collins, a partner with Collins Gann McCloskey & Barry PLLC. “The public would be better served if the agency tracked such information. Obviously if the agency could locate such records with a bit of effort but just didn’t want to, that’s a different problem. Either way, it’s not optimal.”

I was curious as to whether I could get the information through Pacer, the electronic system that FDA’s Kotler mentioned and that I’ve used over the years to track the status of civil and criminal federal cases and download court filings. Collins indicated to me that using Pacer to find the relevant cases wouldn’t be a simple or straightforward feat.

“Prosecutions in cases involving mislabeled or adulterated supplement products are often brought under Title 21 of the U.S. Code, Sections 331 and 333. But those sections of law are not only limited to cases involving dietary supplements,” Collins explained.

Searching Pacer, I would not only end up with “a volume of irrelevant cases,” the criminal defense attorney explained, I would “miss relevant cases because some prosecutions of adulterated supplements are brought under other criminal statutes such as mail fraud, conspiracy or money laundering.”

Collins also recommended I request the information from DOJ since it’s the agency that files such public documents as a criminal information or indictment.

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I still wasn’t finished with FDA. I wanted to hear what relevant parts of the agency had to say about FDA disclosing to me that it had no records responsive to my request.

On Dec. 19, I requested comment from FDA’s Office of Dietary Supplement Programs (ODSP) “on FDA’s FOIA response and asking how the agency can justify requesting new authorities from Congress if it doesn’t know — and keep track of — and/or will not disclose (in response to a FOIA) which publicly filed criminal cases are pending in this area.”

ODSP declined to comment. I basically posed the same question to the Office of the FDA Commissioner on Dec. 19 and haven’t received a response to date.

On Dec. 23, I requested that FDA’s media relations department produce the criminal records for me.

“Seeking to research the requested information through Pacer — a service of the federal judiciary — is not an efficient or accurate way to obtain this information for a variety of reasons,” I argued. “More to the point, the types of criminal investigations that fall under the scope of my request commence with OCI/FDA, and FDA staff is best positioned to research, produce and disseminate this information in a timely manner, in collaboration with the agency prosecuting the cases on behalf of FDA: DOJ.”

Thus far, crickets from FDA.

How can the industry, federal government, lawmakers and other stakeholders have a well-informed, intelligent conversation about the need for additional authorities over dietary supplement products if, for example, the public doesn’t have ready access to the type of information that I requested?

As Collins told me, “Transparency best serves the public interest, and in this case could both help inform consumers and have a chilling effect on bad actors.”