Peptide and Compounded Drug Enforcement
August 22, 2026
11 min read
Aaron M. Cohen

A Peptide Seller Just Got 70 Months. The FDCA Count Carried a Three-Year Maximum.

A peptide seller drew 70 months on a count that caps at three years. The stacked importation charge that did it sits in almost every imported-peptide file.
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Part 1: A Peptide Seller Just Got 70 Months. The FDCA Count Carried a Three-Year Maximum.

Seventy months on a count that caps at three years, plus the key takeaways for anyone selling, sourcing, or administering peptides.

0:000:00

On July 30, 2026, a federal judge in the Northern District of Indiana sentenced the owner of an online peptide business to 70 months in prison and entered a $5 million money judgment against him. His sister, an employee who packaged and shipped orders out of the company's Michigan City warehouse, got 16 months. Both were ordered to pay $78,317.52 in restitution, jointly and severally.

Look at the count of conviction and the number does not add up. Introducing an unapproved new drug into interstate commerce with intent to defraud or mislead carries a three-year statutory maximum. Seventy months is nearly six years. Anyone selling, sourcing, or administering peptides who reads the headline and stops there will draw exactly the wrong lesson from this case.

Online peptide fulfillment warehouse at night, shelves of unlabeled glass vials and shipping mailers, packing bench under a single overhead lamp

Fifty-four thousand customers in all fifty states and more than eighty countries. The shipping records that built the business are the same records that built the case.

Key Takeaways

  • The owner of an online peptide business received 70 months and a $5 million money judgment; a non-owner employee who packed boxes received 16 months.
  • The felony FDCA count under 21 U.S.C. § 333(a)(2) caps at three years. The sentence was driven by a second count, illegal importation under 18 U.S.C. § 545, which carries twenty.
  • Two FDA warning letters, in 2020 and 2022, are what converted a misdemeanor regulatory posture into felony intent to defraud or mislead.
  • Products labeled "research use only" and marketed as SARMs tested positive for testosterone, a Schedule III substance under 21 U.S.C. § 812.
  • Florida sellers face the same structure plus Fla. Stat. § 499.0051, and the Southern District of Florida is one of the most active peptide enforcement districts in the country.

What Actually Happened

According to the U.S. Attorney's Office for the Northern District of Indiana, the company sold peptides, selective androgen receptor modulators, human chorionic gonadotropin, and other drugs through an online storefront between 2019 and 2024, shipping to more than 54,000 customers in all fifty states and more than eighty countries. Gross proceeds were roughly $5 million. Both defendants pleaded guilty on December 10, 2025.

The government's factual basis breaks into three groups, and the groups matter more than the headline.

Representation. The business told customers it was licensed and registered with FDA, manufactured product in its own U.S. laboratories, and tested for purity and pharmaceutical quality. Prosecutors said none of that was true. Product came from China, India, and elsewhere, untested. CBS News reported that the owner admitted certificates of analysis had been forged.

A certificate of analysis is a document. When the government proves it was forged, it stops being paperwork and becomes the clearest evidence of intent in the file.
Laboratory bench close-up under a harsh desk lamp, rack of amber-filled glass vials, one held in a gloved hand, fanned certificate of analysis pages with a chromatography chart

Content. FDA testing of six compounds sold as SARMs found testosterone in all six. Customers who thought they were taking a non-hormonal research compound were taking an anabolic steroid.

Notice. FDA sent warning letters in 2020 and again in 2022 telling the business it was marketing and selling unapproved drugs. Sales continued for two more years. That fact is the hinge of the entire case.

🚨 Case Alert

Sentencing in the Northern District of Indiana on July 30, 2026: 70 months and a $5 million money judgment for the owner, 16 months for a non-owner employee who packaged and shipped orders, and $78,317.52 in restitution against both jointly and severally. Both defendants pleaded guilty on December 10, 2025.

Why the Sentence Is Six Years and Not Three

A first violation of the Federal Food, Drug, and Cosmetic Act is a strict liability misdemeanor under 21 U.S.C. § 333(a)(1). No knowledge needed to convict. Add intent to defraud or mislead and the same conduct becomes a felony under § 333(a)(2), with a three-year cap. That is the ceiling on the FDCA count standing alone, and it is why FDCA cases have historically been treated as survivable.

The importation count removed the ceiling. 18 U.S.C. § 545 punishes knowingly importing merchandise contrary to law by up to twenty years. Once unapproved drug product crosses a border in violation of 21 U.S.C. § 381, the government has a § 545 count sitting on top of the FDCA count with more than six times the exposure. That is a structural feature of every imported-peptide fact pattern, not an artifact of this case.

⚖️ Key Legal Point

The three-year FDCA cap is real, and it is also irrelevant once a § 545 importation count is on the same indictment. Twenty years of statutory exposure resets the ceiling, and the guidelines then decide the number.

The guidelines do the rest. Fraud-driven FDCA conduct cross-references from USSG § 2N2.1 into § 2B1.1, where the loss table governs, and a figure near $5 million moves the offense level roughly eighteen steps before any specific offense characteristic applies. Mass marketing, more than ten victims, sophisticated means, and conscious or reckless risk of serious bodily injury are all available on these facts. Customers reported cardiac problems, suppressed natural testosterone requiring replacement therapy, and psychological effects including suicidal ideation. That is the record a court reads at sentencing.

Note what the government did not charge. Testosterone is a Schedule III anabolic steroid, and distributing it carries ten years under 21 U.S.C. § 841(b)(1)(E). Mail and wire fraud under 18 U.S.C. § 1341 and § 1343 were plainly available on these shipping and marketing facts. Neither appeared in the counts of conviction. The charges filed are the product of decisions made long before any plea.

The Employee Sentence Is the Part Operators Should Not Skip

Sixteen months in federal prison for packaging and shipping. She did not own the company, write the website copy, or source the product from Asia. She worked at the warehouse.

Every peptide, compounding, telehealth, and med spa operation has people in that position. Fulfillment staff, office managers, patient coordinators, the person who signs for deliveries and enters the invoices. When the government builds a case around the front end of an operation, the people who handled the physical product are witnesses first and defendants second, and the order in which they get counsel usually determines which one they end up being. An employee contacted by federal agents needs independent counsel, not the company's lawyer.

💡 Practical Tip

Company counsel represents the company. An employee who sits for an interview with the company's lawyer in the room has no privilege of their own and no one arguing that they belong on the witness list rather than the indictment. That is a separate lawyer, retained early.

Research Use Only Is Not a Defense and Never Was

The label has been treated inside the industry as a legal firewall for a decade. It is not one. Intended use under 21 U.S.C. § 321(p) and § 355 turns on objective evidence of what the seller intended, and the government builds that from marketing copy, dosing guidance, customer service emails, affiliate content, and the fact that a product is sold in injectable form in a human-scale dose to consumers rather than to institutions with IACUC or IRB oversight. A disclaimer at checkout does not survive a customer service inbox full of dosing advice.

Florida Operators Are Not Further From This Than Indiana

South Florida holds a dense concentration of peptide sellers, longevity clinics, hormone practices, and telehealth platforms, and the Southern District of Florida is among the more aggressive federal districts on compounded and unapproved drug enforcement. This case was worked by FDA Office of Criminal Investigations with the U.S. Postal Inspection Service, which means shipping records were evidence, not logistics. Both agencies keep a substantial South Florida footprint.

Federal agents on a warehouse loading dock at dawn, a woman in a navy windbreaker with a clipboard examining stacked shipping cartons while a postal inspector photographs a mailing label
FDA Office of Criminal Investigations worked this case with the Postal Inspection Service. When postal inspectors are on the team, every shipment the business ever sent is already an exhibit.

State law adds a second front. Fla. Stat. § 499.0051 makes it a felony to knowingly purchase or receive a prescription drug from an unauthorized distributor, and the Florida Drug and Cosmetic Act reaches the receiving clinic, not only the seller. A Florida business with this fact pattern defends a Department of Health matter and a federal investigation at once, on overlapping records.

The Mistakes That Make These Cases Worse

Continuing to sell after a warning letter. This is what converted a misdemeanor exposure into a felony here, and it is the single most common error in this industry. A warning letter is not a nuisance. It is the government documenting your knowledge, and every sale after it is a piece of the intent element.

Overhead view of a dark wooden desk under a banker's lamp, a government agency letter beside a stapled court filing with a blue backing cover and an open manila folder
"A warning letter is not a nuisance. It is the government documenting your knowledge, and every sale after it is a piece of the intent element."Aaron M. Cohen, Principal Attorney

Answering an FDA inquiry without counsel. Voluntary interviews with OCI agents feel administrative. They are not. A false or incomplete statement is a standalone five-year felony under 18 U.S.C. § 1001.

Cleaning up the records. Revising certificates of analysis, deleting marketing pages, or reconstructing supplier documentation after FDA makes contact is obstruction under 18 U.S.C. § 1519, a twenty-year felony that has destroyed otherwise defensible cases.

Assuming the plea was inevitable. It was not. The defensible ground in an unapproved drug case sits in intent, in supplier verification performed before the purchase rather than after, in whether the seller actually knew the importation was contrary to law under § 545, and in the loss figure, which drives the sentence more than any other input and is routinely overstated on the government's first calculation.

Where the Defense Work Actually Happens

Before charges. A federal investigation defense lawyer engaged at the warning letter or subpoena stage can do things that become impossible after indictment. Determine whether the client is a witness, a subject, or a target. Negotiate the scope of a federal grand jury subpoena rather than producing the whole server. Put the company's sourcing and testing documentation in front of the prosecutor before agents assemble the timeline without it. Argue the loss calculation while it is still a spreadsheet rather than a paragraph in an indictment. Separate the owners from the employees on the record early.

After indictment, the counts are chosen, the § 545 exposure is on the paper, and the conversation is about how much rather than whether.

🛡️ Defense Strategy

The loss figure drives the sentence more than any other input in a fraud-driven FDCA case, and the government's first calculation is routinely overstated. That fight is cheaper and more winnable while the number is still a spreadsheet than after it is recited in an indictment.

Common Questions

Can I go to federal prison for selling peptides labeled research use only?
Yes. The label does not control. Under 21 U.S.C. § 321(p) and § 355, intended use is proven with objective evidence including marketing, dosing guidance, packaging, and customer communications. A seller in the Northern District of Indiana received 70 months in a case involving products carrying that label, and the court found they were marketed and sold for human consumption.
What does an FDA warning letter mean for criminal exposure?
It documents your knowledge. A first FDCA violation is a strict liability misdemeanor under 21 U.S.C. § 333(a)(1), but conduct continuing after a warning letter supports the intent to defraud or mislead required for the three-year felony under § 333(a)(2). In this case, warning letters issued in 2020 and 2022 preceded two more years of sales and framed the government's intent theory.
How does an FDCA case with a three-year maximum produce a six-year sentence?
Through stacked counts. Illegal importation under 18 U.S.C. § 545 carries twenty years and applies whenever unapproved drug product enters the country contrary to 21 U.S.C. § 381. The guidelines then cross-reference fraud-driven FDCA conduct into USSG § 2B1.1, where loss amount, number of victims, mass marketing, and risk of bodily injury drive the range well past the FDCA cap.
Do employees of a peptide company face charges, or only the owner?
Both. In this case a non-owner employee who packaged and shipped orders received 16 months in federal prison. Employees contacted by federal agents should retain independent counsel rather than relying on company counsel, because the company's interests and the employee's interests separate quickly in these investigations.
Does Florida law add exposure beyond the federal charges?
Yes. Fla. Stat. § 499.0051 makes knowingly purchasing or receiving a prescription drug from an unauthorized distributor a felony, and the Florida Drug and Cosmetic Act reaches the receiving business as well as the seller. Florida operators frequently face a Department of Health proceeding and a federal investigation at the same time, on the same records.

Facing an FDA Inquiry, a Warning Letter, a Grand Jury Subpoena, or a Target Letter?

AMC Defense Law represents peptide sellers, compounding operations, telehealth platforms, med spa owners, physicians, nurse practitioners, and management entities in federal investigations and prosecutions involving unapproved and misbranded drugs, importation, health care fraud, and controlled substances. The firm's South Florida federal criminal defense practice is based in Boca Raton and handles matters throughout Florida and nationwide. If FDA Office of Criminal Investigations, the Postal Inspection Service, or a U.S. Attorney's Office has contacted you or your business, speak with a federal criminal defense attorney before you respond or produce anything.

Aaron M. Cohen federal defense attorney standing at a darkened conference table, hand on a closed case file, dark charcoal suit, white shirt, purple silk tie, night skyline behind him

AMC Defense Law defends peptide sellers, compounders, telehealth platforms, and med spa operators in federal unapproved drug and importation cases in the Southern District of Florida and nationwide.

If you or your loved ones have been arrested or contacted by federal agents, call Aaron M. Cohen, 24 hours a day to get help.

This article is for general informational purposes only and does not constitute legal advice. Reading it does not create an attorney-client relationship. Every case is different, and outcomes depend on specific facts and circumstances. If you are facing an investigation or criminal charges, consult a qualified attorney about your specific situation.

If the legal developments discussed in this article affect your case, don't wait.

Aaron M. Cohen, Principal Attorney

Aaron M. Cohen

Principal Attorney

Aaron M. Cohen is a nationally recognized criminal defense attorney with over 30 years of experience representing individuals and entities in complex criminal investigations and prosecutions across the United States.

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