What Turns a Misbranding Charge Into a Felony? Two Injectable Cases, One Statute, and the Sentence That Separated Them

Published September 28, 2026

One subsection does it. Federal law makes putting a misbranded drug into interstate commerce a crime with a one-year maximum, and then says that the same act carries three years if either of two things is also true: the person has a prior final conviction under the same section, or the person acted with the intent to defraud or mislead. A Louisiana doctor was charged under the first tier and faced a year. An Iowa man selling injectable vitamin B12 online pleaded guilty to the second tier. He had no prior conviction, so the government took the other route — and what it recited as evidence of intent was that the FDA told him he was breaking the law, he shut down for a week, and then he opened a new website and kept going for another twenty-eight months.

Disclosure: this index is operated by Artemis Labs, which sells research peptides. Neither case on this page involves a peptide — one concerns injectable vitamin B12, the other an injectable contraceptive — and no product is named or linked. Nothing here is legal advice and no outcome is predicted. Every quotation is verbatim from a statute or a court record fetched and read for this page, and every source is listed at the bottom. Three limits belong at the top, not in a footnote: neither judgment was read, so this page reports what each statute authorized and not what either man actually received; the two cases were brought in different districts, years apart, against different drugs, so the comparison is an illustration and not a controlled experiment; and the intent evidence described below comes from the government's own announcement, which is a prosecutor's characterization of a record, not a judge's finding.

A related page in this index asks how a person can be convicted of a drug-labeling crime when somebody else wrote the label and he never knew. The answer there was that the basic offense has no intent element at all — you can be guilty without knowing anything. That page ended where this one starts, because if intent is not required for the crime, a fair question is what intent is for.

It is for the penalty. Intent does not decide whether you are guilty. It decides how much trouble you are in, and the gap between the two answers is a factor of three.

Two men, two injectable drugs, one prohibition

Start with what is identical, because it is easy to assume the felony case involved a more serious act and it did not.

Both men were charged under the same prohibition. Federal law lists prohibited acts, and the first one on the list reads:

The introduction or delivery for introduction into interstate commerce of any food, drug, device, tobacco product, or cosmetic that is adulterated or misbranded.

That is the act in both cases. Neither man was charged with making anyone ill. Neither was charged with fraud in the ordinary sense, with forging a document, or with lying to a federal agent. Both put an injectable drug into commerce that the law deemed misbranded.

Two things in that table deserve a second look. The Iowa case ran fifteen days shorter than the Louisiana one despite being the felony. And the Iowa charging document was an information, not an indictment — a charging instrument a defendant consents to, which is the shape of a negotiated plea, not a contested fight. Neither case looked like a battle. The difference between them is not in how hard they were fought.

The penalty statute, and the fact that its own heading gives the answer

The penalties for violating that list of prohibited acts are set out in a separate section. Its subsection (a) carries a heading, and the heading is unusually generous — it names the whole mechanism before you read a word of the text:

second violation; intent to defraud or mislead

Those are the two routes. Here is the first tier, which is what the heading is an exception to:

Any person who violates a provision of section 331 of this title shall be imprisoned for not more than one year or fined not more than $1,000, or both.

No mental state appears in that sentence. Nothing about knowing, intending, or meaning to. That is the tier the Louisiana doctor was charged under, and it is why the announcement in that case could state the exposure in a single clause: ANDRE faces a maximum term of up to one year imprisonment and one year of supervised release.

Now the second tier. The sentence opens with Notwithstanding the provisions of paragraph (1) of this section and then continues:

if any person commits such a violation after a conviction of him under this section has become final, or commits such a violation with the intent to defraud or mislead, such person shall be imprisoned for not more than three years or fined not more than $10,000, or both

Read the two conditions separately, because they are joined by or and they do completely different work.

The first is about your record. If you have already been convicted under this section and that conviction is final, the next violation is a felony automatically. Nothing about your state of mind is examined. It is a recidivist clause.

The second is about your mind. No prior conviction required. If the violation was committed with the intent to defraud or mislead, the three-year maximum applies to a first offense.

Being told by the FDA is not a prior conviction

This is the distinction that is easiest to get backwards, and it matters more than any other sentence on this page.

The Iowa case had an FDA inspection in it. An agency told a man to his face that what he was doing broke the law. It is tempting to read that as the trigger — as though official notice is what flips the switch to felony.

It is not, and the statute is explicit. The first route requires a conviction of him under this section has become final. An inspection is not a conviction. A warning letter is not a conviction. An agency telling you that you are violating the law is, legally speaking, none of the things that clause asks for. The Iowa defendant had no prior conviction under the section, so that route was unavailable to the government.

So the inspection did not operate as a recidivism trigger. It operated as evidence — under the other clause entirely. Its significance is not that an official spoke. It is that after an official spoke, the record shows what the man did next.

What the government recited as intent, and what it did not have to

The announcement of the Iowa plea states the offense in the statute's own words:

one count of introducing a misbranded drug into interstate commerce with the intent to defraud or mislead

It then recites, in two sentences, the factual sequence. The first establishes notice:

the U.S. Food and Drug Administration (FDA) informed Tomlinson during a December 2016 inspection that dispensing the drugs without valid prescriptions violated the Federal Food, Drug, and Cosmetic Act (FDCA)

The second is the one to sit with:

Tomlinson closed his business for a week following the inspection, but then created a new website and continued selling the same kinds of misbranded B12 injections from December 2016 until April 2019

Every element of that sentence is conduct. He closed. He created. He continued. There is no forged document in it, no false statement to an investigator, no smuggling, no fake certificate, no invented credential. The strongest word in the whole recitation is new — a new website, which on its own is an entirely lawful thing to build.

What gives the sequence its force is the order of events and the gap in the middle. The week of closure is doing a great deal of work, because it is the part that is hard to explain innocently. A person who never understood the objection does not pause. A person who closes and then reopens under a different address has demonstrated, without saying a word, that he heard the objection, understood it well enough to react to it, and resumed anyway.

The continuation ran roughly twenty-eight months after the inspection — from December 2016 to April 2019 — which is what turns a stumble into a course of conduct.

The Civil Division official quoted in the announcement described the conduct in terms of supervision, not deceit:

Dispensing drugs such as these without a prescription or the involvement of a medical professional endangers consumers and violates the law

Note what that sentence does not say. It does not say he faked anything.

Why these drugs were “misbranded” at all — two different mechanisms

Both men put a misbranded drug into commerce, but the word misbranded is a legal conclusion that can be reached by several different roads, and these two cases took different ones. This matters, because one of the roads has nothing at all to do with what is printed on the container.

The Louisiana road is the label. The announcements in that case are specific: The Depo-Provera lacked adequate directions for use in its labeling, and, in the earlier charging announcement, The medroxyprogesterone lacked adequate directions for use in its labeling. That tracks a provision under which a drug is misbranded Unless its labeling bears (1) adequate directions for use. The provision continues into requirements about warnings; this page quotes only that first clause and stops there, because the remainder concerns matters of use and administration that are outside this index's scope.

The Iowa road is not the label. The announcement describes the violation as dispensing the drugs without valid prescriptions, and there is a provision that converts exactly that into misbranding by operation of law. It first states that a drug requiring professional supervision shall be dispensed only (i) upon a written prescription of a practitioner licensed by law to administer such drug or by the oral-prescription and refill routes that follow. Then it adds this:

The act of dispensing a drug contrary to the provisions of this paragraph shall be deemed to be an act which results in the drug being misbranded while held for sale.

That is a deeming rule, and it is worth reading slowly. The drug is not misbranded because the container says something wrong. It is misbranded because of how it was sold. A perfectly accurate label, a correct ingredient list, an honest description — none of it helps, because the transaction creates the misbranding, and the printing has nothing to do with it. Sell a prescription drug outside the prescription system and the law supplies the misbranding for you.

The letter grades, and two numbers the statute gets wrong

Federal offenses carry letter classifications, assigned by a general sentencing statute according to the maximum term authorized. Two of its rungs are the ones in play here. A term of less than five years but more than one year is a Class E felony. A term of one year or less but more than six months is a Class A misdemeanor.

Apply that. The first tier's one-year maximum makes it a Class A misdemeanor. The second tier's three-year maximum makes it a Class E felony. The two offenses sit on adjacent rungs of the same ladder — the lowest grade of felony directly above the highest grade of misdemeanor.

The fine figures in the penalty statute, however, are obsolete, and anyone reading the numbers $1,000 and $10,000 at face value will be badly wrong about the stakes. A general fines statute overrides them, allowing an individual to be fined the greatest of several amounts, including for a felony, not more than $250,000 and for a Class A misdemeanor that does not result in death, not more than $100,000.

So the real spread is not $1,000 against $10,000. It is up to $100,000 against up to $250,000, plus the difference between a one-year and a three-year ceiling, plus the difference between carrying a misdemeanor and carrying a felony for the rest of your life.

What does the evidence not show?

Several things, and some of them cut against the framing above.

Neither sentence is known. This is the largest gap on the page. The Iowa announcement records only that sentencing was set for April 15, 2022; the Louisiana announcement records only that sentencing was scheduled for June 6, 2024. The judgments were not among the records that could be reached for this page. Both dockets terminated within days of those dates — the Iowa case on April 19, 2022 and the Louisiana case on June 6, 2024 — which indicates each proceeded to conclusion, but a termination date is not a sentence. A maximum authorized by statute is not a punishment imposed by a judge, and the felony defendant may well have received less actual punishment than this page's framing would lead a reader to guess.

One fragment of the Iowa aftermath is on the docket: an entry titled Notice of Supervision Ended, dated January 31, 2024 — 652 days after the case terminated. That establishes a supervision term existed and ended. It does not establish its length, its type, or whether any custody preceded it.

The comparison is not controlled. Different districts, different prosecutors, different years, different drugs, different defendants, and — importantly — different postures. Both cases were resolved by agreement, and charging decisions in negotiated cases reflect bargaining that the public record does not show. The Louisiana doctor was not charged under the second tier, but nothing in the documents says the government considered and rejected it.

The intent recitation is a prosecutor's account. The new-website sequence appears in a Justice Department announcement summarizing court documents. It is not a judicial finding, not a jury verdict, and not a quotation from the plea agreement itself. In a case resolved by a guilty plea, the facts are the facts the defendant agreed to admit — which makes them reliable as admissions but useless as a test of what a court would have required had someone fought.

No court has held that a new domain equals intent. This page reports a sequence the government recited in one case that ended in a plea. It is not a rule. Nobody should read it as establishing that rebuilding a website after regulatory contact is, by itself, felony evidence — only that in this record, it was the material the government put forward.

The Iowa case has an aggravating fact this page has not leaned on. The announcement states that Tomlinson marketed the injections as weight loss drugs. Marketing a vitamin product that way is its own problem, independent of the prescription question, and it is plausible that it contributed to the government's view of intent. Attributing the felony entirely to the new website would overstate a record that contains more than one unflattering fact.

Where this sits in the record

This index already carries the opposite half of this question. A companion page on the receipt charge examines the first tier — how a conviction is possible with no intent element whatsoever, and what defense the statute writes for a person who only took delivery of someone else's mislabeled goods. That page quotes a fragment of the second tier in passing, to show by contrast that intent is absent from the first. This page is the other direction: what the second tier actually requires, both of its routes, and what one government filing offered to satisfy it.

The pattern of regulatory contact followed by continued operation appears elsewhere in this record in a different legal shape. In the Pinned Aminos prosecution, a website went dark the day after a state regulator made contact and a second site was registered forty-five days later — but there the two sites sat inside a single conspiracy count, so the relaunch mattered to the scope of the charge, not to its severity tier. The mechanisms are worth keeping distinct. The Paradigm Peptides case is covered separately in this index, where its charges are set out in the terms the record uses; no characterization of them is offered here, because no document in that case was among the primary sources read for this page.

The intent route into that second tier is charged again in a 2026 indictment, and there the government builds it without a single false statement to anyone official — out of what the defendant knew, what he did not tell buyers, and an attempt to put a company between himself and the product. See the case in which the whole misbranding theory is a label that names no one.

For what an FDA communication is and is not, this index separately covers what a warning letter actually is and what follows a response to one.

Sources

Every document below was fetched and read for this page on September 28, 2026. Statutory text came from official and university sources, never from a summary. Court records were read through CourtListener's public search records. A note on the Justice Department links: the press-release pages at justice.gov return an automated interstitial to non-browser requests, so the release bodies quoted here were read through the Department's own public press-release API, not from the web pages. The page links are provided for readers, who will see the documents normally.

• 21 U.S.C. § 331, prohibited acts — Cornell Legal Information Institute
• 21 U.S.C. § 333, penalties, subsection (a) — Office of the Law Revision Counsel, U.S. House of Representatives and Cornell Legal Information Institute, both fetched and compared
• 21 U.S.C. § 352, misbranded drugs, subsection (f) — Cornell Legal Information Institute
• 21 U.S.C. § 353, subsection (b)(1), including the deeming sentence — Cornell Legal Information Institute
• 18 U.S.C. § 3559, classification of offenses — Cornell Legal Information Institute
• 18 U.S.C. § 3571, sentence of fine — Cornell Legal Information Institute
• U.S. Department of Justice, Iowa Man Pleads Guilty to Selling Misbranded Vitamin B12 Injectables, release 21-1222, December 8, 2021 — justice.gov. A U.S. Attorney's Office version dated December 10, 2021 was also retrieved; the two bodies are byte-for-byte identical
• U.S. Attorney's Office, Eastern District of Louisiana, Houma Doctor Pleads Guilty to Distributing Misbranded Versions of Injectable Contraceptives to Patients, March 5, 2024 — justice.gov
• U.S. Attorney's Office, Eastern District of Louisiana, Houma Doctor Charged with Distributing Misbranded Injectable Contraceptives to Patients, January 22, 2024 — justice.gov
• United States v. Tomlinson, 4:21-cr-00153, U.S. District Court for the Southern District of Iowa — docket record and entries via CourtListener
• United States v. Andre, 2:24-cr-00001, U.S. District Court for the Eastern District of Louisiana — docket record via CourtListener

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