FDA Misbranding Criminal

Criminal Liability for FDA Misbranding

A corporate officer can be sentenced to federal prison for a violation she did not commit, did not authorize, and did not know was occurring beneath her. Under the Federal Food, Drug, and Cosmetic Act, this outcome is not aberrational. It is the operating principle of a statute whose criminal provisions have functioned on strict liability since 1943, when the Supreme Court held in United States v. Dotterweich that the FDCA’s criminal reach extends to any person who stands in responsible relation to a violation, regardless of personal fault. The question, for anyone who holds a position of authority at an FDA-regulated company, is not whether the government possesses this power. The question is whether the government, on a given Tuesday, will choose to exercise it against you.

Most executives in the food, pharmaceutical, and medical device industries understand that their products are regulated. Fewer appreciate that the FDCA’s criminal enforcement provisions do not require the government to prove they intended, participated in, or even perceived the violation that forms the basis of the charge. The statute operates, in this respect, the way a fire code operates in a building the owner has never visited: the obligation attaches to the position, not to the person’s awareness of the condition.

The Responsible Corporate Officer Doctrine

The legal architecture for this liability rests on two Supreme Court decisions separated by three decades. In Dotterweich, the Court held that an individual could be convicted of FDCA misdemeanor violations based solely on his position within the corporate hierarchy. The defendant, a company president, had no knowledge that the drugs his firm repackaged and sold carried incorrect labels. The jury convicted him. The Court reasoned that Congress, in enacting the FDCA, had intended to place the burden of compliance on those who occupied positions of responsibility in industries affecting public health.

United States v. Park, decided in 1975, refined and expanded the doctrine. Park, the CEO of a national retail food chain, knew of a rodent contamination problem at one of the company’s warehouses but delegated the remediation to subordinates. When the FDA returned and found the problem unresolved, both Park and the company were charged. The Supreme Court affirmed Park’s conviction and held that the FDCA imposed upon corporate officers a duty not merely to refrain from wrongdoing but to seek out violations and correct them. Liability did not require awareness. It required only that the officer held a position of responsibility and authority sufficient to have prevented or corrected the violation, and that he failed to do so.

The doctrine that bears Park’s name has occupied an unusual position in American criminal law ever since. It permits conviction without proof of intent, negligence, or even knowledge. The government’s prima facie case, as more than one commentator has noted, can be constructed from little more than an organizational chart and an inspection report. The only recognized affirmative defense is what practitioners call the “impossibility defense,” available to an officer who can demonstrate that she exercised extraordinary care but was nevertheless unable to prevent the violation. The burden then shifts to the government to prove beyond a reasonable doubt that the officer was not powerless to act. Courts have not been generous in defining what “powerless” means in this context. An officer who delegated a task to a competent subordinate, who followed up, who established protocols, may still be convicted if the violation occurred on her watch.

And the consequences of a Park doctrine conviction extend beyond the statutory penalties in ways that can reshape a career entirely. A misdemeanor conviction under the FDCA can trigger exclusion from participation in federal healthcare programs, a sanction that, for executives in the pharmaceutical or device industry, amounts to a professional termination the court never ordered. Debarment from government contracting follows. The mark of a federal criminal conviction, even a misdemeanor, does not wash off.

The officer who receives a Section 305 notice is not being warned. She is being told that the agency has already decided prosecution is appropriate, and that what happens next depends on what her counsel presents in the next few weeks.

For the better part of four decades after Park, prosecutions under the doctrine were infrequent. The government pursued them where conduct was egregious or where corporate officers had demonstrable involvement in the violations. That posture shifted in the late 2000s, when the DOJ began signaling a renewed interest in individual accountability. The Purdue Pharma case (in which three senior executives pleaded guilty to FDCA misdemeanors as responsible corporate officers, with charging documents that noted, in language one does not often encounter in a federal plea, that the executives did not agree they had personal knowledge of the violations) marked a turning point. The Yates Memo in 2015, the Monaco Memo in 2022, and a series of FDA procedural manual revisions have since confirmed what practitioners in this area already understood: the Park doctrine is no longer a dormant enforcement instrument.

Penalty Structure Under Section 333

Section 333 of the FDCA establishes two tiers of criminal liability. A first offense, absent proof of intent to defraud or mislead, constitutes a misdemeanor punishable by up to one year of imprisonment and a fine. The statutory fine cap of one thousand dollars is symbolic at this point; the general federal sentencing statutes permit fines of up to one hundred thousand dollars for a Class A misdemeanor.

The felony tier applies in two circumstances: where the government proves the violation was committed with intent to defraud or mislead, or where the defendant has a prior conviction under Section 333. Felony penalties include imprisonment of up to three years and fines of up to ten thousand dollars per violation, again subject to the general sentencing statutes. For violations involving prescription drugs, the exposure rises to ten years.

I am less certain about the practical ceiling of these penalties than the statutory text might suggest. In the cases I have reviewed, sentencing outcomes for misbranding convictions have varied depending on the nature of the underlying conduct, the degree of cooperation, and the jurisdiction. The former CEO of Magellan Diagnostics received one year of home detention and a ten thousand dollar fine for a felony misbranding plea. A naturopathic doctor in United States v. Marschall faced felony charges under the recidivist provision for selling products he claimed could treat COVID-19. The numbers in the statute describe a range. Where within that range a particular defendant lands depends on facts the statute does not address.

The Section 305 Hearing

Before the FDA refers a matter to the Department of Justice for criminal prosecution, the FDCA requires, under Section 305, that the prospective defendant receive notice and an opportunity to present views regarding the contemplated proceeding. The hearing is informal. It is not a trial. The FDA’s own regulatory procedures manual describes it as an opportunity for the respondent to discuss mitigating circumstances and corrective actions.

This hearing is the single most consequential moment in the pre-indictment phase of a misbranding investigation, and it is treated, too often, as an administrative formality. The FDA convenes a Section 305 hearing only when it has already concluded that prosecution is likely appropriate; the agency’s compliance policy guide states that the hearing should not be used as a warning to induce corrective action. By the time the notice arrives, the investigative work is complete. What remains is a narrow window in which defense counsel can present information sufficient to dissuade the agency from making the referral.

The hearing will not be offered if the FDA believes it could result in the destruction of evidence, the flight of the prospective defendant, or if a grand jury investigation of a felony is already underway. In those circumstances, the first indication of criminal exposure may be the indictment itself, which arrives without the courtesy of the conversation that Section 305 was designed to provide.

What counsel presents at the Section 305 hearing matters in ways that are difficult to overstate without sounding promotional, so I will state it plainly: documentation of corrective actions, evidence of compliance program enhancements, and a credible narrative of the officer’s role and knowledge can influence whether the FDA forwards the matter to the DOJ. The hearing is not adversarial in form. It is adversarial in substance.

The Felony That Requires No Intent

In United States v. Marschall, the Ninth Circuit addressed a question that had lingered at the margins of FDCA criminal law for decades: whether the felony recidivist provision of Section 333(a)(2) requires proof of scienter. The defendant argued that a felony conviction, carrying a potential sentence of three years, should require the government to prove he acted with knowledge or intent. The court disagreed.

The court reasoned that Section 333(a)(1), the misdemeanor provision, is a public welfare offense that does not require proof of knowledge that the items were misbranded. The recidivist felony provision is defined by reference to that same misdemeanor. Congress included an explicit scienter requirement in one clause of the felony provision (“with the intent to defraud or mislead”) but not in the other. The omission was deliberate. A prior conviction under Section 333, the court concluded, supplies what it termed a functional substitute for a scienter requirement, because the defendant, having been convicted once, is personally aware of the statute’s prohibitions.

Before Marschall, the Dotterweich framework had been understood to apply only to misdemeanors carrying modest penalties. Marschall extends that framework to a felony. The implications are, if one follows the logic to its conclusion, that a corporate officer who received a misdemeanor conviction under the Park doctrine (obtained without any proof of the officer’s knowledge or intent) is now exposed to felony prosecution for a subsequent violation, again without proof of knowledge or intent, in a jurisdiction that follows the Ninth Circuit’s reasoning. The prior conviction becomes both the predicate and the proof. Whether this holding will be adopted by other circuits is a question I cannot answer from this desk.

Facteau, decided by the First Circuit, addressed a related but distinct problem. Two former executives of Acclarent, a medical device manufacturer, were convicted of misdemeanor misbranding for promoting a device for off-label use. The defendants raised First Amendment challenges (which defenders of aggressive off-label marketing will recognize as the argument that commercial speech about a lawful product cannot form the basis of a criminal charge), arguing that their speech about the device’s intended use was protected. The First Circuit distinguished the Second Circuit’s earlier holding in United States v. Caronia and upheld the convictions. The defendants’ statements were used as evidence of the device’s intended use, the court held, not prosecuted as speech.

The practical consequence of Facteau is that statements made by executives about a product’s capabilities, in trainings, in sales meetings, in communications with the FDA, can and will be marshaled to establish the “intended use” element of a misbranding charge. Intended use, under the FDCA, is an objective inquiry determined by the seller’s statements and actions. An executive who describes an off-label application of a device in a training session has, in the government’s view, established the device’s intended use for purposes of the misbranding analysis. The conference room where that training occurred will not feel, in retrospect, like a place where criminal liability was being created.

Recent Prosecutions

In March 2025, three former executives of Magellan Diagnostics entered guilty pleas in the District of Massachusetts. The case involved a scheme to conceal a malfunction in the company’s lead testing devices, which had been producing inaccurately low results. The former CEO and COO each pleaded guilty to felony misbranding counts related to the failure to submit a 510(k) notification and the failure to report device corrections to the FDA. The former Director of Quality Assurance pleaded guilty to making false statements. Sentences ranged from home detention to probation. The company had previously been ordered to pay forty-two million dollars.

In a separate matter, a jury in the Southern District of New York convicted the former Vice President of Sales at U.S. Compounding of conspiracy to distribute adulterated and misbranded prescription animal drugs. Two additional executives pleaded guilty to the same charge. One also pleaded guilty to making false statements in SEC filings, which illustrates something about the way misbranding prosecutions tend to accumulate: the initial charge becomes a point of entry for related federal charges that compound exposure beyond what the FDCA alone would impose.

The White House memorandum issued in September 2025, directing the FDA and HHS to increase enforcement of the FDCA’s provisions governing direct-to-consumer prescription drug advertising, signals that the government’s appetite for misbranding enforcement is not contracting. The FDA characterized certain pharmaceutical advertisements as a conduit of deception, concealing safety risks and promoting medically inappropriate drug use. Whether this language translates into criminal referrals at a higher rate is uncertain, but the institutional posture is clear enough.

One observation from the recent cases: the government does not appear to be limiting misbranding charges to cases involving direct consumer harm. Several prosecutions involved regulatory violations, failures to file 510(k) submissions, failures to report device malfunctions, failures to submit medical device reports, that are, at their core, deficiencies of administrative compliance rather than acts of consumer deception. A device that functions as intended but whose regulatory filings are incomplete can be misbranded under the FDCA. The device worked. The paperwork did not.

Constructing a Defense

The defense of a misbranding charge begins before the charge is filed. Once a Section 305 notice has been received, the opportunity to shape the government’s understanding of the case is limited and getting smaller. Once an indictment has been returned, the defense is reactive. The intervention that matters most is the one that occurs earliest.

For corporate officers and compliance counsel, the first task is to understand the scope of the exposure. The FDCA covers an extraordinarily broad range of conduct. The prohibited acts in Section 331 run to dozens of categories. A company that is out of compliance with its reporting obligations is engaging in conduct that could support a criminal charge, even if no consumer has been harmed and no fraud has occurred. That is the nature of a regulatory criminal statute.

The second task involves documentation. The impossibility defense requires evidence that the officer exercised extraordinary care. That evidence has to exist before it is needed. Compliance programs that were designed but not recorded, or recorded but not enforced, will not sustain the defense. The FDA’s guidelines for evaluating Park doctrine prosecutions consider whether the officer took steps to prevent violations and whether corrective actions were implemented. These are questions answered by records.

For defendants in the distribution chain, the guaranty clause of Section 303(c) provides a limited defense. A person who receives a product in good faith and obtains a written guaranty that the product complies with the FDCA is exempt from misdemeanor liability. The defense does not reach the manufacturer or the person who originated the misbranding, but for distributors and retailers it can be dispositive.

For those facing felony exposure under the intent-to-defraud prong, the defense centers on the absence of the requisite mental state. The government must prove intent to defraud or mislead beyond a reasonable doubt. Good faith reliance on regulatory guidance, the ambiguity of labeling requirements, and the absence of evidence of concealment are all relevant. Felony misbranding cases are more defensible than misdemeanor cases in this respect, because the government bears a burden it does not bear at the misdemeanor tier. The misdemeanor, which requires no intent, is in some ways harder to contest than the felony, which does.

One should not wait for the investigation to announce itself. A consultation is where this work begins, and the distance between regulatory noncompliance and a federal criminal charge is shorter than most officers believe. That distance is measured not in the severity of the violation but in the government’s assessment of whether the person responsible for preventing it chose to look the other way.