Food and Drug Law: Criminal Acts and Violations

The Federal Food, Drug, and Cosmetic Act (FDCA) contains a criminal enforcement framework that is unusual in US law: it allows conviction for certain offenses without proof of intent. A corporate executive can be found guilty of a federal crime because a regulatory violation happened at a facility under their responsibility, even if they had no knowledge of it. This principle, established by the Supreme Court and applied consistently for over 75 years, defines the minimum exposure for anyone operating in food, drug, or medical device industries.

This article covers the criminal provisions of the FDCA: the prohibited acts under Section 301, the penalty structure under Section 303, the strict liability standard and the Responsible Corporate Officer doctrine, the 2025 executive order reshaping enforcement, the December 2025 DOJ restructuring, and recent enforcement cases through 2025.

The Legal Framework: FDCA Sections 301 and 303

The FDCA’s criminal enforcement architecture operates through two sections. Section 301 (21 U.S.C. Section 331) identifies the prohibited acts. Section 303 (21 U.S.C. Section 333) provides the penalties for violating them.

Scope of prohibited acts under Section 301: The list of prohibited acts is extensive and covers adulteration or misbranding of food, drugs, devices, and cosmetics in interstate commerce; receipt or delivery of adulterated or misbranded products; refusal to allow FDA inspection; failure to register a facility; introduction of an unapproved new drug; distribution of counterfeit drugs; and many others. The common thread is that all prohibited acts involve conduct affecting the safety, efficacy, or truthful labeling of products that FDA regulates.

The Penalty Structure Under Section 303

Section 303 creates a two-tier penalty structure based on intent and recidivism.

FDCA criminal penalty structure

Offense type

Intent required

Maximum prison

Maximum fine

Misdemeanor (first offense)

None required (strict liability)

1 year

$250,000 individual; $500,000 organization

Felony (intentional or repeat)

Intent to defraud or mislead, or prior conviction

3 years

$250,000 individual; $500,000 organization (per count)

Special cases (counterfeit, serious harm)

Varies by specific provision

Up to 20 years

Up to $1 million

Fines are per count. A company charged with multiple counts of introducing adulterated product into commerce faces multiplied exposure. In large-scale enforcement actions, criminal fines under the FDCA have reached into the billions when combined with False Claims Act liability and forfeiture.

The Strict Liability Standard: The Dotterweich Doctrine

The most distinctive and consequential feature of FDCA criminal enforcement is the strict liability standard established in United States v. Dotterweich (1943) and elaborated in United States v. Park (1975). The Supreme Court held that corporate executives can be convicted for FDCA misdemeanor violations even without proof that they knew about, participated in, or intended the violation.

The Responsible Corporate Officer (RCO) doctrine: what it means

What the doctrine establishes:

A corporate officer who has the authority and responsibility to prevent or correct a violation of the FDCA can be criminally convicted for that violation even without personal knowledge of it. The key question is not whether the executive knew — it is whether they had the power to prevent the violation and failed to do so.

What the government must prove for a misdemeanor:

The government must show that a prohibited act occurred; that the defendant was a corporate officer or responsible party in a position to prevent the violation; and that the violation was not the result of an exercise of reasonable care. The defendant does not have to be shown to have acted with knowledge or intent for misdemeanor liability.

Implications for executives in FDA-regulated industries:

A CEO, plant manager, quality director, or other officer in a food, drug, or medical device company can be charged with a federal crime based on what happened at their facility — even if they personally took no action toward the violation. The defense is demonstrating that they exercised reasonable care, not that they were unaware.

Recent application: In March 2025, three former executives of Magellan Diagnostics pleaded guilty in the District of Massachusetts in connection with a scheme to conceal a malfunction in lead testing devices that produced inaccurately low lead test results. Magellan itself had previously pleaded guilty to related misdemeanor FDCA charges and entered into a deferred prosecution agreement on felony charges. The individual executive prosecutions demonstrate ongoing DOJ willingness to pursue personal liability for FDCA violations at the executive level.

The Enforcement Landscape: 2025 Changes

Executive Order 14294: Fighting Overcriminalization

On May 9, 2025, President Trump issued Executive Order 14294, “Fighting Overcriminalization in Federal Regulations,” which explicitly states that criminal enforcement of strict liability regulatory offenses is “generally disfavored.” The order directs agencies to consider civil or administrative enforcement rather than criminal prosecution for strict liability offenses, calls for clear mens rea (intent) requirements, and requires agencies to inventory criminal regulatory offenses within one year.

Field Observation

EO 14294 does not change the underlying law. The FDCA’s strict liability provisions remain in effect. What the EO signals is an enforcement priority shift: the current administration will prefer civil and administrative tools over criminal prosecution for no-intent regulatory violations. This matters significantly in practice — FDA misdemeanor referrals to DOJ have historically been the primary vehicle for holding executives accountable without proving intent. If DOJ declines more of these referrals, the practical deterrent effect of the RCO doctrine will diminish, even though the legal standard has not changed.

DOJ Restructuring: December 2025

On December 2, 2025, the DOJ disbanded its Consumer Protection Branch (CPB), which had historically investigated and pursued most FDCA misdemeanor cases. Criminal FDCA functions were transferred to the Criminal Division’s Health and Safety Unit (HSU) within the Fraud Section, established on the same date. Civil FDCA functions moved to the Civil Division’s Enforcement and Affirmative Litigation Branch.

DOJ characterized the HSU’s priorities as criminal actions against companies and individuals who fail to maintain sanitary facilities, distribute adulterated or misbranded food or drug products, conceal safety-related information from the FDA, or make significant misrepresentations to the public.

The practical effect of this restructuring on enforcement volume and strategy remains uncertain as of mid-2026. The CPB had built standardized compliance templates for deferred prosecution agreements over many years; whether HSU continues to use these templates is an open question.

Recent Enforcement Cases

Notable FDCA criminal enforcement cases 2024-2025

Magellan Diagnostics (March 2025):

Three former executives pleaded guilty in connection with concealing a malfunction in lead testing devices that produced inaccurately low results. Magellan itself previously pleaded guilty to misdemeanor FDCA charges and entered a deferred prosecution agreement on felony charges. This case demonstrates continued DOJ willingness to pursue individual executive liability for concealment of safety defects.

Aesculap Implant Systems (AIS) (2024-2025):

AIS agreed to pay $38.5 million as part of a civil settlement and non-prosecution agreement to resolve allegations of introducing two adulterated medical devices into commerce without proper FDA clearance, due to a former employee’s fraud. The former AIS employee pleaded guilty to one felony count of violating the FDCA and was sentenced to one year in prison and one year of supervised release.

McKinsey (2024):

A former McKinsey senior partner pleaded guilty to an obstruction charge in connection with the federal investigation into McKinsey’s role in opioid marketing. This case set a notable precedent as the first known instance of the government alleging that an advisory firm’s advice in connection with a medical product constituted aiding and abetting a conspiracy to violate the FDCA.

What FDCA Criminal Liability Means in Practice

The practical implications of the FDCA’s criminal framework for companies and executives operating in regulated industries:

Key practical points for FDA-regulated entities

►Knowledge is not required for misdemeanor liability. An executive does not have to know about a violation to face criminal charges for it. The RCO doctrine places the burden on executives to ensure compliance in their area of responsibility.

►The FDA inspection creates the record. What FDA inspectors document during facility inspections — including warning letters, 483 observations, and prior correspondence — becomes the evidentiary foundation for criminal referrals. Unaddressed 483 observations are particularly significant.

►Concealment elevates misdemeanor to felony. A strict liability misdemeanor becomes a felony when the defendant acted with intent to defraud or mislead. Concealing known defects — as in the Magellan case — is the clearest path from misdemeanor to individual felony prosecution.

►False Claims Act liability runs alongside FDCA enforcement. Many FDCA enforcement cases are accompanied by FCA allegations when government payers (Medicare, Medicaid) have purchased the adulterated or misbranded product. FCA liability is not subject to the criminal standard — it uses a civil preponderance standard and includes treble damages and qui tam relator provisions.

►Deferred prosecution agreements provide resolution short of conviction. Many corporate FDCA criminal matters are resolved through DPAs that require compliance program implementation, reporting, and monitoring without the company pleading guilty. Individual executives face a different standard; DPAs for individuals are less common.

The FDA Inspection as the Gateway to Criminal Referral

Criminal FDCA enforcement begins with FDA’s inspection and investigation authority. The FDA regularly inspects food producers, pharmaceutical manufacturers, medical device facilities, and other regulated entities. When inspections reveal violations, FDA issues Form 483 observations and, for more serious violations, warning letters. When voluntary compliance is not achieved and FDA determines that criminal prosecution is warranted, it refers the matter to DOJ.

Enforcement sequence: FDA inspection identifies violation. FDA issues 483 observations and requests corrective action. If not corrected or if the violation is serious, FDA issues a warning letter. If the company does not respond adequately or if the violation is criminal in nature, FDA refers to DOJ. DOJ (via the U.S. Attorney’s office and now HSU) decides whether to bring criminal charges, seek a DPA, or decline prosecution. The company’s documented response to FDA observations at each stage significantly affects both the likelihood of criminal referral and the outcome if charges are brought.

Common Compliance Failures That Lead to Criminal Referral

Failure to maintain sanitary facilities

Food facility sanitation violations are one of HSU’s stated priorities. Repeated CGMP deficiencies in a food production facility, particularly following prior 483 observations, are among the most common triggers for criminal referral in the food sector.

Concealing safety-related information from FDA

Concealment of known defects, failures, or adverse events — as in the Magellan case — converts potential misdemeanor strict liability into felony prosecution. Obstruction and making false statements to federal investigators add additional criminal exposure beyond the FDCA itself.

Distribution without required FDA clearance or approval

Introducing a medical device or drug into commerce without required FDA clearance or approval is a strict liability prohibited act under Section 301. No intent to violate the law is necessary for prosecution.

Adulteration or misbranding in interstate commerce

These are the core prohibited acts. Adulteration covers product contamination, subpotent or superpotent drugs, insanitary manufacturing conditions, and many other quality failures. Misbranding covers false or misleading labeling, inadequate directions, and omission of required warnings.

Refusal to permit FDA inspection

Obstructing or refusing an FDA inspection is itself a prohibited act under Section 301. Beyond the FDCA, obstruction of a federal agency proceeding carries additional criminal exposure under 18 U.S.C. Section 1505.

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