FDA Enforcement | FDA Enforcement

FDA in rem Seizures

When FDA has a preponderance of evidence that a regulated product is in violation of the Food Drug & Cosmetic Act (FDCA), the agency has the authority to seek (through the U.S. Department of Justice) a court ordered seizure of the affected products. FDA seizures are implemented through a civil trial in a federal court. Only under very limited circumstances (certain criminal enforcement authorities) can FDA seize something without instituting a court action or at least a seizure warrant.

FDA Administrative Detention (not import detention)

FDA has the authority to administratively detain certain products (human and animal foods and medical devices) while they are in commerce. This administrative action is designed to prevent the owner or possessor from distributing the goods for a limited period of time while an administrative hearing is held respecting the merchandise. These actions are relatively rare and ordinarily only occur if there is a concern that the affected products may be distributed prior to FDA initiating a seizure. Administrative detentions occur pursuant to an administrative hearing and do not occur in a federal court.

FDA Temporary Restraining Orders (TROs) and Civil Injunctions

Occasionally, FDA will seek intervention from a federal judge restraining certain conduct by a person that is believed to be in violation of the FDCA. When the FDA seeks and obtains a TRO, it does so ex parte, which means the private party does not appear at all, but the FDA (through the U.S. Department of Justice) makes an entirely one-sided argument as to why the TRO should issue. Because the private party is not present, TROs are effective for relatively short time frames and are routinely followed up with a Preliminary Injunction hearing before a federal judge. At the preliminary injunction hearing, the person who has been restrained by the TRO has to opportunity to show why he should not now be enjoined by the court until further proceedings can be undertaken against the person. The FDA must demonstrate by preponderance of the evidence that the private party is violating the FDCA, the government is likely to prevail during a full trial seeking to permanently enjoin the party, and the government (or the public) will be harmed if the court does not step in and preliminarily restrain the private person. Permanent Injunctions are trials in federal court and the FDA has the burden of proof.

FDA Criminal Prosecution

The FDCA contains dozens of "prohibited acts," which if committed can result in serious criminal sanctions. The FDCA is a "strict-liability" criminal misdemeanor statute. Persons who commit prohibited acts can be criminally convicted notwithstanding their intentions (or lack thereof) to commit a crime.

  • FDA Criminal Misdemeanors:If convicted for a strict liability misdemeanor crime, the defendant, if an individual, could be incarcerated for up to one year. Any defendant could be forced to pay very hefty criminal fines and penalties and in certain circumstances "disgorgement" is available (where the defendant is ordered by the sentencing judge to "disgorge" itself of profits and gains obtained through criminal conduct). The FDA, through the U.S. Department of Justice, must demonstrate, beyond a reasonable doubt, the FDCA violation occurred and the defendant was the person responsible for it having been committed. FDA need not demonstrate that the defendant intended to perpetrate any fraud in order to obtain a misdemeanor conviction.
  • FDA Criminal Felonies: If a person commits a prohibited act with the intent to defraud or mislead, that person can be convicted and sentenced under the felony provision of the FDCA. A person so convicted could be sentenced to up to 10 years in prison (depending upon the legal provision violated). A person could defraud or mislead the FDA preventing the agency from conducting its statutorily mandated mission to regulate foods, drugs, cosmetics, devices, etc., and be convicted under the felony provisions of the statute.

FDA Consent Decree

Sometimes the U.S. Government and persons it alleges have violated the FDCA will enter into an agreement to settle a case and avoid taking the case to trial. Private parties often will enter into a consent decree with the FDA, agreeing not to participate in certain conduct of market activity. If a consent decree is too broadly worded (something FDA would like to accomplish) it can unnecessarily restrict otherwise legal and unrelated activity that was never at issue in the dispute with the FDA. FDAImports.com, LLC consultants and affiliated attorneys assist clients in protecting their rights while negotiating consent decrees on their behalf.

FDA Debarment

When certain criteria are met, FDA may seek to debar an individual from participating in a particular industry, from filing certain applications with the agency, or from appearing before the agency on behalf of another. The result of debarment is the person is functionally prohibited from engaging in any business involving the relevant product (or even industry). These actions are administrative in nature and occur pursuant to an administrative hearing. FDAImports.com, LLC can assist persons challenging a debarment action. FDA has explicit authority to debar individuals from submitting or participating in the submission of a new drug application.  It also can debar a person from importing food into the US.  These are severe administrative enforcement actions.