When foods make people sick, the U.S. Department of Justice (DOJ) often partners with FDA to investigate and prosecute violations of food safety laws that appear to involve willful failure to follow regulatory requirements. When DOJ elects to get involved, the alleged food safety violations are typically egregious and have caused significant harm to the public. In these circumstances, DOJ may pursue civil penalties, criminal charges, or both.
Abbott Laboratories recently confirmed that DOJ had opened a criminal investigation into operations at the company following the infant formula recall and ensuing crisis in 2022. It was reported that DOJ previously entered into a consent decree with Abbott to allow the company to resume operations as long as they complied with certain requirements imposed by the decree. Reports released about the operations at Abbott assert that senior management at the facility and company may have been aware of the alleged conditions that led to the recall and failed to correct the conditions. FDA additionally alleged that Abbott Laboratories infant formula may have caused the death of two infants.
Other companies have been targeted by DOJ in the past. DOJ has previously, for example, pursued criminal charges against Kerry Inc. for insanitary plant conditions that were linked to a Salmonella outbreak. Blue Bell Creameries and individuals responsible at the corporation were also the focus of DOJ investigations and ultimate charges for Listeria contamination of ice cream. DOJ also used its authority to charge and convict individuals responsible at the Peanut Corporation of America for their conspiracy to distribute Salmonella-contaminated peanut products into interstate commerce.
When the U.S. Congress passed the laws that give FDA authority to regulate food products, Congress expressly included penalties for violations by food companies. The Federal Food, Drug, and Cosmetic Act provides for criminal and civil penalties for violations of the act’s requirements. Specifically, the legislation sets the penalty for an initial violation of certain provisions of the act as imprisonment for no more than one year, a fine of no more than $1,000, or both—for each count. When a violation occurs after a previous conviction for a violation of the act, or if the violation is committed with the “intent to defraud or mislead,” the penalty can be imprisonment for no more than three years, a fine of no more than $10,000, or both imprisonment and a fine (21 U.S.C. § 331(a)). Again, this is for each alleged count.
When a violation is identified, DOJ is responsible for investigating the violation and determining whether civil or criminal penalties should be pursued. Because possible violations are identified every day by FDA, DOJ must evaluate each violation to determine if DOJ’s resources would be best used under those circumstances. Typically, cases are referred to DOJ by FDA after a review of the violation by the agency to determine if a criminal investigation is recommended. FDA has stated that, among other factors, it will consider the likelihood and severity of harm associated with the violation and whether the violation reflects a pattern of behavior or the disregard by the company of prior warnings. DOJ then conducts its own investigation after receiving a referral from FDA, and will consider similar criteria, in addition to evaluating the likelihood of successfully prosecuting the violation.
Voluntary Self Disclosure
Notably, DOJ recently announced a voluntary self-disclosure program that will be applicable to any corporate misconduct prosecutable by a U.S. attorney, including violations of the Federal Food, Drug, and Cosmetic Act. The program allows DOJ to enter into more favorable resolutions with companies that voluntarily self-disclose misconduct that may constitute a violation.