A recent high-profile food safety case illustrates that allegations of product adulteration or misbranding can be prosecuted by the federal government in a number of ways and can result in serious consequences for both companies and individuals. Sandler, Travis & Rosenberg offers a variety of services to help FDA-regulated companies avoid such outcomes by ensuring that compliance is an integral part of their operations.

For his role in a salmonella outbreak that was sparked by contamination in his company’s product, sickened hundreds and killed at least nine, the former president of the Peanut Corporation of America could be sentenced to life in prison, which would be the harshest penalty ever imposed in a food safety case. The former official was found guilty of 71 criminal charges last year after conspiring with others to deny and cover up the contamination. He was prosecuted for violating the Federal Food, Drug and Cosmetic Act by blatantly violating good manufacturing practice requirements, knowingly distributing adulterated food that posed a risk of death or serious injury to consumers even after internal tests revealed the contamination, and concealing or falsifying records. The government also used the Park doctrine, which renders FDCA violations strict liability crimes for corporate officials in positions of responsibility or authority.

An understanding of this case, particularly the factors that may encourage federal authorities to pursue civil or criminal action against a company for FDCA violations, can help both importers and domestic producers as they work to develop or maintain policies and procedures that promote compliance with U.S. food safety rules. Due diligence reviews of GMP programs, FDA inspection preparedness and safety considerations can identify areas where improvement is needed, and recall and other response plans can help address any such problems in a timely manner. In-house training on obtaining approvals and clearances, submitting post-market and adverse event reports, and complying with other statutory and regulatory requirements are also vital elements.

Sandler, Travis & Rosenberg’s seasoned food safety professionals can assist companies with these and other related services. Contact Shelly Garg at (305) 894-1043 for more information.

Click here to access an on-demand webinar on effectively preparing for and managing FDA inspections.

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