How big a problem is foodborne illness in the USA ?
About 48 million people (1 in 6 Americans) get sick, 128,000 are hospitalized, and 3,000 die each year from food-borne diseases, according to recent data from the Centers for Disease Control and Prevention. This is a significant public health burden that is largely preventable.
The FDA and CFIA working together to ensure regulations and enforcement is seamless where possible through their Regulatory Partnership.
FDA Enforcement Actions in Detail:
Warning letters are only one of the enforcement tools available to the FDA, these are issued for food adulteration based solely on insanitary conditions and GMP violations. A dramatic increase in the FDA warning letters can be seen in the chart below, showing the number issued warning letters between 2010 and 2015. Between 2014 – 2015 the warning letters have more than doubled from previous 5 years.
Enhanced Records Inspection
The first of the new tools is expanded authority to obtain and inspect food company records. FSMA Section 101 amended Section 414 of the Food Drug & Cosmetics Act, which itself had been added by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the BT Act).
Suspension of Registration
A more powerful enforcement tool is the suspension of facility registration. FSMA Section 102 allows FDA to suspend the registration of a facility when the agency determines that food manufactured, processed, packed, received, or held has a “reasonable probability” of causing SAHCODHA.
FSMA Section 206 for the first time gives FDA mandatory recall authority of food products. The threshold is a reasonable probability that food is adulterated or mis-branded and evidence that its use or exposure will cause SAHCODHA.
FSMA Section 207 allows for enhanced administrative detention of food, which means FDA can hold adulterated or misbranded food to prevent it from entering the marketplace. The original threshold granted under the BT Act was “credible evidence or information that the food presents a threat” of SAHCODHA. “We never quite met that threshold” to use the authority, Wagner said.
Accredited Third-Party Certification
The final rule establishes a system for the FDA to recognize accreditation bodies that in turn accredit third-party certification bodies to perform food safety audits and issue certifications for foreign food facilities and the foods they produce.
Foreign Supplier Verification Program (FSVP) requirements
Importers will be required to perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that provides the same level of public health protection as that required of domestic food processors and produce farms, and is not adulterated or misbranded with respect to allergen labeling.
More inspections inevitably means that more enforcement actions will follow, and this is exactly what has occurred. The number of Warning Letters issued by FDA based on food inspections has increased dramatically. Letters for food adulteration based solely on insanitary conditions and GMP violations.
Actions for Injunction
Companies that fail re-inspection become candidates for an injunction action, which FDA has increasingly relied upon as an enforcement tool against repeat offenders.
Park Doctrine and Criminal Liability
- FDA has also resurrected usage of the Park doctrine in the drug area and has foreshadowed the agency’s intent to apply it in the food area as well. The Park doctrine is based on a 1975 U.S. Supreme Court case affirming FDA’s right to bring a criminal misdemeanor case against corporate executives based on a strict liability theory.
- Under Park, a corporate official can be held criminally liable for violations of the FD&C Act in areas of the company under the official’s control, even if the official did not intend for the violations to occur.
- Individuals committing prohibited acts under the FD&C Act are subject to a maximum criminal penalty of 1 year’s imprisonment and/or a fine of $100,000 if the violation does not result in death, or $250,000 if death results. The penalties are steeper for organizations, with maximum penalties of $200,000 if the offense does not result in death and $500,000 if it does.
- If the violation is committed with intent to defraud or mislead, or occurs after a prior conviction, it is subject to up to 3 years’ imprisonment, a fine of $250,000 or both. For an organization, the maximum fine in this situation is $500,000.