The FSMA applies to all companies involved in producing, processing, distributing, and importing food for the U.S. market. It is especially relevant for:

• Producers and processors: Including farmers, agricultural businesses, and processing facilities.
• Importers: Imported foods must adhere to the same safety standards as domestic products, with importers responsible for verification through the Foreign Supplier Verification Program (FSVP).
• Distributors and transporters: Companies handling logistics and distribution must follow specific safety protocols during transportation to ensure food safety.

The FSMA sets out several key requirements for food industry operators:

• Preventive safety plans: Companies must develop food safety plans focusing on preventive controls, identifying potential risks, and implementing mitigation measures.
• Traceability and record-keeping: Operators must maintain detailed records of all supply chain stages, aiding in product tracking and facilitating recalls if needed.
• Third-party certifications: Foreign companies importing food to the U.S. must obtain certifications to ensure safety compliance.
• Increased inspections: The FDA now has expanded authority to conduct more frequent inspections of both domestic and foreign facilities.

Failure to comply with FSMA can result in various penalties depending on the severity of the violation:Mandatory recalls:

• The FDA can issue a recall if a product is deemed unsafe, without waiting for voluntary action.
• Fines and penalties: Companies not adhering to safety standards may face substantial financial penalties.
• Production suspension: The FDA can stop production at facilities until compliance is restored.
• Criminal liability: In severe cases, company leaders may face criminal charges, including imprisonment.