FSMA :  US Food Safety Modernization Act

The Food Safety Modernization Act (FSMA) strengthens the food safety system by enabling the FDA to focus more on preventing food safety problems, rather than reacting to problems after they occur. To meet new requirements mandated by FSMA, the FDA has increased the number of routine inspections of all food facilities.

For the first time, the FDA has a legislative mandate to require comprehensive, science-based preventive controls across the whole supply chain. This is the largest mandate change to the FDA since its inception and will have an impact on the food industry for decades to come.

FSMA has several primary focus areas:



Commonality:  Looking Through The Focus Area, Requirements and Exemptions

Focus Areas shares one or more of these common concepts:

  1. Programs require a Preventive Controls Qualified Individual (PCQI).
  2. A written Preventive Control Plan involving:
  • Evaluating the hazards that could affect food safety, such as allergens, sanitation and supply chain.
  • Specifying what preventive steps or controls will be put in place to significantly minimize or prevent possible hazards.
  • Specifying how the facility will monitor these controls to ensure they are working.
  • Maintaining routine records of monitoring.
  • Specifying in writing what actions the facility will take to correct problems that arise (Corrective Action Reports, Crisis Management and recall plans).
  • Develop specific training, implement training and maintain training records.
  • Exemptions based upon food and business size.


The Foreign Supplier Verification Program

FSVP requires the FDA to immediately increase inspections of both foreign and domestic food facilities. These include manufacturers/processors, packers, re-packers, and holders of foods under the FDA jurisdiction. FSMA also mandates an inspection frequency based on risk for all food facilities. Almost all domestic facilities must be inspected within a few years of FSMA’s enactment (2015), and at least once every three years after that. Under some conditions, the inspections will be even more frequent. It is important to note that under FSMA, the FDA has the authority to suspend the location’s FDA registration and stop distribution of a product if the FDA determines that food manufactured, processed, packed, received or held by a registered food facility has a reasonable probability of causing serious adverse health consequences or death to humans or animals.

Within one year of enactment, the law directs the FDA to inspect thousands of foreign facilities and to double those inspections every year for the next five years. If you are the “importer of record” or the “consignee” of this product in the U.S., you will be directly personally responsible for all fees and fines related to this product. This can include criminal prosecution of the product is found to be related to an outbreak, contains a human pathogen, or is intentionally adulterated for economic gain.


ThroughPoint stands ready and prepared to assist you in your FSMA compliance.

Please contact ThroughPoint for further assistance and to answer questions you may have about how to be prepared.