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Consequences of FSVP Non-Compliance

Did you know that your imported entry of food can be refused admission into the United States if it appears that you failed to comply with the requirements of the Foreign Supplier Verification Program (FSVP)?  

Over the course of the last five years, FDA’s mantra has been “educating while regulating” while using its discretionary enforcement authority.  However, we have recently observed that the educational tone has taken a marked shift towards one of an enforcement-guided nature.  During an FDA FSVP inspection, the investigator obtains evidence documented with the issuance of an FDA Form 483a entitled “FSVP Observations.”  

Just as with other types of FDA inspections, there is an enforcement progression with all FDA FSVP inspections starting with the inspection classifications as noted in FDA’s Field Management Directive (FMD) # 86:[1] No Action indicated (NAI)-If the supervisory investigator concludes that no objectionable conditions or practices were found during the inspection, or the objectionable conditions found do not justify further action, an Inspection Conclusion of No Action Indicated (NAI) should be entered; Voluntary Action Indicated (VAI)-If significant objectionable conditions and practices were observed, but the District is not prepared to take or recommend any regulatory action, the supervisory investigator should then assign the District Decision of Voluntary Action Indicated (VAI); and Official Action Indicated (OAI)-If the significant, objectionable conditions or practices warrant a Warning Letter or other regulatory actions listed below in the Regulatory Actions (Advisory, Administrative, or Judicial) section, the Supervisory Investigator will enter the District Decision, Official Action Indicated (OAI).

With the Food Safety Modernization Act (FSMA) signed into law, Congress’s intent was made quite clear. Specifically, FSMA requires each importer of food to perform certain risk-based foreign supplier verification activities for the purpose of verifying that the food imported by the importer is produced in compliance with the requirements regarding hazard analysis and risk-based preventive controls of human and animal foods and standards for produce safety; and that the food is not adulterated or allergen misbranded. Complying with the request of Congress, the FDA added that refusal of admission can be a consequence if an importer fails to comply with FSVP requirements. In addition, FSMA further amended the Federal Food, Drug & Cosmetic Act to include Section 301(zz), which, in pertinent part, states that,…importation or offering for importation into the United States of an article of food without the importer having an FSVP that meets the requirements of section 805 of the Federal Food, Drug, and Cosmetic Act, is a prohibited act under the law.

To assist in the uniform enforcement of these requirements, FDA drafted and implemented Import Alert 99-41, “Detention Without Physical Examination of Human and Animal Food Imported from a Foreign Supplier by an Importer who is not in compliance with the requirements of the Foreign Supplier Verification Program (FSVP) Regulations.”  Specific food or foods from a specific foreign supplier may be included on a red list to identify the food or foods subject to the Import Alert when imported or offered for import by the identified importer.  Often added to these alerts are those importers who are “blatantly disregarding” the regulatory requirements, something which FDA investigators are well-trained to identify.

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