Importing Food, Pet Food, or Dietary Supplements? What You Need to Know About New FDA Guidance for Complying with FSVP Requirements


The U.S. Food and Drug Administration has released new guidance for how food importers can comply with the requirements of the Foreign Supplier Verification Program (FSVP).  The guidance is applicable for all importers of food – including beverages, dietary supplements, chewing gum, and components – for both human and animal consumption.

The guidance addresses how importers should set up their own verification program to ensure that food imported into the U.S. 1) meets all applicable food safety standards and requirements, 2) has not been adulterated with fillers, impurities, or other substances, and 3) does not contain misbranded allergen labeling.

Changes in the guidance include:

  • Foods that are subject to the FSVP regulation
  • Information that must be included in the FSVP
  • Who may develop and perform FSVP activities
  • Hazard analysis requirements
  • Foreign supplier approval requirements
  • Verification activities that must be conducted
  • Hazard control requirements (after importation)
  • FSVP requirements for components of dietary supplements
  • FSVP record maintenance and retention requirements
  • Requirements for very small importers
  • Requirements for certain small foreign suppliers
  • Requirements for origin countries that have food safety systems which are comparable to the U.S., as officially recognized by the FDA

The FDA notes that FSVP food regulations contain several terms that are similar (or are similar sounding) to terms used by U.S. Customs and Border Protection for all merchandise entering the U.S., which many have different meanings.  The new guidance, therefore, clarifies these different interpretations when relevant.

NOTE:  OCEANAIR’s VP of Import Compliance strongly recommends that, if you import any of the products listed above, you should review the new guidance to see how the regulations will affect you.