FDA Law Blog: Food Importers: Wake Up!

FDA Law Blog: Food Importers: Wake Up!

Food Importers: Wake Up! Posted: 23 Mar 2016 03:24 AM PDT By Ricardo Carvajal – That’s our take-away from FDA’s recent public meeting on the implementation of FSMA’s import provisions and the associated regulations (FSVP, VQIP, and Accredited Third Party Certification).  Several comments made at the meeting suggest that many importers may still be unaware of the advent of FSMA’s import-related requirements – perhaps not surprising, given that importers as a class are a new constituency for FDA. Although the compliance date for the FSVP regulation is still over a year away, importers should already be digesting that regulation and considering its implications for their operations.  FDA is scheduling public meetings to help that process along, and this first meeting is expected to be followed by others in different geographic locations.  During the meeting, FDA staff presented on the basic requirements of the regulations, the status of the agency’s implementation activities, and an overview of international outreach efforts.  Among the many issues discussed during the Q&A sessions were these: FDA will issue a guidance document on the FSVP regulation that purportedly will provide much more information than what is provided in the regulation.  Thus, it might make sense to postpone the execution of a detailed compliance strategy pending publication of the guidance, but in our view, any postponement should be subject to re-evaluation if publication of the guidance is significantly delayed. Third party schemes such as GSFI should be useful in ensuring supplier compliance with applicable U.S. requirements, but can’t be relied on without more because they are not identical to those requirements.  There is no exemption from FSVP requirements for an importer whose supplier is owned by the same entity; however, that circumstance could factor into the importer’s determination of appropriate supplier approval and verification activities. Food imported for consumption at trade shows will not be exempt from FSVP requirements. Food contact substances are not exempt from the FSVP requirements, and do not qualify for the VQIP.  Furthermore, such substances are not covered by existing equivalency agreements (currently executed only with New Zealand). Copies of the presentations delivered at the meeting are available on the web page linked above, and if the past is any guide, a full transcript of the meeting should eventually be made available as well. Reminder: Register now for the May 3, 2016 Virginia Tech and HP&M Conference on Effective Documentation.  Information on the conference is available here.