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By Allen Sayler

Ask the Expert offers a chance for our readers to submit questions to EAS regarding areas of regulatory confusion. This month’s question is answered by Allen Sayler, Senior Director of Food Consulting Services. If you’d like to submit a question, please use the “contact us” link on our website.

Question: FDA is cracking down on enforcement of the Foreign Supplier Verification Program (FSVP) through inspections of US-based FSVP importers with almost 200 FDA 483s issued stating “failure to develop an FSVP” which allows FDA to designate the imported food as “adulterated” and demand it be removed from the US marketplace. FDA has budgeted over 2000 foreign inspections/investigations during the coming year so “failure to develop an FSVP” is likely to become more common, forcing FDA’s hand to strengthen its regulatory enforcement. The question is, “When will FDA remove the “soft glove”, training and educational approach and move toward active enforcement of the FSVP regulation?” The second related question is, “How does the FSVP Importer know if their FSVP meets FDA expectation?”

Answer: Interesting questions and one thing I have learned during my long regulatory career is that one can never accurately predict when FDA will publish a new regulation, direct their field investigators to intensify their regulatory effort or ramp-up compliance enforcement. In trying to determine the general time period when FDA may start to take more aggressive regulatory action against US-based FSVP Importers, it is important to look at “signs”. One sign is the recent statistics indicating as of mid-June 2018, the number of FSVP-focused inspections the Agency has conducted is nearly equal to the total number for all of the calendar year 2017. In more detail, well over half of the number of FSVP inspections so far have resulted in the issuance of Form 483s, noting that the FSVP Importer has failed to develop an FSVP program including a written hazard analysis plan, an effective and written supplier management program and the correct foreign supplier documentation available for FDA review at the US-based FSVP Importer’s office. Another sign is when the Agency believes it has fully trained most or all of those field investigators so they are equipped to conduct the on-site FSVP investigations. It appears this has been completed or is near completion for the FSVP regulation. Additionally, foodborne illness outbreaks are a key sign, and over the past year, the incidence of foodborne illness from imported foods does not appear to have increased significantly so this “sign” does not appear to be pushing FDA to strengthen FSVP enforcement, although one serious foodborne illness outbreak attributed to imported foods will immediately change this “sign”. All of these together, indicate that the Agency is preparing for more aggressive FSVP enforcement which will likely mean those importers with inadequate or missing FSVP programs will have their products blocked from import. If one had to guess, we anticipate this stronger FSVP enforcement of FDA to start sometime in late 2018 to early 2019 for human foods.

How can firms ensure that they have a developed FSVP that meet’s FDA’s expectations? As Sharon Mayl, Senior Advisor for Policy in the Office of Foods and Veterinary Medicine at FDA, said in an interview, “FSVP inspections are based on the review of records, rather than observations of food production. In addition to an onsite visit, FSVP inspections may include a documentation review of materials sent to FDA upon request. The investigator will review these materials for deficiencies.

One way to address this is to contract for the services of a qualified consultant to perform the FSVP Qualified Individual responsibilities. This would also solve the second question for US-based FSVP Importers, “How does the FSVP Importer know if their FSVP meets FDA expectation?” The other way is to hire a Qualified Individual that as the credentials identified in the FSVP regulations. Either way, you need a knowledgeable, well trained “Qualified Individual.” EAS has a number of food safety experts available to serve as the Qualified Individual, should you decide to contract out this important responsibility.

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