In follow up to last week’s newsletter on exporting food products, this week we are taking a look at importing foods and ingredients. Although FDA has not put out new rules or guidance, it has recently updated its webpages on the Import Program, FSVP, and Importing Food Products into the United States; posted an “FDA Voice” focused on the visits of FDA delegations to Canada, China and Mexico to discuss food safety and import compliance with FSMA; and opened – and closed – the VQIP application portal for the first time. (See the TAG article, VQIP Now Live – What Does It Mean to You?) All of which is to say that FDA is focused on import safety … which means that, if for no other reason, you must be too. This is further emphasized by the FDA focus on compliance with the Foreign Supplier Verification Program and enforcing this new rule. It’s common industry knowledge that FDA is tasked with inspecting many different types of food products offered for import at U.S. ports of entry – and can detain shipments found to not be in compliance with regulations. But that role does not extend to approving, certifying or otherwise sanctioning food importers or products. So, technically, any importer can import foods into the U.S. without prior sanction by FDA. In actuality, though, any importer can import foods into the U.S. as long as the facilities that produced, stored, or otherwise handled the products are registered with FDA; prior notice of incoming shipments is provided to FDA; and the importer ensures the products are safe, sanitary, and labeled according to U.S. requirements – enough so to pass the inspection. But with imports increasing by 5-10 percent per year for the last decade – with 40 thousand lines of product imported in 2017, and FDA resources continuing to be spread thin, the agency was able to pass a portion of its inspection responsibility on to industry with the passage of FSMA and its Voluntary Qualified Importer Program (VQIP) and Foreign Supplier Verification Program (FSVP). VQIP is a voluntary fee-based program that provides expedited review and import entry of human and animal foods into the U.S. To participate, importers must meet certain eligibility requirements, which include ensuring that the facilities of their foreign supplier are certified under the Accredited Third-Party Certification Program. Interestingly, in its discussion of VQIP, FDA stated that, while the application portal opened in January (and closed May 31), importers would not have been able to apply during this cycle because no certification bodies, which conduct the foreign food facility audits and issue certifications, had yet been accredited under the Accredited Third Party Certification Program. So, at least in this instance, FDA pretty much just checked the box of having the application period open. The agency did say, however, that it would consider early opening of 2019 application cycle. Additionally, in its May 25 Constituent Update noting the expiration of the 2018 period, FDA encouraged importers interested in applying during the next cycle to start preparing now. This would include submitting a notice of intent to participate, begin filling out the application so you’re ready to submit when the portal opens, and reviewing the Public Registry of Recognized Accreditation Bodies to find links to certification bodies. The accreditation bodies will update their websites with a list of certification bodies as they become available. Importers can then begin working with them to obtain certifications for the facilities from which they are importing. Having these certifications ready before January will give importers a headstart in the application process. FSVP is a program that importers (covered by the rule) must have in place to verify that their foreign suppliers are producing food in a manner that meets applicable U.S. safety standards; provides the same level of public health protection as required by FSMA; ensure that the supplier’s food is not adulterated; and ensure accurate allergen labeling. Importers can meet key FSVP obligations by relying on analyses, evaluations and activities performed by other entities in certain circumstances, as long as those importers review and assess the corresponding documentation. In a recent post, TAG Senior Manager of Food Safety Christopher Snabes provided insights on major observations, enforcement statistics, and updates on FSVP inspections. With most compliance dates now in effect (excepting some small, very small, and otherwise qualified facilities), it is critical that food facilities ensure they are in compliance with all requirements. Not sure what they are or if you are? Check out our Q&A on FSVP at FSVP Compliances Due Soon. Are You Ready? If your question isn’t answered there – or you’d like to discuss your individual situation, contact us. We’re here for you. About The Acheson Group (TAG) Led by Former FDA Associate Commissioner for Foods Dr. David Acheson, TAG is a food safety consulting group that provides guidance and expertise worldwide for companies throughout the food supply chain. With in-depth industry knowledge combined with real-world experience, TAG’s team of food safety experts help companies more effectively mitigate risk, improve operational efficiencies, and ensure regulatory and standards compliance. www.AchesonGroup.com
