FDA News: Import Operations, Foreign Supplier Audits, Import Alerts
© , Sandler, Travis & Rosenberg, P.A. Originally published in the [03/19/2020] issue of the Sandler, Travis & Rosenberg Trade Report. Reprinted by permission.
Import Operations Remain Functional
The Food and Drug Administration reports that its import operations remain functional and operational amid the COVID-19 outbreak. FDA activities including prior notice review, entry processing, sampling/examination of high-risk shipments, foreign supplier verification program inspections, filer assessments, and compliance activities are all ongoing.
However, the FDA notes that the import community should expect delays in receiving hard copy notices of FDA action (release notices, sampling notices, etc.). As a result, all members of the import community that deal in FDA-regulated articles are strongly encouraged to utilize the FDA’s Import Trade Auxiliary Communication System for current entry status and to receive FDA notices electronically. ITACS account management functionality may be used by customs brokers (entry filers), importers of record, and consignees with an approved ITACS account.
Importers Temporarily Relieved of Onsite Audits for Foreign Food Suppliers
The FDA has announced that, in response to the global COVID-19 pandemic, it does not intend to enforce supplier verification onsite audit requirements for importers and receiving facilities under the Food Safety Modernization Act if other supplier verification methods are used instead.
The FDA notes that three of the regulations created to implement FSMA – the preventive controls for human foods rule, preventive controls for animal food rule, and foreign supplier verification program rule – require importers and receiving facilities to conduct supplier verification activities based on the hazard analysis conducted as part of their written food safety plan or FSVP. These activities generally include onsite audits, sampling and testing, or a review of food safety records.
However, the travel restrictions and advisories associated with COVID-19 may make some audits temporarily impractical to conduct. As a result, the FDA does not intend to enforce the requirement to conduct or obtain an onsite audit of a food supplier in the following circumstances.
– an FSVP importer or receiving facility has determined that an onsite audit is the appropriate verification activity for an approved supplier, as reflected by its written food safety plan or FSVP
– the supplier due for an onsite audit is in a region or country covered by a government travel restriction or travel advisory related to COVID-19
– because of the travel restriction or advisory it is temporarily impracticable for the FSVP importer or receiving facility to conduct or obtain the onsite audit of the supplier
– the FSVP importer or receiving facility temporarily selects an alternative verification activity, such as sampling and testing food or reviewing relevant food safety records, and modifies its food safety plan or FSVP to incorporate the alternative activity
The FDA states that FSVP importers and receiving facilities should resume onsite audits within a reasonable period of time after it becomes practicable to do so and should update their food safety plans and FSVPs accordingly. The FDA intends to provide timely notice when this temporary non-enforcement policy is withdrawn.
Import Alerts on Foods, Drugs, and Medical Devices That May be Detained
Food and Drug Administration import alerts on the following have been modified in the past week.
– human growth hormone
– infant formula
– fish/fishery products from foreign processors not in compliance with seafood HACCP
– fresh cilantro from the state of Puebla, Mexico
– low-acid canned foods or acidified foods
– foreign-manufactured unapproved prescription drugs promoted to individuals in the U.S.
– foods containing illegal and/or undeclared colors
– honey and blended syrup
– cosmetics adulterated and/or misbranded due to color additive violations
– cantaloupes from Mexico
– raw and cooked shrimp from India
For more information on import alerts and other FDA issues, please contact FDA consultant Domenic Veneziano at (202) 734-3939.
Importers of FDA-regulated goods are responsible for ensuring that such imports are in compliance with FDA laws and regulations. Before shipping into the U.S., importers should be aware of whether or not their product is listed on an import alert.
Import alerts inform FDA field staff that the agency has enough evidence or other information to allow a product that appears to be in violation of FDA laws and regulations to be detained without physical examination at the time of entry. Import alerts may cover products from designated countries or areas (including from all foreign countries), manufacturers, or shippers.
Firms and/or products on the “red list” of an import alert are subject to DWPE, while firms and/or products on the “green list” are not because they have met the criteria for exclusion. Some import alerts include a “yellow list” of firms, products, and/or countries subject to intensified surveillance because the nature of the violations may warrant further field examinations of individual entries and/or additional analyses. In addition, depending on the specific import alert, shipments of products subject to DWPE may still be imported into the U.S. if the importer has demonstrated that the shipment is in compliance.
If a product is detained without physical examination the importer has the right to provide evidence to the FDA in an attempt to overcome the appearance of the violation. If no such evidence is submitted, or if the evidence provided is insufficient, the product will be subject to refusal of entry into the U.S.