Application Period Extended for Importer Program
The Food and Drug Administration has extended from May 31 through July 31 the deadline for importers to submit their notices of intent to participate and completed applications for the Voluntary Qualified Importer Program for the fiscal year 2020 benefit period.
VQIP is a voluntary fee-based program that provides expedited review and importation of human and animal foods for approved applicants who achieve and maintain a high level of control over the safety and security of their supply chains. To participate, importers must meet certain eligibility requirements, which include ensuring that the facilities of their foreign suppliers are certified under the accredited third-party certification program.
Foreign Supplier Program Violations
The FDA continues to issue warning letters to importers concerning noncompliance with requirements under the Foreign Supplier Verification Program, which requires importers to perform certain risk-based activities to verify that the human and/or animal food they import has been produced in a manner that meets applicable U.S. food safety standards.
Most recently, FDA inspections of the facilities of two separate importers found that they did not develop, maintain, and follow the required plans for (1) wheat flour, spice mix, and paneer and (2) noodles and masala imported from India. In addition, one importer’s U.S. facility does not have a valid food facility registration with the FDA.
In each case, the FDA states that within 15 working days the importer should provide information on the specific things it is doing to correct these violations; e.g., documentation of changes made and records to demonstrate implementation of an FSVP. If the importer does not act promptly the FDA may take further action, such as refusing admission of violative products and subjecting them to detention without physical examination.
For more information on the FSVP, please contact FDA consultant Domenic Veneziano at (202) 734-3939.
Import Alerts on Foods, Drugs, and Medical Devices
FDA import alerts on the following have been modified in the past week.
- human and animal foods imported from foreign suppliers by importers not in compliance with requirements of the FSVP regulation
- fresh produce that appears to have been prepared, packed, or held under insanitary conditions
- food products due to the presence of salmonella
- produce due to contamination with human pathogens
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.
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