Instances of Unauthorized Use of a DUNS Number Found by FDA Inspectors

Instances of Unauthorized Use of a DUNS Number Found by FDA Inspectors

The Food and Drug Administration (FDA) recently indicated to industry sources that they’ve detected a number of companies trying to evade the FSVP process through unauthorized use of a DUNS number.

All shipments of imported food into the U.S. require the DUNS* number of a Foreign Supplier Verification Programs (FSVP) Importer. The use of this DUNS number on ACE (Automated Commercial Environment)** signals to the FDA that an importer, (whether it’s an international manufacturer, supplier or exhibitor), has secured a U.S.-based FSVP Importer to verify that the foreign food in that shipment is being produced in accordance with U.S. safety standards. This verification must occur for each type of imported food produced, and is necessary for each shipment of food entering the U.S.

Importers who are unaware of this requirement are violating FDA regulations by listing the DUNS number of an FSVP Importer that had been used previously but was not involved with verifying the new shipment. Importers should not provide their Customs brokers with a FSVP Importer’s DUNS number if they have not engaged FSVP services for the intended shipment, regardless of whether they used the company before or simply know the DUNS number of a FSVP Importer. This is a serious concern because it undermines the FDA’s mandate to protect America’s food supply.

FSMA grants the FDA the authority to recall, detain or seize any food they determine to be unsafe, misbranded, or adulterated, or for otherwise failing to meet the requirements of food safety law. For the last several years, the FDA has practiced education and regulation seeking to first educate the food industry on the changes in the law. However, the agency has indicated that after years of a more flexible approach following the final ruling, 2019 will see more stringent enforcement of the FSVP mandate, including the inspection of DUNS numbers, as well as companies stating they are FSVP Importers but are not meeting the requirements of the FSVP process.

While the costs of implementing a FSVP program may be a new financial outlay for food importers, the costs of not complying can be far more significant. FSMA requires the FDA to conduct thousands of foreign facility inspections each year. Among the most frequently cited violations during inspection is the failure to have an FSVP program in place to adequately control hazards and apply preventive controls. For those foreign food companies supplying an unauthorized DUNS number of a FSVP Importer in order to ship products to America, the potential problems are considerable. When detected by the FDA, this unauthorized use of a DUNS number raises suspicions that the company is not engaging a FSVP Importer to enact a FSVP plan. A firm involved with the import of food that does not comply with FDA regulations may experience such penalties as having shipments detained or refused at entry, being placed on import alert (informs FDA field staff that all future shipments of the imported product may be refused admissions without physically examining the product in each shipment), and warning letters from the FDA.

Ultimately, the most concerning consequences of not verifying safe food production is the possible outbreak of illness, with all that could ensue, from the impact on human life to product recalls, lawsuits, extended governmental audit and scrutiny, suspension of registration of food facilities, and damage to brand reputation.

The FDA is more poised than ever to use its authority without waiting for the adverse effects of unsafe food.

*DUNS number (Data Universal Numbering System), is a system created by Dun & Bradstreet to provide a unique numeric identity to a single business entry. The FDA recognizes a DUNS number as an acceptable unique facility identifier for FSVP.

**The Automated Commercial Environment (ACE) used by Customs and Border Protection is a web-based system to automate border processing. The trade community reports imports and exports through ACE in order for the government to determine admissibility.