WASHINGTON – Yesterday, the U.S. Food and Drug Administration (FDA) issued draft guidance that describes situations when it will publicly disclose the names and addresses of retailers selling or distributing human and animal food undergoing recalls.
Currently, the FDA publicizes information gathered from press releases and other public notices about recalls of FDA-regulated products. It generally provides labeling information, product information, product descriptions, lot numbers and photographs, as well as some geographic or retail-related distribution information.
According to the guidance document, the FDA now will disclose the names and addresses of retailers selling or distributing the recalled food where consumption of the food has a “reasonable probability” of causing “serious adverse health consequences” or death to humans or animals.
The FDA intends to publicize retailer information for food recalls in instances when the food is not identified easily as being subject to a recall from its retail packaging, or lack thereof, and the food is likely to be available for consumption. Some examples would be foods sold directly to consumers with no universal product code or bar code, such as deli cheese, nuts, rawhide chews or pet treats sold in bulk and fresh fruits and vegetables sold individually.
The guidance also states that the FDA may disclose retailer information in other recall situations (even when both criteria above are not met), including when a recalled food is related to a foodborne illness outbreak and where the information is most useful to consumers. Depending on the nature of the recall and the means by which the recalled food was distributed, the FDA may list retail store chains and geographic locations rather than the locations of specific retail stores.
The FDA acknowledges that it has the authority to publicize such information even if doing so would reveal confidential business relationships between suppliers and customers, and notes that the information available to it about retailers may be both under- and over-inclusive. It may be under-inclusive in that a recall announcement may not include all retail locations that have received the recalled food, and it may be over-inclusive and include retail locations that did not receive the recalled food.
Comments on the draft guidance may be submitted through regulations.gov until 60 days after the draft guidance appears in the Federal Register.