FDA Issues Final Guidance for Industry and FDA Staff on Publicizing Lists of Retailers That May Have Received Certain Recalled Food
As covered on this blog, FDA announced a new policy on September 26, 2018 and concurrently released draft guidance detailing the circumstances for publicizing retailer information (e.g., specific retail store name and address) when recalled human or animal food is not easily identified as being the subject of a recall from its retail packaging or lack thereof (e.g., deli cheese, nuts, rawhide chews, or pet treats sold in bulk and fresh fruits and vegetables sold individually) and is likely to be available for consumption (i.e., given its shelf-life or perishability, it may still be in a consumer’s possession). This policy is part of an overall effort to provide consumers with “actionable information” and followed the release a month earlier of draft guidance, subsequently finalized in February 2019, on the use, content, and circumstances for issuing public warnings for consumers in the event of a recall.
On November 23, 2020, FDA announced the Final Guidance on ‘‘Public Availability of Lists of Retail Consignees to Effectuate Certain Human and Animal Food Recalls.’’ Minor changes include a new statement that FDA intends to update the retail consignee lists as the information available to FDA develops and clarification that while this guidance is specific to retail consignees, FDA can disclose the names of restaurants and similar entities where appropriate. FDA intends to post lists of retail consignees associated with a specific recall on FDA’s website. Retailers that typically may be subject to public listing are grocery stores, pet food stores, convenience stores, and online food delivery services. Food recalls at issue are those classified as Class I recalls, or recalls not yet classified that are likely to be classified as Class I, and some Class II food recalls, particularly where a public warning has been issued or there is an association with an outbreak of a foodborne illness. Packaged food would not usually meet the criteria for posting information on the retailer of the recalled food, but FDA may in some cases determine that packaged food was distributed in a manner where identifying the retailer would help prompt consumers to consider whether they possess the recalled product.
FDA’s decision to publicly list retailers of recalled food in certain situations responds to Section 206 of the 2011 FDA Food Safety Modernization Act (FSMA), which directs FDA to consult the policy of the United States Department of Agriculture (USDA) for making publicly the available the names and locations of retail consignees of recalled meat or poultry products that USDA compiles in connection with a recall where there is a reasonable probability that the use of the product could cause serious adverse health consequences or death (Class I recalls) and to consider the circumstances under which it would be appropriate for FDA to provide such a list to the public. While identifying “retail consignees” is subject to restrictions under FDA’s regulations protecting confidential commercial information (CCI), FDA has the authority to make a public disclosure of CCI, including the revelation of confidential business relationships between suppliers and customers, to the extent necessary to effectuate a recall.