• FDA Commissioner Scott Gottlieb announced on September 26, 2018 a new FDA policy on disclosing retail information for products subject to food recalls—particularly in Class I recall situations, where consumption of the food has a reasonable probability of causing serious adverse health consequences or death to humans or animals. Historically, the agency has not released information on retailers where recalled food may have been purchased because such information potentially can reveal confidential supply chain information.
  • In conjunction with the announcement, FDA issued draft guidance detailing the circumstances under which FDA intends to publicly disclose the retail locations that may have sold or distributed a recalled human or animal food. The guidance discusses FDA’s policy to publicize retailer information (e.g., specific retail store name and address) when recalled 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).
  • This is the second in FDA’s policy efforts to provide consumers with “actionable information” for protecting themselves from recalled FDA-regulated products. The first was a draft guidance issued in January on the use, content, and circumstances for issuing public warnings for consumers in the event of a recall. FDA is inviting comments on this new draft guidance for a period of 60 days.