FDA issued a draft guidance that addresses public warning and notification of recalls under the agency’s recall regulation at 21 CFR part 7, subpart C (see here and here). Although the draft guidance extends to recalls of nearly all FDA-regulated products, it is of particular importance to the food sector because it follows on the heels of an HHS OIG report critical about the agency’s oversight of certain food recalls. In response to that report, Commissioner Gottlieb issued a statement indicating that the agency intended to take “additional policy steps… as part of a broader action plan to improve our oversight of food safety and how we implement the recall process.” The issuance of the draft guidance appears to be the first of those additional policy steps.
The draft guidance addresses both public warnings (meaning an alert to the public that a recalled product presents a serious health hazard), and public notification (meaning inclusion in the agency’s publicly available weekly Enforcement Report, which lists all recalls regardless of the level of hazard). The draft guidance discusses the circumstances under which firms should issue public warnings, examples of serious hazards that could warrant a public warning, and the preparation, content, and distribution of such warnings. The draft guidance notes that the agency could choose to issue its own public warning, and also can “publicly issue information that may address outstanding questions about the nature of the incident and/or the agency’s action.” A footnote acknowledges that certain information might qualify as confidential commercial information (CCI) and thereby be generally exempt from public disclosure, but points to an FDA regulation that authorizes disclosure “to the extent necessary to effectuate” an “administrative or court enforcement action within [the agency’s] jurisdiction.”
With respect to public notification, the draft guidance states that recalls will be posted in the weekly Enforcement Report only after FDA has determined that the action qualifies as a recall, as defined by the recall regulation. At that point, the recall will be posted even if it has yet to be classified.
Comments on the draft guidance are due by March 20, 2018.