One key element of the 2011 Food Safety Modernization Act was the Act’s grant to FDA of powers to force a product recall. Prior to FSMA, FDA had no such authority, and was required to use other authorities to “lean” on companies to conduct a recall. Now, FDA may force a recall where it finds that there is a reasonable probability that food is adulterated or misbranded and the use of or exposure to the food will cause serious adverse health consequences or death to humans or animals. In addition to satisfying this fairly substantial threshold, the responsible party must refuse to voluntarily conduct a recall. The result is that FDA has initiated its mandatory recall authority only a couple of times, notably with respect to Kasel Associates Industries, Inc.’s pet treats and dietary supplements manufactured by USPLabs.
FDA recently issued draft nonbinding guidance regarding its mandatory recall authority. The draft guidance, issued in standard FDA Q&A form, primarily outlines the statutory authority and procedure for conducting a mandatory recall. It does identify that it will consider any applicable evidence when determining whether to require a recall, including inspection observations, sample analysis, epidemiological data, Reportable Food Registry data, and consumer ands trade complaints. The guidance also highlights FSMA’s authorization of FDA to collect fees from a noncompliant responsible party or importer to cover FDA’s costs, including technical assistance, effectiveness checks, and public notifications.
In sum, however, FDA has provided little additional clarity around its processes and procedures for pursuing mandatory recalls. Nonetheless, FDA is accepting written comments on the draft guidance within sixty days of its publication.