New F.D.A. Guidance to be ‘as Robust and Transparent as Possible’

The U.S. Food and Drug Administration on Nov. 5 unveiled new guidelines on the implementation of the…

The U.S. Food and Drug Administration on Nov. 5 unveiled new guidelines on the implementation of the agency’s mandatory recall authority in response to cases where companies have refused to voluntarily recall products that violate food safety standards.

“The guidance issued today is part of our efforts to be as robust and transparent as possible and provide answers to questions that many have asked about the F.D.A.’s mandatory recall processes,” said Scott Gottlieb, M.D., commissioner of the F.D.A. “Our aim is to expand the appropriate use of our mandatory recall authority in cases where we have to intervene quickly to help protect consumers from unsafe products.”

Under the new guidance, the F.D.A. will give companies an opportunity to voluntarily recall products before ordering a mandatory recall. Additionally, the new guidance details the evidence or circumstances the F.D.A. will consider before implementing a mandatory recall and clarifies situations in which the F.D.A. would consider a product a serious risk to public health.

The Food Safety and Modernization Act (FSMA) of 2011 gave the F.D.A. the authority to mandate a recall when a manufacturer refuses to remove from commerce a product that has been deemed unsafe. Before FSMA, the agency had to rely on voluntary recalls by manufacturers. Since the enactment of FSMA, Dr. Gottlieb noted, the F.D.A. has issued only one mandatory recall order.

To assist companies with a product recall, Recall Coordinators are available to oversee the day-to-day management and effectiveness of the recall, which could include conducting audit checks and reviewing periodic status reports among other duties.

“While the F.D.A.’s mandatory recall authority plays an important role in ensuring that potentially dangerous food products are removed from the marketplace, the agency remains committed to working with companies to facilitate the orderly and prompt voluntary removal of potentially dangerous products from the food supply,” Dr. Gottlieb said. “That’s why we make F.D.A. Recall Coordinators available to assist firms during the recall process and continue to issue guidance on when and how food recalls should occur.”

This latest round of guidance from the F.D.A. follows draft guidance released in September that clarifies when the F.D.A. will release detailed information about retailers that may have sold or distributed human or pet food that is subject to a recall.

Additionally, the agency released in January draft guidance on public warnings for consumers that detailed situations where the F.D.A. and companies would publicize public warnings to help implement a recall.