Scott Gottlieb, M.D., Commissioner of the Food and Drug Administration
Scott Gottlieb, M.D., commissioner of the Food and Drug Administration, recently announced that FDA will issue guidance on food recall communications within the next six months. His announcement followed a report released in December by the Office of the Inspector General (OIG) at the Department of Health and Human Services that outlined shortcomings in FDA’s process for handling food recalls.
The report supplements a 2016 alert from the OIG that said FDA does not have an effective process in place for initiating recalls. It recommended setting timelines for FDA staff to follow when requesting voluntary recalls and for companies when initiating voluntary recalls. This alert was based on OIG’s review of a sampling of recalls reported between October 2012 and May 2015.
Following the alert, OIG continued its review and has identified four specific issues of concern:
- FDA did not always evaluate health hazards in a timely manner.
- FDA did not always issue audit check assignments at the appropriate level, and they weren’t always completed according to FDA procedures.
- FDA did not always collect timely and complete recall status reports from companies.
- FDA did not always track or maintain key recall data in the Recall Enterprise System designed to capture this data.
In response to the report, Gottlieb said, “The FDA has authority to act in a variety of ways when it is made aware of an unsafe food product. But often the fastest and most efficient way to ensure unsafe foods are recalled quickly is by working directly with the involved companies while simultaneously providing the public with timely, accurate information that they can act on.”
He added, “Among other steps, I want to do even more to make sure that consumers have the information they need to avoid hazardous products that are the subject of recalls, or to seek assistance if they may have been exposed to a recalled food product. The FDA is exploring various ways to better accomplish this goal.”
For more information, members may contact John Allan, IDFA vice president of regulatory affairs and international standards, at email@example.com. “We’re staying closely engaged with FDA officials as they work on the guidance,” said Allan.
Members also may log in to read more details in a memorandum from Hogan Lovells US LLP, IDFA’s outside legal counsel.