OIG Says FDA Monitoring of Imported Food Recalls Inadequate

OIG Often Found Significant Problems with Company Recalls

The OIG reviewed FDA's monitoring of 17 of the 40 Class I recalls (those with the greatest health hazard) that FDA oversaw from July 2007 - June 2008. OIG’s review found the following problems with firms’ recalls:

• Initiation of recalls. Two of the 17 recalls were not initiated until 28 and 102 days, respectively, after FDA became aware of the contamination.
• Recall strategies. The firms did not submit recall strategies or strategies did not contain complete information. For three of the 17 recalls, firms did not submit any recall strategies. For the 14 other recalls, the strategies submitted did not contain complete information.
• Info for consignees. Firms did not issue accurate and complete recall communications to their consignees. For 13 of the 17 recalls, firm communications did not contain essential information on the contaminated products or contained inaccurate information.
• Status reports. The firms did not submit timely and complete recall status reports. Of the 17 recalling firms, five firms did not submit any reports, 10 firms submitted untimely and incomplete reports, and two firms submitted timely but incomplete reports.

FDA Did not Always Follow it Own Procedures

In addition, FDA did not always follow its own procedures to ensure that the recall process operated efficiently and effectively. For example, FDA did not:

• Inspect -- conduct firm inspections or obtain complete information on the contaminated products in 14 of the 17 recalls;
• Audit consignees -- conduct any audit checks of consignees in five of the 17 recalls and conducted untimely and incomplete audit checks in the remaining 12 recalls,
• Review strategies - review recall strategies and promptly issue notification letters to firms conveying the review results and essential instructions in all 17 recalls, and
• Witness disposal - witness the disposal of the products or obtain the required documentation showing that the products had been properly disposed of in 13 of the 17 recalls.

During Period Reviewed, Recalls Were Still Voluntary

The report explains that during the 2007-2008 period analyzed by OIG, there was no statute to authorize FDA to require manufacturers/processors or importers to recall food except for infant formula. When a problem arose with a particular food, the manufacturer/processor or importer could choose to voluntarily recall the product.

Only with the enactment of the FSMA on January 4, 2011 did FDA gain the authority to order a firm to conduct a recall. (See ITT’s Online Archives or 03/07/11 and 01/04/11 news, 11030720 and 11010426, for BP summaries of the FSMA, including the new recall authority.)

Nonbinding Guidance Cannot Compel Compliance or Ensure Safety

The report notes that FDA’s regulations on recalls (21 CFR 7.40 et al) explicitly recognize the voluntary nature of these recalls and refer to the contents therein as “recall guidance.” The OIG states that as this “guidance” is unenforceable, FDA cannot compel firms to follow it or ensure the safety of the U.S. food supply.

Suggests FDA Consider Review in Implementing FSMA, Follow Own Procedures

The report recommends that FDA consider the results of this review in implementing the FSMA and comply with its own procedures for monitoring recalls.

Says FDA Agreed, Described Actions Taken to Improve Recall Monitoring

OIG states that FDA agreed with the recommendations and described actions it has taken to improve how recalls are conducted and monitored.

Report, dated June 2011, available here.