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Source: http://www.cidrap.umn.edu/news-perspective/2017/12/report-finds-gaps-fda-food-recall-process
Report finds gaps in FDA food recall process
Filed Under:
Foodborne Disease
Stephanie Soucheray | News Reporter | CIDRAP News
| Dec 28, 2017
A new report from the Office of the Inspector General (OIG) at the Department of Health and Human Services (HHS) said the Food and Drug Administration (FDA) was lacking when it came to following food recall protocols.
In an effort to determine how and if the FDA had an efficient and effective food-recall process, the HHS reviewed documentation for 30 voluntary food recalls selected from the 1,557 food recalls reported to the FDA between Oct 1, 2012, and May 4, 2015.
The OIG has reviewed the FDA's recall system before, but the new report covers the period in which the agency got new power to require food companies to initiate recalls as part of the 2011 Food Safety Modernization Act.
"We identified deficiencies in FDA's oversight of recall initiation, monitoring of recalls, and the recall information captured and maintained in FDA's electronic recall data system, the Recall Enterprise System (RES)," the HHS said in a Dec 22 press release accompanying the report.
In several cases, the HHS found the FDA failed to act in a quick manner when dealing with food producers, and that the agency lacked the personnel to follow-up with companies that had initiated a voluntary recall of food products.
Timeliness, or lack thereof, was the theme of the HHS's report. The FDA performed audit checks for 25 of the 30 recalls analyzed. For 21 of the recalls, the FDA did not complete the last audit check within 20 days of the issuance of the firm?s recall communication. According to the report, the median days for the FDA to finish conducting all audit checks after the firm issued its recall communication was 69 days (with an average of 118 days and a range of 22 to 547 days).
For 11 of the 30 recalls, FDA either did not request or did not collect status reports.
[h=3]FDA to overhaul recall communication in 2018[/h] FDA Commissioner Scott Gottlieb, MD, issued a response to the report on Dec 26, saying that though the FDA has fixed many of these problems in 2016 and 2017 after the OIG released a draft version of its report, but the agency still has more work to do in improving food recall response.
"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," Gottlieb said in his statement. "The FDA is exploring various ways to better accomplish this goal. Among other steps, the agency will issue guidance on recall communications in the first half of 2018." One possibility is examining situations in which it can disclose stores or food service locations that may have sold or distributed a potentially unsafe food, he said.
Gottlieb said the agency took a huge step forward in addressing the problems in April, when it established the "Strategic Coordinated Oversight of Recall Execution" team, which reviews complex or unusual food safety situations and meets weekly to make recommendations to the FDA.
Gottlieb said the FDA will finalize more changes in 2018 that will help keep consumers safe and streamline the agency.
See also:
Dec 22 HHS report
Dec 26 FDA statement
Report finds gaps in FDA food recall process
Filed Under:
Foodborne Disease
Stephanie Soucheray | News Reporter | CIDRAP News
| Dec 28, 2017
A new report from the Office of the Inspector General (OIG) at the Department of Health and Human Services (HHS) said the Food and Drug Administration (FDA) was lacking when it came to following food recall protocols.
In an effort to determine how and if the FDA had an efficient and effective food-recall process, the HHS reviewed documentation for 30 voluntary food recalls selected from the 1,557 food recalls reported to the FDA between Oct 1, 2012, and May 4, 2015.
The OIG has reviewed the FDA's recall system before, but the new report covers the period in which the agency got new power to require food companies to initiate recalls as part of the 2011 Food Safety Modernization Act.
"We identified deficiencies in FDA's oversight of recall initiation, monitoring of recalls, and the recall information captured and maintained in FDA's electronic recall data system, the Recall Enterprise System (RES)," the HHS said in a Dec 22 press release accompanying the report.
In several cases, the HHS found the FDA failed to act in a quick manner when dealing with food producers, and that the agency lacked the personnel to follow-up with companies that had initiated a voluntary recall of food products.
Timeliness, or lack thereof, was the theme of the HHS's report. The FDA performed audit checks for 25 of the 30 recalls analyzed. For 21 of the recalls, the FDA did not complete the last audit check within 20 days of the issuance of the firm?s recall communication. According to the report, the median days for the FDA to finish conducting all audit checks after the firm issued its recall communication was 69 days (with an average of 118 days and a range of 22 to 547 days).
For 11 of the 30 recalls, FDA either did not request or did not collect status reports.
[h=3]FDA to overhaul recall communication in 2018[/h] FDA Commissioner Scott Gottlieb, MD, issued a response to the report on Dec 26, saying that though the FDA has fixed many of these problems in 2016 and 2017 after the OIG released a draft version of its report, but the agency still has more work to do in improving food recall response.
"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," Gottlieb said in his statement. "The FDA is exploring various ways to better accomplish this goal. Among other steps, the agency will issue guidance on recall communications in the first half of 2018." One possibility is examining situations in which it can disclose stores or food service locations that may have sold or distributed a potentially unsafe food, he said.
Gottlieb said the agency took a huge step forward in addressing the problems in April, when it established the "Strategic Coordinated Oversight of Recall Execution" team, which reviews complex or unusual food safety situations and meets weekly to make recommendations to the FDA.
Gottlieb said the FDA will finalize more changes in 2018 that will help keep consumers safe and streamline the agency.
See also:
Dec 22 HHS report
Dec 26 FDA statement