The system was criticised for not being ‘efficient and effective’ and led to issues with recall initiation, monitoring of them and information collected.
The Office of Inspector General (OIG) raised the concerns in an early alert in 2016 and a draft report last year.
OIG recommended that FDA use its Strategic Coordinated Oversight of Recall Execution (SCORE) initiative to establish set timeframes, expedite decision-making and improve electronic recall data.
The SCORE team were part of the process for suspending the registration of two facilities, blocking them from distributing food to the marketplace.
OIG finds problems
OIG reviewed 30 voluntary recalls from the 1,557 reported to FDA between October 2012 and May 2015.
It identified deficiencies in FDA’s oversight of recall initiation, monitoring of them and information in FDA’s electronic tool - the Recall Enterprise System (RES).
“The RES contained deficient recall information because it did not track all information necessary for FDA to effectively monitor recall activities and assess the timeliness of recalls; the RES also contained inaccurate data.”
FDA said the 30 recalls were ‘extreme outliers’ and it oversaw more than 1,500 recalls during the period examined by OIG.
The agency will issue guidance on recall communications in the first half of this year.
Scott Gottlieb, FDA commissioner, said while it had addressed many findings of the draft report in 2016 there is still work to do.
A patented mobile protection platform wants to bridge the divide between the recall process and customer safety. The IOS application will be released after Q1 2018 and then on Android devices.
Michael Lucas, CEO of i3 Brands, said WatchOut! provides immediate recall and protection insights to the consumer.
“WatchOut! alerts consumers who enter a perimeter of any retailer with recent recall data published by government agencies regarding products that could be sold by the retailer in question," he said.
“Retailers will have the ability to manage the data published by having the ability of removing defective products. The response time by the retailer provides a transparency between the retail management, manufacturers and more importantly the customer.
“With over 100 million products in our database and numerous data points, we have been in development since 2015 to ensure both data accuracy and relevancy to the consumer, while protecting their identity.”
“As one example of the new steps we’re considering, the FDA is examining in what situations it can help consumers get information about the stores and food service locations that may have sold or distributed a potentially unsafe, recalled food, and what company may have supplied the product.
“If we’re able to disclose this information, consumers would have an easier time knowing if they might have, or have been, exposed to a recalled product that could cause potential risks if it were consumed.
“One of the most significant steps we took in April of last year was to establish a team of senior leaders charged with reviewing complex or unusual food safety situations and determining the proper action to address the problem if it isn’t clear. The team meets at least weekly and makes recommendations about what actions to take and how to make sure they occur.”
Reliance on voluntary recalls
Initiation of the recalls looked at ranged from nine to 303 days after FDA learned the product was potentially hazardous.
“FDA could not always ensure that firms initiated recalls promptly; therefore, some consumers became ill and others were at risk of illness or, in some cases, death,” said OIG.
“FDA relies primarily on voluntary recalls, which makes the timeliness of the recalls largely dependent on the firm’s willingness to take action. The timeliness of recalls depended primarily on how quickly firms chose to act on information they received from FDA or other sources indicating that their products were potentially hazardous.
“When firms were reluctant to initiate timely recalls, FDA’s food-recall initiation process could not ensure the efficiency and effectiveness of food recalls to protect the nation’s food supply from hazardous products.”
FDA said recall initiations took place, on average, in less than four days, and, for its highest risk recalls, in less than three days.
A recall ‘audit check’ is a visit, phone call or letter from FDA staff to a consignee to verify they have been notified of the recall and taken appropriate action.
For eight recalls, the FDA monitoring district office issued fewer audit check assignments than what was required in the proposed audit program.
FDA also relies on the distribution list provided by the firms so the recall coordinator can identify the consignees for audit checks.
For 21 recalls, the median for FDA to finish all audit checks after the firm issued its recall communication was 69 days (range of 22 to 547 days).