Dive Brief:
- The U.S. Department of Health and Human Services' Office of Inspector General has called out the FDA for having a food recall initiation process that is not "efficient and effective," per preliminary findings from the OIG's ongoing audit of the FDA's food recall program.
- The OIG said in its report that FDA's policies and procedures do not adequately ensure that responsible parties initiate recalls promptly after discovering food contaminations. This has resulted in contaminated products not being recalled for several weeks after FDA initially became aware of the potentially hazardous product. This endangers the public and "requires FDA’s immediate attention," the OIG said.
- In a blog post, the FDA acknowledged the OIG's concerns and confirmed that two particular instances in question were "unacceptable." But the agency also said that the OIG based its conclusions on a "judgment sample" selected based on their risk factor, which does not accurately reflect the outcomes of thousands of food recalls the FDA has overseen to protect the safety of the U.S. food supply.
Dive Insight:
The two "unacceptable" instances in question included salmonella-tainted nut butter that the FDA did not forcibly recall for 165 days following confirmation of the contamination, and 14 people had fallen ill, linked to consuming the product. The other instance involved contaminated cheese that the FDA did not recall for 81 days and which was linked to eight sickened people and the death of one baby.
The OIG also noted that these instances occurred despite the FDA having the power to institute a mandatory recall, per FSMA regulations passed in 2011, and technology that enables faster detection of pathogens, particularly whole genome sequencing. Both recalls happened in 2014 and were among the 30 recalls between 2012 and 2015 that OIG is currently investigating.
These issues are ongoing. Last week, The Wall Street Journal uncovered reports that show a history of recurring problems at the CRF Frozen Foods facility in Pasco, WA, which has been linked to a massive recall that impacted dozens of brands, including many retailers' private labels. Last year, reports revealed that health officials discovered listeria contamination at one of Blue Bell's plants more than a month before the products were widely recalled.
In its blog post, the FDA announced a "new process" that aims to "streamline and strengthen decisions about compliance and enforcement actions." The Strategic Coordinated Outbreak Response and Evaluation (SCORE) team is comprised of key senior leaders from federal organizations advised by senior scientific, medical, communications, and policy experts. FDA says SCORE will bring "an integrated approach to identifying timely and efficient measures to help mitigate public health risks."
Because of the newness of SCORE, it's unclear what role the team will play in terms of interactions with manufacturers. But the FDA seems confident in its ability to improve upon recall protocols between its efforts to develop SCORE and the mandatory preventive controls requirements manufacturers must comply with per FSMA. Those requirements include developing and documenting a recall plan and identifying and solving any food safety risks that could lead to a recall.
Manufacturers are working toward FSMA preventive controls compliance in varying capacities, as certain manufacturers require more changes and additional documentation than others. Many companies must be compliant by September, though "very small businesses" have more time, per recently released draft guidance. Depending on the survey, manufacturers' belief in their FSMA preparedness ranges from 61% to 25%.