In planning for your company’s 2018 regulatory priorities, you might want to review and optimize its recall procedures. Recall policies and procedures likely will be a focus of FDA in the coming year.
The Office of Inspector General (OIG) within the Department of Health and Human Services recently published a Report, The Food and Drug Administration’s Food-Recall Process Did Not Always Ensure the Safety of the Nation’s Food Supply (Dec. 2017). The Report is based on OIG’s selective review of documentation for 30 voluntary food recalls from the 1,557 food recalls reported to FDA between October 1, 2012, and May 4, 2015. OIG focused on FDA’s (1) oversight of each company’s initiation of food recalls, (2) monitoring of company initiated recalls, and (3) maintenance of food-recall data in the electronic recall data system, i.e., the Recall Enterprise System (RES).
Enactment of the FDA Food Safety Modernization Act (FSMA) in 2011 gave FDA new authority to order a mandatory recall and require companies to recall harmful foods. OIG conducted its review to determine whether FDA is fulfilling its responsibility to safeguard the nation’s food supply now that it has mandatory recall authority. The Report follows-up on an Early Alert memorandum that OIG sent to FDA in June 2016 (included as Appendix B in the Report), which raised concerns that FDA did not have policies and procedures adequate to ensure that food facilities take prompt and effective action in initiating voluntary recalls.
The Report makes and discusses the following essential findings:
- FDA could not always ensure that companies initiated recalls promptly.
- FDA did not always evaluate health hazards in a timely manner.
- FDA did not always issue audit check assignments consistent with the level in the proposed audit program.
- FDA did not always complete audit checks in accordance with procedures.
- FDA did not always collect timely and complete status reports from recalling firms.
- FDA did not track key recall data in the electronic RES.
- FDA did not always maintain accurate recall data in the RES.
In prompt reply to issuance of the Report, FDA published a Statement from FDA Commissioner Scott Gottlieb, M.D. on efforts to support more efficient and effective food recalls (Dec. 26, 2017). The Statement acknowledges that the Report raises “significant concerns,” only some of which have been addressed since receipt of the Early Alert memorandum. For example, in April of last year, FDA established the SCORE team (i.e., “Strategic Coordinated Oversight of Recall Execution”), a group of senior leaders charged with reviewing complex or unusual food safety situations and determining the proper action to address the problem, if unclear. Also, last year, after a comprehensive review of its recall processes, FDA developed a new strategic plan that outlines actions to improve the agency’s recall management. That plan helps to standardize how FDA assesses a company’s recall efforts, and provides additional training to its staff involved in recall efforts so they can properly monitor and assess the effectiveness of a recall.
FDA intends to say more in early 2018 on additional policy steps it will take as part of a broader action plan to improve the agency’s oversight of food safety, and how it implements the recall process. FDA’s focus on food recalls provides a timely opportunity for industry to do the same. FSMA provided FDA with the authority to suspend a company’s food facility registration(s) under proper circumstances; such a suspension would prevent the company from lawfully distributing food in commerce – a consequence to be avoided.
In reviewing your company’s recall procedures, consider doing the following:
- Submit a Freedom of Information Act (FOIA) request to FDA for a copy of the new strategic plan for recalls (mentioned in the published Statement of FDA Commissioner Gottlieb). It might suggest areas for specific focus.
- In the first quarter of 2018, monitor for FDA’s announcement of additional policy steps it intends to implement relative to food safety and recalls.
- Ensure that your company’s recall procedures address all facets of FDA’s recall guidelines, 21 C.F.R. Part 7, Subpart C.
- Confirm that in the event of a Class I recall, your company knows how to submit requisite notice to the Reportable Food Registry.
- Review the 7 findings of the Report to see if they suggest areas where your company’s recall procedures need strengthening.
Also, following any recall prospectively, submit a FOIA request for recall data in the RES to ensure that it is accurate.