WASHINGTON — The Food and Drug Administration does not have “an efficient and effective food recall initiation process that helps ensure the safety of the nation’s food supply,” according to an audit published by the Office of Inspector General within the Department of Health and Human Services. This inefficiency puts consumers at risk, the department said.
In a June 8 letter to Robert M. Califf, commissioner of food and drugs for the F.D.A., Daniel R. Levinson, inspector general, said the F.D.A. “did not have policies and procedures to ensure that firms or responsible parties initiated voluntary food recalls promptly.”
“This issue is a significant matter and requires F.D.A.’s immediate attention,” Mr. Levinson said.
The audit contained the preliminary findings of a review of 30 voluntary food recalls reported to the F.D.A. between October 2012 and May 2015. Mr. Levinson wrote that after the F.D.A. first became aware that an adulterated or misbranded product could be in the food supply chain, the agency did not prescribe a timeline for each company to initiate a recall.
“For two recalls, the firms did not initiate the recall of all potentially harmful products until 165 days and 81 days after F.D.A. became aware of the potential contaminations,” Mr. Levinson wrote. “The delays in the firms’ recalls may have occurred because F.D.A. did not have policies and procedures that instruct its recall staff to establish set timeframes for 1) F.D.A. to request that firms voluntarily recall their products and 2) firms to initiate voluntary food recalls. As a result, consumers remained at risk of illness or death for several weeks after F.D.A. knew of potentially hazardous food.”
For example, Mr. Levinson in the audit cited a recall involving nut butter in which at least 14 people became ill with a strain of Salmonella. He said 165 days passed between the identification of the potentially adulterated product and the date the company initiated a voluntary food recall.
|Sandra Eskin, director of food safety at the Pew Charitable Trust|
“This alert should serve as a wakeup call for F.D.A. to make recalls quicker and more effective,” said Sandra Eskin, director of food safety at the Pew Charitable Trust, an independent, non-profit, non-governmental organization whose public policy areas include the environment, state policy, economic policy and health and human services.
Most often the F.D.A. works with companies for voluntary recalls. The F.D.A. Food Safety Modernization Act empowers the agency to act to cease distribution and recall a product with science-based evidence that it is unsafe, or reasonably likely unsafe. Enforcement tools of the Act include mandatory recall.
In a June 9 blog posting, Stephen Ostroff, deputy commissioner of foods and veterinary medicine at the F.D.A., and Howard Sklamberg, deputy commissioner for global regulatory operations and policy at the F.D.A., agreed that more can be done.
|Stephen Ostroff, deputy commissioner of foods and veterinary medicine at the F.D.A.|
“This finding is unacceptable… We fully agree with the O.I.G. that we must move as expeditiously as possible,” Mr. Ostroff and Mr. Sklamberg said. “We also agree that timeframes should be set, but they must be done on an individual basis rather than by setting arbitrary deadlines. The complexities surrounding recall events make it difficult for the F.D.A. to establish a single timeline applicable to all situations.
“To speed the F.D.A.’s response when regulated foods are tied to real and potential public health risks, including outbreaks of human illness, the agency has recently established a new process to help streamline and strengthen decisions about compliance and enforcement actions.”
Mr. Ostroff and Mr. Sklamberg said the F.D.A. has established a Strategic Coordinated Outbreak Response and Evaluation (SCORE) team that will help to identify timely and efficient measures to help mitigate public health risks, goals shared by the O.I.G.
|Howard Sklamberg, deputy commissioner for global regulatory operations and policy at the F.D.A.|
“(The team) will review investigations that have, or may have, a link to specific foods or a food facility when there is a serious human health risk,” they said. “It will also be involved when the case involves complex policy questions, when additional expert support is needed, or when response timelines have not been met. The SCORE team’s involvement will speed the F.D.A.’s response by evaluating the whole range of options for use of compliance and enforcement authorities as quickly as possible.”
Mr. Ostroff and Mr. Sklamberg stressed the F.D.A.’s mission to protect public health “is more than just words on paper.”“We are always working to be better at our job and will use the O.I.G.’s input as it was intended — to further strengthen our protection of the food supply.”