FDA Food Recall Policy Lax, Inspector General Says

By Casey Wooten

June 9 — The Food and Drug Administration doesn't adequately police how companies roll out voluntary food recalls, leaving consumers “at risk of illness and death,” the agency's top watchdog said in a letter to the FDA commissioner.

“Specifically, we found that FDA’s policies and procedures did not instruct its recall staff to prescribe to the firms a time and a manner in which to initiate the voluntary recall,” Daniel Levinson, inspector general for the Department of Health and Human Services, said in the June 8 letter. “We also found that FDA did not have policies and procedures to ensure that firms initiated voluntary food recalls promptly.”

The letter, known as an early alert, highlights preliminary findings of the inspector general's ongoing study into the FDA recall process.

Releasing an early alert is a rare step for the watchdog office and marks a setback for the agency, which in May finalized the last of seven rules implementing the 2011 Food Safety Modernization Act, a sweeping law designed to reduce outbreaks of food-borne illness. The inspector general's alert could signal that federal overseers and lawmakers want to press the agency for additional action to improve food safety (See previous story, 05/27/16) (44 PSLR, 6/13/16).

No Time Line

Food companies usually opt to voluntarily recall contaminated products, but the FDA has the authority to issue a mandatory recall in case of inaction. The inspector general said the FDA didn't press companies to quickly roll out voluntary recalls, which in some cases meant tainted food stayed on store shelves for months.

“For two recalls, the firms did not initiate the recall of all potentially harmful products until 165 days and 81 days after FDA became aware of the potential contaminations,” the letter said.

The inspector general recommended the FDA set firm time frames for voluntary recalls, both for the agency and food companies.

The inspector general did not say when his office would release its final report.

The audit follows up on a 2011 report in which the inspector general found that the FDA didn't have the authority to require food makers to recall certain foods and the FDA didn't always follow through on its own procedures.

FDA Officials Respond

FDA officials responded to the inspector general's letter with a June 9 blog post backing the way the agency handles voluntary recalls.

“To consumers hearing about the OIG alert, we want to be clear that the FDA is totally committed to its public health mission of ensuring the safety of the food supply,” Stephen Ostroff, deputy commissioner for foods and veterinary medicine, and Howard Sklamberg, deputy commissioner for global regulatory operations and policy, said in their post to the FDA website.

The officials said that the instances described in the alert, in which companies took months to clear store shelves of their contaminated products, were “unacceptable,” but rejected a one-size-fits-all solution.

“We fully agree with the OIG that we must move as expeditiously as possible,” the alert said. “We also agree that time frames should be set, but they must be done on an individual basis rather than by setting arbitrary deadlines.”

Hill Reaction

Lawmakers from both sides of the aisle called on the FDA to tighten its standards for voluntary recalls.

Sen. Lamar Alexander (R-Tenn.), chairman of the Senate Health, Education, Labor and Pensions Committee, said in a statement that the FDA needs to revamp its recall procedures.

“I hope to find the FDA is taking seriously all of the inspector general’s recommendations and will take the steps necessary to immediately focus on its core mission and get its house in order so Americans aren’t bringing potentially dangerous food into theirs,” Alexander said in a statement.

Rep. Rosa DeLauro (D-Conn.), who sits on the House subcommittee responsible for funding the FDA, called on the agency to force food companies to act faster by implementing more mandatory recalls.

“The FDA should require producers to recall contaminated food during an outbreak to better protect consumers,” DeLauro said in a statement. “This report demonstrates that the FDA’s action—or inaction—can have life-threatening consequences for American families.”

To contact the reporter on this story: Casey Wooten in Washington at cwooten@bna.com

To contact the editor responsible for this story: Heather Rothman at hrothman@bna.com

For More Information

Text of the inspector general's report is available at http://oig.hhs.gov/oas/reports/region1/11501500.pdf.

Text of the FDA officials' blog post is available at http://src.bna.com/fL1.