Insights Into the FDA Recall Process: Part I

By Karin Krisher

One of many recalled Kasel Associated Industries products.

You’ve no doubt heard about the staggering amount of food and drug recalls in the United States last year. Because we in the animal health industry are so frequently confronted with a new chicken jerky concern, we decided to take a deeper look into the recall process. In this three part blog series, we’ll discuss the actual process, the potential downfalls of the current system, and what you can do to stay informed.

At the First Signs of a Problem

On a Friday in early September 2011, the Colorado Department of Public Health and Environment released some concerning information in the form of a media announcement: Listeria cases, which normally ranged around two per month, were up to seven in August. The Signals and Surveillance Team at the FDA saw the announcement and took action, reaching out to the FDA’s Denver office to get the ball rolling.

Through involving the CDC and the rest of the CORE (Coordinated Response and Evaluation) Network, of which the SST is one piece, the team determined the Listeria outbreak was multi-state and began a response effort.

But what if the media announcement came a week later? What if the Colorado Department of Public Health and Environment didn’t receive proper information, and reported just the normal two cases? Where would the SST have found its information, then?

The Source of the Scare

According to a consumer update on its website, the Signals team uses a combination of databases to gather info, largely relying on the efforts of state agriculture departments. They consider themselves constant sensors. (One member even likened the team to a smoke detector.)

fda-recall-process-3Some of those databases aren’t databases at all, like consumer complaints to the FDA, or Epi-X, a state secure and CDC discussion network. Others include:

“The PulseNet WebBoard, an online bulletin board coordinated by CDC that is dedicated to states’ results of PFGE, or Pulsed Field Gel Electrophoresis testing, which determines the DNA patterns of disease-causing organisms. Scientists are able to compare these patterns to see if clusters of illnesses are related.” (

  • FDA databases used by field staff, which include information on food sample collections, imports and inspections of food
  • CDC FoodNet, which conducts surveillance for foodborne infections
  • FDA Center for Veterinary Medicine databases
  • European and international notification databases

Finally, the team reviews “anything found in the public domain, such as on the Internet and in print. One useful online source is Foodtrack, a service that tracks product recalls, outbreaks, tampering incidents and food defense threats.” (

Then What?

Once the SST has determined a threat exists, they transfer the case to the CORE Network. Internal CORE files state that the SST evaluated 143 incidents between its launch in 2011 and early June 2012. Only 46 were passed to CORE for a response. Reasons for not transferring an investigation include ones that could give pause. Example: The product could not be identified.

The CORE Network then takes action however it deems necessary. In the Listeria case, that meant contacting Denver offices and the CDC to begin tracking the cases. The Network’s mission is to identify the source and subsequently cut it off before there is any significant spread. That process can involve review of hospital data, interviews with victims, visits to any suspected facility, and an issuance of a suggestion for a voluntary recall. (Read this update for more specifics on the Listeria outbreak.)

New Power, New Responsibility?

fda-recall-process-2In the past, the FDA has not had the authority to order recalls. Instead, it would simply suggest to the manufacturer that a recall be issued, then attempt to communicate that recall to the public in a timely fashion. The regulations for voluntary recalls like those are public information, contained in the Code of Federal Regulations.

Since the power to order a recall was upgraded by the Food Safety Modernization Act (FSMA) in January, 2011, the FDA has developed “interim internal procedures describing the steps it will take to order a food recall, but these procedures have not been made public, and the agency has not provided information on when they will be.” (United States Government Accountability Office report)

Further, FSMA does not require the FDA to issue regulations or industry guidance measures to “clarify for the public procedures for ordering food recalls,” despite the fact that it has issued such regulations concerning medical devices, biological products, and radiation-emitting electronic products. (USGAO)

So, where is the responsibility that comes with such power hidden? Does there in fact exist procedural documentation on the ordering process that the FDA chooses to keep private, or has drafting such regulations been placed on the back burner while CORE Network gains its footing as a new body? And in either case, how does the FDA really keep the consumer informed and safe if not through leveraging the power to order a recall?

We’ll try to answer these questions and we’ll address other concerns with the recall process in our next segment on the topic, due for posting in one week.