Insights Into the FDA Recall Process: Part II

Last week, we discussed the FDA recall process itself, highlighting procedural and administrative actions. This week, we’re ready to dive into the food and drug safety system in all its glory—and to explain why there might be cause for questioning the effectiveness of current practices.

Food Safety Modernization Act

food-safety-modernization-actWhen the FSMA upgraded the FDA’s power to order a mandatory recall, it was a big deal. Never before did the FDA hold the power necessary to force independent companies to recall their products—instead, it was strongly suggested, and the suggestions were usually followed. Interestingly, this is still the case. The FDA doesn’t jump to mandates for just anything.

While the FSMA highlights the procedures for determining the need for a mandatory recall, reporting it afterward, informing the responsible party and the like, the FDA has also added interim procedures that have not been made publicly available. Is it a problem for the public to not know exactly who reports what to whom and when and how? According to the U.S. Government Accountability Office, it certainly is.

Public Information for Public Health Concerns

In January 2007, the USGAO released an update to its high-risk report which outlines why food safety is such a huge public concern. The report states:

“Agriculture, as the largest industry and employer in the United States, generates more than $1 trillion in economic activity annually. Any food contamination could undermine consumer confidence in the government’s ability to ensure the safety of the U.S. food supply, as well as cause severe economic consequences.” Source

Undermining confidence is surely a monumental concern. If consumers can’t trust their designated regulatory bodies, how can we function without constant paranoia in a society where most things come to us only after passage through many figurative and literal hands? To that end, one of the biggest issues surrounding food safety in the U.S. is dissemination of information. How will the consumer know if she or he is eating contaminated food or taking an ineffective or adulterated drug?

food-recallFSMA refocused FDA efforts, from targeting contamination response to working toward contamination prevention, according to the FDA. It even serves as an outline for how to publicize information the FDA deems appropriate to publicize (that concerning public health or about a product already in consumers’ hands).

But informing the public in a timely, organized fashion will always be an issue in the process, regardless of established guidelines—because the public isn’t a homogenous mass. Rather, people use various news sources or none at all—and most do not access the FDA’s website itself.

Why Are There Still Concerns After FSMA?

The GAO’s High Risk list is updated every two years. The 2013 list still features food safety oversight, even after the approval of FSMA in 2011. Citing the jumbled involvement of multiple regulatory bodies and three trends (importation, minimally processed foods and growing populations of susceptible people [e.g. the elderly]), the report notes that FSMA does not necessarily address some of these issues. Therefore, its passage is not enough to remove federal oversight of food safety from the High Risk category of national concerns.

“It does not apply to the federal food safety system as a whole or address USDA’s authorities, which remain separate and distinct from FDA’s. What’s more, because FSMA is not yet fully implemented and a number of the regulations required under the law are still under development or review, it is too early to understand in depth the impact of the law on federal oversight of food safety.” Source

In short, FSMA did not fix everything. Despite its many measures that work toward prevention, the system itself is large and dynamic, so flaws will always exist. One of the most prominent of these flaws is the potential for economic harm to individual producers and the perceived inability of the federal government to properly track and compensate such losses.

Economic Edification:  How Could We Improve?

Section 206 of the FSMA includes reference to a report the Comptroller General is required to submit to Congress within 90 days after the date of the Act’s enactment. The report must include an evaluation of “new or existing mechanisms available to compensate persons for general and specific recall-related costs” when the recall is determined to have been an error. It also must “consider models for farmer restitution implemented in other nations.” Source

spinachWhen the big spinach recall was a sweep, spinach farmers seriously suffered. There are a lot of reasons for that: the FDA hadn’t yet identified the source (one of the largest issues in its response process), but knew the health concern was great enough that it issued statements about recalling all spinach; consumers read headlines first and details later, if at all; the follow-up was less than ideal; once a story has been seen heard, it cannot be unseen or unheard—a permanent scar was left on the spinach industry.

On top of that, a law called Sovereign Immunity dictates that a state institution cannot be sued for actions within the scope of its power. As the FDA is a federal body, it can exercise Sovereign Immunity, leaving spinach farmers (or the latest mistaken recall victim, Zachary candy) in a state of economic woe that can’t be easily undone.

Your Role in Federal Safety Oversight

What can we do to ensure our food and drug supply is safe and our farmers and manufacturers compensated for inevitable mistakes? We can demand greater accountability, but the system is large, as mentioned, and difficult to police on an individual level.

Perhaps a more appropriate question, then, would sound like this: “How can I ensure my safety and the safety of my family?” Tackling this concern first could lead us to a place where we can improve others’ health, including that of the system itself.  Next week, we’ll talk about your role in the process, and much more.