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FDA Violations

FDA Recalls and U.S. Food Supply Safety

— January 22, 2018

The Food Safety Modernization Act became law in 2011, but did it help the FDA improve our food supply safety? A House subcommittee asked, the FDA answered.

The CDC estimates that 1 in 6 Americans gets sick every year from foodborne illnesses. That’s 48 million of us, while 128,000 are hospitalized and 3,000 people die. Obviously, food safety is a massively important issue for citizens and lawmakers on both sides of the aisle. Last Friday, the Oversight and Investigations subcommittee of the House of Representative’s Energy and Commerce committee held a hearing concerning food safety and the FDA’s ability to hold up its end of the bargain when it comes to insuring food supply safety for all Americans.

In 2010, Congress passed FSMA, the Food Safety Modernization Act, which was signed into law by President Obama on January 4, 2011. You may remember the flurry of public dismay surrounding the Act; it’s the law that was supposed to outlaw grandma’s vegetable garden and drive all the small farms out of business. Last I checked, Grandma was still growing those Brandywine tomatoes and the local food scene is as active as it’s ever been (at least since we, collectively, went all-in for an industrially grown and processed food system).

Regardless of where your food comes from, food supply safety is a critical issue. Nobody wants to end up in the hospital (or the morgue), whether they eat a mass-produced treat made from tainted peanut butter or a delicious, creamy, salmonella-rich artisanal cheese. That’s why FSMA was enacted, but a law does no good if it’s not creating the desired effect. That’s why the Energy and Commerce committee heard testimony from Douglas Stearn, a director of enforcement in the Office of Regulatory Affairs at the FDA, and Gloria Jarmon, a deputy inspector at the Office of Inspector General (OIG) at HHS.

The issue at hand? While FSMA has been in force for seven years now, the FDA still has significant problems and a tarnished record as far as keeping track of food supply safety. To help, the Office of the Inspector General at HHS performed an audit of the FDA’s practices in 2016, found them lacking in a few key areas, and provided some suggestions for changes going forward. The FDA is already working on implementing the OIG’s suggestions, but in the meantime, Congress wanted to know how it’s going. After all, in 2017 there were over 3,600 recalls of tainted food and food-adjacent products (such as dietary supplements) in the United States alone. How can the FDA improve?

According to the OIG, three reasons the FDA fell flat include deficiencies in the oversight of the recall process (especially initiating recalls), insufficient monitoring those recalls, and poorly recorded or maintained data in the FDA database, particularly when it comes to keeping track of the date the FDA learned of potential dangers to food supply safety. (As one example, a faulty date entered into the system made it appear that the FDA took action only ten days from learning of a danger, instead of about 300 days.) Long delays in this context mean that potentially contaminated products are still available on store shelves, possibly sickening more people.

A trio of French cheese wedges, stacked on a white surface, sits in front of a grey and white stone wall.
Food supply safety is a critical issue. Nobody wants to end up in the hospital (or the morgue), whether they eat a mass-produced treat made from tainted peanut butter or a delicious, creamy, salmonella-rich artisanal cheese. Photo by Alexander Maasch, via Unsplash.

The FDA responded by forming the SCORE Team, which stands for Strategic Coordinated Oversight of Recall Execution. This is a multi-disciplinary team of specialists with leadership roles in major fields affected by FDA policy. The quality and quantity of expertise brought to the table is intended to streamline and speed FDA response to food supply safety threats.

Another ace up the FDA’s sleeve is the power to mandate product recalls, granted to them by the FSMA. While that power has only been directly used twice, Mr. Stearn testified that it played an important role in negotiations with firms whose products have tested positive for pathogens, stating that when a company knows that the FDA could demand a recall, the company is more likely to voluntarily recall dangerous products on its own.

A major takeaway from the hearing is the amazing complexity of America’s industrial food system. The labyrinthine path (from industrial farms, through multiple processing and distribution facilities, to America’s dinner tables) that makes contamination so much likelier to occur in the first place and spread to multiple states is the same maze that complicates the FDA’s ability to effectively monitor food supply safety. The FDA ends up relying heavily on voluntary compliance and firms that police themselves. And as we all know, the private sector’s profit-motivated urge to push product to market while cutting costs is a compelling reason for the FDA to exist.

Complexity is a self-creating feedback loop, at least until it implodes. A complex economy in a large country with a convoluted food system necessarily spawns a many-layered bureaucracy just to keep track of everything safely. While re-localizing the food economy could be a win for many small producers and an ecological benefit in general, it would also cut down on the “size” of government we need to insure food safety while limiting the scope of outbreaks. Our outcomes reflect the choices we collectively make every day, and this is in no way an exception.

Related: Trumping the Safety of our Food


Safety of the U.S. Food Supply: Continuing Concerns Over the Food and Drug Administration’s Food-Recall Process
FDA Food Safety Modernization Act (FSMA)
Strategic Coordinated Oversight of Recall Execution (SCORE)


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