FDA enforcement actions on the decline since President Trump’s inauguration

According to an investigation published in Science, the U.S. Food and Drug Administration’s (FDA) compliance and enforcement actions have plummeted since U.S. President Donald Trump took office. The agency’s “warning letters”—a key tool for keeping tainted foods off the market—have fallen by one-third, for example. Such letters typically demand swift corrections to protect public health and safety. FDA records from Trump’s inauguration through May 22, 2019 show the agency issued 1,033 warning letters, compared with 1,532 for the most recent equivalent period under former President Barack Obama. Compared with the start of the Obama presidency, Trump-era letters dropped by nearly half.

Several other FDA actions under Trump show similar declines when measured against the end of the Obama administration. FDA inspection reports labeled “official action indicated”—typically a trigger for warning letters or similar actions—have fallen by about half under Trump and are continuing to trend downward. Even FDA’s rare injunctions, a more forceful step than warnings to prevent sales or distribution of unsafe or otherwise illegal products, fell from 35 in the last part of the Obama administration to 26 under Trump. (During a comparable period at the start of the Obama years, the FDA issued 51 injunctions.) The agency’s “untitled letters”—for concerns that fall short of thresholds for formal warnings—also have dropped sharply under Trump.

FDA did not dispute the enforcement and compliance data, which Science compiled from the agency’s own public records. In a written statement, the agency responded, “Sometimes the actions we take are visible, like warning letters (or) recalls. … At other times, our actions to protect consumers are less discernible, but equally vital.”

Science article