Is It Time for a ‘New FDA’ to Regulate Food and Dietary Supplements?
A recent Politico article reported that a long-running joke among U.S. Food and Drug Administration (FDA) officials is that “the ‘F' in FDA is silent.” As FDA dedicates most of its budget and resources to drugs and medical devices, regulating food—including dietary supplements—appears to be less of a priority for the agency. This perceived disparity in regulation has led some to express concerns over the safety and reliability of our food supply.
Recently, FDA's delayed responses to issues identified both during inspections and in whistleblower reporting likely contributed to the national infant formula shortage. Following criticism of the agency's handling of the formula shortage, FDA Commissioner Robert Califf has asked the Reagan-Udall Foundation—an independent nonprofit created by Congress to advance the mission of FDA—to evaluate the agency's food program.
Furthermore, recalls of conventional food products make up the majority of FDA recalls and are estimated to cost the country billions of dollars per year. In addition, millions of people in the U.S. are sickened by foodborne illness annually, despite the fact that most cases of foodborne illness are preventable. Altogether, confidence in FDA's ability to keep Americans and our food supply safe has waned.
Calls for Reform
Critical of FDA's inattention to food safety, dietary supplement industry leaders who have worked collaboratively with lawmakers on responsible regulation of the category—including the American Herbal Products Association (AHPA)—agree that improvements to federal oversight of food and dietary supplements are needed. This consensus raises the question: is it time to reassign the responsibility for the regulation and safety of the U.S. food supply?
Though such amendments to FDA authority would be unprecedented and complex to carry out, proponents in Washington have recently thrust the idea into the spotlight for public discourse. Chief among them are U.S. Senator Dick Durbin (D-IL) and Congresswoman Rosa DeLauro (D-CT), who introduced the Food Safety Administration Act of 2022 (S.4520; H.R.8358) earlier this year in response to FDA's “inadequate responses to recalls, a failure to implement a culture of outbreak prevention, and proposed rules and initiatives that languish for years.”