On April 8, 2022, POLITICO published an investigation report by Helena Bottemiller Evich that reveals serious dysfunction in the FDA’s food branch. The investigation report has led to increasing concern among consumers and industry groups alike. The report gained further clout when a group of consumer/public health groups, industry groups, and state government representatives wrote a joint letter to the FDA’s Commissioner, Dr. Robert Califf, addressing the primary concerns presented in POLITICO’s report and called for an immediate reformation of the department.
POLITICO’s investigation report gathered information from over 50 people, including current and former high-ranking FDA officials, as well as other prominent consumer advocates and food industry leaders. Among the various interviews, the consensus was overwhelming,“the agency is simply not working”. POLITICO reports, “current and former officials and industry professionals used terms like ‘ridiculous,’ ‘impossible,’ ‘broken,’ ‘byzantine’ and ‘a joke’ to describe the state of food regulation at FDA.”
The primary concerns addressed in the joint letter to the FDA Commissioner are “structural, governance, and performance problems”, particularly the issue of the “lack of a single, fulltime, fully empowered, and expert leader”. Stephen Ostroff, a former two-term acting FDA commissioner says, within the FDA “the food program is on the back burner.” He contrasts the attention given to the drug department, as opposed to the food department, saying, “there’s nobody really pushing very hard to get [things] done in the same way that [they are] pushing very hard to get the Covid vaccines out there and authorized. We don’t have that imperative and that pressure to actually make things happen on the food side of the Food and Drug Administration.”
The joint letter to the FDA Commissioner urges him to “unify the FDA food program under a deputy commissioner for foods, with accountability to the commissioner and direct line authority over CFSAN, CVM, and the food-related components and operations of ORA”, in order address the pressing issue of the lack of real leadership and execution.
It is no coincidence that the POLITICO report comes in the wake of a Cronobacter outbreak connected with baby formula that sent four infants to the hospital and resulted in two infant deaths. POLITICO reports that it took the FDA months between the time of the first infant illness report and the time of a facility inspection, and furthermore, another month before a recall was issued. This delayed response is just one example of the real-life gravity of the FDA’s dysfunctional system and reveals the necessity that industry leaders and consumers demand that the food branch of the FDA be reformed.
