Foods Program reform misses the mark

Imagine you are presented with a brand new car, given the keys and told that you are the owner. But then you discover other people have keys to the car and they believe they are also the owners. This is the most accurate analogy that could be applied to the US Food and Drug Administration (FDA)’s plan to reform the Foods Program. Unfortunately, the flawed plan would cement a fragmented structure that lacks focused leadership and accountability, and will continue to fail consumers and virtually guarantee another situation similar to the infant formula crisis.

Numerous factors contributed to bring about that event, which prompted calls for reform at the FDA. First and foremost, the actions of food manufacturer Abbott were particularly problematic, especially after the FDA first detected Cronobacter at the company’s Sturgis, MI facility in 2019 and given the allegations outlined in a whistleblower report released in February 2021.

However, this episode also raised numerous questions about how the organisational structure, governance and performance of the FDA Foods Program impacted the infant formula recall, and whether the FDA performed its regulatory role effectively throughout this process. The evidence suggests that the agency was too slow to act, failed to take the issue seriously, and was not forthcoming with information to parents and caregivers.