FDA’s efforts to ensure that infant formula – often the sole source of nutrition for infants – is safe have typically exceeded the Agency’s approach to traditional food products. For instance, the Food and Drug Administration (“FDA” or “Agency”) has a policy of annually inspecting formula manufacturers, while traditional food facilities are inspected once every 3-5 years.
Because of safety concerns, FDA has historically approved only a few formulas for import. The United States imports only about 2 percent of baby formula a year – the rest is made domestically. Imported infant formula that has incorrect labeling or does not contain the FDA required nutrients may end up being placed on an FDA import alert or “red list” and can be detained without physical examination or seized.
FDA’s import authority doesn’t always result in a protection of public health, however, and instead can impose arbitrary requirements on legitimate products that can further compound supply shortages and adversely affect the public welfare. Furthermore, seizure authority is placed in the hands of local field officers who may incorrectly apply certain controls.
In response to the infant formula shortage, if the Agency is willing to waive some of the requirements that apply to foreign manufactured infant formula on a case-by-case basis, one has to ask if certain Agency requirements were necessary (or appropriately applied) in the first place. It seems that the Agency is realizing this – and is loosening restrictions on imports of formula manufactured abroad that may not have meet prior federal requirements but are still perfectly nutritious and safe for infants.