In fact, it can be traced back to the beginning of the pandemic, when families across the country, facing lockdowns and closures stocked up on many basic foods including formula. Of course this problem was exacerbated this February, when the FDA instituted product recalls and closed the big Abbott plant in Sturgis, Michigan, with more than 483 “observations,” including the possible though unproven tie of several cases of bacterial contamination causing illness and death of two infants.
But this closure has now stretched on for months, which is far too long, and with all the media attention and panicked buying, more than 40% of America’s baby formula supplies are now out of stock on store shelves.
In other words, in a highly regulated attempt to ensure formula safety, the FDA has helped create a greater problem in terms of hungry even starving infants. Dr. Scott Gottlieb, former FDA commissioner, tweets that “a modernization act by Congress for infant formula should include more FDA staff, stepped up cadence of inspections, more frequent testing requirements for plants, incentives through use of review resources and how WIC is allocated to support new entrants to create more suppliers.”
WIC is the USDA’s Women, Infants and Children’s program, which supplies the majority of the formula in this country to the states, especially to help low income and underserved communities. Nearly half of the infants in the program have an Abbott product as their primary source of formula, which also makes much of the specialty formulas required by infants with restrictions, including for allergies. So the FDA Abbott recalls reverberate across the entire infant formula sector, and is amplified by the panicked buying that has resulted. Back in February, at the time of the recalls, WIC did increase its flexibility, but clearly not enough.
And while I agree with Dr. Gottlieb, I also think the problem and the solution go way beyond staffing, speeding up inspections, incentives and WIC allocations.
For starters, FDA regulations in this area are excessive when you consider that many involve labeling rather than safety requirements. Especially during a shortage, much of the red tape needs to be cut away, much as formal review processes for new vaccines and drugs gave way to Emergency Use Authorizations during the pandemic.
The formula shortage is also a public health crisis and should be treated accordingly. Not only should there be less regulation, but infant formula (from Europe and Canada) are crucial, should not be routinely seized or confiscated at the border, leading to a much more risky “black market” than if they were simply screened and utilized to augment supply.
The fact that the vast majority of infant formula used in the U.S. is manufactured here is not automatically a good thing; it contributes to the problem. Meanwhile, Abbott (Similac), Mead Johnson (Enfamil), and Nestle (Gerber) and Perrigo provide close to 90% of all the formula. More companies and competition are clearly needed.
Finally, the most important thing the Biden administration can do is to invoke the Defense Production Act, not just to pre-pay for formula in an attempt to bolster production, but to establish a precedent which will hopefully lead to a national reserve or stockpile. We don’t think twice about stockpiling vaccines, ventilators, masks, but infant formula is no less important.
Our babies are the future of this country. According to the CDC, though 85% of women breastfeed, at the same time close to two-thirds of infants require formula at some point over the first six months of life. An essential role of government is to make sure that they have it.