Another Infant Formula Shortage? Blame the FDA

On December 28, 2023, the Food and Drug Administration received information that a sample from a hypoallergenic infant formula called Nutramigen was contaminated with salmonella. Since then, Nutramigen’s producer Reckitt/Mead Johnson Nutrition voluntarily recalled 675,000 cans of formula and began undergoing hygiene and safety inspections conducted by the FDA. The plant is still under inspection.

The recall and ensuing plant shutdown are causing a national shortage of hypoallergenic infant formula. While less common than standard formula, hypoallergenic is vital for an estimated ten percent of infants with severe protein allergies who need it to receive adequate nutrition. 

The shortage is quickly getting worse. Infant formula producer websites urge parents to check their real-time inventory updates to see if stores within 200 miles of their zip code have supplies. Facebook groups with over 1,000 members recently formed to support parents struggling to find hypoallergenic formulas for their infants. 

Fearing a return to the devastating infant formula shortage of 2022, several politicians are demanding accountability and answers. 

Pennsylvania Senator Robert Casey Jr. from Pennsylvania wrote Reckitt/Mead Johnson Nutrition to ask whether they anticipate further supply disruptions, if other plants can ramp up production to mitigate the shortage, and whether the FDA’s inspection is preventing Nutramigen from reaching shelves. Writing directly to the FDA, Florida Senator Rick Scott wants to know what the agency is doing to help other infant formula producers make more hypoallergenic formulas and when the facility where the contaminated formula was found will be operating again. 

Both senators and countless parents have the right to be upset and concerned. However, asking the FDA for guidance and remedies for this formula shortage fundamentally misunderstands the source of the problem. 

Much like the current shortage, the devastating infant formula shortages in 2022 began with massive recalls after the FDA received information that some infants became sick after using formula produced by a plant in Sturgis, Michigan. The plant started recalls and underwent a full inspection. The plant remained closed for months after the inspection– even when the US infant formula supply shrank by 40 percent.

If anything, the FDA is doing a worse job in detaining plants from reopening safely this time. According to the agency’s report, “The voluntarily recalled Nutramigen product was manufactured between June 6, 2023, and June 29, 2023.” Thus, it’s overwhelmingly likely that any contaminated formula was consumed months ago. 

Rather than urging the FDA to work quickly and help producers, the agency could dramatically improve the problem by eliminating barriers to importing formula.

As my co-author and I addressed in an article in Fortune written during the first infant formula shortage, the FDA could quickly increase formula supplies by relaxing their mandatory 90-day waiting period to allow foreign formula to hit markets. The agency also prohibits foreign formulas that do not meet nutritional labeling requirements even when the agency’s nutritional standards are met.

None of these easy-to-implement ideas were considered in 2022 and are less likely to be used now. Instead, European formula producers are more likely to face additional regulatory hurdles as part of the agency’s most recent effort to increase oversight over imported goods. 

Sadly, as I noted in a blog for The Beacon last November, despite the FDA claiming they “never want to have this [formula shortages] happen again,” they haven’t addressed any of the reasons for infant formula shortages in the US. 

Until they do, we remain vulnerable to more shortages, this being just another predictable example.