Late last month, the Food and Drug Administration (FDA) sent warning letters to three different baby formula companies expressing concern over the manufacturers’ practices for handling contamination in their products.

“You did not establish a system of process controls covering all stages of processing that was designed to ensure that infant formula does not become adulterated due to the presence of microorganisms in the formula or in the processing environment,” the FDA wrote in its letters to ByHeart Inc., Reckitt/Mead Johnson Nutrition, and Perrigo Wisconsin. The FDA also requires the companies to respond within 15 days with “the specific steps you have taken to correct the stated violations, including an explanation of each step being taken to identify violations and make corrections to ensure that similar violations will not recur.”

These letters indicate that another formula crisis should soon be underway. Just four companies—including Mead Johnson and Perrigo—comprise 90 percent of the U.S. baby formula market, meaning that if just one factory is forced to stop production due to safety concerns, it could send a massive shock to the U.S. formula supply, creating a repeat of last year’s baby formula shortage.

[I’m sure the White House is all over it. Camp offers her thoughts on how to prevent it by lowering the tariffs and restrictions on imported formula. That might have more of an impact on compliance by domestic producers than strongly worded memos. — Ed]