https://www.wsj.com/articles/fda-seizing-seizes-baby-formula-crisis-shortage-europe-abbott-nutrition-hipp-holle-kendamil-infant-producers-11653248212?mod=opinion_lead_pos9
Hundreds of thousands of parents in the U.S. are scrambling to find formula for their babies, and President Biden has invoked the Defense Production Act, a Cold War-era national-security law to boost domestic production. Yet the Food and Drug Administration has been enforcing an effective ban on formula from Europe, the world’s largest producer and exporter.
Some of the current shortage of baby formula derives from pandemic-related labor and supply-chain problems, as well as a recall of Abbott Nutrition formula products, which knocked out a large chunk of domestic supply. The other domestic suppliers, such as Bobbie Baby Formula, simply can’t “flip a switch and just make more formula,” as CEO Laura Modi put it.
The FDA has announced streamlined regulatory approvals for European formula, but it’s unclear whether such popular brands as Hipp, Holle and Kendamil will be permitted in the U.S., because their infant formula products aren’t registered with the FDA.
European baby formulas are regulated by European regulatory authorities, and research has found that most meet FDA-required nutrient levels. They don’t meet FDA labeling and other requirements, however. Most don’t have formula-preparation instructions in English, specific labeling on iron content or instructions on how to store the product. The FDA also has concerns about European formulas requiring less water per scoop, the temperature conditions under which they are stored, and their lack of a system to notify U.S. consumers of recalls. Major European producers such as Hipp and Holle have not spent the time and money needed to comply with FDA regulations.