Note: The information below doesn't pertain to formula being imported from Europe to address the formula shortage in spring, 2022. That formula comes from an FDA-approved facility and doesn't carry the risks of the formulas described in this article.
In the more than 150 years they’ve been around, baby formulas have gotten quite a bit better at delivering the complex mix of nutrients infants need to thrive. They can’t quite match the gold standard — breastfeeding — but where that’s not doable, they do a good job.
That’s in part because, these days, every baby formula you’ll find in the U.S. is tightly regulated by the Food and Drug Administration, or FDA: what they contain, how they’re manufactured, even the way they’re stored.
Even so, in the last few years, some parents are increasingly choosing to feed their infants European baby formulas (HiPP and Holle are the most popular brands) that aren’t sold in the states, but rather are purchased from third-party vendors. Some, like Organic Baby Shop and Beyond Organic Baby, advertise heavily online.
The problem is that these European baby formulas are actually illegal to sell in the U.S., because they’re not regulated by the FDA. And without regulation, they pose a real risk to the babies who depend on them.
How regulation keeps baby formula healthy and safe
“For many babies, formula is their sole source of nutrition”, says Sherry Archuleta, MS, RD, Director of Clinical Nutrition at Children’s Hospital Colorado. “So if it’s all they’re getting, it had better be high-quality and safe.”
In the U.S., all infant formulas are required to meet strict, evidence-based nutrition requirements designed to get them as close as possible to the nutrition profile of breast milk. That’s true for many European formulas as well — but without FDA regulation, it’s not guaranteed.
The FDA also requires infant formulas to be made using a medical standard known as “Good Manufacturing Practices,” which ensures the formulas are safe and free from infectious agents. The FDA conducts frequent inspections of products and facilities — and if something goes wrong, they’ll require a recall.
That’s one of the problems with foreign formulas, says Archuleta: “If a European formula company had an issue or a contamination — which happens not infrequently — and they issued a recall, there’s no way people in the U.S. would have any idea.”
The risk of unregulated baby formula
Baby formula is carefully engineered, which means the way it’s shipped, stored and prepared is crucial not only to its safety, but to its nutrition profile.
“It’s unlawful to sell unregulated infant formula in the U.S. for that reason,” says Nancy Krebs, MD, MS, Head of the Department of Nutrition at Children’s Colorado.
By effectively skirting oversight, Europe-based third-party vendors avoid being held to the same storing and shipping standards as regulated manufacturers. That puts their products at risk for deterioration and contamination. Even if a formula left Europe in perfect shape, there’s no way to be sure it’ll be that way when it gets to your door.
And when it does get there, it’s hard to be sure you’re preparing it correctly, since the instructions are often not in English. Even the scoop sizes are different, so if the scoop gets lost, it’s impossible to replace without ordering more formula. Parents can try to guess at the right ratio, but that’s a dangerous proposition: an incorrect mix can lead to a baby getting dehydrated or malnourished.
A (baby) formula for success
So why do parents buy a European baby formula in the first place? They’re easy to find online, and many health-conscious parents may not know the risks. A quick google search of “organic baby formula” pulls up European products from several third-party vendors whose websites look perfectly legitimate, even promising that the product ships from the U.S. You’d have no way of knowing that what you’re buying for your baby is in fact unregulated and illegally sold.
HiPP and Holle in particular offer infant formulas that are both organic and based on milk from grass-fed cows, a combination not currently available from any U.S. manufacturer (although there are several organic infant formulas on the market here at home).
There’s scant evidence that grass-fed cow’s milk has any effect on infant nutrition. But even if there were, the risks far outweigh the benefits. When in doubt, ask your pediatrician. In fact, your pediatrician is a great resource for setting your baby up for success.
“We want babies to thrive and grow,” says Archuleta. “If one formula doesn’t work, we encourage parents to work with their pediatrician to find one that does. We know many babies will do well on one formula and not another, but there are lots of options on the U.S. market, and we can work with parents to find the right fit — safely.”