What You Should Know About European Formulas and the FDA

By Katie Black

If you’re at all familiar with the world of infant nutrition, you’ll know breast milk versus formula is a hot topic. But today we’re going to turn our focus on a different showdown: American versus European formula. How are they different? Why can’t you legally purchase European formula in America, and why is this a lightning rod for the FDAs shortcomings?

Sugars

In recent years, the EU has taken a firm stance on using certain sugars in milk-based formulas, such as corn syrup. These sugars are banned and highlight just how important lactose is as the main energy carbohydrate in human milk. In fact, EU regulations require that at least 30% of the carbohydrates in baby formulas come from lactose —many experts believe lactose is more suitable for babies.

Funny enough, while European formulas meet most of the FDA nutritional guidelines, the same cannot always be said for American formulas. The EU has additional regulations that the FDA doesn’t, setting a higher standard for formula composition and safety.

Vitamins and Minerals

Both the EU and US share common ground when it comes to adding most vitamins and minerals in baby formula. However, two differences stand out—iron and the omega-3 fatty acid DHA.

In the US, baby formulas often have higher levels of iron as recommended by the American Academy of Pediatrics to prevent iron deficiency and the potential neurodevelopmental effects that come with it. On the other hand, the EU recently added requirements for higher levels of DHA in formulas. While DHA is considered safe and found naturally in breast milk, the jury is still out on the benefits of the higher amounts in European formulas. The FDA currently doesn’t have any DHA requirements, but most American formulas contain it anyway.

Milk Bases

When it comes to milk-based options, European formulas offer more compared to the US. In the US, all milk-based formulas remove milk fat and replace it with plant-based fats. Some studies have looked into the possible benefits of a part of milk fat called Milk Fat Globule Membrane (MFGM), which might be good for fighting infection and have cognitive benefits for babies. European formulas based on whole milk have a natural source of MFGM.

Gentle Formulas

In the US, caregivers looking for "gentle" formulas with some broken-down proteins are often met with options that have corn sugar. On the other hand, European formulas offer the same with lactose as the only carbohydrate, the preference of experts for most babies.

So if European and American formulas are comparable with Europe having even stricter rules, why can’t American consumers buy European formula legally? The short answer: the FDA can’t effectively regulate them. The long answer is a bit more complicated.

The FDA

As you probably already know, the Food and Drug Administration is an agency in the United States responsible for ensuring the safety and effectiveness of food, drugs, medical devices, cosmetics, and other products. While the FDA is definitely necessary for protecting public health, there are legitimate concerns about how it operates.

The FDA has very strict labeling policies which European formula companies often don’t meet. Things like having clear instructions in English and a different number of required scoops than most American formula brands could pose a risk, but there are other factors at play as well.

For one, the high tariffs placed on formula imports discourage foreign brands from getting FDA approval. These tariffs were one of the biggest criticisms at the beginning of the formula shortage before they were temporarily waived.

Back in 2005, the FDA had some concerns about their systems so they had the Institute of Medicine (IOM) conduct an independent assessment. In 2006, the IOM committee released a report called "The Future of Drug Safety: Promoting and Protecting the Health of the Public," which had a bunch of recommendations for improvement.

The IOM committee found four weak points in the U.S. drug safety system:

There was chronic underfunding, which really hurt the system's effectiveness.
There were organizational problems, especially with data review before and after releasing something to market.
There were a variety of technical problems because there wasn’t enough high-quality data and the system was bad at monitoring the risks and benefits of products after they hit the market.
There was a lot of uncertainty around regulatory authority and little flexibility in regulatory tools. Clearer guidelines were needed.

But these aren’t the only issues. In addition to the IOM’s findings, other criticisms of the FDA often cited are:

Regulatory capture: where the FDA's decision-making process is influenced by the very industries it’s supposed to regulate. Some argue that the FDA's close ties with the pharmaceutical and food industries can lead to conflicts of interest, hurting how well the agency can act independently and in the public's best interest.
Approval Process: The FDA's approval process for new drugs and medical devices is often criticized for being slow and difficult. Some claim that the FDA's strict requirements lead to excessive regulation and prevent innovative products from ever entering the market.
Influence of Lobbying: The FDA's decision-making process is open to lobbying efforts from stakeholders, including the pharmaceutical industry, consumer groups, and patient advocacy organizations. Critics say that these lobbying efforts can shape FDA policies and priorities, maybe even leading to decisions that favor certain interest groups over public health concerns.

Overall, while it seems to make little sense why European formulas are illegal to purchase in America, it adds up when keeping the FDA’s limits in mind. There simply aren’t enough resources for the FDA to do a good job at regulating European formulas. It’s less to do with whether or not European formulas meet all their requirements, and more to do with the process of confirming and regulating the imports. This is disappointing for parents who would prefer feeding their child European formula, but it’s always possible things can change in the future.