Is Holle Baby Formula FDA Approved?

April 26, 2019

Since its founding in 1906, the Food and Drug Administration (FDA) has been responsible for protecting public health here in the U.S. It does this by regulating basically anything that can be ingested: food, supplements, medications, the list goes on. It makes sense, then, that baby formula is included within the FDA’s scope.

Naturally, you would never want to feed your baby something that isn’t safe. We all strive to give our little ones the best nutrition possible. Holle baby formula offers just that. So it may surprise you to know that none of the baby formulas manufactured by Holle are actually approved by the FDA. So where is the disconnect? Why is Holle formula not FDA approved? Is Holle formula safe? Read on for some answers to these important questions.

The simple answer is that the FDA regulates items manufactured within the U.S. — and Holle baby formulas are made in Germany. This means that Holle falls within European regulation, which is governed by the European Commission.

The European Commission is an institution of the European Union responsible for upholding regulations that apply to all EU countries. This includes the manufacturing of baby formulas. While both the FDA and the European Commission require sterile manufacturing environments and packaging as well as a number of other similar stipulations around infant formula, the European Commission takes it one step further.

The European Commission established regulations for baby formula manufacturers back in 2006. These included standardizing how baby formula was labeled and prohibiting the manufacturers from adding sucrose (sugar).

In 2016, the European Commission updated its directive on baby formulas. This directive called for formulas to contain no detectable levels of pesticide residue and prohibited the use of toxic pesticides. What’s more, it created provisions on the use of food additives as well as contaminants that could come into contact with the formula during its production. The European Commission’s requirements far exceed those set up by the FDA when it comes to manufacturing baby formulas.

To ensure their formula contains truly the best ingredients, Holle goes beyond the European Commission’s regulations: it adheres to Demeter biodynamic standards as well. Demeter certification is highly coveted and awarded only to companies that practice biodynamic agriculture. The standards require specific measures be taken to ensure the longevity of the soil, plant, and livestock and to preserve the environment for future generations to enjoy. This includes prohibition of chemical-synthetic fertilizers, spraying agents, and GMOs throughout the entire farm where the ingredients are being grown.

As you can see, European baby formulas are absolutely safe and those made by Holle are undoubtedly the highest quality. Do you feed your baby Holle baby formula? We’d love to hear about your experiences in the comments below!