September 25, 2019

Is Baby Formula FDA Approved?

For the health and safety of consumers, the U.S. Food and Drug Administration has laws and regulations. But what about European baby formula?

The U.S. Food and Drug Administration (FDA) is responsible for the standards in food that is manufactured in the United States. Because infant formula is the primary, if not only, source of nutrition for many children under the age of 12 months, it is the FDA's responsibility to regulate its commercial production to ensure nutrients and food safety. Baby formula companies have to register with the FDA before they can market any of their product.

What Does the FDA Regulate in Baby Formula?

One of the requirements that the FDA regulates is nutrition. The FDA has specifications that every type of baby formula must have. All baby formula must have a minimum of 29 nutrients. There are nine nutrients that must have the maximum amounts for the recommended daily value. All baby formulas that are marketed in the United States must meet the dietary guidelines unless it has an exemption. Some of the baby formula variations are exempt because it meets the nutritional needs for those with medical or dietary problems. Overall, the baby formula that is manufactured in the United States must meet these requirements whether they are the top name brand or the generic formula sold by specific store chains.

Another requirement established by the FDA concerns food safety. One rule is the universal use of a “use by” date on all baby formulas. This means that the product must be consumed on or before the date stamped on the package. Any consumption after that date can have consequences to your baby. The nutritional value will decrease as the product will start to deteriorate and go bad. There are also health and safety concerns with expired product.

You can find more information regarding the FDA and its regulations on baby formula at

Are European Baby Formula Brands Approved by the FDA?

No.  The reason is that the FDA only approves manufacturers in the United States. They establish the rules and regulations in this country and have no control beyond the borders.

Which Organization Regulates Baby Formula from Europe?

The European Commission is responsible for the nutrition and food safety for the countries in the European Union. In 2016, the Commission updated their regulations regarding infant formula and follow-on formulas for the nutritional requirements and safety guidelines. One provision specifically restricts or prohibits pesticides or pesticide residues in both types of formula.

What Does This Mean for Your Baby Formulas Choices?

If you are concerned about nutrition and food safety, you can be confident that there are regulations in place under the FDA in the United States. However, if you want to have more choices, do not let the lack of FDA approval on European baby formulas such as Hipp, Holle, Lebenswert, or Loulouka deter you from these products.

Edited and reposted from April 2018

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