Formula Safety
Is HiPP and Holle Formula FDA Approved?
What FDA rules mean for HiPP and Holle, and how to buy them safely
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Quick Answer
No, HiPP formula is not FDA approved, and neither is Holle, because the FDA does not approve any infant formula before it is sold. US brands instead notify the FDA and must meet its nutrient and labeling rules prior to market launch. HiPP and Holle are regulated and sold under EU infant formula law, and for that reason are outside of the FDA's jurisdiction. Direct to consumer sites such as Grow Organic Baby are the best way for US families to access these formulas, as they are shipped directly from Europe to you.
Does the FDA approve any baby formula?
No. The FDA does not specifically approve infant formulas before they can be marketed. That surprises a lot of parents, because "FDA approved" sounds like the gold standard. It is a phrase that belongs to drugs, not to food or formula.
What the FDA does is set the rules that every formula sold in the US has to follow, such as minimum and maximum levels for each mandatory ingredients and nutrient, quality controls in manufacturing and storage as well as specific labeling requirements. A manufacturer has to notify the FDA at least 90 days before it markets a new formula, and a formula sold without that notification is treated as adulterated under US law. So when you see a US formula on a store shelf, it really means "notified to the FDA and subject to FDA rules," not "approved."
Why is HiPP and Holle formula not FDA approved?
Both are focused on the EU market and for that reason have never attempted the US notification process. HiPP and Holle makes formulas for European families, to European rules, with European labels. That is why you will not find them at Target or Walmart.
Neither brand is breaking a rule, they are European companies focused on selling in Europe, and US parents who want them buy can do so from websites such as Grow Organic Baby, who ship directly from The Netherlands. If you are deciding between the two brands, our HiPP vs Holle comparison goes through the differences stage by stage.
What did the 2022 enforcement discretion change?
During the 2022 formula shortage the FDA issued guidance, on May 16, 2022, that let certain foreign manufacturers ship formula into the US even though they did not meet every US requirement. Companies received individual letters of enforcement discretion. In September 2022 the FDA followed with a transition plan for firms that wanted to stay in the US market for good. They had to work toward full compliance and file new infant formula submissions, which the FDA expected by July 15, 2025.
Kendamil is one of the brands on the FDA's transition plan list, which is why some Kendamil formulas now appear on US retail shelves. HiPP and Holle did not participate in the discretionary period or the transition plan, and are not on the FDA's list of infant formulas marketed in the US.
Is HiPP and Holle legal in the US?
HiPP and Holle Infant Formula is allowed to be sold and shipped for personal use, directly to US consumers from Europe. It is not allowed to be stored, shipped or sold domestically through US retailers.
US parents have been buying European formula from importers for over 15 years, and the formula itself is made to the much higher and stricter EU standards. Established retailers such as Grow Organic Baby, who launched in 2016, and maintain an impeccable record for trustworthiness and customers service are the best ways to source the products.
How EU law covers HiPP and Holle
HiPP and Holle infant formulas are made under Commission Delegated Regulation (EU) 2016/127, which has applied to infant and follow-on formula since February 22, 2020. It sets the composition of every infant formula sold in the EU. A few of its rules parents ask about most:
- DHA is required. Every EU infant formula must contain DHA, between 20 and 50 mg per 100 kcal. US rules do not require it.
- Pesticide residues are capped at 0.01 mg/kg for each pesticide, a limit the regulation sets on the precautionary principle, with stricter limits for a handful of specific pesticides.
- Sesame seed oil and cottonseed oil are prohibited, and trans fats are capped at 3% of total fat.
- Sucrose and glucose may only be added to formula made from protein hydrolysates, so a standard cow or goat milk infant formula cannot be sweetened with table sugar.
On top of that, HiPP and Holle are both certified organic under EU organic rules, and Holle is also Demeter certified biodynamic.
How to buy HiPP and Holle safely in the US
- Buy from an established seller that specializes in European formula, not a marketplace listing without a track record.
- Check every tin when it arrives. The FDA's advice for spotting tampered or counterfeit formula applies here too, look for damage to the can, and check that the lot number and use-by date are printed clearly and match the packaging.
- Follow the preparation instructions for the exact version you buy. HiPP makes Dutch, German and UK versions, and they are separate products with their own labels. Our guide to HiPP Dutch vs German vs UK compares the versions.
Related guides
- US vs European baby formula ingredients: what differs on the label.
Rodney Hyde
International Formula Expert at Grow Organic Baby
This article is for educational purposes and is not a substitute for medical advice. Always consult your pediatrician about your baby's nutrition.
