The short answer: no, most European infant formulas are not FDA-registered, but the FDA does not treat that as a reason to stop parents from buying them for personal use. The longer answer has genuine nuance that matters for understanding the risk and the legal status, and both "they're totally safe and it's fully legal" and "you're breaking the law" are oversimplifications that get repeated in parenting forums.
Here's the actual regulatory picture as of April 2026.
What "FDA-approved" means for infant formula
The FDA does not "approve" infant formulas the way it approves drugs. The relevant mechanism is registration under 21 CFR Part 107, a manufacturer notifies the FDA of a new infant formula product, submits the required composition data, passes facility inspections, and becomes registered. "FDA-registered" is the accurate term; "FDA-approved" is commonly used but technically imprecise.
The FDA registration process involves:
- Pre-market notification (manufacturer submits product data 90 days before launch).
- Facility inspection of the manufacturing plant.
- Composition verification against 21 CFR 107 nutrient minimum/maximum requirements.
- Ongoing compliance audits and surprise inspections.
Registration is a US regulatory framework. European manufacturers are subject to the parallel EU framework (Regulation 2016/127 for composition, Regulation 2018/848 for organic certification, plus national-level requirements), which has comparable or in some cases stricter composition requirements than the US version. A European organic infant formula is regulated. It is just regulated by a different agency.
Which European brands are FDA-registered
A short list. As of April 2026:
| Brand | FDA status |
|---|---|
| HiPP (Dutch, German, UK) | Not FDA-registered |
| Holle (Cow, Goat, A2) | Not FDA-registered |
| Kendamil (Classic, Organic, Goat) | FDA enforcement discretion for direct US retail |
| Lebenswert | Not FDA-registered |
| Jovie | Not FDA-registered |
| Kabrita | FDA enforcement discretion for direct US retail |
| Loulouka, Löwenzahn | Not FDA-registered |
Kendamil and Kabrita are distinct: they received FDA enforcement discretion for direct US retail sale during the 2022 Abbott Cronobacter shortage, and have retained that status through subsequent renewals. You can buy Kendamil at Target and Kabrita at Target / Walmart as a legitimate retail transaction, not a personal import.
HiPP, Holle, Lebenswert, and Jovie continue to be imported under "enforcement discretion for personal imports," which is a narrower and more specific legal posture.
What "enforcement discretion" actually means
The FDA has a formal policy of exercising enforcement discretion on infant formula imports that are:
- Destined for personal consumption by the purchaser or their family.
- Imported in quantities consistent with personal use (typically under $800 in value per shipment).
- Accompanied by a clear understanding of the regulatory status by the purchaser.
This is documented on the FDA's own infant formula guidance page. It's not a loophole, it's a specific policy, and it's been stable for years.
What enforcement discretion is not:
- Not "FDA approval." The formulas remain unregistered.
- Not a blanket permission for commercial resale. Buying 500 tins to resell at US retail without FDA registration is not covered by enforcement discretion, and the FDA has taken action against such operations historically.
- Not immunity from customs or USDA. A shipment of European infant formula can still be delayed or occasionally scrutinized, but personal-use shipments typically clear without issue.
What enforcement discretion is:
- A stable, documented policy of not prosecuting parents who order European infant formula for their own children.
- A framework that remained in place even during the 2022 shortage crisis, and was formally expanded to cover additional imports during that period.
- A regulatory position consistent with the practical reality that thousands of families use European formula, including some with medical recommendations from their pediatricians.
The 2022 shortage and what changed
The February 2022 recall of Abbott's Sturgis facility created a US formula supply crisis so severe that the FDA formalized and expanded its enforcement discretion for imports. During 2022-2023:
- Kendamil received direct retail enforcement discretion and started shipping to Target stores.
- Kabrita expanded its US distribution under the same framework.
- HiPP, Holle, and others maintained personal-import enforcement discretion with somewhat relaxed scrutiny.
Since the shortage resolved (late 2023-2024), the enforcement posture has held steady. The FDA has not reversed any of the expansions, and has publicly acknowledged that families rely on imported formula for specific composition preferences (organic, goat milk, specific regional variants).
What are the actual risks?
A parent asking "is it safe?" wants to know three things:
1. Is the formula itself safe?
Yes, in the sense that EU-regulated infant formula meets or exceeds US nutritional standards and is manufactured under comparable safety audits. The EU compositional requirements (Regulation 2016/127) are in some areas stricter than FDA 21 CFR 107, notably on carbohydrate composition (lactose must be predominant) and DHA minimums (20 mg/100 kcal mandatory since Feb 2020).
Nothing in the EU regulatory framework makes European formula "less safe" than US formula. If anything, the composition requirements are tighter on specific axes.
2. Is ordering it legal?
For personal use, yes. The FDA has explicit guidance acknowledging this. You are not committing a crime by ordering HiPP Dutch Stage 1 for your own baby. You are operating within an explicit enforcement-discretion framework.
Commercial resale without FDA registration is a different legal situation. The FDA has taken action against commercial operators who exceeded personal-import scope.
3. Will my shipment arrive?
Most shipments from established resellers (Organic's Best Shop, Formuland, My Organic Company) arrive in 5-10 days without customs issues for personal-use quantities. Occasional customs delays happen, rarely, a shipment is held for review, but confiscations of personal-use infant formula are extremely rare and not a meaningful practical risk for most families.
See our how to buy European formula guide for shipping logistics and red-flag reseller signals.
What about labeling differences?
European infant formula labels are designed for European markets. Specifically:
- Preparation instructions may be in metric units (grams of powder per milliliter of water, not scoops per ounce).
- Language may not be English: HiPP Dutch ships with Dutch instructions. HiPP German ships with German.
- Allergen declarations use EU conventions, not always matching US FDA allergen labeling format.
Reputable US resellers typically include English translation documents with shipments. HiPP also ships English-labeled variants for US-focused distribution channels. This is not a safety issue, but it is a practical consideration for first-time importers.
Comparing to US-registered options
For parents who specifically want FDA registration and simpler regulatory posture, the US options are:
- Bobbie. USDA Organic, FDA-registered, explicitly EU-style formulation. The clearest "US equivalent" to HiPP Dutch for parents prioritizing US registration.
- ByHeart: FDA-registered US premium with 5 HMOs. Note: currently under active recall (November 2025) for infant botulism; see the ByHeart brand page for details.
- Similac. US market leader, FDA-registered, WIC-eligible.
- Enfamil. US #2, FDA-registered, WIC-eligible.
- Earth's Best Organic — USDA Organic, FDA-registered, widely retailed.
- Kendamil: European manufacturer with FDA enforcement discretion for direct US retail (middle ground).
For parents who want European-style composition depth, the personal-import channel is the answer, and the legal framework supports it.
FAQ
Is it illegal to buy HiPP or Holle in the US?
Why is Kendamil in Target but not HiPP?
Is European formula actually regulated?
What happens if my shipment gets held at customs?
Are the instructions in English?
Which has stricter standards, FDA or EU?
Primary sources
- FDA Infant Formula Guidance and Regulatory Information, the canonical reference for US infant formula regulation and enforcement discretion policy. fda.gov
- FDA Enforcement Discretion for Certain Imported Infant Formula Products, specific policy document covering the import framework. fda.gov
- FDA 21 CFR Part 107, the US infant formula regulation itself. ecfr.gov
- EU Commission Delegated Regulation 2016/127, the parallel EU infant formula regulation. eur-lex.europa.eu
This site provides research and comparisons, not medical advice. Consult your pediatrician before changing your baby's formula.