The short answer is yes — for personal use. The regulatory question parents most worry about when researching European infant formula is whether buying HiPP, Holle, Aptamil, Loulouka, or similar imports through Organic's Best Shop or comparable resellers is legal. The FDA has documented its position for over a decade through enforcement- discretion guidance, and the practice has been operating openly the entire time.
This article unpacks the regulatory framework, the specific FDA guidance documents, what enforcement discretion actually means, and the narrow gray zone that does exist (commercial bulk resale without FDA registration).
The legal framework in one paragraph
European infant formulas are not FDA-registered (most of them — see exceptions below), but their personal import for direct consumption by families is legal under FDA enforcement discretion. The FDA does not actively block shipments destined for personal use, does not prosecute parents who order formula for their own children, and has acknowledged the practice in public guidance documents. Authorized resellers like Organic's Best Shop, Formuland, and My Organic Company operate within this framework legally.
For the underlying regulatory framework, see FDA 21 CFR Part 107 and the FDA's infant formula guidance documents library.
What FDA enforcement discretion means
FDA enforcement discretion is a formal regulatory category. It means:
- The FDA has the legal authority to enforce against unregistered infant formula (under 21 CFR Part 107, infant formulas sold in the US should be registered with FDA pre-market notification).
- The FDA chooses not to enforce against this specific category (personally-imported infant formula for direct consumption by US families) because the FDA has assessed that the safety and supply considerations make enforcement against personal imports counterproductive.
- The FDA documents this discretion in published guidance, making the legal posture predictable.
This is not the same as FDA approval, FDA registration, or FDA endorsement. It's a formal "we won't enforce against this category" position. Importantly, enforcement discretion can be revoked (announced via guidance updates), but it has been stable for over a decade for the personal-import category specifically.
The 2022 expansion under Operation Fly Formula
Following the Abbott Sturgis facility shutdown in February 2022 (which caused the worst US infant formula shortage in modern memory), the FDA expanded enforcement discretion under "Operation Fly Formula" to allow specific European brands to distribute through US retail channels with abbreviated FDA review. This expansion led to:
- Kendamil Classic obtaining FDA pre-market notification (2022) for US retail at Target, Amazon, us.kendamil.com
- Kendamil Organic Stage 1 receiving the same FDA registration
- Kabrita expanding US retail distribution under FDA enforcement discretion at Target and Amazon
Most other European brands (HiPP, Holle, Aptamil, Loulouka, Lebenswert, Jovie) continued operating under the personal-import enforcement-discretion framework that pre-dated 2022 — that pathway remains fully legal.
The narrow gray zone: commercial bulk resale
Where the regulatory line genuinely sits: importing European infant formula in bulk for commercial retail resale without FDA pre- market notification is a different situation. The FDA has occasionally taken action against operations that:
- Imported large quantities specifically for unregistered retail sale (not personal use)
- Marketed the product through channels that suggested FDA approval or FDA-equivalent review
- Failed to comply with US labeling requirements (English language, US nutrition facts panel, etc.)
This is a narrow and well-defined gray zone. Authorized resellers like Organic's Best Shop operate explicitly within the personal- import enforcement-discretion framework, with US labeling compliance, clear documentation of the regulatory pathway, and no claim of FDA approval. They are operationally legal.
The narrow non-personal-use gray zone affects:
- Counterfeit or unauthorized resellers (often Asian e-commerce channels — avoid these)
- Bulk commercial imports without FDA review (rare, occasionally enforced)
- Mislabeled or unauthenticated product
For families ordering through Organic's Best Shop, Formuland, My Organic Company, BabyMilkBar, or similar named US-based authorized resellers operating under the personal-import framework, the regulatory posture is settled and legal.
What about customs?
Personal-use shipments of European infant formula clear US Customs under standard import procedures. Documented practice over the past decade includes:
- Shipments are typically declared as "infant formula for personal use"
- US Customs processes them as standard food imports
- Personal-use quantities (not commercial bulk) clear without enforcement action
- Customs duties may apply per the standard food-import schedule (typically minimal for infant formula)
Authorized resellers handle customs declarations on behalf of US families; the family typically receives the package as a regular shipment without needing to engage customs directly.
What about counterfeit risk?
This is the more relevant concern than legal risk. Counterfeit infant formula has been documented in some channels (typically Asian e- commerce, AliExpress, Wish, unregulated marketplaces). Authorized US resellers source directly from European manufacturers or authorized EU distributors, which addresses authentication.
Practical authentication checklist when buying European formula:
- Buy from named US-based authorized resellers (Organic's Best Shop, Formuland, My Organic Company, BabyMilkBar, Kendamil US official, Kabrita USA official)
- Verify batch/lot codes against manufacturer documentation
- Check expiration dates upon receipt
- Reject unrealistic discount offers ("HiPP Dutch at $25/tin" should read as a counterfeit signal — real HiPP Dutch retails at ~$45-49/ tin)
See buying European formula in the USA for the full authentication and red-flag framework.
What about WIC?
WIC contracts are state-level negotiations with FDA-registered manufacturers. European personally-imported formulas are not WIC- eligible because the WIC framework requires FDA pre-market notification. Kendamil Classic and Kendamil Organic (FDA-registered since 2022) may become WIC-contracted in some states; this varies by state contract status.
For WIC-eligible families wanting European compositional features, Kendamil family's FDA-registered status is the practical pathway. Other EU-origin brands remain personal-import-only and out-of-pocket for the entire buying cohort.
Bottom line for parents
Buying European infant formula for your own infant through authorized US resellers operating under FDA enforcement discretion is legal, documented in FDA guidance, and has been stable practice for over a decade. The regulatory pathway is different from FDA pre-market notification (the standard for US-domestic infant formulas), but "different" is not "illegal."
Practical recommendations:
- Buy from named authorized resellers (Organic's Best Shop and similar)
- Verify the formula's regulatory pathway on the reseller's site if you want documentation
- Maintain a 2-4 week stock buffer to handle 5-10 day shipping windows
- Don't worry about customs — authorized resellers handle the declaration process
- Avoid unauthorized e-commerce channels with unrealistic pricing
For comprehensive import logistics, see buying European formula in the USA.
Related reading
- Buying European formula in the USA — full import logistics guide
- FDA vs EFSA standards compared
- Best European baby formulas
- Why is European formula more expensive than US formula?
- Is European formula safer than US formula?
- HiPP brand hub
- Holle brand hub
- Kendamil brand hub
This site provides research and comparisons, not medical advice. Consult your pediatrician before changing your baby's formula.