The short answer
Foods for babies get FDA’s strictest treatment. Processed baby foods have lead action levels since 2025, and infant formula needs FDA notification before it can be sold — one of the toughest market entries in U.S. food.
What exporters should watch for
⚖️ Lead in baby food
FDA’s January 2025 guidance sets lead action levels for processed food for children under 2: 10 ppb for fruits, most vegetables, mixtures, yogurts, custards and single-ingredient meats, and 20 ppb for single-ingredient root vegetables and dry infant cereals.
🍼 Infant formula
A new infant formula must be notified to FDA at least 90 days before marketing, and the manufacturer must meet FDA’s infant formula quality control, nutrient and testing rules (21 CFR Parts 106 and 107).
🧪 Testing
Baby foods should be tested for lead, arsenic (especially rice-based cereals) and other contaminants. FDA’s “Closer to Zero” plan aims to lower these levels over time.
🏷️ Labels
Foods for children under 2 have their own Nutrition Facts format and claim rules. Infant formula labels have specific required statements and directions.
Common reasons shipments are stopped
- Lead above the action levels
- Infant formula without FDA notification
- Arsenic in rice-based infant cereals
- Labeling — wrong Nutrition Facts format for under-2s
- Facility not registered or no Prior Notice
🏢 No U.S. company to act as FSVP importer? Orionex offers an FSVP importer service for food and dietary supplements — from $80 per shipment, with the program and Qualified Individual included.
What you need to register — and what it costs
| Product type | FDA requirement | Orionex price |
|---|---|---|
| Food, beverages, supplements | Food facility registration + U.S. Agent, renewed every 2 years; Prior Notice for each shipment | $300/year or $450 for 2 years |
| Cosmetics | MoCRA facility registration (every 2 years) + product listing + U.S. Agent | $300/year or $450 for 2 years; listing $150/product |
| Medical devices | Establishment registration (yearly, FDA fee paid separately) + device listing; 510(k) for many Class II devices | $550/year; listing $50/device |
| Drugs (incl. OTC) | Drug establishment registration (yearly) + NDC labeler code + drug listing | $550/year; listing $350/product |
Every Orionex registration includes the U.S. Agent service, D-U-N-S number set-up where needed and a Certificate of Registration. All prices →
Tell us your product — we’ll confirm what FDA requires, in writing, by email.
Frequently asked questions
What are FDA’s lead limits for baby food?
Under FDA’s January 2025 guidance, the action level is 10 ppb for most processed baby foods (fruits, vegetables except single-ingredient root vegetables, mixtures, yogurts, custards and single-ingredient meats) and 20 ppb for single-ingredient root vegetables and dry infant cereals. The levels apply to packaged foods for children under 2.
Can a foreign company sell infant formula in the U.S.?
Yes, but only after meeting FDA’s infant formula rules: facility registration, notification to FDA at least 90 days before marketing a new formula, and compliance with U.S. nutrient, quality control and testing requirements.
Sources
- Covington — FDA finalizes action levels for lead in processed food for babies and young children (Jan 2025)
- eCFR — 21 CFR Part 106, Infant formula requirements
- eCFR — 21 CFR Part 1 Subpart H, Registration of Food Facilities
Checked against FDA and other official sources on November 11, 2026. This guide is general information, not legal advice.