The short answer
Ireland is one of the world’s biggest pharmaceutical manufacturing hubs and a major exporter of infant formula, butter and dairy, and whiskey to the U.S. Each of these follows a different set of FDA rules.
What Irish exporters should watch for
💊 Pharmaceutical plants
Under the EU–US Mutual Recognition Agreement, FDA can rely on GMP inspections by EU authorities for human medicines made in Ireland. FDA drug establishment registration, NDC and drug listing are still required every year.
🍼 Infant formula
Infant formula is one of the most tightly regulated foods in the U.S. Beyond facility registration, a new infant formula must be notified to FDA at least 90 days before marketing, and the plant must meet FDA’s infant formula manufacturing and quality rules.
🧈 Butter and dairy
Dairy plants register with FDA; labels need U.S. Nutrition Facts, milk declared as an allergen and net weight in ounces and grams. Some dairy products have extra U.S. standards.
🥃 Whiskey
Distilleries must register with FDA as food facilities and file Prior Notice; labels and permits go through TTB, not FDA.
Common reasons Irish shipments are stopped
- Infant formula without FDA notification
- Drug listings not renewed or out of date
- Labeling — EU nutrition panel, metric-only weights
- Undeclared allergens under the U.S. list
- No Prior Notice for food and drink shipments
🏢 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 products — we’ll confirm what you need to register, in writing, by email.
Frequently asked questions
Can Irish infant formula be sold in the U.S.?
Yes, but only after meeting FDA’s infant formula rules: the facility registers with FDA, the manufacturer notifies FDA at least 90 days before marketing a new formula, and the formula must meet U.S. nutrient and quality control requirements. It is one of the strictest food categories in the U.S.
Do Irish pharma plants still need FDA registration under the MRA?
Yes. The Mutual Recognition Agreement lets FDA rely on EU GMP inspections, which can reduce FDA inspections, but every plant making drugs for the U.S. must still register with FDA every year, have an NDC labeler code and list its drugs.
Sources
- eCFR — 21 CFR Part 106, Infant formula requirements
- EMA — EU–US mutual recognition agreement for inspections
- TTB — Public Law 107-188 (Bioterrorism Act) and FDA registration for alcohol beverage facilities
Checked against FDA and other official sources on November 11, 2026. This guide is general information, not legal advice.