FDA compliance for European brands
Birch & Co. helps European food, beverage, wine, supplement, and cosmetic brands handle the FDA paperwork required to legally sell in the United States. From registrations to label review, we simplify compliance so you can focus on growing your business.
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Cleared for export
7
Years of experience
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Direct founder communication
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European manufacturers supported
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Dedicated Point of Contact
01 — Services
Whether you're preparing your first shipment or expanding an established business into the United States, Birch & Co. handles the regulatory paperwork required to move forward with confidence.
Appoint Birch & Co. as your required U.S. Agent and maintain an official point of contact for FDA communications.
We prepare and submit FDA facility registrations accurately and efficiently so your business is ready to export.
We review product labels against FDA requirements to identify potential compliance issues before products reach the U.S. market.
Stay compliant year after year with reminders, renewals, and ongoing regulatory support.
02 — Why Birch
Most compliance firms are built for enterprise clients. We built Birch & Co. for independent European brands that value direct communication, practical expertise, and responsive service.
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Work directly with experienced founders. No account managers, no ticket systems.
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Simple pricing with no unnecessary consulting hours attached to it.
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Fast answers from the people actually completing your paperwork.
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Built on years of FDA work supporting one of the largest Europe–United States wine importing businesses.
03 — Industries
Facility registration, prior notice, and label review for still, sparkling, and fortified wine producers shipping to U.S. importers.
Registration and label compliance for olive oil, coffee, tea, chocolate, preserves, and packaged foods.
Facility registration, claim review, and Supplement Facts panel checks before your first shipment.
MoCRA facility registration and product listing, responsible-person duties, and label review for skincare and beauty brands.
04 — How it works
A short form and a conversation. No lengthy discovery process.
You receive a written scope with a fixed price and a timeline.
Filings, agent appointment, and label notes, handled by the founders.
Documentation in hand, renewals tracked, questions answered.
05 — About
Birch & Co. was created after years of helping European manufacturers navigate FDA registrations and import compliance behind the scenes.
We repeatedly saw smaller brands paying enterprise consulting fees for work that could be handled more efficiently by experienced specialists. So we built something different — a boutique consultancy where clients work directly with the people completing their paperwork.
No unnecessary complexity. No layers of management. Just accurate documentation, responsive communication, and practical guidance from people who understand both European manufacturers and U.S. regulatory requirements.
06 — FAQ
Most food, beverage, supplement, and cosmetic facilities exporting to the United States must register with the FDA before shipping. We confirm your exact obligations in a short review of your products and facility.
Facilities outside the United States must appoint a U.S.-based agent as the FDA's point of contact. Birch & Co. can act as your agent and handle that correspondence on your behalf.
Straightforward registrations are usually completed within days of receiving your product and facility details. Label work depends on how many SKUs are involved.
Yes. We check ingredient statements, allergen declarations, net quantity, nutrition or supplement panels, and required U.S. disclosures, then send a clear list of what to change.
No. Wine is where we started, but we work with food, olive oil, coffee, tea, chocolate, supplement, and cosmetics producers across Europe.
Yes. We handle renewals, keep your registrations current, and stay available as you add products or shipments.
07 — Get started
Let's make the paperwork the easiest part of your international growth. Tell us what you make and where you're shipping — we'll reply with a fixed quote.