Need "FDA approval"? Find out what your product really needs
Your US product requirements and next steps, set out clearly.
Free, no obligation. Talk to a specialist, not a sales team.
Trusted by 1,500+ clients in 30+ countries
Hands-on representation, not just advice.
Tell us what you need to import
Consultation
Tell us what you need to import.
Share your product, target market and compliance question. A member of our team will respond promptly.
Your US product requirements and next steps, set out clearly.
Device pathway support
Device classification and predicate analysis for the applicable pathway.
Prior Notice filing
Prior Notice support for food imports entering the U.S.
Ingredient review
We review your NDI, GRAS and claims considerations for supplements.
510(k) clearance support
Support for Class I and II devices through the correct clearance route.
One team for US, UK and EU
One team coordinates your compliance requirements across US, UK and EU markets.
What “FDA approval” really means
Most products sold in the US are not “FDA approved”, but they must comply with FDA rules. FDA does not approve food products, but certain ingredients such as food additives need FDA approval. Cosmetics and their labelling do not need FDA approval. FDA does not approve dietary supplements or their labelling before sale. FDA does not approve manufacturing facilities: registration is not approval. Our work is to identify the right pathway for your product and make it compliant.
Why compliance is required
Free, no obligation. Talk to a specialist, not a sales team.
Book a 20 minute callWho needs it
Brands, manufacturers, importers and e-commerce sellers launching food, beverages, dietary supplements, cosmetics or medical devices in the US, especially those unsure which category their product falls into.
What happens if you get it wrong
- Choosing the wrong category can mean the wrong rules: a supplement claiming to treat, prevent or cure disease is regulated as a drug
- Food from an unregistered facility can be held at the port (21 CFR 1.285)
- Missing or inaccurate Prior Notice makes food subject to refusal (21 CFR 1.283)
- Products can face warning letters, import alerts and DWPE
How it works
- Product classification: food, supplement, cosmetic or medical device
- Identify whether registration, listing, notification or premarket submission applies
- A written compliance roadmap for your product
- Registration, US agent and submissions prepared and filed
- Label and claims review before you print
- Import readiness: Prior Notice and FSVP for food
Free, no obligation. Talk to a specialist, not a sales team.
Book a 20 minute callWhat you need to provide
- Product description, intended use and full ingredient or component list
- Draft labels and marketing claims
- Manufacturer and facility details
- For devices: technical description and any predicate device information
How Global Import Agent helps
- Product classification and regulatory assessment
- FDA facility registration and US agent services for foreign companies
- 510(k) preparation support and establishment registration and listing for devices
- GRAS analysis and new dietary ingredient documentation
- Label and structure/function claim review
- Prior Notice and FSVP agent services for food imports
- clients supported
- 1,500+
- countries served
- 30+
- registrations handled
- 10,000+
- client rating
- 5/5
How it works
Book a 20 minute call
Share your product and target market with a specialist.
We tell you what you need
Receive the requirements and next steps in writing.
You approve a fixed-fee proposal
Review the scope and agree the proposal before work begins.
We file and keep you compliant
We handle the agreed filings and ongoing compliance support.
Global Import Agent
Supporting importers since 2019 across food, supplements, cosmetics and medical devices.
PCQI-qualified team
Hands-on representation
We act as your US Agent, FSVP Agent or Importer of Record, not just advisers.
Who we help
Foreign manufacturers, Amazon and Shopify sellers, and U.S. and UK importers.
Offices in the UK and US
I had hit a brick wall trying to get my FDA number for export of my rum to the USA. Ryan and James knew all the right contacts to sort this out for me. I could not have done it without Global Import Agent. They even sorted out my prior notification paperwork for me. I can highly recommend them.
Global Import Agent have successfully worked with me to land product in the U.S and remain compliant for FDA regulations. I'm really happy with their response times, and easy to use tech platform that facilitates the process.
Need "FDA approval"? Find out what your product really needs
Straight answers to what exporters ask us most.
Book a 20 minute callVery few products are formally FDA approved. Food, dietary supplements and cosmetics are not approved before sale, though certain ingredients such as food additives need approval. They must still comply with FDA rules on registration, labelling and safety.
It depends on the product. Food and supplements generally need registration and compliance, not approval. Many medical devices need 510(k) premarket notification, and some need PMA under 21 CFR Part 814.
No. We are a private company and cannot grant or promise FDA approval. We identify the pathway that applies and prepare compliant registrations, submissions and labels.
You may need a new dietary ingredient notification to FDA before marketing. We assess whether it applies and help prepare the documentation.
No. FDA does not pre-approve food labels. Labels must meet 21 CFR Part 101, and we review them against the requirements before you print.
No. Registration is a listing with FDA. FDA does not approve manufacturing facilities.
Non-compliant products can be held or refused at the border, placed on an import alert or receive warning letters. Getting the pathway right early avoids disruption.
Share your product and target market. We will set out which requirements apply and what you need to do next.
We discuss your product and target market, set out what you need in writing and provide a fixed-fee proposal for the agreed work.
No. We're a private company. FDA doesn't approve or certify facilities, agents or registrations.
Not sure what you need? That's what the call is for.
In 20 minutes we'll tell you which rules apply to your product and what to do next.