FEI vs DUNS vs FDA Registration: Which ID Goes Where?
Explore the differences between FEI, DUNS, and FDA registration to find out which ID fits your business needs best.
December 18, 2025
No Comments
We provide expert US, EU, UK and Canadian regulatory compliance consulting services for food, beverages, supplements, cosmetics and medical devices to make sure that your products are compliant in your target market. We will help you with:
At Global Import Agent, we help businesses around the world meet regulatory requirements in the U.S., United Kingdom, and European Union—so you can expand into new markets without costly delays, detentions, or compliance issues. From FDA and FSVP in the U.S. to food labeling, customs, and safety standards in the UK and EU, we handle the details so you can focus on growth.
Here’s how we support your success across global markets:
From startup brands to global suppliers, Global Import Agent provides the regulatory expertise and hands-on support you need to succeed across the U.S., UK, and EU food and supplement markets.
Ensure full compliance with FDA food safety regulations and import requirements, including the Foreign Supplier Verification Program (FSVP), food facility registration, labeling rules, and preventive controls.
We help you navigate the complexities of U.S. FDA laws, ensuring that your food products, supplements, cosmetics or medical devices meet all legal and safety obligations before entering the U.S. market. Whether you're a direct importer, foreign supplier, or distributor, our FDA compliance services keep you covered.
We support:
Bringing food and beverage products into the U.S. requires compliance with a range of FDA, USDA, and U.S. Customs regulations. From facility registration and labeling to Prior Notice and FSVP documentation, Global Import Agent helps importers and foreign manufacturers ensure every product meets U.S. requirements—before it reaches the border.
Dietary supplements face a high level of regulatory scrutiny in the U.S. market. We support international brands and importers with comprehensive FDA compliance services—from labeling and NDI assessments to FSVP programs and GMP verification. Whether launching on Amazon or scaling into retail, we help you meet every rule under FSMA and 21 CFR Part 111.
Importing medical devices and cosmetic products into the U.S. involves strict regulatory oversight from the FDA. From establishment registration and device listing to labeling compliance and MoCRA readiness, we help manufacturers, relabelers, and importers ensure their products meet all applicable requirements. Whether you're launching a Class I device or a cosmetic skincare line, we guide you through every step of the compliance process.
Beyond the U.S., we help brands meet the requirements for UK and EU food & supplement compliance—including product labeling, allergens, customs procedures, and responsible party appointments. For non-U.S. entities shipping to America, we also offer full Importer of Record (IoR) services, acting as your legal representative for regulated imports.
Read what our clients have to say about our services and how we have helped them export their products.
In most cases, FDA approval is not required, but compliance is.
For example:
Food and beverages do not need pre-approval but must comply with facility registration, labeling, and Prior Notice requirements.
Dietary supplements must meet GMP standards (21 CFR Part 111) and submit an NDI notification if they include new ingredients.
Medical devices may require 510(k) clearance, device listing, and establishment registration depending on classification (Class I, II, or III).
Cosmetics must comply with labeling and ingredient safety rules, though they are not subject to pre-market approval.
We help determine your product's classification and guide you through the exact FDA pathway needed.
The Foreign Supplier Verification Program (FSVP) is a requirement under the Food Safety Modernization Act (FSMA). It places responsibility on U.S.-based importers to verify that their foreign suppliers meet FDA food safety standards.
If you’re a foreign manufacturer, you’ll need to appoint a U.S.-based FSVP Agent (like Global Import Agent) to represent your products. If you’re a U.S. importer, you’re legally responsible for maintaining documentation such as:
Supplier GMP certifications
HACCP plans or food safety plans
Ingredient COAs and allergen declarations
Risk assessments and verification procedures
We build and manage FDA-compliant FSVP files so you're always inspection-ready.
An Importer of Record (IoR) is the legally responsible party for ensuring that imported goods comply with all U.S. laws and regulations. This includes submitting customs documentation, managing FDA entry requirements, and paying duties and taxes.
If you are a foreign business without a U.S. entity, you must appoint an IoR to legally import regulated goods like food, supplements, cosmetics, and medical devices.
Global Import Agent provides full IoR services—handling customs clearance, coordinating with freight forwarders, and ensuring all FDA/USDA documentation is correct.
The FDA requires strict formatting and content for all product labels. Non-compliant labels can lead to import refusals, retail rejections, or platform suspensions (e.g., Amazon).
Required label elements include:
Nutrition or Supplement Facts Panels (with correct formatting, font size, and DV%)
Ingredient list using common names
Allergen disclosures (under FALCPA)
Net quantity of contents in U.S. and metric units
Product identity (e.g., “Dietary Supplement”)
Name and address of manufacturer or distributor
Proper disclaimers for claims (especially on supplements)
We review your labels to ensure they meet 21 CFR Part 101 and 111 and are ready for both the FDA and retail partners.
Importing into the UK or EU requires compliance with local food safety, labeling, and customs rules. Each region has its own requirements:
UK: Must comply with FSA and Trading Standards, including allergen labeling (Natasha’s Law), nutritional declarations, and import checks via Port Health Authorities.
EU: Labels must comply with Regulation (EU) No 1169/2011, including multi-language requirements, allergen formatting, and accurate ingredient lists. High-risk foods and organic products may need health certificates or third-country listing.
Both regions require a responsible importer or food business operator (FBO) to handle compliance duties.
We help ensure your products meet UK and EU food law, labeling, customs documentation, and market readiness.
A detention can occur if your shipment is missing required documentation, has non-compliant labeling, contains undeclared allergens or ingredients, or fails an inspection. You’ll receive a Notice of FDA Action or similar, and you’ll need to respond quickly.
We assist by:
Reviewing and correcting root compliance issues
Coordinating corrective documentation or reconditioning requests
Communicating with FDA or USDA on your behalf
Supporting long-term resolution, including removal from Import Alert if necessary
Fast action is essential. We help resolve detentions efficiently to prevent financial loss or re-exportation.
Our team is friendly, responsive and we love to talk to people interested in what we do. Feel free to get in touch and one of our team will always get back to you. Guaranteed!
Catch up on our latest blogs and food safety news below
Explore the differences between FEI, DUNS, and FDA registration to find out which ID fits your business needs best.
Explore the importance of samples and R&D batches, focusing on when PN and FSVP regulations still apply in product development.
Explore DTC & e-commerce imports with insights on PN, returns, and accurate recordkeeping for enhanced business efficiency.
Contact us today to find out more on how we can help you expand your global trade network and meet all required compliance measures with ease.
Our friendly team is always happy to help and will reach out as soon as possible.