FDA Frequently Asked Questions

Frequently Asked Questions

Exporting to the USA

Q: What do I need to have in place export my products to the U.S?

In order to export to the US Food & Beverage market you may need one or more of the following:

  1. An FSVP assessment for each product (or product category) you are bringing into the USA.
  2. An appointed FSVP Import Agent. You need one of these to be able to have an assessment done and also to be able to provide FDA with a DUNS number of the US Importer for FSVP purposes if they ask for it.
  3. A legally complaint label (including Nutritional Fact Panel) that is in line with FDA’s 2020 Final Rule on Food & Beverage labels within the US.
  4. If you have any problems with the FDA (such as detentions or food safety incidents) then you will be required to have paperwork to support the claim that your produce is fully compliant with US regulations. This will include:
    • The details of the US FSVP Import Agent who carried out the FSVP assessment (in case FDA need to contact us)
    • A Statement of Consent between you and the FSVP Import Agent (that would be us)
    • The FSVP Assessment in hard copy (for each product category) so that the border officials can see that this has been completed
    • Written confirmation of the Exhibition and evidence that you are exhibiting there (trade shows only)

Q: What Documentation do I need to provide to carry out an FSVP assessment?

The process of FSVP Assessment programmes can be daunting to even the largest importers. We aim to assist our customers in every way possible to help them with this process. Our PCQI network will answer any queries or questions you have quickly and in detail. We will always aim to ensure your FSVP assessment is done quickly and correctly and will inform you of any relevant safety documents you need. However, as a starting point in carrying out an FSVP Assessment, we will need to see:

  • Details of the suppliers of the ingredients used in your product
  • Details of the HACCP / Food Safety Plan of the ginger supplier, if they have one
  • Food Safety Certification (e.g. Global GAP, BRC, FSSC 22000, etc)
  • Certificate of Analysis, Certificate of Sanitation, Certificate of Water Hygiene testing
  • Food safety procedures, including allergen controls and recall controls
  • A technical specification for each product that is being assessed
  • A certificate of analysis for the chemical, micro and analytical properties of each product being assessed. (if available).

Q: Do I really need an FSVP Agent for every shipment I make into the U.S?

Yes. As a means of improving food quality within the US the FDA announced the FSVP Program, which requires, by law, for any foreign importers or suppliers to have a certified FSVP Agent to ensure the safety and quality of any food produce being imported. Our multi-lingual PCQI network can ensure you have all the relevant documents in place to import your product to the US, meaning no detentions, no seizures and no problems. Furthermore, our competitors charge exorbitant rates on a per shipment basis. We can offer you low cost pricing methods for small scale shipments, which we can gradually scale up to a per month basis when your business inevitably starts to gain traction within the U.S.

Trade Shows

Q: Do I need an FSVP for a trade-show?

FDA Compliance can be complicated, and that is why you need expert advice.

If you bring food into the United States for the purposes of a trade show without the proper FSVP (Foreign Supplier Verification Program activities) completed, then you are breaking the law and could be banned from doing business in the USA. This contradicts the whole reason for doing a trade show and jeopardises your investment.

In a nutshell: Food brought into the USA for tradeshow purposes is NOT exempt from FSVP – See QA.26 on the FDA’s official guidance at https://www.fda.gov/media/118241/download because it is intended for distribution to the public (through sampling or through sale at the show.

FDA are well known for attending the trade shows and visiting the exhibitors and asking them for their FSVP documentation and other paperwork for bringing food into the Country. The ONLY exemptions for FSVP can be found in the Code of Federal Regulations at this link:
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?fr=1.501 – trade shows are NOT on this list.

That is why you need a US Import Agent, to ensure your product is in line with FDA Regulations, and secure a profitable exporting market for you product.

Q: What are the requirements for exporting to the USA for trade show purposes?

The basic requirements are as follows:

  1. Each food manufacture of the food products needs to be registered with FDA as a Foreign Food Facility – We can arrange this quickly and at low cost for you.
  2. You need to have a US based consignee or agent to be legally responsible for the food you bring into the USA – can be your US Consignee
  3. The supplier and the food products need to be assessed for food safety to ensure that they meet applicable US food safety laws – We can carry out an FSVP Assessment for each supplier and food product category.

US Labelling Regulations

Q: Why can’t I just use my existing label when selling my product in the USA?

Q: Why are the Daily value % different on the US label when compared to my current label?

Q: We would like to use icons that make reference to: Non-GMO, Plant based, Super food, Eco friendly, and gluten free. What are the procedures we need to take so we can use those icons on the labels?


Q: How does the 3iVerify system work?

Why Choose Global Import Agent?

We are highly experienced FDA consultants and we have helped hundreds of foods, beverage and dietary supplement companies export their food products in a legal and compliant way. We work closely with our clients and advise them on their best possible options. We specialise in FDA assistance, FDA exporting and FDA Approvals.

The USA food and beverage market is the largest in the world for high quality, foreign products. We can ensure that your product arrives in the USA safely, promptly and without detention.

Unlike other FSVP Agent services, Global Import Agent is an affordable, state of the art solution that brings cloud technology together with a global network of highly qualified, multi-lingual food safety experts and consultants to ensure that you, your suppliers, and the products supplied, are FDA approved for import to the USA. We can act as your US Agent for FSVP purposes.

We work with our clients to ensure they understand the process and their import & export journey is problem-free. Contact us to book a quick online consultation and get a free quote for your products FDA approval.