FDA Frequently Asked Questions

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)

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

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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).

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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?

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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.

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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.

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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.

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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.

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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

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

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As of 2016 the FDA announced several small but significant changes to US labels and what must be on them by law. We can review your label and will create high quality, US Complaint labels that will follow both current and future FDA legislation. We currently operate and design any labels we review to the planned 2020 labelling format, meaning that once your label is reviewed, re-designed and completed, it will be in compliance for a minimum of 5 years.

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

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US regulations on these claims differ to many EU and foreign countries laws. Everything must be able to be substantiated by supporting documentation. Some key takeaways:

• Vegan – all ingredients must be substantiated as ‘Vegan’ as defined for the US market and backed by validated documentation & Certification.

• Super Food – this is low risk provided the nutritional elements are checked and within those limits given by the FDA surrounding “Health Food” claims.

• Gluten free – a certificate of analysis showing that the product is less than 20ppm would be required to show that the claim is validated.

• Eco-Friendly - you will need to substantiate this through documented or scientific evidence, e.g. is Bamboo a sustainable product? What evidence can we place on record for this?

• Non-GMO – Ideally your product should be certified as Non-GMO and substantiated through evidence, however the US terminology being adopted is Non Bioengineered, so you may wish to consider placing this as the claim in place of “Non-GMO” or "GMO-Free".

• Plant based – Again, should be OK and low risk as long as the ingredients are demonstrably so and are substantiated by evidence.

• Organic – Certification for proven Organic produce must be in place by a reputable source then this may be a risk.

• Natural – documented evidence of no artificial colours, additives, processing aids would be required to be able to prove this claim.

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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?

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US regulations on these claims differ to many EU and foreign countries laws. Everything must be able to be substantiated by supporting documentation. Some key takeaways:

• Vegan – all ingredients must be substantiated as ‘Vegan’ as defined for the US market and backed by validated documentation & Certification.

• Super Food – this is low risk provided the nutritional elements are checked and within those limits given by the FDA surrounding “Health Food” claims.

• Gluten free – a certificate of analysis showing that the product is less than 20ppm would be required to show that the claim is validated.

• Eco-Friendly - you will need to substantiate this through documented or scientific evidence, e.g. is Bamboo a sustainable product? What evidence can we place on record for this?

• Non-GMO – Ideally your product should be certified as Non-GMO and substantiated through evidence, however the US terminology being adopted is Non Bioengineered, so you may wish to consider placing this as the claim in place of “Non-GMO” or "GMO-Free".

• Plant based – Again, should be OK and low risk as long as the ingredients are demonstrably so and are substantiated by evidence.

• Organic – Certification for proven Organic produce must be in place by a reputable source then this may be a risk.

• Natural – documented evidence of no artificial colours, additives, processing aids would be required to be able to prove this claim.

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3iVerify

Q: How does the 3iVerify system work?

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Our system, 3iVerify, lets us streamline the process of FDA Compliance through quick document distribution and easy to understand questionnaire formatting.
When you register a service with us, our system will instantly send you a Username and Password which allows you to login and submit any relevant documents through easy to understand, rapid cloud-based software.

The benefits of this are that we can quickly assign a PCQI to your needs and expedite the process for urgency. It also allows the added benefit of complete audit-ability, further strengthening your company’s reputation with the FDA, and allowing us to rapidly solve any outstanding issues.
Once your service has been complete, our system also allows you to review your documents in PDF format and download them for your future records.

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