US Market Entry Plan

Compliance with FDA requirements are depicted in the diagram above. Under the hood, this means that the following must be in place:

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• FDA Registration - The manufacturing facility must be registered with FDA.
   

• FSVP for US Importers -  According to FDA US based importer is the 'FSVP Importer' by law and must have FSVP (Foreign Supplier Verification Program) in place.
   

• FSVP Agent if no US Importer - If there is no US based importer, e.g. you are selling on Amazon or Direct to Consumer, then the non us based owner / seller of the product must, by law, have an FSVP Agent (FDA calls this the 'FSVP Importer'). If you do not your product is highly likely to be detained by US Customs.
   

• FDA Compliance Product Label - All food and supplement products for humans and animals must have an FDA compliant label.  For supplements, it is important to understand what claims you can make on the product and on your web site / Amazon listing as FDA considers online material part of your product label. This is a common reason for detention at US Customs and santions by FDA.
   

• FDA Prior Notice - When shipping products to the US, you also must file an FDA Prior Notice.
   

• US Agent Prior Notice - When using an FSVP Agent you also need to file shippment records with the Agent to ensure that they have a record of all products you are selling in the US market as they are responsible to FDA for the compliance monitoring of your products and may be inspected at short notice by FDA on their FSVP, verification and record keepign activities.

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At Global Import Agent, we understand that 'becoming FDA compliant' for a foreign food company is:

 

• Costly

• Confusing

• A Barrier to US market entry

 

This is especially the case for small businesses looking to exhibit at a trade show, sell on Amazon, operate direct to consumer or simply test the market.

 

To address this very real business problem, we have created a package that allows food and supplement product owners who qualify as small businesses to ensure compliance while keeping costs down. We achieve this by bundling our services and spreading payment for our services over a period of time . This is subject to an intial deposit and a monthly subscription payment by credit / debit card.

 

The core services you will need are:

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• FDA Registration and Renewal

• FSVP Agent / Qualified Individual Service

• FSVP / Product Safety Assessment

• Prior Notice Shipment Compliance Checks

• Compliant FDA Labelling

 

With the above service package, your company will be FDA compliant and able to trade legally in the United States with minimal disruption. We will bundle all your services into a single package and ask for a deposit, typically around 40% of the first year bundle costs, before getting to work on your compliance activities. The remaining balance of the payment is then charged by a monthly subscription to your credit / debit card for the duration of the agreed term. This is subject to qualification as a small business and a minimum project cost, please contact us for details and to discuss your options.

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We are highly experienced in this field and provide you with no nonsense, clear advice and explain it all in a simple, easy to understand way. We have helped over 500 companies get to market in the US across almost every kind of product you can think of.

 

Please fill out the form to set up a fast and friendly chat about your needs. We will schedule a time to meet with you and understand more about your product and requirements and then send you a proposal.

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If you like our proposal, we can get started right away and help you accelerate into the US market without compliance issues boggin you down.