How US Imports Can Help Kickstart Your Amazon Supplement Business

Are you interested in selling dietary supplements on Amazon, but don’t know where to start?  We hear that a lot and that’s why US Imports has created an Amazon Sellers Essential Bundle. This bundle gives foreign-based companies the essential U.S. Food and Drug Administration (FDA) compliance tools they need to start marketing on Amazon for sales in the United States.  

When you buy this bundle, US Imports will handle your FDA manufacturing facility registration, file your first Prior Notice of Shipment to the U.S., and serve as your U.S. Agent for purposes of compliance with the Foreign Supplier Verification Act.  These compliance tools are must-haves for any non-U.S. company selling dietary supplements in the U.S. 

With the purchase of the Bundle, US Imports will also review your product label for basic FDA compliance and perform an in-depth review of one product claim on your label.   

What’s included in the Bundle

FDA Registration and U.S. Agent

Before you can start selling dietary supplements into the United States, you must register your manufacturing facility with the FDA, and appoint a U.S. Agent to receive communications from the FDA.  This is why our Amazon Sellers Essential Bundle includes both FDA registration and provides that US Imports will serve as your U.S. Agent. 

Basic Product Label Review and Claims Review

To comply with FDA regulations, all imported food and dietary supplement labels must be in English and comply with stringent FDA labeling rules.  Dietary supplements are regulated separately from food products and have unique labeling requirements and additional mandatory product disclosures.  Incorrect labeling can lead to detention or refusal at U.S. ports.  That is why our Amazon Essentials Bundle provides for one basic FDA-compliance label review and in-depth review of one label claim (e.g., “good source of calcium”).  US Imports provides a second review of the same label at no additional cost.  Review of additional label claims and additional product labels can be purchased as add-on services.     

FDA Prior Notice

To import dietary supplements in the U.S., you must give the FDA prior notice of shipments before they leave the country of origin.  The required filing is called a “Prior Notice.”  A Prior Notice essentially notifies the FDA that the product is being imported or offered for import into the United States.   

Failure to file a Prior Notice with the FDA can cause a delay in entry at the border or even rejection by the U.S. Customs and Border Patrol.   The Amazon Sellers Essentials Bundle provides for your first Prior Notice to be filed by US Imports.  Additional Prior Notice filing services can be purchased separately and at bulk discounts.

Takeaway 

FDA compliance for importing dietary supplements to sell on Amazon doesn’t have to be a painful process. In fact, our Amazon Sellers Essential Bundle was designed to alleviate the pain of compliance by giving your company the essential FDA compliance tools at the click of a button.