When importing food, beverages, and dietary supplements into the United States after selling through Amazon, everything must comply with the FDA regulations for not only labeling and ingredients but claims as well. Your specialists here at US Imports are here to assist sellers with FDA compliance so they are not shut out of the largest market in the world – Amazon.

How do I sell legally on Amazon?

That is a great question! To start selling on Amazon legally, our Amazon Sellers Essentials Bundle has everything you need! There are several things that need to be completed including FDA Registration, U.S. Agent, FDA Label Review, FDA Claims Review, and FDA Prior Notice. Here is a little breakdown of what each one consists of.

• FDA Registration and U.S. Agent – Importers are responsible for designating an FSVP Agent upon entry of a food product into the United States. As an FSVP Agent, you must be a qualified individual that is physically located within the U.S. to serve as the importer
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Running a business can be overwhelming if you don’t have all your ducks in a row. You think you’ve checked all the boxes and are ready to ship to the United States, only to find out the facility that manufactures your products is not registered with the FDA. If this is you, US Imports is here to help.

If your brand is manufactured by someone else, you must get permission to register their facility with the FDA. The FDA requires that all U.S. and foreign facilities that manufacture, process, pack or store food, beverages, or dietary supplements exported to the United States must register. If your facility is not registered with the FDA, your business may face serious consequences.

Why Do You Have to Get Permission to Register a Food Facility?

Only the owner of a facility can register with the FDA. However, the owner can give someone written permission to register their facility. If you fail to obtain permission from the owner the registration may be rejected by the FDA and your prod...

The food and dietary supplement industries are unique and so are the contracts needed to keep you protected. From marketing agreements to supply contracts, it is important to make sure you document in writing the terms of the deals with your vendors and suppliers to keep your operations running smoothly. At US Imports, we offer customized contracts for food, beverage and dietary supplement businesses that include terms specific to your industry. Here are some of the types of agreements we provide:

General Business

Non-Disclosure Agreement

This is an agreement to protect your confidential information prior to entering into discussions with potential business partners. 

Permission to Register Facility with the FDA

This is a letter that gives someone permission from the owner of a facility to register with the U.S. Food and Drug Administration.

Purchase Order

A purchase order template can be used over and over again to place orders with your vendors.

Sales Order Confirmation a...

Every importer of food, beverages and supplements into the United States should be aware of the U.S. FDA’s Foreign Supplier Verification Program, or FSVP. FSVP rules require importers to have a FSVP plan verifying that imported products are manufactured in accordance with U.S. food safety standards. The FSVP also requires importers to designate a qualified FSVP Agent to serve as the point of contact with the FDA.

What is the Foreign Supplier Verification Program?

The Foreign Supplier Verification Program (FSVP) was created by FDA after passage of the Food Safety Modernization Act in 2011. The FSVP rule requires importers to perform “risk-based activities” to verify that the food, beverages and dietary supplements brought into the United States have been produced in a manner that meets U.S. food safety standards. The FSVP rule is complex and can be confusing to importers.  

What is the role of an FSVP Agent?

Foreign businesses who don’t have headquarters or employees physically loc...

In 2011, the FDA Food Safety Modernization Act (FSMA) amended U.S. food safety laws, requiring all foreign and domestic food businesses to register their facilities that manufacture, process, package or store food. This allows FDA to have access to all food facilities so that they may be inspected if necessary, in order to prevent serious adverse health reactions. 

Under FSMA, all food facilities must renew their registrations with FDA every even-numbered year. 

Domestic owners of a food business can submit a registration form for facilities online. However, foreign food businesses must designate a U.S. Agent for their facilities before they are able to register. This Agent must physically reside in the United States and be  available 24-hours a day to handle all communications with FDA regarding questions about shipments and scheduling facility inspections. Your agent must be listed on your FDA registration documents. 

Each facility is also required to provide a Unique Facility Ide...

In 2011, the FDA Food Safety Modernization Act (FSMA) amended U.S. food safety laws, requiring all foreign and domestic food businesses to register their facilities that manufacture, process, package or food intended for human or animal consumption. Dietary supplements are included in this requirement. This allows FDA to have access to all food and dietary supplement facilities so that they may be inspected if necessary, in order to prevent serious adverse health reactions. Under FSMA, all dietary supplement facilities must renew their registrations with FDA every even-numbered year. 

Domestic dietary supplement companies can submit a registration form for facilities online. However, foreign dietary supplement companies must designate a U.S. Agent for their facilities before they are able to register. This Agent must physically reside in the United States and be  available 24-hours a day to handle all communications with FDA regarding questions about shipments and scheduling facility ...

Nearly all businesses must obtain an employer identification number (EIN) from the U.S. Internal Revenue Service (IRS). Foreign businesses need an EIN when filing U.S. Customs paperwork and registering a facility with the FDA.

What is an EIN?

An EIN is a 9-digit identification number for taxpayers. The IRS assigns an EIN to most businesses to comply with tax and U.S. Customs regulations. More specifically, it is used for paying taxes and claiming tax exemptions from the IRS. If you are buying and receiving goods in the U.S., your business will likely need an EIN number to comply with U.S. regulations.

How do you obtain an EIN?

Most businesses can apply for an EIN online through the IRS website. However, unless you either have a legal residence or principal place of business located in the U.S., then the online option will not work.

Most foreign importers will instead need to fill out Form SS-4 and send it in by mail or fax. Filling out this form without knowledge of the specificat...

Dietary supplements imported into the United States are governed by a complex body of laws and regulations. These laws and regulations govern manufacturing practices, product and ingredient safety, labeling, marketing claims, importing procedures, among other things.

Failure to comply can result in regulatory action by the U.S. Food and Drug Administration (FDA), including product detentions, warning letters, refusals of entry at U.S. ports, and fines. This is why it is imperative to be familiar with these laws and regulations before importing dietary supplements to the U.S.,.

FDA Facility Registration

All dietary supplement products offered for import must be manufactured in a facility register with the FDA. If the facility is located outside of the United States, you will need to appoint a U.S. Agent physically located in the U.S. to handle communications with the FDA. Upon registration, you will receive an FDA facility registration number. This number is important for confirming ...

All U.S. and foreign facilities that manufacture, process, pack or store food and/or beverages to be consumed in the United States must register with the Food and Drug Administration (FDA). Before importing food or beverages for sale in the U.S., familiarize yourself with these guidelines on registering your food facility with the FDA.

When to Register a Food Facility

The FDA requires food facilities to register before importing food into the U.S. in order to avoid regulatory enforcement action. After registering, you will receive a food facility number confirming your FDA registration. Most customers and suppliers, as well as customs officials, will require proof of U.S. FDA registration.

Renewing a Food Facility Registration

The Food Safety Modernization Act initiated the requirement of renewing food facility registrations every other year. Failure to renew a registration results in an expired registration. Food products offered for import with an expired registration will be ref...

Are you aware of the requirements to import food and beverage products into the U.S.? The process can be quite complicated, especially for newcomers in the food business. From food safety requirements to labeling guidelines, the U.S. FDA closely monitors imported products to ensure full compliance with Federal regulations. If a product does not comply, the consequences can significantly impact your business including refusal of entry at the port or seizure of the products. Before you import into the United States it is important to review these 10 key things to protect your brand and business.

1. Importers are required to designate an FSVP Agent

An FSVP Agent acts as a liaison between your business and the FDA for the purpose of complying with the Foreign Supplier Verification Program. The FDA requires that an FSVP Agent is a “qualified individual”. The agent handles the scheduling of inspections, verifying a foreign supplier’s compliance with food safety requirements, and a variety ...