Do you have a great idea for a food product? Or maybe you want to import your favorite food from overseas and introduce it to American consumers? If either of these scenarios describe you, congratulations! But before you move forward with your new business venture, you first need to be aware of a few things that govern food in the United States, especially when it comes to ingredients.

All businesses engaged in the manufacturing of foods must ensure that ingredients and substances added to their products are lawful under the laws and regulations administered by the U.S. Food and Drug Administration (“FDA”). Under the Food, Drug and Cosmetic Act (“FDCA”), foods are defined as:

• Articles used for food or drink, such as a apples or soda.
• Chewing gum.
• Articles used for components of those articles, such as food additives.
  (21 U.S.C. § 321(f))

Substances added to food must be either:

• FDA-approved food additives, which are substances having an intended use that results in their bec
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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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Have you ever seen a claim made on a food, beverage or supplement label that seemed too good to be true? Unfortunately, this happens all the time. However, the companies producing these products won’t get away with it for long. The FDA has strict rules for claims made on labels. If your label does not adhere to these rules, you may be subject to serious consequences. In this article, we’re going to cover what a claim is, what happens if you make a false claim, and how US Imports can help.

What Are Claims?

A claim could be a variety of things, such as “100% Organic” or “All Natural.” These particular claims are permissible so long as your product qualifies. Some claims are preapproved by the FDA and others are allowed if they are truthful and do not mislead consumers.  An example of a preapproved health claim would be “you can reduce your risk of osteoporosis with physical daily exercise, vitamin D, and calcium.” This claim is backed by scientific data and has been proven by scientist...

Mislabeling your products can harm your business's reputation and cause you to lose sales. Customers want to be able to find all the information they need without having to look hard for it. Moreover, similar to food and beverage, the FDA requires cosmetic products to be labeled properly. Below is a list of common labeling mistakes and how to fix them before you start selling your products.

Product Name

To prevent misbranding, you need to make sure the front of the label properly lists what the actual product is. For example, “Rose Scented Lotion” would be the proper name for a skin lotion that smells like roses because a fragrance is added to the product. However, if instead the label states “Rose Lotion” this would imply that the lotion contains roses and if it did not contain roses themselves the product would be considered misbranded.

Ingredient List or Not

FDA requires products that make at least one claim to include an ingredient list on the label. For example, if your product ...

Before your products arrive in the United States, you must have a Foreign Supplier Verification Program (FSVP) Plan in place. If you don’t have a physical presence in the USA, then you need to then appoint an FSVP Agent to communicate with the FDA. However, there are a few things you need to know before you start drafting up an FSVP Plan and finding an FSVP Agent.

What is the FSVP?

FSVP is a requirement under the Food Safety Modernization Act (FSMA) created as a preventive measure to prevent foodborne illnesses in the USA. FSVP rule is a way to ensure foreign food suppliers are following the same food safety standards as those required in the USA.

Who must comply with FSVP?

All importers who import food into the US must comply with the FSVP. If you are a US importer and your food is coming from a foreign supplier, you must have an FSVP Plan in place before importing your products. If you do not have a representative in the US then you will need to appoint an FSVP Agent. The FSVP Ag...

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...

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 di...

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 addition to other label requirements, dietary supplements sold in the United States must provide the contact information of the person responsible for receiving reports of adverse events related to taking or using the supplement.  These adverse events must then be reported to the United States Food and Drug Administration.

The adverse agent contact information on your label must be either (1) a United States mailing address, or (2) a United States toll free telephone number.  The responsible person must be located within the United States.  If the label does not include a U.S. address or phone number, the product is misbranded and may be denied entry into the U.S.  US Imports can serve as the agent for purposes of this required adverse event reporting. 

What is the definition of an adverse event?

An adverse event is an undesired experience that occurs after using or taking a dietary supplement. These experiences can vary from mild, unexpected symptoms to extreme reactions. Risk...