When importing dietary supplements into the United States, importers must comply with the U.S. Food and Drug Administration (FDA) regulations. Specific FDA regulations govern proper labeling, approved ingredients, and more. Taking care to properly file a Prior Notice before the shipment arrives at the port is essential.

Our guide below provides importers with everything they need to know about importing dietary supplements into the U.S.

What are Dietary Supplements?

Dietary supplements are foods that are orally ingested, usually in the form of a pill, tablet, capsule, gummy, liquid concentrate, powders, drinks or energy bars. They are taken to supplement the diet, promote general health and well-being, and affect the structure or function of the human body (like drugs). Dietary supplements must be ingested, so they are never topical creams, ointments, or oral or nasal sprays. The FDA will review how a product is marketed when classifying how to enforce its standards and failing to d...

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...

Did you know that if your label doesn’t meet FDA requirements, it can cause a delay at the port? Label mistakes can have a huge impact on your Amazon business if you don’t know what you’re doing. How can you fix this? You can have your label reviewed by professionals well-versed in FDA labeling regulations. Sure, you could try to figure it out on your own, but is it worth the risk? At US Imports, our FDA specialists help minimize this risk by reviewing your label and providing suggestions to keep your labels compliant with U.S. laws.

How can US Imports help you?

We offer two FDA label review packages. Our Basic Package Label Review provides an extensive review of your label for FDA compliance. As part of this review, you will receive a detailed report with suggested changes to your label. Once you implement the changes, you can resubmit your revised label to us for another review to ensure the changes were made correctly.

Our Expert Package Label Review contains everything in the ...

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...

Dietary supplements have become a popular choice for individuals who want to improve their health.  

However, the U.S. Food and Drug Administration (FDA) does not regulate dietary supplements the same way as prescription or over-the-counter drugs are regulated. In fact, the FDA does not approve dietary supplements before they are available for purchase in the marketplace. To mitigate the potential risk dietary supplements pose to the safety and health of consumers, the FDA requires all supplement labels to list how adverse reactions can be reported.

How does the FDA regulate dietary supplements?

The FDA regulates dietary supplements with the adverse event reporting system. Anyone who experiences an adverse reaction and suspects that a dietary supplement could be the cause can submit an adverse event report. The report is made to either the supplement manufacturer or distributor via the adverse event reporting information provided on the label. The FDA requires this reporting inform...

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...

Prior Notice must be provided to the U.S. Food and Drug Administration (FDA) for all dietary supplements offered for import into the United States. Prior notice consists of the following information that must be provided before arrival of the shipment at a U.S. port:

• Information about the product, including quantity, packaging type and number of packages, manufacturer information, and FDA Product Code 
• Country origin 
• Country from which the article is shipped
• Anticipated port of arrival 
• Anticipated arrival date
• Anticipated arrival time
• Whether the shipment has been denied entry into another country

You will also need to submit documentation of your shipment, including a bill of lading, airway bill or tracking number, as appropriate.

If you fail to file a timely Prior Notice, the FDA will not authorize release of your dietary supplements, and the Customs and Border Patrol will not allow entry of the shipment. If you fail to file within the required timeframe depending on t...

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...

Certain countries require U.S. exporters to be listed in FDA’s export list for certain products. Without a spot on the  export list, U.S. exporters of certain food products are barred from access to applicable foreign markets. If you’re wondering whether your U.S. food export business is subject to these requirements, keep reading to learn more about the FDA’s export list.

What products are required to be on an FDA export list?

Although each country requires export lists for different products, the types of products include:

•  Dairy
•  Seafood
•  Shellfish
•  Infant formula
•  Collagen products
•  Gelatin products

Which countries require exporters to be listed?

Each country has their own requirements for the types of products appearing on export lists., so U.S. exporters’ eligibility may differ from one country to another. The three countries/territories that require exporters to be listed on the FDA export list for certain products are: 

•  European Union — The EU uses certain co...