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 ...

All exporters of food and dietary supplements to the United States are required to provide the U.S. Food and Drug Administration (FDA) with advance notice of all arriving shipments. This advance notice allows the FDA to more effectively protect the U.S. food supply against foreign threats. Your shipment will be refused at U.S. ports if you fail to file Prior Notice on time. This can have devastating effects that reverberate all the way down your supply chain and interfere with your business.

What is Prior Notice?

The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the “Act”) directed the FDA to take measures to protect the public from threatened or actual terrorist attacks on imported food. Under rules promulgated by the Act, the FDA requires importers to alert them of incoming shipments by filing Prior Notice. In 2011, the FDA published a final rule that a person submitting Prior Notice disclose the name of any country in which their product was refuse...

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 ...

As Americans have become increasingly health conscious over the years, the use of supplements and health products have skyrocketed. This trend towards wanting to live healthier lifestyles is a wonderful shift to see, but there is a drawback. With increased demand for supplements and more options entering the market, the FDA has turned their attention to the claims these products make. Dietary supplements that promise to treat, cure, prevent, mitigate, or diagnose a disease may be flagged and potentially held at import. It’s imperative to review your product’s label carefully with the aid of an expert to avoid the consequences of false or misleading claims.

How does the FDA regulate dietary supplement claims?

According to the Dietary Supplement Health and Education Act of 1994, dietary supplements must adhere to certain guidelines and stay within the approved parameters with the claims they make. The Dietary Supplement Health and Education Act also requires specific “Supplement Facts”...

As Americans have become more health conscious, dietary supplement sales have surged the past few years. By the same token, Amazon has become a popular platform for dietary supplements because of the convenience for both the seller and consumer. Businesses who desire to sell dietary supplements on Amazon should be familiar with the U.S. Food and Drug Administration (FDA) laws and regulations. Failure to comply with the FDA regulations will result in the removal of the dietary supplements from Amazon’s storefront.

The FDA does not preapprove products for compliance, it is the business’ responsibility to ensure that the FDA requirements are met. Dietary supplements exported to the United States face extra requirements importers must follow. Listed below are some of the FDA requirements for dietary supplement imports.

Facility Registration with FDA

All dietary supplement manufacturer’s facilities must be registered with the FDA if the product or ingredients are being exported to the U...

Dietary supplement importers must engage an agent physically located in the United States to verify their foreign suppliers compliance with U.S food safety laws. In fact, in 2019 the FDA cited the lack of developing a foreign supplier verification program (FSVP) as one of the most cited violations for FDA registered facilities. The deadline for FSVP compliance has now passed, so all importers must have a FSVP plan in place before shipping. FDA requires importers to present their FSVP's upon request.

The FSVP rule requires importers to perform “risk-based activities” to verify that the food they bring into the United States has been produced in a manner that meets U.S. food safety standards.

One of the key elements of the FSVP rule for foreign dietary supplement importers or exporters with no employees located in the U.S. is the requirement to designate an "agent" to carry out FSVP responsibilities on behalf of the importer. The agreement with the agent must be in writing and the agen...

Dietary supplements offered for import into the United States and marketing to U.S. consumers are governed by a complex body of federal laws and regulations enforced by the FDA. These laws and regulations establish requirements for manufacturing practices, product and ingredient safety, labeling, marketing claims and importation procedures, among other matters.

If you plan to import supplements into the U.S. and don’t know where to start, below is a checklist of items to consider.

Ingredients

• Check the ingredient list for non-permitted ingredients and/or colors, or colors that require certification
• Check ingredient name for the proper declaration

Labeling

All labels should include, at a minimum the following items:

• Statement of Identity
• Net Quantity
• Supplement Facts
• Ingredient List
• Manufacturer, Packer, Distributor name and address
• Country of Origin

Ingredient Permits

Do any of the ingredients of animal-origin requiring a permit (APHIS/USDA)?

Claims

Claims are a...