What You Need to Know About Importing Dietary Supplements to U.S.

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 common red flag for FDA inspectors. Make sure to review any disease or health claims for compliance with applicable regulations.

FDA Facility Registration

Make sure the facility that manufactures the product is registered with FDA prior to importation to avoid delays.

Prior Notice

Each shipment requires a prior notification to be filed with FDA before the product arrives at its port of entry. Failure to file the prior notice in a timely manner can result in customs refusing entry of your shipment.

Foreign Supplier Verification Program

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. Importers must also develop a Foreign Supplier Verification Program (FSVP) plan to evaluate and perform “risk-based activities” on all suppliers. Compliance with FSVP is mandatory and businesses found in violation of the FSVP rule can face a variety of penalties, from seizure of the imported products to criminal prosecution. For more information on the FSVP rule, check out this article.

US Imports can assist your business with every step of the import process. Click here to see the services we offer to ensure your products meet FDA requirements for importing dietary supplements.