Dietary supplement products that are destined for importation into the United States and for marketing to U.S. consumers are governed by a complex body of federal laws and regulations. These laws and regulations establish requirements that pertain to product manufacturing practices, product and ingredient safety, product labeling, marketing claims and product 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
Label Format
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)?
Low-acid or acidified canned food
Is the product a low-acid or acidified canned food (pH/water activity) requiring additional process filings with FDA?
Claims
Claims are a common red flag for FDA/Customs inspectors. Make sure to review any disease or health claims for compliance with applicable regulations.
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.
If you are unsure if the dietary supplements you plan to import comply with FDA regulations, contact our import specialists at SINI Healthcare LLP for a FREE consultation.