In this short video, FDA compliance attorney Lisa Capote covers key FDA compliance guidance. Watch below, then read the full transcript.
Video Transcript
Hey there. I’m Lisa, an FDA compliance attorney. Importing dietary supplements into the United States involves navigating a specific set of FDA requirements — and getting it wrong can result in your shipment being detained at the border.
First, the foreign facility manufacturing the supplements must be registered with the FDA. Facility registration is required under 21 CFR Part 1 for any facility that manufactures, processes, packs, or holds food — and dietary supplements are regulated as a category of food under the FD&C Act.
Second, the product must be properly labeled in accordance with FDA dietary supplement labeling regulations. That includes a Supplement Facts panel, an ingredient list, and all required labeling elements under 21 CFR Part 101.
Third, the U.S. importer of record must comply with the Foreign Supplier Verification Program, or FSVP. This requires the importer to evaluate the hazards in the supplement, assess the foreign supplier’s performance, and conduct supplier verification activities — which could include on-site audits, records review, or product testing.
Fourth, you must provide prior notice to the FDA before the shipment arrives at the U.S. port of entry.
If any of these requirements aren’t met, the FDA can refuse admission of your shipment. Getting your compliance in order before you ship saves significant time and cost. We help importers navigate the full compliance process. Reach out anytime.
Have FDA compliance questions? Contact Capote Law Firm or call (786) 207-1174.