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. If you’re an international food brand looking to enter the U.S. market, this video is for you.
First things first: any food facility that manufactures, processes, packs, or holds food for consumption in the United States must register with the FDA under 21 CFR Part 1, Subpart H. This includes foreign facilities. Registration must be renewed every two years during October through December.
Second, your product labeling must comply with FDA requirements — including a statement of identity, net quantity of contents, nutrition facts panel, ingredient list, and manufacturer or importer information. Labels must be in English, though they can also appear in other languages.
Third, if you’re importing food into the U.S., the importer of record must comply with the Foreign Supplier Verification Program, or FSVP. This means conducting a hazard analysis for the food, evaluating the supplier’s performance and the risk of the food, and conducting appropriate supplier verification activities.
Fourth, prior notice. FDA regulations require that FDA receive prior notice before food imported for human consumption arrives in the United States.
Entering the U.S. market takes planning. The compliance requirements are real and they apply from day one. We help international food companies navigate the U.S. regulatory framework from registration through import and beyond. Reach out anytime.
Have FDA compliance questions? Contact Capote Law Firm or call (786) 871-5680.