FDA Stories #017 — A Japanese Matcha Company Was Selling a Dietary Supplement With a Food Label

A shea butter producer in Kano, Nigeria, operated two facilities. The first was a processing plant where raw shea nuts were crushed, refined, and turned into cosmetic-grade shea butter. The second was a warehouse and packing facility in Lagos, 900 kilometers away, where the refined butter was stored, packed into retail containers, and prepared for export.

The processing plant in Kano had an FDA food facility registration (shea butter for cosmetic use is still classified as food for FDA facility registration purposes if it can also be used in food). The warehouse in Lagos had no registration at all.

Why the warehouse needed its own registration

Under 21 CFR Part 1, Subpart H, any facility that manufactures, processes, packs, or holds food for consumption in the United States must register with the FDA. The Lagos warehouse was packing and holding food for US export — two registerable activities. Each physical facility needs its own registration, its own DUNS number, and its own US Agent designation. The Kano registration did not cover the Lagos warehouse. They are different facilities in different cities.

If a shipment from the Lagos warehouse had been traced back during an FDA inquiry, the FDA would have found that the product was packed and held at an unregistered facility. Under Import Alert 99-33, products from unregistered food facilities are subject to detention without physical examination.

The fix

We obtained a separate DUNS number for the Lagos warehouse, registered it as an FDA food facility, and designated ourselves as US Agent for both facilities. The Kano processing plant and the Lagos packing warehouse now each have their own registrations, their own registration numbers, and their own compliance records in the FDA system.

If your company operates more than one facility that handles products destined for the US — even if one is just a warehouse — each facility probably needs its own FDA registration. This is especially common in countries where processing and packing happen in different locations. Check with us at fdabridge.com/contact.