Vitamin B12 and Its Derivatives

Importers should provide a certificate of analysis confirming identity, purity, and potency; the manufacturer's facility registration number with FDA; and documentation of intended use (pharmaceutical, dietary supplement, or feed grade). For pharmaceutical-grade material, a Drug Master File reference may also be required.

All forms of Vitamin B12 and its derivatives fall under the single tariff line 2936260000 regardless of grade. However, admissibility and labeling requirements differ significantly between pharmaceutical USP grade, dietary supplement grade, and feed-additive grade — each governed by distinct FDA or USDA regulatory frameworks. Misrepresenting grade can trigger enforcement action at the port of entry.