Sterols and Inositols

Inositol used in infant formula is subject to FDA review as a food additive or GRAS substance. Importers should provide a certificate of analysis confirming purity and identity, documentation of the foreign manufacturer's FDA registration, and any applicable food-safety certifications. A licensed customs broker familiar with FDA-regulated food ingredients can help ensure smooth entry.

The US schedule separates them at the 10-digit level: inositols enter under 2906131000 and sterols under 2906135000. Correct classification requires identifying the compound by name and CAS number on the commercial invoice, as the two sub-lines carry different statistical reporting and may have different duty treatment depending on origin.