Worked Vegetable & Mineral Carving Materials; Molded Articles of Wax, Resin & Gelatin

Unfilled hard gelatin capsules used as drug delivery components are regulated by FDA. Importers should ensure the foreign manufacturer is registered with FDA and that shipments comply with current Good Manufacturing Practice (cGMP) requirements. FDA may detain shipments from unregistered facilities or those with prior import alerts. Consult a licensed customs broker or regulatory affairs specialist familiar with FDA entry procedures before importing. Classification and admissibility of pharmaceutical components can be complex; a licensed customs broker should be consulted.

Vegetable capsules are typically made from hydroxypropyl methylcellulose (HPMC) or pullulan rather than animal-derived gelatin, making them suitable for vegetarian, vegan, and halal or kosher-certified supplement products. For HTS purposes, the distinction is explicit: gelatin capsules enter under 9602001040 while vegetable capsules enter under 9602005010. Importers should ensure the commercial invoice and product documentation clearly identify the capsule shell material to support correct classification.