FDA's classification hinges primarily on the product's intended use as communicated through labeling, marketing materials, and claims. A botanical product making disease-treatment or cure claims is regulated as a drug requiring pre-market approval; one marketed for general wellness or nutritional support may qualify as a dietary supplement under DSHEA. Importers should ensure labeling is consistent with the intended regulatory pathway before entry.

Yes. Bulk vitamin raw materials and finished encapsulated or tableted supplements may follow different FDA review pathways and carry distinct HTS classifications. Bulk APIs intended for further manufacturing are subject to drug facility registration requirements if they are drug substances, while finished dietary supplements are reviewed under DSHEA. Consulting a licensed customs broker is advisable to confirm the correct classification and compliance obligations.