FDA looks primarily at the product's labeling and intended use. Patches marketed as nicotine replacement therapy to help people quit smoking are regulated as drugs by FDA's Center for Drug Evaluation and Research (CDER) and must meet drug approval or OTC monograph requirements. Patches not carrying cessation claims but delivering nicotine transdermally could fall under the Center for Tobacco Products. Importers must confirm which regulatory pathway applies before entry, as the documentation and admissibility requirements differ substantially.

For drug-regulated patches, FDA entry documentation must accompany the shipment, and the product must be from an FDA-registered facility. For tobacco-product-regulated items, FDA's Center for Tobacco Products premarket authorization documentation is required. In both cases, CBP will coordinate with FDA on admissibility. Working with a licensed customs broker experienced in FDA-regulated goods is strongly recommended given the dual-pathway complexity.