FDA classifies tampons as Class II medical devices, meaning imported tampons are subject to FDA review at entry. Sanitary napkins generally are not regulated as medical devices, but any product making therapeutic or antimicrobial claims may trigger additional FDA scrutiny. Importers should consult a licensed customs broker and confirm FDA registration status for tampon manufacturers prior to shipment.

The critical factor is the primary material: products composed principally of paper pulp, cellulose wadding, or webs of cellulose fibers fall under this heading, while diapers constructed primarily from textile nonwoven fabrics are classified elsewhere. Composite products require analysis of the essential character of the component materials, which can be a significant classification challenge for modern multi-layer absorbent cores.