Topics/Regulated Products & Health

OTC & Medical Products

High risk

Rules for over-the-counter medications, medical devices, medical supplies, and health products regulated by the FDA.

OTC drugs must comply with FDA monograph or have approved NDAMedical devices require FDA clearance (510k) or exemption documentationDrug facts panel required for all OTC drug products

What this covers

Over-the-counter drug products must include a compliant Drug Facts panel and meet FDA monograph requirements before listing — selling an OTC product outside the applicable monograph without an approved NDA is an unlicensed drug violation. Medical devices require FDA clearance (510(k)) or a documented exemption, and listing a device without it triggers removal even if the product is functionally identical to a cleared device. TikTok Shop treats device and OTC drug classification as seller responsibility: if your product qualifies as one, the burden of documentation is on you.

Start with the current guidance below, then use recent updates for context on what shifted.