TikTok Shop US Classifies OTC Drugs as a High-Risk Category
TikTok Shop US classifies over-the-counter drugs as a restricted, high-compliance-risk category; children’s or infant OTC drugs may also be subject to additional requirements.
What are the key facts?
- 1OTC drugs are a restricted category subject to eligibility requirements
- 2Sellers must contact their account manager to confirm selling eligibility
- 3Children’s or infant OTC drugs may be subject to additional requirements
What happened?
TikTok Shop US’s recently updated seller policy continues to classify over-the-counter drugs as a restricted category with high compliance risk. Relevant sellers must contact their account manager to confirm whether they are eligible to sell and must comply with applicable federal, state, and local laws, FDA labeling requirements, and relevant DEA rules. Children’s or infant OTC drugs are a higher-risk subcategory and may be subject to additional requirements. The requirements apply to sellers of dietary supplements, topical medicines, pain relievers, cold medicines, and children’s health products selling to the United States from China, South Korea, Japan, and Europe. Sellers cannot list products solely on the basis of English packaging supplied by a supplier or a standard testing report. They should also verify ingredients, labeling, efficacy claims, the importing entity, and state-level restrictions, while keeping product pages, packaging, and advertising content consistent.
What does this mean for cross-border sellers?
TikTok Shop US continues to treat OTC drugs as a restricted category with high compliance risk. Whether these products can be sold depends on eligibility confirmation and applicable FDA, DEA, federal, state, and local requirements. Sellers must also verify ingredients, labeling, efficacy claims, and the importing entity, ensure consistency across product pages, packaging, and advertising, and review children’s or infant OTC drugs separately.
What should sellers do now?
- 1Immediately contact the TikTok Shop account manager to confirm US-site eligibility item by item for topical medicines, pain relievers, cold medicines, and children’s health products, retain the written response, and create a SKU approval list.Listing Optimizer
- 2Review each relevant US-site OTC listing, package, and advertisement for ingredients, labeling, efficacy claims, the importing entity, and state-level restrictions; create an issue list and mark the pages requiring revisions.