Do I need FDA approval to sell a mushroom extract serum in the US?

Mushroom serums are regulated as cosmetics in the US, not drugs, so FDA pre-market approval is not required. However, you must comply with FDA labeling rules (21 CFR Part 701), use correct INCI names, and ensure your preservative system meets safety standards. If you make drug-like claims (e.g., 'treats eczema'), the product may be reclassified. EU sales require a full Safety Assessment under Regulation 1223/2009.