Do I need FDA approval to sell a private label hyaluronic acid serum in the US?

Hyaluronic acid serums are classified as cosmetics under US law, not drugs, so they do not require pre-market FDA approval. However, manufacturers must comply with FDA 21 CFR Part 700 and cosmetics GMP guidelines. If you make drug claims (e.g., 'repairs skin barrier at the cellular level'), the product may be regulated as a drug. AJ Cosmo Labs connects you with ISO 22716-certified manufacturers who understand cosmetic compliance.