Does a snail mucin serum need FDA approval before I can sell it in the US?

Snail mucin serums are regulated as cosmetics, not drugs, under US law — so no pre-market FDA approval is required. However, under MoCRA (effective 2023–2024), responsible persons must register facilities and list products with FDA, maintain safety substantiation records, and follow updated labeling rules. A cGMP-compliant manufacturer sourced through AJ Cosmo Labs will typically already have these compliance structures in place.