Does MoCRA affect indie skincare brands in 2026?

Yes. The FDA's Modernization of Cosmetics Regulation Act now requires US facilities to register with the FDA, designate a responsible person for each product, maintain safety substantiation records, and report serious adverse events within 15 days. Brands selling into the EU additionally need a CPSR and product notification via the CPNP portal. These compliance steps are non-negotiable and should be budgeted from the outset of your launch plan.