In the USA, cosmetic products and OTCs are regulated at federal level (FDA) by the FD&C Act and the FPLA as well as by local laws in each state. EcoMundo will take care of each step in the compliance procedure, enabling you to market your products in the 50 American states.
cosmetic or OTC?
OTC complianceOTC COMPLIANCE
- Validation of the formula according to the monograph defined by the product’s function
- Validation of OTC claims
- Creation of OTC labels: Drug Facts
- Registration of the product with the FDA: Drug listing
- Registration of the manufacturer with the FDA: Drug Establishment Registration
- US Agent service