PMRASYSTEM LLC
FDA Registration & MoCRA Compliance
In accordance with the U.S. Food and Drug Administration (FDA) guidelines and the Modernization of Cosmetics Regulation Act (MoCRA):
- Facility Registration: All NovaLuma skincare products are manufactured in the United States at a facility registered with the FDA (Registration / FEI #: 3019756102).
- Cosmetic Classification: Under U.S. law, cosmetic products do not require pre-market FDA approval, provided they are safe for intended use and properly labeled.
- Safety & Adverse Event Reporting: Every NovaLuma formula undergoes stability and microbiological testing, with a Batch Certificate of Analysis (COA) maintained for each production run. Consumers or healthcare professionals may report any adverse reactions directly via our dedicated U.S. compliance line at +1 (307) 292-4780 or info@novaluma.us.