MoCRA
MoCRA
With the enactment of the Modernization of Cosmetics Regulation Act (MoCRA) on December 29, 2022, the FDA is now empowered with enhanced oversight of the cosmetic industry to bolster product safety. MoCRA is designed to address concerns relating to fragrance allergen labelling, underreporting of adverse health events, lack of a mandatory quality standard for manufacturing facilities, and a communication gap between brand owners and consumers.
Focal Point Research has been assisting companies with US cosmetic compliance for over three decades. Let us help you fulfil your regulatory and quality assurance roles in this ever-growing industry. Get tailored advice and guidance curated by Focal Point experts on how to navigate the new MoCRA requirements.
Focal Point Research offers the following
MoCRA Consulting Services
Services
- Help identify if you qualify for the small business exemption
- Help obtain a FEI, if you do not already have one
- Prepare your business for MoCRA implementation
- Cosmetic Facility Registration
- Cosmetic Product Listings
- Help you meet Annual and Biennial renewal requirements
- Review your Product Label, Insert, Marketing Material, Website, and Advertising for U.S. Compliance
- Compile evidence to substantiate product safety
- Develop procedures for handling of Adverse Events
- Adverse Event Evaluation and Serious Adverse Event Reporting
- Setup and implement FDA Cosmetic GMP Quality Management System, including SOPs
- Assist with ongoing Cosmetic GMP compliance
- Conduct GMP audits for FDA Cosmetic GMP Compliance
“Focal Point Research has consistently and professionally looked after regulatory and quality issues of our brand for years. Through a courteous and knowledgeable team, they have managed to navigate us through an ever changing regulatory landscape while maintaining our interests, and allowed us to correctly distribute and sell within Canada.”
“I have truly enjoyed working with you over the last 8 years! You and your team have been an amazing resource for me. I have always been impressed by the knowledge and professionalism of everyone at Focal Point, which is a true testament to your leadership.”
Connect With Us
The Focal Point Research team is ready to help with all of your scientific and regulatory needs. Our team has the experience and expertise you need to see your product to market and we are eager to help you.
