In this episode of Demystifying Cosmetics, host Jennifer sits down with regulatory expert and clean beauty advocate Nyree Bekarian-Mack to discuss the modernization of cosmetic regulations under MoCRA (Modernization of Cosmetics Regulation Act) and its impact on the beauty industry. From safety substantiation to navigating regulatory gaps, Nyree provides a deep dive into the challenges and opportunities for brands adapting to this new regulatory landscape.

Key Takeaways:

The Significance of MoCRA:

• MoCRA marks the biggest regulatory shift for cosmetics in the U.S. since 1938, focusing on transparency, safety, and FDA authority.
• Key changes include mandatory facility registration, product listing, adverse event reporting, and recall authority.

Gaps in U.S. Regulations:

• Unlike the EU, the U.S. lacks prescriptive safety testing requirements, leaving brands to navigate vague guidelines.
• The need for third-party validation and stronger oversight on raw materials and claims substantiation remains critical.

Challenges for Indie Brands:

• Compliance with MoCRA can be expensive and complex for small brands, requiring proactive safety testing, GMP adherence, and detailed labeling.

Actionable Recommendations:

• Work with FDA-licensed facilities.
• Ensure robust safety and claims substantiation.
• Monitor adverse events and stay informed about emerging regulations.

Timestamps:

00:00 – Start
00:30 – Meet Nyree Bekarian-Mack and her extensive background.
01:21 – What is MoCRA and why is it important?
03:29 – U.S. vs. EU regulations: Why MoCRA is a step forward but still falls short.
06:51 – Key updates under MoCRA: Registration, GMP, and adverse event reporting.
12:35 – Timelines and delays in MoCRA implementation.
15:12 – Advice for brands: Partnering with FDA-licensed facilities and ensuring compliance.
20:17 – Challenges indie brands face with safety testing and claims substantiation.
28:32 – How safety and quality intersect in product development.
34:08 – Adverse event reporting under MoCRA: New requirements and timelines.
40:50 – Industry response to MoCRA and its impact on innovation.
47:54 – Future considerations: What brands can do to stay ahead.