In the ever-evolving landscape of regulatory compliance, the beauty and personal care industry is undergoing a significant transformation. As a full-service medical device development company, we’ve long navigated the stringent requirements of FDA regulations for medical devices. Now, with the implementation of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), cosmetics are stepping into a similar spotlight. Enacted as part of the Consolidated Appropriations Act of 2023, MoCRA represents the most substantial update to cosmetics oversight since the Federal Food, Drug, and Cosmetic Act of 1938. This new framework brings cosmetics regulation closer to the standards we’ve mastered in medical devices, emphasizing safety, transparency, and accountability.
At Occam Design, we see MoCRA not as a hurdle, but as an opportunity for innovation and enhanced consumer trust. In this blog post, we’ll break down what MoCRA entails, its key implications, and how our expertise in medical device development can support cosmetics manufacturers in achieving seamless compliance.
What is MoCRA and Why Does It Matter?
MoCRA is a landmark legislation that expands the FDA’s authority over cosmetic products, addressing long-standing gaps in oversight. Previously, cosmetics were largely self-regulated, with voluntary reporting and minimal federal intervention. Now, MoCRA introduces mandatory requirements that mirror those in pharmaceuticals and medical devices, such as good manufacturing practices (GMP) and adverse event reporting.
Key drivers behind MoCRA include rising concerns over product safety, ingredient transparency, and public health. With cosmetics used daily by millions, incidents like contamination or allergic reactions highlighted the need for stronger protections. As of 2025, enforcement is in full swing, with the FDA actively registering facilities and monitoring compliance. For manufacturers, this means adapting to a more rigorous environment, one that’s familiar territory for medical device firms like ours.
Key Provisions of MoCRA: A Breakdown
MoCRA’s changes are phased, but many are now mandatory. Here’s a closer look at the core elements and how they align with medical device regulations:
1. Facility Registration and Product Listing
- All cosmetic manufacturing facilities must register with the FDA, and products must be listed with detailed information on ingredients and intended use. This is akin to the establishment registration for medical devices under 21 CFR Part 807.
- Implication: Helps the FDA track supply chains and respond to safety issues quickly. For global manufacturers, this adds layers of documentation, something we’ve streamlined for our medtech clients through automated compliance tools.
2. Adverse Event Reporting
- Serious adverse events (e.g., infections, severe allergic reactions) must be reported to the FDA within 15 days, with records maintained for six years.
- Implication: This parallels the Medical Device Reporting (MDR) requirements we’ve helped clients implement, ensuring rapid response and risk mitigation. Early detection can prevent recalls and protect brand reputation.
3. Good Manufacturing Practices (GMP)
- The FDA is establishing GMP standards for cosmetics, similar to those for drugs (21 CFR Parts 210/211) and devices (21 CFR Part 820). While final rules are pending, draft guidances emphasize sanitary conditions and quality controls.
- Implication: Manufacturers must audit processes for contamination risks, much like ISO 13485 for medical devices. Our team has decades of experience designing GMP-compliant workflows, from cleanroom setups to validation protocols.
4. Safety Substantiation and Labeling
- Companies must substantiate product safety with scientific evidence and label products with allergen information.
- Implication: This elevates cosmetics to a “premarket” scrutiny level, requiring robust testing—areas where our R&D expertise shines, especially for hybrid products like aesthetic devices that blur lines between cosmetics and medtech.
5. Recall Authority and Fragrance Allergen Disclosure
- The FDA now has mandatory recall powers for unsafe cosmetics, and fragrance allergens must be disclosed on labels.
- Implication: Enhances consumer safety but demands proactive risk assessments, drawing directly from our medical device post-market surveillance strategies.
These provisions mark a “new era” in cosmetics safety, as noted by experts, shifting from reactive to proactive regulation.
The Intersection with Medical Devices: Opportunities for Crossover Expertise
While MoCRA targets cosmetics, there’s notable overlap with medical devices, particularly in aesthetic and dermatological products. Devices like laser hair removers or microneedling tools often fall under both categories, requiring dual compliance. Our full-service approach at Occam Design bridges this gap: We’ve developed FDA-cleared devices that incorporate cosmetic elements, navigating 510(k) submissions alongside emerging MoCRA rules.
For cosmetics firms, this means leveraging medtech best practices to stay ahead. We’ve assisted clients in:
- Implementing quality management systems (QMS) that satisfy both ISO 13485 and forthcoming MoCRA GMP.
- Conducting biocompatibility testing and risk analyses that double as safety substantiation.
- Streamlining registration and reporting through digital platforms, reducing administrative burdens.
In an industry where non-compliance can lead to recalls or fines, our end-to-end services, from concept design to regulatory submission, ensure you’re not just compliant, but competitive.
Looking Ahead: Preparing for MoCRA Compliance
As MoCRA enforcement ramps up in 2025, proactive preparation is key. Start with a compliance audit, update your QMS, and invest in training. At Occam Design, we’re here to guide you through this transition. Whether you’re a cosmetics manufacturer eyeing medtech expansion or vice versa, our team of engineers, regulatory experts, and quality specialists can tailor solutions to your needs.
Ready to discuss how MoCRA affects your pipeline? Contact us today for a complimentary consultation. Let’s turn regulatory challenges into innovation drivers.