Anthony Girand on MoCRA and the Future of Cosmetics Compliance

6 min read

Why MoCRA Is the Most Important Regulatory Shift in Cosmetics in a Generation

I've spent more than three decades navigating regulatory environments across Wall Street, healthcare, fintech, and enterprise SaaS. I've watched industries get blindsided by regulatory shifts they saw coming but didn't prepare for. The Modernization of Cosmetics Regulation Act — MoCRA — has all the hallmarks of exactly that kind of moment for the cosmetics industry.

Signed into law in December 2022 as part of the Consolidated Appropriations Act, MoCRA represents the first comprehensive overhaul of cosmetics regulation in the United States since 1938. Let that sink in. For 84 years, the FDA's authority over cosmetics was so limited that it couldn't even require companies to register their facilities or report serious adverse events. That era is over.

What I find most striking — both as an attorney and as someone who builds AI compliance infrastructure — is how many brands are still treating MoCRA as a distant concern. It isn't. Key compliance deadlines have already passed or are actively approaching, and the FDA has made clear it intends to enforce. For cosmetics founders, GCs, and operations leaders, the time to act is now.

What MoCRA Actually Requires: Breaking Down the Core Obligations

The law introduces several interlocking compliance obligations that collectively represent a fundamentally new operating reality for cosmetics companies. Here's what every brand needs to understand:

Facility Registration

Any facility that manufactures or processes cosmetic products distributed in the U.S. must now register with the FDA. This includes both domestic manufacturers and foreign facilities exporting to American consumers. Registration was required by December 29, 2023, and must be renewed biennially. Smaller brands that relied entirely on contract manufacturers are not exempt — they need to ensure their manufacturing partners are registered and verify that status as part of their vendor management process.

Product Listing

Every cosmetic product must be listed with the FDA, including a complete ingredient declaration. For brands with large SKU catalogs — think mid-size indie beauty companies with dozens or hundreds of products — this is a non-trivial operational exercise. Ongoing listing obligations apply whenever a new product is commercialized or an existing formulation changes.

Good Manufacturing Practices (GMPs)

The FDA is in the process of promulgating mandatory GMP regulations for cosmetics. While the final rule is still being finalized, brands should be aligning their internal quality systems with existing industry standards now. Waiting for the final rule before beginning GMP alignment is a strategic mistake — the companies that will be caught flat-footed are those treating this as a future problem.

Serious Adverse Event Reporting

This is the provision with the most immediate legal exposure. Cosmetics manufacturers and distributors must now report serious adverse events — including events that result in hospitalization, disfigurement, infection, or significant disability — to the FDA within 15 business days of receiving notice. They must also maintain records for six years. For brands that previously had no formal adverse event intake process, building that infrastructure quickly is critical.

Labeling and Safety Substantiation

MoCRA also strengthens requirements around product safety substantiation and professional-use product labeling. The FDA now has explicit authority to require recalls for unsafe cosmetics — authority it previously lacked entirely.

The Compliance Burden Falls Hardest on Small and Mid-Size Brands

Large multinationals — your L'Oréals and Estée Lauders — have entire regulatory affairs departments built for exactly this kind of compliance environment. They'll adapt. The real challenge falls on the thousands of indie brands, DTC startups, and mid-market beauty companies that have grown up in a largely unregulated environment.

These companies often don't have in-house regulatory counsel. Their ingredient documentation may be scattered across email threads and supplier PDFs. Their adverse event reporting process, if it exists at all, is informal. Their contract manufacturers may or may not be registered. This is not a criticism — it reflects the environment these companies were built in. But MoCRA changes the environment, and that requires a deliberate operational response.

"The companies that will thrive in the post-MoCRA environment are those that build compliance infrastructure as a core operational competency — not those that treat it as a legal checkbox."

Where AI-Native Compliance Changes the Equation

This is why I founded ProductProof.ai and built MoCRA Intelligence. The compliance problem MoCRA creates is, at its core, a data and workflow problem — and that is precisely where AI agents deliver transformative value.

Consider what a comprehensive MoCRA compliance program actually requires on an ongoing basis:

Continuous monitoring of FDA guidance updates, enforcement actions, and regulatory communications
Document management across product listings, facility registrations, ingredient documentation, and safety substantiation files
Adverse event intake, triage, and reporting within strict timelines
Vendor verification to confirm that manufacturing partners maintain current registration
Ingredient screening against evolving FDA prohibited and restricted substance lists
Audit-readiness — maintaining the documentation chain that demonstrates compliance at every level

Each of these tasks, performed manually, requires significant time from trained personnel. For a brand without a dedicated regulatory team, they are nearly impossible to execute consistently at scale. AI agents change this calculus entirely.

At ProductProof.ai, we've built intelligent workflows that automate the repetitive, high-volume elements of MoCRA compliance — continuous regulatory monitoring, document extraction and classification, adverse event workflow management — while surfacing the decisions that genuinely require human legal judgment. The result is a compliance infrastructure that a small brand can actually maintain without hiring a team of regulatory specialists.

The Broader Strategic Principle

What I've learned building AI systems across healthcare, fintech, and now cosmetics compliance is that the highest-value AI applications aren't the ones that replace judgment — they're the ones that protect against the failure modes of purely manual processes: inconsistency, gaps in monitoring, documentation that falls through the cracks. In a regulatory environment like MoCRA, where the FDA now has real enforcement authority, those failure modes carry real legal consequences.

What Cosmetics Brands Should Do Right Now

If you're a founder, CEO, or compliance officer at a cosmetics company, here is where I'd focus immediately:

Confirm facility registration status for all manufacturing partners. Don't assume — verify.
Audit your product listing completeness. Every SKU currently in commerce needs to be listed with the FDA.
Build or formalize your adverse event intake process. The 15-business-day reporting clock starts the moment your company receives notice of a serious adverse event.
Document your safety substantiation for existing products. This should exist in a retrievable, organized format — not scattered across email.
Engage regulatory counsel to assess your current GMP posture against anticipated FDA standards.

MoCRA is not a future regulatory concern. It is the present operating environment for every company in the cosmetics space. The brands that build real compliance infrastructure now — whether through internal resources, external counsel, or AI-native tools — will be positioned to compete. The brands that don't will face enforcement risk, reputational exposure, and the far greater cost of reactive remediation.

I've seen this pattern play out across every regulated industry I've worked in. The companies that treat compliance as a strategic investment consistently outperform those that treat it as a tax. In the post-MoCRA world, that lesson has never been more relevant to the beauty industry.