The Regulatory Moment Cosmetic Manufacturers Cannot Afford to Miss
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) represents the most significant expansion of FDA authority over cosmetics in more than eight decades. Among its most consequential provisions is the mandate for FDA to establish formal Good Manufacturing Practice (GMP) regulations for the cosmetics industry—a regulatory framework that will fundamentally reshape how companies design, document, and defend their manufacturing operations.
FDA has signaled its intent to move forward with notice-and-comment rulemaking on cosmetic GMPs, and the agency's announcement of public meetings and stakeholder engagement opportunities marks a critical inflection point. Companies that treat this process as a passive regulatory formality do so at their own peril. The rules FDA ultimately adopts will govern facility design, documentation protocols, supplier qualification, testing regimes, and recordkeeping obligations for years to come.
Why This Rulemaking Window Matters
Unlike many regulatory actions that arrive as faits accomplis, MoCRA's GMP mandate includes a structured opportunity for industry input before the rules are finalized. This is not merely a courtesy—it reflects Congress's recognition that cosmetic manufacturing spans an enormous range of business models, from multinational conglomerates to small-batch artisanal producers.
FDA has indicated that its forthcoming GMP framework will likely draw upon existing international standards, including ISO 22716, which many sophisticated manufacturers already follow voluntarily. However, the agency retains significant discretion in determining:
- The scope of recordkeeping and documentation requirements
- Thresholds for facility registration and inspection readiness
- Supplier verification and raw material testing obligations
- Deviation investigation and corrective action protocols
- The treatment of contract manufacturers versus brand owners
Each of these determinations carries material compliance costs and operational implications. Companies that fail to engage now may find themselves implementing frameworks poorly suited to their actual manufacturing realities.
The Strategic Case for Participation
From a business and legal risk management perspective, engagement in this rulemaking process is not optional—it is a fiduciary and operational imperative. Several considerations support this view.
First, administrative law favors those who build the record. Under the Administrative Procedure Act, agencies must consider substantive comments submitted during the public comment period. A well-documented, technically rigorous comment carries far more weight than post-hoc litigation challenging a rule after it takes effect. Companies that articulate specific operational concerns—supported by data, cost analyses, and real-world manufacturing scenarios—create a record that can shape both the final rule and any subsequent judicial review.
Second, early engagement allows companies to shape achievable compliance timelines. FDA has statutory deadlines for issuing proposed and final GMP rules, but implementation timelines for covered facilities remain subject to negotiation through the comment process. Smaller and mid-sized manufacturers, in particular, have a strong interest in advocating for phased compliance periods and tiered requirements based on facility size or production volume.
Third, trade associations alone cannot adequately represent every stakeholder's interests. While industry groups such as the Personal Care Products Council will undoubtedly submit comprehensive comments, individual companies—particularly those with unique supply chain structures, novel manufacturing technologies, or specialized product categories—should consider independent submissions or participation through legal counsel to ensure their specific circumstances are reflected in the rulemaking record.
Practical Steps for Meaningful Engagement
Companies seeking to influence the GMP rulemaking process should consider a multi-pronged approach:
- Attend FDA's public meetings directly. These sessions provide real-time insight into FDA's thinking and allow companies to ask clarifying questions that may shape how they frame written comments.
- Conduct an internal gap analysis now. Benchmark current manufacturing practices against ISO 22716 and anticipated FDA expectations to identify areas where proposed requirements may impose disproportionate burden.
- Engage legal counsel to draft substantive comment letters. Comments grounded in regulatory and administrative law principles—rather than general objections—carry greater persuasive weight with agency staff.
- Coordinate with industry peers facing similar operational challenges, while still preserving the ability to submit company-specific concerns.
- Document cost and feasibility data regarding proposed requirements, since FDA must consider economic impact under its rulemaking obligations, including potential Regulatory Flexibility Act analysis for small businesses.
Looking Ahead
FDA's cosmetic GMP rulemaking will likely unfold over multiple stages, including a notice of proposed rulemaking, a formal comment period, and eventual publication of a final rule. Given FDA's demonstrated willingness to extend timelines on other MoCRA provisions, companies should expect this process to involve genuine back-and-forth rather than a predetermined outcome.
This extended runway is an asset, not a reason for delay. Companies that engage early—through public meeting participation, substantive written comments, and proactive internal readiness assessments—position themselves to shape a workable regulatory framework rather than merely react to one imposed upon them.
The Bottom Line
MoCRA's GMP rulemaking process represents a rare opportunity for cosmetics manufacturers to directly influence the regulatory architecture that will govern their operations for the foreseeable future. Sophisticated companies should treat FDA's public meetings and comment periods not as bureaucratic checkpoints, but as strategic inflection points warranting the same level of attention given to major litigation or transactional matters. The cost of silence during this rulemaking window may well exceed the cost of thoughtful, well-resourced engagement today.