The new Spring 2025 Unified Agenda for FDA MoCRA confirms what many in the cosmetics industry suspected: FDA has shifted the Cosmetics GMP rulemaking into “Long-Term Actions,” with the proposed rule date listed as “To Be Determined.” That placement means FDA does not expect to publish a Notice of Proposed Rulemaking within the next 12 months. The Agenda entry also flags 21 CFR part 711 as the future home for cosmetics GMP and shows that the statutory NPRM deadline—December 29, 2024—has already passed, underscoring the size of the delay and the uncertainty surrounding timing.

This delay has real consequences. Manufacturers relying on timely rulemaking must now navigate ambiguity while still maintaining product safety and compliance. The risk of waiting is clear: FDA inspections continue, and public scrutiny around safety remains high. Those that hesitate risk falling behind competitors who treat this uncertainty as a signal to prepare rather than pause.

At the same time, other MoCRA-related priorities remain on a schedule. FDA’s plan continues to show a December 2025 NPRM to prohibit formaldehyde and other formaldehyde-releasing chemicals in hair-smoothing and straightening products, a May 2026 NPRM for fragrance-allergen labeling, and a March 2026 final rule establishing standardized asbestos testing for talc-containing cosmetics that builds on the proposal issued in December 2024. These dates are aspirational—agencies frequently miss them—but they still provide a reliable signal of where FDA attention is heading while GMP temporarily takes a back seat.

MoCRA GMP Takes a Back Seat—but Not a Break

This shift is significant for manufacturers and brands that rely on FDA’s progress to set their own compliance calendars. The “Long-Term Actions” designation means GMP is not expected within a year, leaving companies in a holding pattern while they continue to face regulatory expectations for product safety and quality. The extra time can be used strategically—but only if companies stay proactive.

The danger lies in mistaking “delay” for “downtime.” A slower timeline does not mean FDA will ease scrutiny. In fact, the absence of formal rules increases the risk of subjective enforcement and reputational damage for those who underperform on safety. Acting now, before requirements are codified, demonstrates foresight and positions companies as industry leaders.

FDA’s entry for RIN 0910-AJ00 (Good Manufacturing Practice for Cosmetic Product Facilities) now reads Agenda Stage: Long-Term Actions with “NPRM—To Be Determined.” The listing cites 21 CFR 711 and notes the statutory deadline for an NPRM (12/29/2024). The move signals that the agency doesn’t anticipate proposing the regulation within a year, despite MoCRA’s expectation of timely GMP rulemaking. The item remains “Included in the Regulatory Plan,” so it’s not abandoned—just delayed. For industry, that means more time but also more ambiguity about the exact contours of the final expectations.

In practical terms, this delay should be treated as breathing room—not a pause button. The FD&C Act’s adulteration provisions still apply, and FDA continues to evaluate manufacturing controls during inspections and compliance actions. Modern, auditable GMP remains the most effective way to reduce risk and demonstrate operational integrity while the regulation catches up.

The MoCRA Priorities Still Moving Forward

Even though GMP has slowed, other parts of MoCRA are moving forward. The following initiatives highlight where FDA is focusing its resources and how companies should prepare for the upcoming rulemakings. Each action represents an early signal of FDA’s enforcement mindset and where compliance expectations are tightening.

Formaldehyde Ban: The Next Major Product Safety Shift

FDA’s RIN 0910-AI83 remains in motion, with the Unified Agenda targeting an NPRM in December 2025. The abstract is explicit: ban formaldehyde and FA-releasing chemicals (e.g., methylene glycol) in hair-smoothing or straightening products used with heat. This initiative is a clear response to years of health concerns related to salon exposure. Expect a science-and exposure-heavy docket and strong public-health framing. Brands with salon portfolios should expect scrutiny on ingredient disclosures and salon protocols even before the NPRM appears. Failure to adapt early could mean product disruptions or recalls once the rule takes effect.

Fragrance-Allergen Labeling: A Hidden Compliance Challenge

Fragrance-allergen labeling continues to be one of the more anticipated MoCRA actions. Under RIN 0910-AI90, FDA says it will identify certain substances as fragrance allergens and require disclosure on cosmetic labels—a MoCRA mandate. The Spring 2025 Agenda points to an NPRM in May 2026. This timeline lags far behind MoCRA’s original statutory target, but it remains a live initiative, and supply-chain preparation—especially at the component level—takes considerable time. Companies waiting for the final rule may find themselves unable to reprint or relabel fast enough to meet new requirements.

Talc and Asbestos Testing: The Push for Analytical Precision

The last of the near-term priorities concerns talc and asbestos testing. FDA’s RIN 0910-AI82 would require standardized methods for asbestos detection in talc-containing cosmetics and add corresponding adulteration provisions. The proposed rule published December 27, 2024, and the Agenda pegs a final rule for March 2026. Expect specified test methods such as PLM and TEM and recordkeeping obligations; non-compliance risks a finding of adulteration. Lab capability and method validation will matter more than ever. Those who act now to align testing infrastructure will be ready long before enforcement begins.

Why the Delay—and What It Means for You

The delay raises an obvious question: what caused it? There’s rarely a single reason behind an action being moved to the “Long-Term” column. Instead, several overlapping factors likely contributed, each with different implications for industry planning. Understanding these drivers helps companies anticipate where FDA scrutiny might next appear.

• Bandwidth and sequencing: The agency appears to be moving forward on talc methods and formaldehyde—both perceived as high-impact risk-reduction efforts—while GMP, a complex cross-cutting system rule with heavy stakeholder impact, takes longer to shape. Companies should assume this prioritization reflects FDA’s limited internal resources.
• Scope and harmonization questions: Expect debate over alignment with ISO 22716, microbiological controls, environmental monitoring, water systems, supplier qualification, and how prescriptive the U.S. rule should be versus allowing risk-based flexibility. This uncertainty makes early alignment with global standards the safest path.
• Economic significance: The entry is marked “Economically Significant,” which typically invites deeper analysis and interagency review, further stretching timelines. Larger economic impact means additional scrutiny before publication.

Ignoring these signals could cost companies far more than compliance. A late pivot after the rule is finalized will lead to costly retrofits, documentation overhauls, and production delays. The lesson is clear: early investment in system maturity pays off exponentially when the regulation arrives.

Turning the MoCRA Delay Into Strategic Momentum

This delay offers an opportunity to strengthen internal systems before FDA sets its formal baseline. The following steps will help companies maintain forward momentum and avoid falling behind when the rule finally arrives. Use this period to create measurable momentum—each action here translates to reduced inspection anxiety and smoother audits later.

1. Run a pragmatic GMP gap assessment. Map your current quality system against the likely pillars of a future 21 CFR 711 framework: management responsibility, change control, document control, training, supplier qualification, production controls (including preservation systems and water), environmental monitoring, laboratory controls, complaint handling, and CAPA. Use ISO 22716 as a reference point, and pay special attention to micro control such as product preservation, in-process hygiene, and facility design, where many cosmetics firms are still underdeveloped.
2. Pressure-test your supplier network. MoCRA has already pushed brands to clarify who’s the responsible person and how information flows. Take the GMP delay as an opportunity to tighten quality agreements, implement incoming-material controls, and qualify alternative suppliers for critical ingredients and packaging.
3. Strengthen your data and documentation spine. Future inspections will look for consistency and traceability: batch records, deviations, investigations, and CAPAs that actually close the loop. If your systems—or those of your contract manufacturers—are paper-heavy, consider digitizing the highest-risk workflows now, before a rule makes the transition harder under time pressure.
4. Pilot “inspection-ready” behaviors. Even without a final GMP rule, FDA can inspect and take action on adulterated cosmetics. Act as if an investigator could sample your most risk-prone product tomorrow. Mock audits, record-retrieval drills, and stability or micro-trend reviews are simple exercises that expose gaps you can fix quickly.

Each of these steps turns uncertainty into progress. Companies that execute them signal accountability and leadership in an industry still learning to adapt to MoCRA’s new expectations.

The 90-Day Compliance Sprint

Companies don’t need to wait for new rules to make tangible progress. The following actions can create immediate risk reduction and long-term compliance advantages. Completing even part of this checklist demonstrates initiative and positions your brand as forward-thinking when regulators take notice.

1. Stand up a cross-functional GMP “sprint.” Gather quality, R&D, operations, regulatory, and procurement teams for short-term projects addressing high-risk areas such as water systems, preservation strategy, micro trending, and deviation/CAPA hygiene. Use ISO 22716 as a benchmark and document before-and-after evidence for every fix.
2. Inventory fragrance components and map likely allergens. Secure up-to-date allergen statements or IFRA certificates from your fragrance houses. Tag potential allergens in PLM/ERP systems so label redesigns can be executed quickly once FDA proposes the allergen list and thresholds.
3. Audit hair-smoothing or straightening SKUs and begin reformulation. Identify any formaldehyde-releasing systems and begin alternative chemistry evaluations now. Develop salon education materials that explain post-reformulation changes such as processing times, heat, and ventilation.
4. Pre-qualify talc methods and labs. Align specifications and COAs with the proposed test methods (for example, PLM and TEM) and build recordkeeping SOPs consistent with the rule’s direction. Lock in lab capacity now to avoid bottlenecks close to finalization.
5. Keep your MoCRA “hygiene” tight. Facility registration—including biennial renewal—and product listing obligations continue uninterrupted. Maintain 60-day updates, preserve serious adverse event files, and document safety substantiation for every marketed product.

Each completed task builds confidence and measurable readiness. Teams that adopt this mindset won’t just meet the rule—they’ll define the benchmark others follow.

Finding Opportunity in Regulatory Delay

It’s counterintuitive, but a delay can save organizations money when used to sequence work strategically. The following approaches help convert downtime into long-term advantage. These aren’t theoretical gains—they’re operational efficiencies that compound over time.

• De-risk recalls and enforcement by elevating GMP now—before it’s mandated.
• Right-size labeling change waves by bundling fragrance-allergen updates with other planned design refreshes.
• Lock in lab capacity for talc methods early to secure favorable rates and scheduling.
• Pilot digital quality records on one site or product family to demonstrate ROI before a wider rollout.

When GMP finally lands, companies that treated this as a preparation window—not a pause—will be ready to comply faster and at lower total cost. More importantly, they’ll stand as models of consistency and foresight when the rest of the industry scrambles to catch up.

The Road Ahead: Lead the Industry, Don’t Chase It

The message is clear: GMP is delayed with no new date, but MoCRA is still advancing on other high-impact fronts such as talc testing, formaldehyde prohibition, and fragrance-allergen labeling. Use this period to make your operations inspection-ready, your labels change-ready, and your suppliers audit-ready. By doing so, when 21 CFR 711 finally arrives, your organization will be positioned not just for compliance, but for competitive strength.

The most successful companies won’t simply respond—they’ll lead. Each investment in readiness builds an identity rooted in reliability and trust. When FDA’s rule arrives, these companies won’t scramble for compliance; they’ll already embody it.