Product Listing Under Cosmetics MoCRA: Key Deadlines and Responsibilities

A Guide to the New Obligations for Responsible Persons

MoCRA (the Modernization of Cosmetics Regulation Act of 2022) significantly reshapes U.S. cosmetic oversight, imposing new product‑level and facility‑level obligations on manufacturers, packers, and distributors. This guide explains the deadlines and duties that fall to the Responsible Person for each cosmetic product marketed in the United States and highlights practical steps to stay compliant.

Defining the Responsible Person and the New Compliance Landscape

MoCRA introduces the “Responsible Person” as the central compliance actor for each cosmetic product. Under the new framework, duties have expanded beyond facility registration to include product listing, adverse‑event reporting, labeling obligations, and future Good Manufacturing Practice rules—making the Responsible Person accountable for holistic product safety and regulatory responsiveness.

The Crucial Role of the Responsible Person

The Responsible Person is the manufacturer, packer, or distributor whose name appears on the product label. That entity is legally responsible for ensuring the product meets MoCRA requirements, maintaining records, and serving as the point of accountability for the FDA on product safety matters. The Responsible Person must also ensure product listings and adverse‑event files are accurate and timely as part of ongoing compliance obligations.

Product Listing vs. Facility Registration

Product Listing notifies the FDA about a specific cosmetic product—formulation, ingredients, and marketing details —while Facility Registration informs the FDA where products are manufactured or processed. Both are mandatory under MoCRA but serve different oversight purposes: listings help the FDA track products in the marketplace; facility registration helps the agency identify and inspect manufacturing locations.

Product Listing Deadlines: Initial and Annual Requirements

Responsible Persons must understand the distinct deadlines that apply to legacy products and new launches, and they must maintain an annual cadence for updates.

The Initial Product Listing Deadline

Products already on the U.S. market at MoCRA’s effective date were subject to an initial listing deadline established by the FDA and guidance documents. That deadline required Responsible Persons to submit comprehensive product listings —including full ingredient declarations— within the specified initial compliance window to ensure the FDA had an accurate inventory of marketed cosmetics.

Product Listing for New Products

New products introduced after the initial deadline must be listed with the FDA within the statutory timeframe applicable to post‑effective‑date launches—commonly within 90 days of U.S. commercialization—so that regulators have timely visibility into changes in the marketplace.

The Annual Update Obligation

Product listings are not “set and forget.” Responsible Persons must review and, when necessary, update listings annually to reflect formulation changes, labeling revisions, or other material alterations. Regular reviews preserve listing validity and reduce the risk of enforcement or detention during safety investigations.

Reporting Adverse Events: The 15-Day Clock

MoCRA elevates post‑market surveillance for cosmetics with strict reporting timelines for serious incidents.

Defining a Serious Adverse Event

A Serious Adverse Event is an injury or health outcome linked to cosmetic use that results in hospitalization, significant disability, life‑threatening conditions, birth defects, or death. Responsible Persons should have clear triage criteria to identify events meeting this threshold so they can trigger reporting protocols immediately.

The Mandatory 15-Day Reporting Deadline

When a Serious Adverse Event occurs, the Responsible Person must notify the FDA within 15 business days. This short clock underscores the need for rapid incident escalation, effective consumer complaint capture, and robust recordkeeping; MoCRA also requires entities to retain adverse‑event records for specified retention periods to support investigations.

Labeling Requirements: Deadlines and Compliance Details

MoCRA tightened labeling obligations to improve consumer access to reporting channels and product transparency.

Mandatory Contact Information on the Label

Labels must display contact details for the Responsible Person (address and/or phone number) so consumers can report complaints directly. The FDA set compliance timelines for label changes—registrants should align labeling updates with product packaging cycles and regulatory guidance to meet the agency’s schedule for implementation.

Fragrance Allergen Labeling: Future Deadlines

MoCRA directs the FDA to develop rules for disclosing certain fragrance allergens. The final list and the deadline for compliance will follow FDA rulemaking and will include an implementation window (e.g., a specified number of days after publication) for industry to adapt labels and disclosures.

Future Compliance Deadlines: Good Manufacturing Practices (GMP)

MoCRA mandates binding GMP regulations to raise manufacturing standards across the cosmetic industry; these rules remain subject to final agency rulemaking and phased implementation.

MoCRA’s Mandate for GMP Standards

The FDA is tasked with issuing mandatory GMPs to govern facility operations, sanitation, and quality controls. The timing of GMP compliance obligations depends on rule finalization and transitional timelines established in the rulemaking process—Responsible Persons should monitor progress and prepare to adopt written quality systems once the FDA issues final requirements.

Different Requirements for Small Businesses

MoCRA provides scaled obligations or exemptions for qualifying small businesses (based on U.S. gross receipts thresholds). These provisions can reduce certain burdens—like registration or GMP scope—for eligible small entities, but small businesses must confirm eligibility and remain aware that some MoCRA duties (for example, certain reporting) may still apply.

Mitigating Risk: Turning MoCRA Deadlines into Ongoing Market Security

Cosmetics MoCRA transforms cosmetic product oversight by placing the Responsible Person at the center of a comprehensive compliance lifecycle—from initial product listing and ongoing updates to rapid adverse‑event reporting, labeling changes, and future GMP adherence. Success requires a structured compliance calendar, clearly assigned responsibilities, and systems to capture consumer complaints and regulatory communications.

Techlink International LLC offers MoCRA product‑listing and Responsible‑Person compliance support for companies marketing cosmetics in the United States. We help prepare and submit product listings, set up adverse‑event intake workflows, coordinate label updates, and establish renewal calendars—without promising FDA outcomes. Contact us to discuss how we can help your brand meet Cosmetics MoCRA deadlines and maintain regulatory readiness.