The FDA now regulates cosmetics like never before. MoCRA made GMP compliance mandatory for every cosmetics manufacturer in the United States. Are you compliant?
If you make, package, or distribute cosmetics in the U.S., you face new federal requirements for facility registration, product listing, adverse event reporting, and Good Manufacturing Practice. The deadlines are here.
The Modernization of Cosmetics Regulation Act (MoCRA) is the most significant change to U.S. cosmetics regulation in over 80 years. Signed into law on December 29, 2022, it fundamentally transforms how the FDA oversees the cosmetics industry.
Before MoCRA, cosmetics were the least regulated consumer product category under the FDA. The previous framework dated back to the original Federal Food, Drug, and Cosmetic Act of 1938. Cosmetics manufacturers operated with minimal federal oversight — no mandatory facility registration, no product listing requirements, no adverse event reporting obligation, and no enforceable GMP standards.
That era is over. MoCRA establishes mandatory federal GMP requirements for every company that manufactures, packages, or distributes cosmetics in the United States. For many cosmetics businesses, this means complying with formal quality systems for the very first time.
If you have been operating without structured GMP documentation, without a formal adverse event reporting system, or without FDA facility registration — you are already behind. The compliance clock is ticking.
No FDA facility registration required
Mandatory facility registration with the FDA
No product listing obligation
All cosmetic products must be listed with the FDA
No enforceable GMP standards
Mandatory GMP compliance for all manufacturers
No mandatory adverse event reporting
Serious adverse events must be reported to FDA within 15 days
Cosmetics manufacturers face two overlapping compliance frameworks. Understanding where they align — and where they diverge — is critical for building an efficient quality system.
International Cosmetics GMP Standard
U.S. Federal Law (Mandatory)
The FDA has indicated that MoCRA's GMP regulations will align closely with ISO 22716. Companies that implement ISO 22716 now are building a quality system that will satisfy MoCRA requirements when the final GMP rule is published. Our approach implements both frameworks simultaneously — giving you U.S. regulatory compliance and international market access with a single, unified quality system.
MoCRA introduces six major compliance obligations for cosmetics manufacturers. Each one carries enforcement consequences if ignored.
Every facility that manufactures or processes cosmetics for U.S. distribution must register with the FDA. This includes contract manufacturers, repackagers, and relabelers. Registration must be renewed biennially.
Deadline PassedSerious adverse events must be reported to the FDA within 15 business days. You must maintain records of all adverse events for 6 years. This requires a formal intake system, investigation process, and reporting workflow.
In Effect NowEvery cosmetic product marketed in the U.S. must be listed with the FDA, including ingredient lists and product categories. Proper batch coding enables traceability from raw materials through distribution.
Deadline PassedMoCRA directs the FDA to establish GMP regulations for cosmetics. The FDA recognizes ISO 22716 as the benchmark standard. Smart manufacturers are implementing ISO 22716 now — SOPs, batch records, equipment qualification, cleaning procedures, and QC testing.
Final Rule PendingThe responsible person must maintain records substantiating adequate evidence of safety for each cosmetic product. This means documented safety assessments, ingredient reviews, stability testing, and microbiological testing results.
In Effect NowMoCRA adds new labeling requirements including contact information for adverse event reporting and fragrance allergen disclosure. Products marketed as "professional use only" must still meet all safety and labeling requirements.
Phased ImplementationFrom initial gap analysis through full ISO 22716 and MoCRA compliance, we build the quality systems your cosmetics business needs — without disrupting your production.
We audit your current operations against both MoCRA requirements and ISO 22716 standards. You receive a detailed gap assessment report with prioritized action items, estimated timelines, and a compliance roadmap tailored to your facility.
We handle the entire FDA registration process — facility registration through the Cosmetics Direct portal, product listing submissions, and responsible person designation. Complete and accurate the first time.
Complete ISO 22716-aligned documentation: SOPs for production, quality control, packaging, storage, and distribution. Master batch records, cleaning procedures, equipment qualification protocols, raw material specs, and finished product testing procedures.
We design and implement your adverse event intake, investigation, and FDA reporting workflow from scratch. Consumer complaint forms, internal investigation protocols, severity assessment criteria, the 15-day reporting process, and 6-year record retention.
Hands-on GMP training customized to your team's roles — production operators, quality personnel, warehouse staff, and management. We also conduct mock inspections to prepare your team for FDA visits and third-party audits.
We help build your product safety substantiation files — ingredient safety assessments, stability testing protocols, microbiological challenge testing, and preservative efficacy testing. Plus label review for MoCRA's new adverse event contact and fragrance allergen requirements.
MoCRA compliance is not a future event — most deadlines have already passed. Here is the complete timeline every cosmetics manufacturer needs to know.
MoCRA Signed Into Law. Adverse event reporting requirements and safety substantiation took effect immediately. All cosmetics on the market must have adequate evidence of safety.
Facility Registration & Product Listing Deadline. All cosmetics manufacturing facilities were required to register with the FDA. All products were required to be listed. If you missed this deadline, register and list immediately — the FDA is actively enforcing.
FDA GMP Rulemaking Deadline. Congress directed the FDA to issue proposed GMP regulations by this date. The final rule is expected to closely mirror ISO 22716. Companies waiting until the rule is final will face a compressed implementation timeline.
Fragrance Allergen Labeling. MoCRA requires labeling of fragrance allergens. The FDA is developing the specific allergen list and format. Manufacturers should begin reviewing formulations and preparing updated labels now.
Mandatory GMP Compliance. Manufacturers will have up to two years after the final GMP rule to come into full compliance. Small businesses may receive an additional two years. Manufacturers implementing ISO 22716 now are future-proofing their operations.
The Time to Act Is Now
Companies that wait for the final GMP rule will face a compressed implementation timeline and higher costs. Companies that implement ISO 22716 now will have their quality system in place before MoCRA GMP enforcement begins — and gain international market access as a bonus.
Most consultants offering MoCRA help are generalists scrambling to learn the new law. Jared Clark has been helping FDA-regulated manufacturers build compliant quality systems for over eight years — across pharmaceuticals, dietary supplements, food, and cosmetics.
With the CPGP (Certified Pharmaceutical GMP Professional), a law degree providing deep understanding of regulatory frameworks, and the RAC (Regulatory Affairs Certification) from RAPS, Jared brings cross-industry GMP expertise that is rare in cosmetics consulting. You are not getting someone learning on your dime.
Our GMP consulting expertise extends across all product categories affected by MoCRA:
Common questions about MoCRA compliance and cosmetics GMP consulting.
MoCRA was signed into law on December 29, 2022. Key deadlines: facility registration and product listing were required by December 29, 2023; adverse event reporting became mandatory immediately; FDA was directed to establish GMP regulations by December 29, 2025, with manufacturer compliance required within two years after the final rule. Safety substantiation requirements apply immediately to all cosmetics on the market.
Most cosmetics businesses must comply. Businesses with average gross annual sales under $1 million in cosmetics over the previous 3-year period qualify for certain exemptions from facility registration and product listing. However, adverse event reporting, safety substantiation, and labeling requirements apply to ALL businesses regardless of size. FDA enforcement actions can result in product seizure and injunctions.
ISO 22716 is an international voluntary standard with detailed guidelines for 17 management areas. MoCRA is a mandatory U.S. federal law. While both address manufacturing quality, MoCRA GMP requirements (still being finalized) are expected to align closely with ISO 22716. Companies already ISO 22716 compliant will have a significant head start on MoCRA GMP compliance.
MoCRA gives the FDA significant enforcement authority: warning letters, product seizure, import alerts blocking products at the border, mandatory recalls (a new power under MoCRA), and injunctions halting manufacturing. The FDA can also suspend a facility's registration if products present a reasonable probability of serious adverse health consequences.
Facility registration and product listing: 2-4 weeks. Adverse event reporting system: 4-6 weeks. Full GMP implementation aligned with ISO 22716: 3-6 months with some quality systems in place, or 6-9 months starting from scratch. We recommend starting immediately — several MoCRA deadlines have already passed and FDA enforcement is active.
Facility registration and product listing deadlines have already passed. Adverse event reporting is mandatory now. GMP requirements are coming fast.
Every day without a compliant quality system is a day of risk — for your products, your brand, and your business. Let us help you get ahead of enforcement, not react to it.