For heads of product development, quality managers, and procurement leaders in the U.S. health, wellness, and personal care sectors, the regulatory landscape has changed fundamentally. The passage of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) marked the end of the largely voluntary system that governed the industry for decades.
These new FDA requirements can feel challenging for growing wellness and personal care brands. Compliance is now essential and directly tied to your market access and risk profile.
The cost of non-compliance under MoCRA is steep. Failure to adhere to the requirements for registration of cosmetics and manufacturing facilities exposes your brand to FDA enforcement actions, including mandatory recalls, facility suspension, and costly delays at the border.
This guide breaks down the technical steps you must follow to meet MoCRA’s 2026 cosmetic product registration and submission requirements.
TL;DR
- Facility Registration (Form FDA 5066): Mandatory for all manufacturers; renew every 2 years. Requires an FEI before filing through Cosmetics Direct. The FDA may suspend registration and stop operations.
- Product Listing (Form FDA 5067): Mandatory for the Responsible Person; update yearly. Must include the facility’s FEI and full ingredient list in SPL format.
- Enforcement: Active now. Missing registration or listing makes products misbranded/adulterated, risking border holds and recalls.
- Operational Support: Partnering with an FDA-registered, cGMP turnkey manufacturer reduces technical workload and supports continuous compliance.
What is The Foundation of Mandatory Compliance in Cosmetics (MoCRA)
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is the most significant update to the Federal Food, Drug, and Cosmetic (FD&C) Act since 1938. It transitioned the industry from the antiquated Voluntary Cosmetic Registration Program (VCRP) to a powerful, enforceable regulatory framework.
Why Voluntary Registration is Now Irrelevant
The VCRP allowed manufacturers to voluntarily submit information. Since March 2023, the FDA has ceased accepting VCRP submissions, rendering any prior voluntary submissions null and void for MoCRA compliance.
- The Regulatory Imperative: MoCRA’s provisions, particularly Section 607 of the FD&C Act, establish statutory requirements for facility registration and product listing, turning voluntary compliance into an absolute, non-negotiable step.
- The Responsible Person: The regulatory burden falls primarily on the Responsible Person, the entity named on the product label. This includes making sure that the product is listed and that the facility where it is manufactured is registered.
What is the Operational Role of the Contract Manufacturer?
For brands that outsource production, the contract manufacturer plays a critical role in minimizing compliance friction. MoCRA explicitly states that only a single facility registration is required for each manufacturing site, regardless of how many Responsible Persons utilize it.
- Compliance Consolidation: Reputable turnkey partners simplify this. By registering their FDA facility, they provide the brand with the necessary facility information, significantly reducing the client’s internal regulatory workload and helping to reduce operational complexity.
Who Must Register Under MoCRA?
The compliance duties are split between two key entities, and their roles must be clearly understood to manage risk effectively.
| Entity Responsible |
Compliance Duty |
MoCRA Requirement |
Operational Outcome |
Responsible Person
(Brand Owner/Distributor) |
Product Listing (Form FDA 5067) |
Mandatory Annual Submission |
Make sure of traceability and FDA knowledge of the product formula. |
Facility Owner/Operator
(Contract Manufacturer) |
Facility Registration
(Form FDA 5066) |
Mandatory Biennial Renewal |
Mitigates Supplier Risk by ensuring the production site is compliant. |
Looking for a partner aligned with MoCRA, cGMP, and operational performance? Respect Manufacturing’s turnkey system supports consistent output, documentation accuracy, and supply chain reliability.
Understanding Facility Registration with FEI and Biennial Renewal
Mandatory facility registration is the bedrock of MoCRA compliance. It enables the FDA to track the supply chain and identify potential sources of contamination or risk. Failure here introduces immediate and severe supplier risk.
A. The Technical Steps to Facility Registration
The process requires two specific technical prerequisites to make sure that the submission is accepted and traceable.
Step 1. Obtaining the FDA Establishment Identifier (FEI)
The FDA has adopted the FDA Establishment Identifier (FEI) as the required registration number.
- FEI as Prerequisite: Every owner or operator of a facility must obtain this unique identifier before submitting the registration. The FEI is used across multiple FDA-regulated industries for inspections and tracking.
- Procurement Verification: Procurement Heads must verify that any potential contract manufacturer already possesses an active FEI number as a non-negotiable check against Supplier Risk.
Step 2. Submitting via Cosmetics Direct (Form FDA 5066)
Facility registration is submitted electronically using Form FDA 5066 through the Cosmetics Direct Portal, the FDA’s dedicated electronic system (though paper forms are available, electronic submission is strongly encouraged for efficiency).
| Submission Detail |
Requirement |
Operational Impact (KPI) |
| Initial Deadline |
Initial compliance enforcement began July 1, 2024. New facilities must register within 60 days of beginning manufacturing. |
Critical for lead time stability; registration is required for legal market entry. |
| Renewal |
Registration must be updated and renewed biennially (every two years). |
Requires inclusion in the quality/regulatory management calendar to prevent Downtime Reduction from lapsed registration. |
| Required Data |
Facility name, address, email, FEI number, brand names manufactured, and Responsible Person information. |
Accurate data is vital for making sure of swift traceability during any FDA inquiry. |
Note: Before submitting Form FDA 5066, verify that all continuation pages and attachments are included. You can find the mailing and email submission addresses at the top of this page.
B. Facility Suspension Authority
The most profound operational threat MoCRA poses is the FDA’s new power to suspend a facility’s registration.
- Grounds: If the FDA concludes that a cosmetic made at the facility could reasonably cause serious harm or present a risk of death to consumers.
- Impact on the Brand: A suspended registration is a prohibited act. The facility cannot introduce or deliver products into U.S. commerce. This results in zero throughput and an immediate supply chain crisis for all client brands using that site. This risk underscores the value of using a cGMP-compliant partner like Respect Manufacturing.
Facility registration lays the foundation for MoCRA compliance, but it is only half of the mandate. The next requirement is knowing the high-risk exceptions.
Also Read: Guidelines for FDA Cosmetics Compliance
MoCRA Exemptions Explained for Small Businesses and High-Risk Products
The question of compliance often starts with, “Are there any exemptions to complying with MoCRA?” The answer is yes, but the exceptions are critical.
A. The Small Business Exemption Criteria
Section 612 of MoCRA provides exemptions from facility registration, product listing, and GMP requirements for small businesses.
- Financial Threshold: The entity must have average gross annual U.S. sales of cosmetic products of less than $1 million over the preceding three-year period.
- Reduced Adverse Event Record-Keeping: Qualifying small businesses only need to retain adverse event records for three years, instead of the standard six years.
B. The Non-Exempt “High-Risk” Product Exception
The small business exemption does not apply if the entity manufactures or processes any of the following high-risk products, regardless of revenue:
| Product Category |
Example (Why it’s High-Risk) |
Compliance Trigger |
| Eye Mucous Membrane Contact |
Mascara, eyeliner, eyelash adhesive. |
High risk of infection/injury in a sensitive area. |
| Injected Products |
Products are intended for administration via injection. |
Direct entry into the bloodstream/tissues. |
| Internal Use |
Products are intended to be ingested or absorbed internally. |
Systemic exposure and higher toxicity risk. |
| Long-Term Alteration |
Products are intended to alter appearance for more than 24 hours (e.g., permanent eyebrow dye, gel nail polish). |
Removal is not customary; extended contact time increases risk. |
Even with certain exemptions, product listing remains mandatory for the majority of cosmetic brands. This brings us to the SPL format and yearly update process.
Unsure whether your product triggers full MoCRA compliance? A single non-exempt product activates full MoCRA requirements. Contact Respect Manufacturing for operational excellence in innovation, quality, consistency, and transparency.
Understanding Product Listing with SPL and Yearly Registration Requirements
The second pillar of MoCRA compliance is the mandatory cosmetic product registration, officially called Product Listing. This provides the FDA with the necessary ingredient and formulation data to monitor product safety across the market.
A. Key Technical Hurdle
The FDA mandates that all product listing data be submitted using the Structured Product Labeling (SPL) format, an XML standard previously used primarily for drugs. This requires technical proficiency or the use of the user-friendly Cosmetics Direct Portal.
Form FDA 5067 Submission Requirements
The Responsible Person must submit Form FDA 5067 for each product.
- Annual Update: The product listing must be updated annually to confirm formulation accuracy and facility linkage.
- Mandatory Ingredient Disclosure: The listing must include a complete list of all ingredients in the product, including fragrances, flavors, and colors. This demands close coordination between the brand’s regulatory team and the manufacturer’s R&D department.
| Required Product Data Field |
MoCRA Compliance Goal |
Operational Importance |
| Facility FEI Number |
Links the product to a registered manufacturing site. |
Essential for traceability; without it, the listing is invalid. |
| Product Category |
Standardized categorization (e.g., “Skin Cleansing,” “Shaving”). |
Used by the FDA for risk prioritization and market analysis. |
| Full Ingredient List |
Includes flavors/fragrances, often proprietary. |
Requires a transparent R&D partnership to secure intellectual property while achieving compliance. |
Also Read: The Ultimate MOCRA Guide 2025: FDA Requirements & Timelines
B. The Risk of Misbranding
Failure to meet the mandatory requirements for registration of cosmetics, including the listing and required labeling changes (e.g., listing a U.S. contact for adverse event reports), renders a cosmetic product legally “misbranded” or “adulterated.”
Non-compliance increases the likelihood that incoming shipments will be detained or seized by the FDA at U.S. ports, directly impacting inventory and throughput.
With your product listings structured accurately and updated on schedule, the next step is making sure that every formulation and process behind those listings meets FDA safety and cGMP expectations.
C. Selecting the Correct Category Code
FDA’s product listing system relies on 17 official cosmetic categories. Here is a clear, simplified breakdown:
- Baby Products: shampoos, lotions, oils, wipes
- Bath Preparations: bath oils, salts, bubble baths
- Eye Makeup: eyeliners, mascaras, eyeshadows, removers
- Children’s Eye Makeup
- Fragrance Products: perfumes, colognes, talcum powders
- Hair Care (Non-Coloring): conditioners, shampoos, sprays, grooming aids
- Hair Coloring Products: dyes, tints, bleaches, coloring shampoos
- Makeup (Non-Eye): foundations, powders, blush, lipsticks
- Children’s Makeup (Non-Eye): paints, powders, lip products
- Manicure & Nail Products: polishes, removers, creams
- Oral Care: dentifrices, mouthwashes
- Personal Cleanliness: soaps, deodorants, wipes
- Shaving Products: creams, aftershaves, beard softeners
- Skin Care: cleansers, moisturisers, masks, sprays
- Suntan Products: gels, lotions, spray tanning
- Tattoo Products: permanent & temporary inks
- Other Products: any cosmetic not covered above
Note: For high-risk cosmetic types and small-business MoCRA requirements, check the official FDA website.
Integrated Compliance: Safety, cGMP, and the Turnkey Solution
The most effective way for scaling brands to manage the complexity of MoCRA is by integrating compliance into their manufacturing process from the start, prioritizing partners who already meet or exceed the coming requirements.
A. Mandatory Safety Substantiation and R&D
MoCRA requires the Responsible Person to ensure and maintain records supporting adequate safety substantiation for every cosmetic product.
- Quality Assurance (QA): This elevates the importance of a robust QA program. A manufacturer that offers comprehensive stability testing, material compatibility checks, and microbial testing provides the documentary evidence necessary to support mandatory safety claims.
- Adverse Event Reporting: The Responsible Person must report serious adverse events within 15 business days and keep records for six years (three for small businesses). Strong cGMP standards, automated production and packaging lines, and thorough AQL testing help prevent such events and reduce liability risk.
B. Preparing for Final cGMP Regulations
MoCRA mandates that the FDA issue binding regulations for Good Manufacturing Practice (GMP) for cosmetics (expected by late 2025).
- Proactive Compliance: Respect Manufacturing’s FDA-registered, global cGMP facility already follows the quality, consistency, and documentation standards expected under the upcoming rule, meaning client products are produced in conditions aligned with future requirements.
- Operational Benefit: Choosing a manufacturer with this established compliance infrastructure avoids the inevitable equipment uptime disruptions and remediation costs that will face non-compliant facilities when the final GMP rule takes effect.
After integrating safety substantiation, cGMP practices, and turnkey operations, brands must assess whether their partner can consistently uphold these standards. A focused MoCRA due diligence checklist helps you verify this capability.
Selecting Your Compliance Partner: A Due Diligence Checklist for MoCRA
For procurement and operations teams, choosing a contract manufacturer is now a compliance and risk decision. Use the criteria below to confirm your vendor can stabilize your supply chain under MoCRA.
| Due Diligence Checklist Item |
Compliance Requirement Satisfied |
Operational KPI Protected |
| Active FEI Registration |
Mandatory Facility Registration (MoCRA Sec. 607) |
Supplier Risk (Eliminates risk of facility suspension) |
| Existing cGMP Audit History |
Future cGMP Requirements (MoCRA Sec. 606) |
Equipment Uptime (Ensures lines won’t be shut down for remediation) |
| Full R&D Ingredient Transparency |
Safety Substantiation & Product Listing (MoCRA Sec. 608, 607) |
Traceability (Provides mandatory ingredient data for Form 5067) |
| AQL/In-House Testing Protocols |
Adverse Event Prevention (MoCRA Sec. 605) |
Scrap Rate (Reduces product failures that lead to consumer complaints) |
| Turnkey Documentation Support |
Records Access (MoCRA Sec. 610) |
Operational Complexity (Consolidates documentation burden) |
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Conclusion
MoCRA marks a permanent shift in U.S. regulation, pushing the cosmetics industry toward the same accountability standards seen in drugs and devices. For brand owners, complying with mandatory registration of cosmetics and product listing is essential not only for avoiding penalties but also for maintaining market access and protecting brand trust.
The process for obtaining an FEI, filing SPL submissions through Cosmetics Direct, managing biennial renewals, and maintaining safety substantiation is complex and resource-heavy. The most strategic path for growing brands is to partner with a cGMP-certified, FDA-registered turnkey manufacturer who can manage these technical requirements end-to-end.
This reduces operational burden, strengthens compliance, and safeguards product quality, transparency, and safety. By focusing on a partner who exemplifies Respect Manufacturing’s rigorous standards, you turn regulatory compliance into an advantage, reinforcing both supply chain stability and long-term brand growth.
Connect with Respect Manufacturing to validate packaging, formulation, and production fit so your operations stay stable as you scale.
FAQs
1. What if our manufacturer doesn’t renew FDA facility registration?
Your products become misbranded/adulterated, and the FDA can suspend the facility, stopping all production. Always verify renewal annually.
2. How is MoCRA Product Listing different from VCRP?
VCRP was voluntary, whereas MoCRA Product Listing is mandatory and must be filed in SPL format, and missing it can trigger seizure or recall.
3. How does MoCRA affect fragrance allergen labeling?
Brands must disclose fragrance allergens once rules are finalized. You’ll need full allergen data from suppliers and must update your SPL listing accordingly.
4. Does the Small Business Exemption remove cGMP requirements?
It does not exempt safety substantiation or adverse event reporting.
And contract manufacturers must still meet cGMP standards.
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