The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) represents the most significant update to U.S. cosmetics law since the Federal Food, Drug, and Cosmetic Act of 1938. This legislation introduces binding safety and transparency requirements across the entire supply chain.
With enforcement beginning in stages throughout 2024 and into 2025, brands must act quickly to avoid penalties. A trusted cosmetic product manufacturing company can help brand owners meet these new standards with precision and accuracy.
MoCRA shifts the U.S. cosmetics industry from a voluntary safety model to one of mandatory compliance. For skincare brands, this means aligning with new federal requirements that apply to all marketed products. Major mandates include:
Facility registration deadlines begin July 1, 2024, with product listings submitted shortly thereafter. FDA inspections will now assess compliance with MoCRA, not just existing food and drug rules. Skincare brands are no longer shielded by small-batch exceptions—MoCRA applies to nearly all product types and sizes. Delays or gaps in compliance may lead to enforcement action, product recalls, or reputational damage. So, this makes collaboration with a MoCRA-compliant cosmetic product manufacturing company more important than ever.
Work with Medpak Solutions to meet every MoCRA requirement with confidence. Let our cosmetic product manufacturing company safeguard your brand’s compliance.
A cosmetic product manufacturing company is more than a producer. It’s a compliance partner. These companies support brands by aligning production workflows with FDA requirements, submitting facility registrations, and updating product listings. They maintain operations that meet or exceed GMPs to avoid compliance failures.
By choosing a MoCRA-aware cosmetic product manufacturing company, your brand gains a strategic advantage. The right partner brings regulatory knowledge, technical infrastructure, and documentation systems that help prevent delays and FDA violations.
MoCRA now mandates adherence to FDA-established GMPs. A compliant cosmetic product manufacturing company builds its facilities to meet stringent operational standards. This spans from equipment maintenance to ingredient handling. FDA-registered facilities must maintain controlled environments, standard operating procedures, and staff training protocols.
The registration process involves submitting detailed facility data to the FDA and confirming that operations meet safety and hygiene benchmarks. Registered sites are subject to FDA inspection, and failure to comply can result in shutdowns.
So, working with an FDA-registered cosmetic product manufacturing company reduces risk. Your brand doesn’t need to retrofit operations or build internal compliance teams. Instead, you can depend on your partner’s qualified systems to meet MoCRA expectations from day one.
One of the new MoCRA requirements is maintaining detailed records and submitting reports for serious adverse events. This includes reactions linked to product use like:
A full-service cosmetic product manufacturing company integrates software tools to manage batch records, lot tracing, and customer complaint data. These systems allow swift documentation and investigation of any incidents.
Reporting must be submitted to the FDA within 15 business days, and manufacturers must retain records for at least six years. A cosmetic product manufacturing company that already uses compliant documentation systems can help your brand avoid gaps and penalties during FDA audits.
MoCRA requires brands to demonstrate that products are safe when used as intended. Safety substantiation can include:
A qualified cosmetic product manufacturing company provides access to in-house chemists. These professionals generate and organize the technical files your brand needs to validate product safety.
In fact, private label products cosmetics benefit from this structure. The manufacturer already has data, test results, and documentation to support safety claims. So, as a brand, working with an experienced manufacturer avoids the need to hire external consultants or develop substantiation files from scratch.
MoCRA introduces new labeling rules, including mandatory contact details for adverse event reporting and a list of fragrance allergens. These disclosures must appear directly on product labels or packaging.
A cosmetic product manufacturing company with a regulatory team helps brands adapt labels to meet new FDA requirements. This includes verifying fragrance compositions against FDA-published allergen lists and updating labels with accurate ingredient names.
Manufacturers maintain formulation databases that track ingredient sources, functions, and allergenic potential. This allows brand owners to maintain compliance and transparency while focusing on marketing and distribution.
Yes, private label products cosmetics fall under MoCRA requirements. While the FDA places the primary responsibility for compliance on the “responsible person”—usually the brand owner—manufacturers are still critical to ensuring compliance is possible.
For private label products cosmetics, the brand may not control the formulation or facility, but they are still accountable for listing products, reporting events, and confirming safety. This creates a shared responsibility between the brand and the cosmetic product manufacturing company. A compliant manufacturer provides the needed:
Working with a cosmetic product manufacturing company that ignores MoCRA or lacks FDA registration increases the risk of delays and non-compliance. As a brand owner, it’s important to select a partner with up-to-date regulatory systems, dedicated compliance staff, and experience handling FDA audits. With private label products cosmetics, accountability is unavoidable—and the right cosmetic product manufacturing company helps reduce your brand’s exposure.
MoCRA introduces non-negotiable rules that every cosmetic brand must follow. A reliable cosmetic product manufacturing company helps brands avoid risk by handling registrations, safety substantiation, GMPs, and more. Remember that choosing a MoCRA-informed partner protects your brand and ensures long-term success.
MoCRA introduces non-negotiable rules that every cosmetic brand must follow. A reliable cosmetic product manufacturing company helps brands avoid risk by handling registrations, safety substantiation, GMPs, and more. Remember that choosing a MoCRA-informed partner protects your brand and ensures long-term success.
Need help with MoCRA compliance? Contact Medpak Solutions—your trusted cosmetic product manufacturing company.
Most Frequently Asked Questions About Working With Cosmetic Manufacturer
Yes. If your business makes under $1 million in annual U.S. sales and doesn’t produce high-risk products (like eye-area or injectable cosmetics), it qualifies for exemptions from GMPs, facility registration, and product listings. You also have fewer recordkeeping requirements.
Yes. MoCRA allows states to keep regulating cosmetic ingredients. Over 20 states have already passed laws limiting certain chemicals like formaldehyde, mercury, and PFAS in personal care products.
It impacts any business involved with cosmetics sold in the U.S. Manufacturers must register facilities and follow GMPs. Brands are responsible for product listings and adverse event reporting. Raw material suppliers need to provide detailed safety data. Brokers, importers, and retailers can be involved in recalls if a product is found to be unsafe or mislabeled.
The FDA will set standard rules for testing talc products for asbestos. Once final, brands must work with manufacturers to follow these rules and test all talc-containing products properly.
