Cosmetics Regulatory Consulting

MoCRA Registration and Product Listing

MoCRA made FDA registration and product listing mandatory for most of the cosmetics industry. We handle the mechanics and the judgment calls: registering your facility, listing your products correctly, determining whether a small business exemption genuinely applies to you, and keeping registrations current as your product line changes. For brands using contract manufacturers, we sort out who is responsible for what, so nothing falls through the gap between you and your manufacturer.

• FDA facility registration
• Cosmetic product listing
• Small business exemption analysis
• Responsible person obligations for brands

Safety Substantiation, Labeling, and Adverse Events

MoCRA requires adequate substantiation that every product is safe, labels that meet FDA requirements, and a working process for recording adverse events, with serious adverse events reported to FDA within 15 business days. We build the product safety documentation behind each formula, review your labels before they go to print, and set up simple adverse event procedures your team can actually follow, so every obligation has a system behind it.

• Product safety substantiation files
• Cosmetic labeling review
• Adverse event recording and reporting procedures
• Ingredient review and documentation

Cosmetic GMP Systems That Fit Your Operation

Good manufacturing practice is at the center of MoCRA, and it is where cosmetics companies feel the most pressure. We design and implement GMP-compliant workflows, SOPs, and quality systems tailored to cosmetics production, from receiving of ingredients to finished product out the door. Our team has worked with manufacturers producing a wide range of cosmetic products, and we build simple systems your team can operate with ease and confidence. When you want the full picture, start with a GMP gap assessment, and if findings ever pile up, our GMP remediation programs close them out. For the regulation itself, see FDA's official MoCRA page.

• Cosmetic GMP systems and SOPs
• Batch records and documentation templates
• Gap assessments against GMP expectations
• Staff training for cosmetics teams

MoCRA and Cosmetics Questions

What is MoCRA?

The Modernization of Cosmetics Regulation Act is the biggest change to US cosmetics regulation since 1938. It requires cosmetics manufacturers and brands to register facilities with FDA, list their products, substantiate product safety, report serious adverse events, and follow good manufacturing practices.

Who has to register with FDA under MoCRA?

Facilities that manufacture or process cosmetics for the US market must register, and responsible persons must list their products. Certain small businesses qualify for exemptions, though the exemptions have exceptions for higher-risk product types. We help you determine exactly what applies to your operation.

What counts as safety substantiation?

Adequate evidence that each product is safe, supported by tests, studies, or other data an expert would find sufficient. In practice that means organized safety documentation for each product, built from ingredient data, testing, and scientific literature, ready to stand behind if FDA asks.

Do you work with both manufacturers and brands?

Yes. We work with contract manufacturers building compliant GMP systems and with brands that need registration, listing, labeling, and safety documentation handled correctly, including brands whose products are made by a contract manufacturer.