Navigating the Modernization of Cosmetics Regulation Act (MoCRA)
The Modernization of Cosmetics Regulation Act (MoCRA) is the most significant expansion of the FDA’s authority to regulate cosmetics since the Federal Food, Drug and Cosmetic (FD&C) Act was passed in 1938.
It provides new authorities to both the FDA and industry and requires that industry comply with regulations established by the FDA.
New Authority to FDA
- Records Access – the FDA can access and copy certain records, including safety records
- Mandatory Recall Authority – the FDA has the authority to order a mandatory recall
New Authority to Industry
- Facility Registration – manufacturers and processors must register their facilities and renew them every two years. Guidance for Industry: Compliance Policy for Cosmetic Product Facility Registration and Cosmetic Product Listing (fda.gov)
- Product Listing – each marketed product must be listed with the FDA, including ingredients, and be updated annually
- Naming a Responsible Person – name must appear on the product label
- Adverse Event Reporting – required to report serious adverse events associated with use of a cosmetic product
- Safety Substantiation – ensure and maintain records supporting scientifically robust methods of safety substantiation. Product Testing of Cosmetics | FDA
Industry Compliance Requirements
- Fragrance allergen labeling – any fragrance deemed an allergy, must be properly labeled.
- Standardized testing methods for detecting and identifying asbestos in talc containing products
- Good Manufacturing Practices (GMPs) – Draft Guidance for Industry: Cosmetic Good Manufacturing Practices | FDA.
We bring extensive expertise to assist clients, ranging from large enterprises to small businesses, in establishing or enhancing their current Good Manufacturing Practices (cGMPs) across diverse industries. Our specialized focus includes comprehensive guidance tailored for the cosmetics sector, covering the following key categories:
| GMP Requirement |
Response |
| Documentation | Develop policies and procedures to show how products are manufactured and tested. |
| Records | Identify and develop required record and retention schedules. |
| Buildings and Facilities | Facility maintenance and cleaning procedures, pest control, temperature monitoring, etc. |
| Equipment | Develop calibration, cleaning, sanitization, and maintenance procedures. |
| Personnel | Implement personnel hygiene policies and procedures, visitor polices, etc. |
| Raw Materials | Develop a process to qualify suppliers and the associated raw material specifications. |
| Production | Create standard batch records including yield, contamination controls, and labeling. |
| Laboratory Controls | Establish sampling procedures, specifications, test methods, and technician trainings. |
| Internal Audit | Develop procedures for internal audits: frequency, scope, and qualification. |
| Complaints | Develop complaints handling SOP for documenting, investigating, and responding. |
| Adverse Events | Define adverse events, document required data, and report to MedWatch. |
| Recalls | Develop procedures for managing a recall and conducting mock recalls. |
Who’s Exempt?
Small businesses exempt from sections 606 (GMPs) and 607 (Registration and Product Listing) if:
- Average gross annual sales <$1,000,000 (adjusted for inflation).
- Do not engage in manufacturing or processing described in subsection (b).
Stay Ahead with cGMP Consulting:
To navigate the complexities of MoCRA, organizations can benefit from cGMP Consulting services. cGMP Consulting can assist in developing and implementing policies, procedures, and practices, ensuring a smooth transition and a comprehensive understanding of your organization’s obligations under MoCRA. Staying ahead of compliance requirements is not just a regulatory necessity but a commitment to consumer safety and industry integrity.
Tamara Neumann, Project Manager & Marketing Manager
Celine Lam, Business Administrator & Marketing
