How brands and manufacturers can prepare for the new Cosmetics Regulation Act (MoCRA) in the US

The cosmetic industry constantly evolves, driven by consumer demands and regulatory updates. The United States (all 50 states) recently introduced the MoCRA (Modernization of Cosmetics Regulation Act), which will come into force on 29th December 2023. This represents a significant change for manufacturers and brands involved in the cosmetics market. This blog post aims to shed light on the essential requirements imposed by MoCRA and its impact on manufacturers, brands, and distributors in the personal care market.  

We will delve into each requirement, providing insights and clarifications to help businesses navigate the complex landscape of the new regulations. 

This act highly applies to cosmetic brands, cosmetic manufacturers and contract manufacturers, excluding businesses in labelling/relabelling, packaging/repackaging, distributors, and small businesses (<$1mln in revenue).

Prepare in 8 Steps:

Here are 8 steps how to prepare your business: 

1. Get Facility Registration with FDA: Under MoCRA, all compounding and filling operations must register with the US Food and Drug Administration (FDA). This requirement ensures that manufacturing facilities adhere to stringent quality and safety standards.  

2. Register your products: Another vital aspect of MoCRA is mandatory product registration. Before introducing a cosmetic product to the market, manufacturers, brands, and distributors must complete the registration process. This step enables the FDA to evaluate the safety and efficacy of the product, ensuring it meets the necessary standards before reaching consumers. Product registration is a safety assurance to protect consumers when buying cosmetics. 

3. Assign US Agent/Responsible Person: For international companies based outside of the United States, MoCRA requires the appointment of a US Agent or Responsible Person. This representative acts as a liaison between the company and the FDA, facilitating communication and ensuring compliance with regulatory obligations. The agent is crucial in bridging the gap between global businesses and the US regulatory framework. 

4. Provide Product Safety Substantiation: Safety substantiation is a critical requirement outlined by MoCRA. Before launching a cosmetic product, manufacturers must provide scientific evidence demonstrating the safety of the ingredients used in the finished product. This requirement ensures that consumers are protected from potential adverse effects caused by cosmetic products, bolstering confidence in the industry. 

5. Prioritise Accurate Labelling/Fragrance: MoCRA places significant emphasis on accurate labeling and fragrance disclosure. When introducing a product to the market, manufacturers, brands, and distributors must declare the presence of 26 allergens in their product formulations. This disclosure enables consumers to make informed choices, particularly those with specific allergies or sensitivities. It also benefits from building trust and transparency from a brand's perspective. 

6. Stay Current with GMP Regulation: MoCRA aligns with the Good Manufacturing Practices (GMP) guidelines, emphasizing compliance with ISO standards. While the details of GMP regulation are yet to be determined, adhering to ISO standards underscores the industry's commitment to manufacturing practices prioritising quality, safety, and consistency. By complying with GMP regulations, manufacturers and brands can demonstrate their dedication to producing cosmetics of the highest standards. 

7. Provide Record Access: MoCRA mandates that manufacturers, brands, and distributors maintain comprehensive records relating to their products. These records serve as evidence of compliance with regulatory requirements and allow for traceability in the event of an adverse incident. Businesses contribute to a transparent and accountable cosmetic industry by ensuring easy access to these records. 

8. Set Prompt Ingredient Issues/SAE Reporting/Recall Procedure: Under MoCRA, manufacturers, brands, and distributors must promptly address ingredient issues, report any Serious Adverse Events (SAEs), and establish effective recall procedures. These measures prioritize consumer safety by swiftly addressing concerns related to product ingredients, promptly reporting adverse events, and enabling efficient recalls when necessary. By proactively addressing such issues, businesses can mitigate risks and protect the consumers. 

Stephenson and our customers 

Here at Stephenson, we are actively preparing for the implementation of the MoCRA cosmetic regulations in the United States. To comply with these regulations, we are registering our manufacturing facilities with the FDA, appointing a US Agent as a liaison with regulatory authorities, and strengthening adherence to Good Manufacturing Practices (GMP).

By taking these proactive measures, we aim to ensure seamless compliance with the new regulations and maintain our commitment to producing high-quality and safe cosmetic products for our customers in the US market. 

If you would like to know more about the steps we are taking to comply with new MoCRA regulations, get in touch by reaching out to your account manager or by contacting us on our Contact us page.