The Impact of MoCRA on Cosmetic Industry Regulations

MoCRA significantly expands the FDA's authority over cosmetic products, introducing new requirements for facility registration, product listing, adverse event reporting, and labeling. The act mandates that manufacturers adhere to strict Good Manufacturing Practices (GMPs) and maintain records demonstrating product safety. These changes align U.S. regulations more closely with international standards, such as those in the European Union, which Canadian companies may already be familiar with.

Elements to consider in the MoCRA include:

• Fragrance Allergen Disclosure: Cosmetic labels must list all fragrance allergens for greater consumer transparency about potential product allergens.
• Responsible Person Information: Labels must include contact information for the Responsible Person (RP) to facilitate adverse event reporting.
• Adverse Event Reporting: Manufacturers must report serious adverse events to the FDA within 15 business days and maintain these records for six years.
• Mandatory Registration and Listing: Facilities and products must be registered with the FDA, ensuring all entities are on the agency's radar.
• Exemptions for Small Businesses: MoCRA provides certain exemptions for small businesses with less than $1 million in average gross annual sales in the U.S. over the previous three years. These businesses are exempt from some requirements, such as GMP, facility registration, and product listing. However, these exemptions do not apply to products that touch the eye's mucous membrane, are meant for injection or internal use, or change the appearance for more than 24 hours and are not removed in general by the consumer.

Steps U.S. and Canadian Companies Are Taking

To comply with MoCRA, cosmetic companies operating in both the U.S. and Canada are implementing several strategies:

• Facility and Process Upgrades: Ensuring that manufacturing facilities meet GMP standards and processes are well-documented.
• Training and Personnel Management: Providing comprehensive training to staff to ensure compliance with new regulatory requirements.
• Quality Assurance and Control: Implementing rigorous quality control measures and maintaining detailed records to demonstrate compliance.
• Regulatory Compliance: Engaging with regulatory bodies to ensure all necessary licenses and approvals are in place.

Embracing Opportunities and Overcoming Challenges

While MoCRA introduces additional regulatory requirements, it also presents opportunities for cosmetic companies to streamline compliance efforts across major markets like the U.S. and the EU. By leveraging the expertise of partners like Neopharm Labs, companies can ensure their products are safe, compliant, and of high quality, positioning themselves for success in a competitive global market.

In summary, the changing regulations pose challenges and opportunities for cosmetic companies in the U.S. and Canada. Companies need to understand the impact of MoCRA and proactively adhere to new GMP requirements. Doing so will help them meet regulatory standards, enhance their reputation for quality and safety, and ultimately drive growth and success in the global cosmetics industry.

Neopharm’s Expertise in cosmetic product testing

Neopharm offers a range of services to help companies in the U.S. and Canada comply with MoCRA:

1. GMP Quality Control Testing: Ensuring products meet safety and quality standards through reliable testing.
2. Microbiology and Sterility Testing: Verifying product safety by testing for harmful microorganisms and contaminants.
3. Method Development and Validation: Developing and validating analytical methods to ensure consistent and reliable testing.

Source:

https://www.fda.gov/cosmetics/registration-listing-cosmetic-product-facilities-and-products

Disclaimer: This article provides an overview of MoCRA and its implications for cosmetic companies. However, it is not exhaustive, and regulations may continue to evolve. For the most current and comprehensive information, please check the official FDA website at www.fda.gov/cosmetics