Cosmetic GMPs and MoCRA

Updated Requirements for Cosmetic Companies

MoCRA enacts the most significant expansion of the US FDA to regulate cosmetics since 1938. After 85 years of being effective, the Modernization of Cosmetics Regulation Act of 2022 , also known as  “MoCRA” has been updated. It was enacted by Congress as part of the 4,155 pages of the Consolidated Appropriations Act in December of 2022, and signed into law by President Biden on December 29, 2022.

The details of these new requirements for cosmetic companies can be found in the Consolidated Appropriations Action under Subtitle E – Cosmetics, SEC. 3501, pages 3,576-3,612.

The act covers changes to mandatory reporting and regulatory oversight for cosmetics companies, new product registration, ingredient listing requirements, the establishment of Good Manufacturing Practices (GMP), and the reporting of Serious Adverse Events.

MoCRA does not immediately change anything. MoCRA establishes compliance dates and directs the FDA to issue guidance and final rule changes. The FDA is tasked with providing more information and compliance guidance.

Most small businesses will be exempt from certain significant changes. These include extended timelines for implementation, and special considerations for budgets and company size.

Highlighting some MoCRA Changes

Section 605: Adverse Events

The requirement to report and maintain records of Adverse Events is a crucial change for cosmetics companies. Compliance with this section is important as it ensures that any adverse events related to the use of cosmetic products are properly documented and reported to the FDA. Companies need to establish robust systems for receiving and processing Adverse Event complaints via multiple channels, including physical address, telephone number, and electronic format. QAC expert consultants can assist companies in developing compliant processes for Adverse Event reporting and maintaining the necessary records, mitigating potential risks and ensuring compliance with MoCRA.

QAC can help!  We understand the current GMP requirements and proposed new guidelines.  We are already working with cosmetic companies to identify and remediate gaps.  Contact Us today to speak with an expert.

Section 606: Good Manufacturing Practice (GMP)

The inclusion of GMP requirements under MoCRA is a significant development for cosmetics companies. Compliance with GMP guidelines ensures that cosmetic products are manufactured, processed, and packaged in a consistent and controlled manner, meeting the highest quality standards. The FDA will issue guidance on the required GMP guidelines, and it is important for companies to stay updated and implement these guidelines effectively. The QAC consulting team can provide valuable insights and assistance in understanding and implementing GMP requirements, including any simplified practices for smaller businesses, helping companies maintain compliance and uphold product quality.

Section 607: Registration and Product Listing

The requirement for facilities and product listings to be registered with the FDA is a crucial change for cosmetics companies. Compliance with this section ensures that the FDA has a comprehensive record of all facilities and products in the market, facilitating effective oversight and regulatory control. Companies need to understand the registration timelines and requirements, including renewal periods, to avoid penalties and non-compliance.  The QAC Consulting team can guide companies through the registration process, ensuring accurate and timely submissions, and helping them meet their facility and product registration requirements.

Section 608: Safety Substantiation

The inclusion of safety substantiation requirements highlights the importance of ensuring the safety of cosmetic products. Companies must have evidence, such as testing, studies, research, or other relevant data, to support the safety of their products. Compliance with this section is crucial as it demonstrates a commitment to consumer safety and allows companies to address any potential risks proactively. QAC expertise in Regulatory Sciences can help companies develop comprehensive safety substantiation strategies and maintain adequate records to meet MoCRA requirements.

Section 609: Labeling

Changes to labeling requirements, such as providing electronic contact information for the responsible party, listing fragrance allergens, and identifying professional-use products, are important for companies to comply with MoCRA. Accurate and informative labeling is essential for consumer safety and informed decision-making. Companies need to review their labeling practices, incorporate the required changes, and ensure compliance with the FDA’s additional guidance once available. QAC compliance consultants can assist in aligning labeling practices with MoCRA requirements, reducing the risk of non-compliance and potential penalties.  Labeling requirements include:

  • Electronic contact information for the responsible party
  • Fragrance allergens are required to be on the label
  • Professional-use products are required to be identified (Licensed Professionals only)

Sections 610 and 611: Records and Mandatory Recall Authority

The authorization for FDA inspections and the ability to enforce mandatory recalls signify the importance of maintaining accurate records and ensuring product safety. Compliance with record-keeping requirements is essential for facilitating inspections and demonstrating adherence to regulatory standards. Mandatory recall authority empowers the FDA to take swift action in cases where products may pose risks to public health. QAC team can help companies establish robust record-keeping systems and prepare for FDA inspections, ensuring compliance and mitigating recall risks.  MoCRA authorizes the FDA to inspect facilities and their records and provide the FDA with the ability to enforce mandatory recalls on products which may be adulterated, misbranded or pose a public health risk.

Sections 612 and 613: Exemptions

Understanding the exemptions provided for small businesses and the clarification regarding drug requirements is essential for companies to determine their compliance obligations under MoCRA. Small businesses may have extended timelines for implementation and special considerations based on their size and budget. QAC compliance consultants can assist small businesses in assessing their eligibility for exemptions and navigating the regulatory requirements accordingly.

Section 614: Preemption

The preemption of state or local laws that differ from the federal framework on cosmetics regulation brings consistency and clarity to compliance obligations. Companies need to ensure that their practices align with the federal requirements outlined in MoCRA to avoid conflicts with state or local laws. QAC expertise in Quality Management Systems (QMS) alignment can help companies assess their systems, identify gaps, and implement necessary changes to comply with the federal framework.

In conclusion, the changes introduced by MoCRA have significant implications for companies in the cosmetics industry. Compliance with these changes is essential to ensure product safety, adhere to regulatory standards, and avoid penalties. QAC team of expert consultants can provide valuable guidance and assistance to companies, helping them navigate the complex regulatory landscape, understand the requirements of MoCRA, and implement effective compliance strategies. By leveraging QAC expertise, companies can confidently adapt to the evolving regulatory environment and maintain their competitive edge.

If you have additional questions in understanding if your systems are ready for these changes, Contact Us to learn how our compliance consultants can help you navigate your Quality Management Systems (QMS) alignment.

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