Good Manufacturing Practices and MoCRA - What You Should Know

Good Manufacturing Practices to meet MoCRA FDA regulations.

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) has ushered in significant changes for cosmetic manufacturers, particularly concerning Good Manufacturing Practices (GMPs). The FDA is actively developing enforceable GMP regulations to ensure the safety and quality of cosmetic products distributed in the United States.

Understanding MoCRA and Its Implications

MoCRA grants the FDA enhanced authority to regulate cosmetic products, including the power to establish mandatory GMPs for manufacturing facilities. This move aims to protect public health by ensuring that cosmetics are produced under conditions that minimize contamination and ensure product consistency.

FDA's Draft Guidance on Cosmetic GMPs

In May 2023, the FDA issued a draft guidance outlining its current thinking on what constitutes GMPs for cosmetics. This guidance incorporates elements from the International Organization for Standardization's ISO 22716:2007 standard, adapting them based on the FDA's experience. Key areas addressed include:

The draft guidance covers several critical areas:

  • Documentation and Records: Emphasizes the importance of maintaining detailed records of operations, procedures, deviations, and corrective actions to ensure traceability and accountability.
  • Buildings and Facilities: Outlines requirements for the design, construction, and maintenance of facilities to prevent contamination and ensure cleanliness.
  • Equipment: Specifies that equipment used in manufacturing should be appropriately designed, maintained, and calibrated to prevent contamination and ensure consistent product quality.
  • Personnel: Highlights the need for adequately trained personnel who follow proper hygiene practices to prevent product contamination.
  • Raw Materials: Stresses the importance of proper storage, handling, and testing of raw materials to ensure they meet quality standards.
  • Water Quality: Addresses the need for water used in manufacturing to meet defined quality specifications and be regularly tested to prevent contamination.
  • Color Additives: Requires that color additives used in cosmetics be approved and meet specific labeling requirements.
  • Prohibited and Restricted Ingredients: Provides a list of ingredients that are prohibited or restricted in cosmetic products, along with relevant regulatory citations.
  • Production and Laboratory Controls: Emphasizes the need for written procedures, in-process controls, and laboratory testing to ensure product quality and consistency.
  • Internal Audits: Recommends regular internal audits to assess compliance with GMPs and identify areas for improvement.
  • Complaints, Adverse Events, and Recalls: Advises on procedures for handling consumer complaints, reporting adverse events, and conducting product recalls when necessary.

It's important to note that this draft guidance is not legally binding but serves as a recommendation to help manufacturers align with the FDA's expectations. 

Public Engagement and Feedback

On June 1, 2023, the FDA held a virtual listening session to gather input from stakeholders, including small businesses, contract manufacturers, and consumer organizations. The session focused on topics such as the practicality of aligning with ISO standards, flexibility in GMP requirements for various facility sizes, and the economic impact of implementing these practices. 

Timeline for Implementation

While MoCRA set ambitious timelines for establishing GMP regulations, the FDA has indicated delays in the rulemaking process. As of December 2024, the proposed rule for cosmetic GMPs is expected to be released by October 2025.

Preparing for Compliance

Cosmetic manufacturers should proactively assess their current manufacturing practices against the FDA's draft guidance and ISO 22716:2007 standards. Implementing robust quality control measures, maintaining detailed records, and ensuring proper training for personnel are critical steps toward compliance.

The evolving regulatory landscape under MoCRA emphasizes the importance of GMPs in the cosmetic industry. By staying informed and engaging with the FDA's guidance and public consultations, manufacturers can ensure they are well-prepared to meet upcoming regulatory requirements and continue to provide safe, high-quality products to consumers.

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