Deciphering New FDA Cosmetic Rules: What You Need to Know About Dermatologist Developed Skin Care Product Labeling Laws

The skincare industry is no stranger to innovation and change, but the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) has introduced significant shifts in regulatory requirements that will change the way skincare businesses operate. Understanding the implications of MoCRA is crucial, particularly when it comes to compliance, renewal, stability testing, safety assessments, and the introduction of the Responsible Person role.

Previously, skin care brands could register their facilities and products through the Voluntary Cosmetic Registration Program, however, the Food and Drug Administration (FDA) stopped the program because of the FDA’s plans to develop a program for submission of the facilities and products listing mandated by the “Modernization of Cosmetics Regulation Act of 2022.

Core Compliance Requirements

MoCRA mandates specific requirements for cosmetic brands and manufacturers who have been distributing cosmetic or personal care products in the U.S. since December 29, 2022. These requirements encompass several key components:

  1. Mandatory Facility Registration & Product Listing: All cosmetic facilities and products sold in the U.S. on December 29, 2022, must be registered, and listed with the FDA. The deadlines for facility registration and product listing are critical to note for compliance.
  • Initial Registration (Facilities existing before December 29, 2022): Owners and operators were required to register their facilities by December 29, 2023.
  • New Facility Registration (Facilities established after December 29, 2022): If a facility began manufacturing or processing cosmetic products after December 29, 2022, they must register within 60 days of commencing such activity or by February 27, 2024, whichever is later.
  • Biennial Renewal (for all facilities): Every two years, all facility registrations must be renewed, even if there are no changes in your facility’s information.
  1. Good Manufacturing Practice (GMP) Requirements: Ensuring products are manufactured according to the highest quality standards.
  2. Cosmetic Safety Substantiation: Demanding that a “Responsible Person” guarantees the safety of each cosmetic product through rigorous testing, research, or other substantiated evidence. This substantiation must be achieved by December 29, 2023.
  3. Adverse Event Recordkeeping & Serious Adverse Event Reporting: Requiring companies to report and maintain records of serious adverse events associated with cosmetic product use.
  4. Cosmetic Labeling and Fragrance Allergen Transparency: Mandating clear and transparent labeling practices, especially for products intended for professional use. This requirement affects product labeling by December 29, 2023, as well as annual updates.
  5. Mandatory Recall / Cease Distribution Authority: Granting the FDA new powers, including the ability to order mandatory recalls if a cosmetic poses a health risk, and suspending facility registrations if serious health concerns are identified. Before a suspension, there is a chance for an informal hearing, and a corrective action plan must be submitted for reinstatement.
  6. Talc Related Rule / Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS): Introducing regulations related to talc-containing cosmetic products and substances like PFAS.

The Role of the Responsible Person

MoCRA introduces a new requirement—the Responsible Person. This individual, whose name appears on the label of a cosmetic product, plays a pivotal role in compliance. The Responsible Person is responsible for ensuring that the cosmetic product complies with all regulatory requirements, including safety assessments, stability testing, and GMP standards. Now is the time, if your business has not already, to consult with professionals who can help you comply. Skin care brands should consider consulting with experts to serve as the responsible person for their products.

Navigating Compliance with MoCRA

Understanding and adhering to these renewal schedules, stability testing requirements, safety compliance measures, GMP standards, and the role of the Responsible Person are critical for skincare businesses to maintain compliance with MoCRA. Failing to meet these deadlines or ensure safety compliance can result in non-compliance with regulatory obligations, potentially impacting your skincare products’ market presence.

In a rapidly evolving industry, partnering with experts who possess a deep understanding of cosmetic policy and safety, such as the Equity and Wellness Collaborative (EWC), a consulting firm with expertise in cosmetic policy and FDA compliance can be invaluable. Consultants can provide the guidance, safety assessments, and support needed to navigate these regulatory changes seamlessly, ensuring that your skincare products meet the necessary standards and continue to offer safe and effective solutions to consumers.

The advent of MoCRA and the evolution of clean beauty practices are ushering in a transformative era for the skincare industry. As regulatory requirements grow more robust and consumers become increasingly discerning, it is essential for skincare brands to prioritize compliance, safety, and transparency. By aligning with MoCRA’s regulations and the principles of clean beauty, skincare brands can shape a future where safety and ethics are paramount, and consumers can trust in the products they apply to their skin.

If you have any questions, reach out to Marcha at the link below.

Leslie Baumann MD and Marcha Isabelle Chaudry Esquire

October 17, 2023 Uncategorized , ,