As the July 1st deadline for compliance with the Modernization of Cosmetics Regulation Act (MoCRA) rapidly approaches, cosmetic companies are glamorously gearing up to meet the new regulatory requirements set forth by this landmark legislation. As a reminder, MoCRA represents a significant overhaul of the regulatory framework governing the cosmetics industry, ushering in a new era of safety, transparency, and accountability. With just two months left until the deadline, it is crucial for cosmetic companies to powder, pout and take proactive steps to ensure compliance and mitigate potential risks. We discuss here what cosmetic companies should be doing to navigate the impending deadline successfully and fabulously!
Understanding the Modernization of Cosmetics Regulation Act (MoCRA)
MoCRA, enacted to modernize and strengthen the regulation of cosmetics in response to evolving consumer demands and technological advancements, introduces several key changes aimed at enhancing product safety and transparency. These changes include stricter ingredient labeling requirements, mandatory reporting of adverse events, and increased oversight of cosmetic manufacturing practices.
Cosmetic Facility Registration and Cosmetic Listing
MoCRA mandates that cosmetic product manufacturers and processors register their facilities with the FDA, update content within 60 days of any changes, and renew their registration every 2 years, by July 1, 2024. This also requires a responsible person to list each marketed product with the FDA, including product ingredients, and to provide FDA any updates annually. Note that there are some exemptions from this requirement including that small businesses (average sales of 1 million per year for the preceding 3 years, except those making eye products and a few other exceptions) are exempt.
Conducting Ingredient Assessments
One of the primary requirements under MoCRA is the assessment of cosmetic ingredients for safety and potential risks to consumer health. Cosmetic companies must review their product formulations and conduct thorough assessments of each ingredient to ensure compliance with MoCRA’s safety standards. This involves evaluating the toxicity, allergenicity, and potential long-term effects of ingredients used in cosmetic formulations.
Enhancing Labeling and Packaging Compliance
Under MoCRA, cosmetic companies are mandated to provide clearer and more comprehensive labeling information to consumers. This includes disclosing all ingredients used in cosmetic products, including fragrance and color additives, and providing warnings for allergens or potential irritants. Companies should review their labeling and packaging practices to ensure compliance with MoCRA requirements and make any necessary updates before the deadline.
Implementing Adverse Event Reporting Systems
MoCRA introduces new requirements for cosmetic companies to report adverse events associated with their products to regulatory authorities. Companies must establish robust systems for monitoring and reporting adverse events, including incidents of allergic reactions, skin sensitivities, or other adverse reactions. This involves implementing procedures for collecting, documenting, and reporting adverse event data in a timely manner.
Developing and Implementing a Recall Procedure
As FDA now has authority to order a mandatory recall if the Agency determines that there is a reasonable probability that a cosmetic is adulterated or misbranded, and the use of or exposure to such cosmetic will cause serious adverse health consequences or death, we recommend cosmetic companies develop a recall procedure or review an existing procedure now. As businesses must efficiently and defensibly make a decision to recall, and effectuate a recall with FDA, we also recommend that businesses identify in advance their recall team and outside counsel as part of the recall procedure and recall strategy. Additionally, we recommend conducting mock recalls, and ensuring that draft notifications (consumer notifications and press releases) are readily available.
Ensuring Good Manufacturing Practices (GMP)
Compliance with Good Manufacturing Practices (GMP) is essential for ensuring the safety and quality of cosmetic products. Cosmetic companies should review and update their manufacturing processes to align with GMP standards outlined in MoCRA. This includes implementing quality control measures, maintaining proper sanitation protocols, and conducting regular inspections to prevent contamination or adulteration of cosmetic products.
Conducting Product Testing and Safety Assessments
Product testing and safety assessments play a crucial role in demonstrating the safety and efficacy of cosmetic products. Companies should conduct comprehensive safety assessments, including dermatological testing and stability testing, to ensure their products meet MoCRA’s safety requirements. Additionally, companies should establish procedures for post-market surveillance to monitor product safety and address any emerging risks.
Engaging with Regulatory Authorities and Stakeholders
Effective compliance with MoCRA requires proactive engagement with regulatory authorities, industry associations, and other stakeholders. Cosmetic companies should stay informed about regulatory updates and guidance documents issued by relevant authorities and actively participate in industry forums and working groups to share best practices and address common challenges.
Investing in Training and Education
Employee training and education are essential components of MoCRA compliance efforts. Companies should invest in training programs to educate employees about the requirements of MoCRA, their roles and responsibilities in ensuring compliance, and the importance of upholding safety and quality standards in the cosmetics industry.
As the deadline for MoCRA compliance approaches, we recommend cosmetic companies prioritize efforts to ensure their products meet the new regulatory standards outlined in this landmark legislation and be prepped and primed for a regulatory glow-up.
By conducting ingredient assessments, enhancing labeling and packaging compliance, implementing adverse event reporting systems, ensuring GMP compliance, conducting product testing and safety assessments, engaging with regulatory authorities and stakeholders, and investing in training and education, cosmetic companies can navigate the complexities of MoCRA with confidence and continue to deliver safe and high-quality products to consumers. We will continue to keep our readers informed of cosmetic regulatory and enforcement updates.
For questions on U.S. FDA cosmetics compliance and MoCRA, including with regulatory strategy, labeling, substantiation, adverse event reporting, recalls, cosmetic registration and listing, import detentions, import alerts, inspections, and more, please feel free to contact us at info@garg-law.com.
