We’re down to Days (No More Delays)
In this Datafoundry Blog, we bring you a timely update regarding the regulation of cosmetics in the US.
The US FDA has been in the process of implementing the Modernization of Cosmetics Regulation Act (MoCRA), a pivotal step towards ensuring the safety and efficacy of cosmetic products. MoCRA is now entering its final phase, with a deadline of July 1, 2024 for compliance.
MoCRA represents a comprehensive effort to modernize the regulation of cosmetics, addressing various aspects ranging from ingredient safety to labelling requirements. The primary objective of MoCRA is to enhance consumer safety by providing greater transparency and oversight within the cosmetics industry. By mandating regulations and standards, MoCRA aims to mitigate potential risks associated with cosmetic products and ensure that consumers can make informed choices about the products they use.
The enactment of the MoCRA signalled a positive step toward improved cosmetic regulation. However, its implementation encountered delays. Originally scheduled for enforcement in December 2023, the Food and Drug Administration (FDA) postponed the deadline to July 1, 2024. The FDA cited the need for additional time to collaborate with industry stakeholders and address logistical challenges. This delay, understandable given the complexity of the new regulations, caused uncertainty among many stakeholders regarding the compliance timeline. With the July 1, 2024 deadline approaching, the cosmetics industry is poised for a significant regulatory shift.
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However, the FDA has reached a significant milestone in the implementation of MoCRA. In a recent statement, the FDA confirmed that there will be no further delays in the enforcement of MoCRA provisions.
As MoCRA moves towards full enforcement, it is essential to understand the key provisions and how they will impact the cosmetics industry.
MoCRA provides new authorities to FDA and requirements for industry including:
- ➢ Facility Registration: Cosmetic product manufacturers and processors must register their products and facilities with FDA, update their registration to reflect changes to their registration information within 60 days of any changes, and renew their registration every two years.
- ➢ Product Listing: A responsible person must list each marketed cosmetic product with FDA, including product ingredients, and provide any updates annually.
Further, MoCRA mandates stricter evaluation of cosmetic ingredients, requiring manufacturers to provide comprehensive safety data for all ingredients used in their products. This includes conducting thorough assessments of potential risks and ensuring compliance with established safety standards, including submission of Safety Cases
Labeling Requirements: Under MoCRA, cosmetics labels must provide clear and accurate information about the product’s ingredients, usage instructions, and potential allergens. This transparency empowers consumers to make informed decisions and avoid products that may pose risks to their health.
MoCRA emphasizes the importance of adherence to GMP standards to ensure the quality and consistency of cosmetic products. Manufacturers are required to implement robust quality control measures throughout the production process, from ingredient sourcing to final product distribution.
To monitor the safety of cosmetic products after they enter the market, MoCRA establishes enhanced post-market surveillance mechanisms. This enables the FDA to promptly identify and address any emerging safety concerns or adverse reactions associated with cosmetics.
The enforcement of MoCRA represents a significant paradigm shift for the cosmetics industry, necessitating compliance with stricter regulatory standards. While this may entail initial challenges for manufacturers and suppliers, it ultimately benefits both businesses and consumers by fostering trust, transparency, and accountability within the industry. By prioritizing consumer safety and product quality, companies can differentiate themselves in the market and build stronger brand loyalty.
As a trusted provider of leading-edge solutions, Datafoundry is fully committed to ensuring compliance with MoCRA and upholding the highest standards of safety and quality. We understand the importance of staying informed about the latest regulations and adapting your business practices accordingly.
As we embrace this final phase of implementation, it is imperative that the industry works together to ensure a smooth transition and achieve the ultimate goal of enhanced consumer safety.
Schedule your free MoCRA consultation (readiness assessment) or demo today to see how Datafoundry can help you navigate MoCRA compliance with confidence.