The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) is a milestone in the FDA's authority to oversee cosmetics since the passage of the Federal Food, Drug, and Cosmetic (FD&C) Act in 1938. This new legislation aims to enhance the safety of cosmetic products that millions of consumers use in their daily routines.
Commencing in 2023, MoCRA will bring forth substantial amendments to U.S. cosmetics regulations, incorporating novel aspects such as the concept of a U.S. "Responsible Person" (RP), updated labelling requirements, obligatory product listing and facility registration, the reporting of serious adverse events, and finished product safety assessment. Additionally, the regulation will establish a fresh Good Manufacturing Practice (GMP) standard for cosmetic products manufactured within the U.S.
Ringier Beauty and Personal Care talked to Seongmin (Mike) Sohn, General Manager, REACH24H Consulting Group, Korea, on the impact of MoCRA on cosmetics companies across the globe.
Perhaps MoCRA is a long time coming – what prompted the new legislation, and what was the process behind its creation?
The ageing of existing regulations, FD&Cact (Federal Food, Drug, and Cosmetics Act), and more recently, the COVID-19 pandemic have both had a profound impact on the establishment of MoCRA.
The FD&Cact, a U.S. cosmetics regulation, was enacted in 1938 and has been long criticised for falling behind the pace of development of consumer and industry demands. However, throughout the pandemic, interest in personal care products such as cosmetics and pharmaceuticals increased both at consumer and national government levels.
In reality, domestic industry protection has strengthened globally. The Chinese Cosmetics Regulations (CSAR), implemented in 2021, has already shown that the rapid and successful tightening of national regulations is possible. This has led to U.S authorities considering a new, scalable, and efficient market management system. Therefore, MoCRA was created to establish new regulations and expand market intervention by strengthening the position of authority bodies through the systematisation and standardisation of product safety and system management.
Who is covered by MoCRA?
Almost all cosmetics-related industries are likely to be affected, especially brands and manufacturers of cosmetic ingredients and products that export to the United States.
Unlike traditional Voluntary Cosmetic Registration Programmes (VCRP), it is now mandatory to submit information about facilities and products owned or operated to the authorities. As a first step, cosmetic ingredient manufacturers must register their facilities with the Food and Drug Administration (FDA). Local agents in the U.S. from manufacturers, brands, distributors, and packaging companies will hold responsibility to whistle-blow and act as responsible persons (RP) if any non-compliance issues are known; Understandably increasing the volume of sanctions by the FDA if issues or non-compliance arise.
What are the significant points of the MoCRA?
The intent of MoCRA is to facilitate convenient and easy management of cosmetic facilities and products by the FDA, and also appoint RPs to strengthen the management of regulations within the supply chain, which govern misconduct.
Although MoCRA is yet to be implemented on a full scale, Good Manufacturing Practice (GMP), for manufacturing facilities, flavouring agents, allergen labelling, and side effect record management – which is currently just ‘highly recommended’ outside of the European Union - can now be selected as standardised factors.
MoCRA has ultimately been created for the FDA to manage the safety of cosmetics with a higher degree of interest and intention than ever before. It can be interpreted that the institutional basis for direct market intervention by authorities, through the creation of safety regulations for cosmetics, from GMP to end consumers. In line with this, industry officials require closer communication and regulatory responses than before.
Should cosmetics companies outside the US (such as those in Asia) be concerned with the new legislation?
Yes, all countries should pay attention to MoCRA, especially the U.S. which owns the world's largest cosmetics market. In the future, fast monitoring and responding to authority mandates will be a big part of entering and expanding the U.S. market, a common goal for non-U.S. companies.
In particular, the registration of facilities, agents, and RPs is unfamiliar to some companies, and many may be cautious as it involves cooperation with local companies. Product quality documents, safety data preparation, and other relevant tasks will also be an additional burden.
Above all, major local cosmetic distribution channels will strongly demand revised regulatory compliance. A very important change not only for local companies in the U.S. but also for all companies planning to tap into the market. If the authorities do not require the submission of relevant data, manufacturing facilities, consumers, and major distributors are still forced to comply with the system if they demand strong compliance.
Please share your thoughts on Asia’s cosmetics industry in terms of safety. Do you think the region’s cosmetics industry should revisit its cosmetics safety laws? What else should the region’s industry improve on?
Industry awareness around the importance of cosmetics safety is growing, and voices are uniting globally on the need to introduce authority bodies. Luckily, the need for regulations has begun to be addressed in the U.S. with MoCRA, and similar safety assessment systems are being introduced by EU, ASEAN and Chinese authorities. In addition, Japan has already introduced and operated guidelines for voluntary cosmetics safety evaluation. However, it has recently been reported that their authorities are preparing to introduce tighter mandatory cosmetics safety regulations, as part of a global approach.
Reach24H is currently in the final stage of detailed discussions around the rules and level of regulations, with the aim to come into force in 2024 and 2025. This means that Korea, China, Japan, and ASEAN will have an industrial system related to cosmetic safety, showing that the Asian market is adapting to changing demands. The Asian and global harmonisation of industry safety is a desirable shift and a huge achievement. However, the time to further refine and develop this growth through cooperation with each country is fast approaching.
Seongmin (Mike) Sohn, General Manager, REACH24H Consulting Group, Korea is talking on ‘MoCRA: A comprehensive overview of new regulations and potential impact on cosmetics ingredients’ in the Marketing Trends and Regulations Theatre on 8th November 2023 (13:00) at in-cosmetics Asia, held at BITEC, Bangkok. For more information about this year’s event or to register to attend, visit: https://www.in-cosmetics.com/asia/en-gb.html