Understanding the impact of MoCRA on FDA Cosmetic Regulations Changes – in 2023 and beyond.
From haircare, perfume, make-up, male grooming and skincare, American adult consumers use up to 12 cosmetic items each day, with some products containing as many as 112 unique ingredients*. Now, in a transformative move, the United States Food and Drug Administration (FDA) is set to implement significant modifications to cosmetic regulations, marking a new era for beauty brands operating in the US market.
On 29th December 2022, in response to consumer demands for improved safety, transparency and quality within the beauty industry, US President Joe Biden signed into law the Consolidated Appropriations Act of 2023, which includes The Modernization of Cosmetics Regulation Act of 2022 (MoCRA).
MoCRA’s new regulation marks the most significant expansion of the FDA’s authority to regulate cosmetics since the Federal Food, Drug, and Cosmetic (FD&C) Act was passed in 1938.
Continuing the industry’s transformation from being self-governing to federally regulated, the Act includes a wide range of changes that affect the entire cosmetics supply chain.
With the 29th December 2023 deadline now less than one month away, understanding the implications of MoCRA’s new regulatory landscape is essential to maintaining compliance and safeguarding brand reputation.
As a leading beauty fulfilment provider, we understand the complexities faced by beauty brands as they navigate this new legislation. In this blog, we will provide an overview of the regulation changes and its implications, outlining who is affected and addressing the actions you can take to ensure compliance.
Who is Affected by the New Regulations?
MoCRA applies to responsible persons (manufacturers, packers, distributors as indicated on the product label) that market cosmetic products in the US.
Other companies throughout the supply chain, including ingredient suppliers and manufacturers, will also need to adapt their processes to meet MoCRA’s requirements.
Overview of FDA Cosmetic Regulation Changes
- Ingredient Transparency
A crucial aspect of the new Act (which brands must meet by the December 2024 deadline) requires brands to disclose information on allergens on labels.
- Product Listing
Brands must ensure product labels provide accurate and comprehensive information about potential allergens, usage instructions and contact information in the event of adverse reaction. Any changes to these must be communicated to consumers in a transparent manner.
- Facility Registration
Manufacturers and processors must register their facilities with the FDA and renew their registration every two years.
- Alternatives to Animal Testing
While MoCRA itself does not enforce a ban on animal testing, in a bid to reduce and eventually eliminate the practice, the Act reflects a global trend toward cruelty-free practices and beauty brands are now strongly advised to find alternative testing methods for the purposes of cosmetic safety substantiation.
- Good Manufacturing Practices
The FDA is intensifying its focus on ensuring that beauty brands adhere to Good Manufacturing Practices (GMP). This entails maintaining stringent quality control measures throughout the production process to guarantee the safety and efficacy of cosmetic products. By 29th December 2024, the proposed rule on GMP is to be presented by the FDA. By 29th December 2025, the Agency must adopt the final regulation.
- Enhanced Reporting Requirements
Beauty brands will be required to set up a system to receive communications on adverse events associated with their products, to promptly report to the FDA serious adverse reactions and to maintain records of such reporting for 6 years. This aims to facilitate faster response times and interventions in the event of unexpected issues.
What Action Do You Need to Take?
Compliance to MoCRA regulation requires US brands to have a well-defined strategy. This includes:
- Compliance Review
In a continuation of best practice, brands should thoroughly review their product formulations to identify any ingredients that may be banned or require pre-market approval. They should ensure they hold evidence of product safety (i.e. safety substantiation documentation); collaboration with suppliers is essential to obtain the necessary documentation.
- Update Product Labelling
The ingredients of each marketed cosmetic product must be listed with the FDA with any updates provided annually by a responsible person. This means the manufacturer, packer or distributor of a cosmetic product whose name appears on the label of such cosmetic product in accordance with section 609(a) of the FD&C Act or section 4(a) of the Fair Packaging and Labelling Act.
- Implement Good Manufacturing Practices (GMP) to Meet Standards
While the FDA has yet to publish the rule on GMP, it is advised for brands to carefully follow updates on the FDA’s rules around GMP, to check current international standards for GMP and to internally increase GMP awareness and competences. This may involve investing in training for production staff, upgrading manufacturing facilities and strengthening internal quality control processes to ensure consistent adherence to quality standards.
- Explore Alternative Testing Methods
Brands are encouraged to invest in research and development to explore and adopt alternative testing methods that eliminate the need for animal testing, meeting MoCRA’s requirements and consumer demand for cruelty-free products.
- Stay Informed
The cosmetic regulatory framework is continuously evolving; by subscribing to COSlaw, the Information Platform on the Cosmetics Regulations, those involved in the industry can remain up-to-date with the latest developments. Furthermore, given the complexity of MoCRA and its implications, beauty brands may benefit from collaborating with regulatory consultants specialising in the cosmetic industry (eg. Obelis), who can provide guidance on compliance, documentation and navigating the regulatory landscape.
- Supply Chain Transparency
To ensure that their supply chain is transparent and traceable, from ingredient sourcing to product fulfilment and logistics, brands should ensure that the contract manufacturers they collaborate with are aware of MoCRA requirements and appropriately register their facilities in the FDA Direct database and (for non US facilities) appoint a US Agent.
Consumer awareness of product safety, in general, is on the rise, and the new MoCRA regulation is a significant milestone for the cosmetics industry, providing even safer products to consumers worldwide.
While it may appear complex, challenging – and costly, the aim of MoCRA’s increased industry transparency is an improvement in rigorous safety standards and ethical practices. By committing to and complying with the new mandatory framework, beauty brands will, in turn, enjoy an enhanced brand reputation.
If you are a US beauty brand looking to grow your UK and EU sales, we offer world-class e-commerce fulfillment and delivery-to-retail services. Find out more >
If you’re looking for a trusted partner for regulatory compliance visit the Obelis website here.
When Does MoCRA go into Effect?
For cosmetics businesses to have time to prepare to meet the new MoCRA requirements without threat of penalty, the FDA is using a phased approach for enforcement. The key dates for compliance are as follows:
By December 29th, 2023: despite this published deadline, all applicable businesses have until July 2024 to register their facilities and submit product listings with detailed information. From the same date, manufacturers must also have in place a system for recording and evaluation of adverse events and reporting of serious adverse events. Your company should be prepared by assembling the necessary materials and facts.
By June 29th, 2024: The FDA is mandated to establish regulations concerning fragrance allergens, requiring their labelling when certain concentrations are exceeded. MoCRA will instruct the FDA to consider the allergen requirements already in effect in the EU.
By December 29th, 2024: all applicable businesses must disclose known allergens in their products and provide the contact information to receive customers’ communication on adverse events. For now, your key personnel can review FDA hearings on fragrance allergen disclosures and evaluate candidates to act as a vigilance contact point.
By December 29th, 2025: all applicable businesses must provide proof of adherence to GMPs. Reviewing what those practices entail, as well as the related hearings of the FDA, should help your organisation understand what is necessary to satisfy this requirement.