The Modernization of Cosmetic Regulations Act of 2022 (MoCRA)
Stay ahead of the curve. Our specialist MoCRA Compliance team can help you ensure regulatory alignment.
Keeping up to date with MoCRA requirements and your legal responsibilities
The Modernization of Cosmetic Regulations Act of 2022 (MoCRA) is part of the Food and Drug Omnibus Reform Act of 2022 (FDORA) that President Biden signed into law late last year. MoCRA greatly expands the FDA’s oversight authority over cosmetic products and their manufacturers, marketers, and distributors. However, many of these companies still do not know about the new requirements under MoCRA, and the clock is quickly ticking for compliance, despite the FDA’s recent extension of several key deadlines. As the purpose of MoCRA is to ensure that the cosmetic products a United States consumer uses are safe, it is safe to assume that the FDA will aggressively enforce the requirements of MoCRA. So all companies in this space should act quickly to ensure compliance.
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Frequently asked questions about MoCRA
Typically, what service elements might this involve?
U.S. MoCRA Responsible Person Representative
– U.S. MoCRA Responsible Person Representative Agreement.
– A retainer fee billed monthly.
– The agreement to include an appendix with a list of products to be covered.
U.S. Agent
– U.S. Agent Monthly retainer
– Obtaining FEI Number
– Facility Registration
– MoCRA Regulatory Service Update
Reponsible Person Respresentative (for products)
– Responsible Person Monthly Retainer
– Product Listing
– Label Compliance Review (inc. Prop65)
– Adverse Reactions Handling Service
– MoCRA Regulatory Service Update.
Facility registration
ADSL are able to provide facility registration service. This costs £50 as a one off cost. Any changes impacting facility registration must be reported to ADSL.
Future development: USA Product registration
The FDA are currently trialling this process with 8 companies who applied for the trial. ADSL was not selected for the trial; however, we will advise on this service as soon as we have further information.
What other services does my product require?
Talk to our team of experts and we will be able to advise on all aspects of your products requirements. We take time to understand you claims and product attributes and create a recommendation of the exact services we can provide to get your product to market. Explore our recommended services below, try our product checkup or book a free consultation with our team.
How long does it take?
This varies depending on the product, but we aim to work closely within your timeframe and constraints. Our customer service offer is designed to make your life as easy as possible with a dedicated point of contact in most cases and a detailed schedule to keep you up-to-date with the process.
Why use ADSL?
Formed in 2008, our fully qualified, independent team of Chartered Chemists, Toxicologists, Microbiologists and Regulatory experts specialise in formulation and testing services within the cosmetic, household goods, food and industrial sectors. We are a UKAS accredited testing laboratory offering a range of accredited and non accredited microbiological tests. Our team includes individuals with a host of industry qualifications including Fellows of the Royal Society Of Chemistry and a “Chartered” Chemist and Scientist, Members of The Society Of Cosmetic Scientists, Members of the British Toxicology Society, Members of Society of Dermatology, Members of International Society of Dermoscopy, Members of European Academy of Dermatology & Venereology (EADV) along with Chem CSci, CChem FRSC and PhD attainment. With our exceptional expertise and complementary skills in manufacturing, process controls, industry regulation, health and safety, marketing, and project management we are with you every step of the way to see your product through to successful market launch. Furthermore, our technical consulting helps many businesses by cost effectively filling gaps in their skills and knowledge base and providing a fresh perspective and strategy on the best way forward. Fundamentally we have the the knowledge and know-how to successfully take your cosmetic product to market. Your product inside out.
We are the UK’s leading provider of compliance testing and supporting services
Concept to shelf
We deliver our extensive range of services from our own leading UK based facilities, meaning better support and service for you. Whether a full “turnkey” product development from concept to shelf is needed or a single regulatory or testing requirement, we can help from under one roof.
Trusted by leading brands
From household names to start-ups, we support brands of all sizes, helping them get their products on to the shelf. We have a wide range of testing & compliance capabilities to assist at every part of the development lifecycle process.
Unrivalled expertise
Experts in our field, we have over 20 years of cosmetic formulation, compliance, testing and safety experience. Through this experience we can help customers to navigate through the increasingly demanding regulatory landscape.