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Understanding US Cosmetics GMPs Requirements Under MoCRA
In the US cosmetics industry, adherence to Good Manufacturing Practices (GMPs) has historically been voluntary, albeit highly encouraged. However, with the implementation of the Modernization of Cosmetics Regulation Act (MoCRA), there is a significant shift as GMP requirements will become mandatory for all cosmetic manufacturers. What is MoCRA? On December 29, 2022, U.S. President Joe Biden signed the Modernization of
Guidance on US FDA Cosmetic Facility Registration under MoCRA
In a significant move on August 7, 2023, the U.S. Food and Drug Administration (FDA) unveiled a draft guidance on cosmetic facility registrations and product listings (draft guidance). As a crucial supporting document of the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), this draft guidance is open for public consultation until September 7, 2023. The draft guidance refines the requirement
How to Conduct Cosmetic Product Listing under US MoCRA?
On August 7, 2023, the U.S. Food and Drug Administration (FDA) released a draft guidance on cosmetic facility registrations and product listings (draft guidance). This document, available for public consultation until September 7, 2023, holds significant relevance under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). The draft guidance refines the requirements for cosmetic facility registration and product listing.
What is INCI Name? An In-Depth Guide for International Nomenclature Cosmetic Ingredient
The INCI Name is a systematic designation employed worldwide to identify cosmetic ingredients. Developed, reviewed, and assigned by the International Nomenclature Committee (INC), the INCI Name is officially published in the International Cosmetic Ingredient Dictionary and Handbook by the Personal Care Products Council (PCPC) and is available through the wINCI online database. It is important to note that the INCI
Guide to US FDA Cosmetic Registration
Understanding the regulatory landscape is crucial for companies operating in the U.S. cosmetic industry. This article provides an overview of the federal regulations, the role of the FDA, the definition of cosmetic products, and the recent changes brought about by the Modernization of Cosmetics Regulation Act (MoCRA). We also highlight the importance of facility registration, product listing, and the services offered by
2024 Review: U.S. FDA Rejects 1,300 Batches of Imported Cosmetics
Under the Food, Drug, and Cosmetic Act (FD&C Act), the U.S. Food and Drug Administration (FDA) has the authority to detain and refuse entry to any product found to be non-compliant with the Act. When a product is detained, the FDA issues a “Notice of FDA Action” to the product’s owner or consignee, detailing the violation nature. The recipient is then given an opportunity for an informal
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- Facility Registration & FEI Application
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- Cosmetic Safety Substantiation
- INCI Name Application
- U.S. Local Agent Service
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