USFDA Cosmetics
Back to the previous page Overview ：
On 29 December 2022, the US President signed into law the Consolidated Appropriations Act 2023, which included the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), a long-awaited reform of the US cosmetics regulation. The key changes introduced by MoCRA:
1.Mandatory FDA registration for cosmetic facilities, both domestic and international.
2.Mandatory product listings for cosmetics sold in the USA.
3.Compliance with Good Manufacturing Practices (GMPs; will be issued by the FDA).
4.Declaration of fragrance allergens on labels
5.Labelling requirements for professional-use products.
6.Labelling of RP contact information
7.Record-keeping, including safety substantiation and adverse events documentation.
8.Reporting of adverse events to the FDA.
9.Mandatory recall authority for the FDA.
10.New regulations on talc, asbestos, and PFAS (will be published by the FDA).
11.Phasing out animal testing.
Business Challenges ：if you need a third-party services of US legal agent (in US) for facility registration (cosmetics manufacturer) with FDA and of responsible person (in US) for product listing (cosmetics brand company or distributor) with FDA to protect your trade secrets (including formula); if your customer in US does not know what to do to be compliant with FDA including the ingredients and label compliance.
Our service ：
(1) Ingredients & Label review
(2) Facility registration
(3) Product registration
(4) US Agent/RP service (a)adverse report (b)keep the PIF for post marketing purposes
(5) Cosmetics regulatory consultation
How to start ：Please send us the picture of the product.
Why SCG ：We have plenty experience for the following : Bath preparations, Eye makeup preparations (other than children’s eye makeup preparations), Children’s eye makeup preparations, Hair preparations (non-coloring), Hair coloring preparations, Makeup preparations (not eye)(other than makeup preparations for children), Makeup reparations for children (not eye), Personal cleanliness, Skin care preparations (creams, lotions, powder, and sprays)….