As per MoCRA, a responsible person is required to list each marketed cosmetic product intended for sale in the US with FDA and update such listing regularly.
A responsible person is the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label.
A cosmetic product listing will require detailed information about the product, its ingredients, including any fragrances, flavors, or colors.
For Cosmetic products marketed on or before December 29, 2022, the listing is due by no later than July 1st, 2024. Any updates must be submitted annually. FDA expects the product listing for a cosmetic product first marketed after December 29, 2022, to be submitted within 120 days of marketing the product.
MoCRA exempts certain small businesses from facility registration and product listing requirements.
However, such exemptions do not apply to facilities that manufacture or process, or responsible persons for, the following cosmetic products:
- Products that regularly come into contact with mucus membrane of the eye under customary or usual conditions of use.
- Products that are injected.
- Products that are intended for internal use.
- Products that are intended to alter appearance for more than 24 hours under customary or usual conditions of use and removal by the consumer is not part of such conditions of use.
Some Exemptions also exist for certain products and facilities that are subject to requirements for drugs and medical evices.
Liberty Management Group Ltd. can help you with registration or listing under FDA MoCRA regulations.
Namrata
Regulatory Consultant
support@libertymanagement.us