Month: January 2024

COSMETIC PRODUCT LISTING

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

http://www.fdahelp.us

COSMETIC FACILITY REGISTRATION

As per MoCRA, owner or operator of a facility that manufactures or processes cosmetic products for US distribution must register with FDA, whether the facility is located in the US or abroad. Registration requires certain information to be provided to FDA, such as all brand names under which the cosmetic products are manufactured or processed in the facility are sold, the product category or categories, and the responsible person for each cosmetic product manufactured or processed at the facility. A responsible person is the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label.

A manufacturing facility needs to submit only one facility registration regardless of whether that facility manufactures or produces cosmetic products for themselves or on behalf of multiple responsible persons.

This requirement excludes certain beauty shops, salons, and retailers and establishments that only perform labeling, relabeling, packaging, repackaging, holding, and distributing of cosmetic products.

Facilities that manufactured or processed cosmetic products on or before December 29, 2022, must register by July 1st, 2024. Facilities that engaged in manufacturing or processing after December 2022 must register within 60 days of first engaging in such activity or by July 1st, 2024, whichever is later.

Facilities registrations must be renewed biennially. Registration must be updated with new information within 60 days of such a change.

FDA has launched new submission portal to facilitate registration.

Liberty Management Group Ltd. can help you with registration under FDA MoCRA regulations.

Namrata

Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us