Cosmetics


Wise Company Inc. provides consulting service on U.S. FDA Cosmetics registration service based on years of accumulated FDA and CE regulatory experience and data.

Termination of VCRP in accordance with MoCRA (Modernization of Cosmetics Regulation Act) of 2022
  1. VCRP is no longer valid from Mar. 27, 2023. Registration of facility and listing of cosmetic products in accordance with Modernization of Cosmetics Regulations Act (MoCRA) will be possible from Oct. 2023. 
  2. Data registered in accordance with VCRP is no longer valid. Registerers shall comply with requirements of new regulation including registration of facility and products. 

Main takeaways of MoCRA
  1. – Reporting and maintaining adverse events records
  2. – FDA registration of facility and products
  3. – Demonstration of cosmetic safety
  4. – Establishing labeling in accordance with requirements정
  5. – Authorizing FDA to suspend facilities, access to records, and force recall
  6. – Revised GMP requirements and strengthened compliance obligation
  7. – New rules regarding Talc scheduled to be established

Facility registration
  1. Timeline
    • – The owner/operator of facilities involved in the manufacturing/processing of cosmetics intended for distribution in the United States prior to December 29, 2023: Until Dec. 29, 2023
    • – The owner/operator of a facility first involved in the manufacturing/processing of cosmetics intended for distribution in the United States after December 29, 2023.: Within 60 days from the date first involved in the activity or within 60 days from December 29, 2023.
  2. Renewal: Every TWO years

  3. Contents of Registration
    • – Name of the owner and/or operator
    • – Name, location, and contact information of the facility
    • – Contact information for the U.S. agent for foreign facilities outside the United States
    • – Facility registration number (FEI)
    • – All marketed brands manufactured/processed at the facility
    • – Product categories manufactured/processed at the facility and the person responsible
    • – Type of submission (Initial, Amendment, Regular Renewal, Abbreviated Renewal)
    • – Additional information that may be requested: Parent company name, facility DUNS number, additional contact information

Product Registration Requirements
  1. Timeline
    • Products marketed in the United States before December 29, 2023: By December 29, 2023
    • Products starting U.S. marketing after December 29, 2023: Within 120 days of the marketing date or by 120 days from December 29, 2023
  2. Renewal: Annually

  3. Contents of Registration
    • – Facility registration numbers (FEI) for all facilities where the cosmetic is manufactured/processed (multiple facilities possible)
    • – Name and contact information of the Responsible Person and the name of the cosmetic as shown on the label/li>
        Responsible person: Manufacturer, packer, or distributor whose name appears on the cosmetic label
    • – Cosmetic category
    • – List of cosmetic ingredients (including fragrances, flavors, and color additives)
    • – Product listing number (if previously assigned)
    • – Submission type (Initial, Regular Renewal, Abbreviated Renewal)
    • – Additional information that may be requested: Parent company name, Type of operation (manufacturing/packing/distributing), Label artwork, Product web link, Indication of professional use, DUNS number of the responsible person as shown on the label, Unique Ingredient Indentifiers (UNII)

Regulatory Relaxations for Small Businesses

  Small businesses are defined as companies with an average annual gross sales of less than $1,000,000 over the past three years of cosmetic sales in the United States. These businesses are exempt from facility registration and product listing, as well as being subject to less stringent GMP and adverse event record-keeping requirements, except for:
  • – Products that come into contact with the mucous membranes of the eye
  • – Products that are injected (e.g., tattoos)
  • – Products intended for ingestion (e.g., mouthwash)
  • – Products designed to alter appearance for more than 24 hours under normal use conditions
  However, even if classified as a small business, cumbersome procedures during export processes may arise, such as customs requesting registration documents (e.g., registration numbers) or proof of exemption (e.g., evidence of sales figures). Therefore, we recommend facility and product registration to avoid complications.

 

Services and Quotation of WISE COMPANY
  • – We provide up-to-date information by checking the latest FDA notices to ensure you are prepared for upcoming deadlines and have a clear understanding of the requirements for MoCRA and cosmetic registration.
  • – Ingredient and label review services are offered based on FDA cosmetic requirements and our expertise and experience.
  • – We provide CPSR (Cosmetic Product Safety Report) issuance services for FDA compliance with cosmetic safety demonstration requirements.
  • – U.S. Agent agreement services are available to ensure compliance with label requirements.
  • – Assistance with obtaining a DUNS number is also provided.

Please CONTACT US for any further question.