Tag: mocra

MoCRA

MoCRA stands for the Modernization of Cosmetics Regulation Act of 2022. It expands the FDA’s authority over cosmetics, introduces mandatory registration, safety, and reporting requirements, and aims to strengthen public health protections for cosmetic products.

Key aspects of MoCRA include:

  • Facility Registration: Cosmetic manufacturers and processors must register their facilities with the FDA and update such registration biennially.
  • Product Listing: A responsible person must list every marketed product (including ingredients) and renew such listing annually.
  • Good Manufacturing Practices (GMP): The law requires compliance to GMPs, which sets standards for product safety and quality in manufacturing.
  • Adverse event reporting: Manufacturers must track and report any serious adverse health incidents linked to their products.
  • Safety substantiation: Companies must do all safety testing and keep evidence.
  • Labeling requirements: Product labels must be FDA compliant.

Certain Small businesses may be exempt from some MoCRA requirements, although exemptions do not apply to products intended for use in the eyes, injected, or otherwise specifically regulated under FDA drug regulation.

Liberty Management Group Ltd can help facilities with FDA Registration & product listing and label compliance.

Namrata

Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

Does the FDA approve cosmetic products or companies?

Cosmetics are articles that are intended to be rubbed, poured, sprinkled, sprayed or applied to human body for cleansing, beautifying, or altering appearance.

FDA does not approve cosmetic products or companies. Facilities that are engaged in manufacturing, processing & distribution of cosmetic products are required to comply with below FDA requirements under FDA’s MoCRA regulation.

Cosmetic products and ingredients do not need FDA premarket approval. However, FDA can enforce action against cosmetic products on the market that are not in compliance with the law. It is the responsibility of cosmetic manufacturers or distributors to ensure the safety of their products.

If the FDA determines that a product is adulterated or misbranded, there are several actions the agency might take namely; criminal penalties, detention at port or file in an injunction to prevent the company from manufacturing the product.

Liberty Management Group LTD  provides assistance with Cosmetic Product Registration, Cosmetic Product Listing, Label Review and other FDA regulations.

Namrata

FDA Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

Key Terms under MoCRA

FDA requires every person that owns or operates a facility that engages in the manufacturing or processing of a cosmetic product for distribution in the US to submit cosmetic facility registration with FDA.

FDA also requires that for each cosmetic product, the responsible person must submit to FDA a cosmetic product listing.

Key terms under MoCRA:

CONTRACT MANUFACTURER — a facility that manufactures or processes a cosmetic product on behalf of another entity.

COSMETIC PRODUCT– a preparation of cosmetic ingredients with a qualitatively and quantitatively set composition for use in a finished product.

DUNS NUMBER — The Data Universal Numbering System (DUNS) number is a unique nine-digit identification number issued by D&B. The DUNS Number is sites specific. Therefore, each distinct physical location of an entity (such as branches, divisions, and headquarters) may be assigned a DUNS number.

FACILITY – any establishment (including an establishment of an importer) that manufactures or processes cosmetic products distributed in the United States.

Excluding:

  • Beauty shops and salons
  • Cosmetic product retailers
  • Hospitals, physicians’ offices, and health care clinics
  • Public health agencies and other nonprofit entities that provide cosmetic products directly to the consumer
  • Entities (such as hotels and airlines) that provide complimentary cosmetic products to customers incidental to other services
  • Trade shows and other venues where cosmetic product samples are provided free of charge
  • An establishment that manufactures or processes cosmetic products that are solely for use in research or evaluation, including for production testing and not offered for retail sale
  • An establishment that solely performs one or more of the following with respect to cosmetic products:
  • Labeling
  • Relabeling
  • Packaging
  • Repackaging
  • Holding
  • Distributing

FEI – FDA Establishment Identifier – It is also known as the Firm or Facility Establishment Identifier. The FEI number is a unique identifier assigned by the FDA to identify firms associated with FDA-regulated products. FDA intends to use a facility’s FEI number as the cosmetic product facility’s registration number.

MANUFACTURING OR PROCESSING OF A COSMETIC PRODUCT – means engaging in one or more steps in the making of any cosmetic product by chemical, physical, biological, or other procedures, including manipulation, sampling, testing, or control procedures applied to the product.

OPERATOR – a person who has management authority over an establishment.

OWNER – a person who has an ownership interest in an establishment.

RESPONSIBLE PERSON – the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label of such cosmetic product in accordance with section 609(a) of the FD&C Act or section 4(a) of the Fair Packaging and Labeling Act.

SMALL BUSINESSES — means responsible persons, and owners and operators of facilities, whose average gross annual sales in the U.S. of cosmetic products for the previous 3-year period is less than $1,000,000, adjusted for inflation, and who do not engage in the manufacturing or processing of certain cosmetic products:

  • Cosmetic products that regularly come into contact with mucus membrane of the eye under conditions of use that are customary or usual
  • Cosmetic products that are injected
  • Cosmetic products that are intended for internal use
  • Cosmetic products that are intended to alter appearance for more than 24 hours under conditions of use that are customary or usual and removal by the consumer is not part of such conditions of use that are customary or usual.

Liberty Management Group Ltd. can help you with FDA MoCRA regulations & US Agent service.

Namrata

Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

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

US FDA Cosmetics Responsible Person

As per US FDA’s new regulation for regulating cosmetic industry – MoCRA (Modernization of Cosmetics Regulation Act of 2022), FDA now requires cosmetic companies to register their facility and list the cosmetic products with FDA.

The FD&C Act defines cosmetics as articles intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance without affecting the body’s structure or functions. Some examples are listed here.

MoCRA defines a Responsible Person as the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label of such cosmetic product in accordance with section 609(a) of the FD&C Act or section 4(a) of the Fair Packaging and Labeling Act.

Under MoCRA, the Responsible Person will have following responsibilities:

  • To obtain the relevant facility registration number or where small business exemption applies, the facility name & address, for each facility where its cosmetic products are manufactured or processed
  • Submit product listing for each marketed cosmetic product with FDA, including product ingredients, and provide any updates annually.
  • Reporting serious adverse events associated with the use of cosmetic products in the US to FDA within 15 business days. If the responsible person receives medical or other information about the adverse event within 1 year of the initial report to FDA, they must submit this new information to FDA within 15 business days.
  • To ensure and maintain records supporting adequate safety substantiation of their cosmetic products.

Liberty Management Group Ltd. provides assistance with Cosmetic Facility Registration and Cosmetic Product Listing.

Namrata

Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

WHAT INFORMATION MUST BE SUBMITTED IN COSMETIC FACILITY REGISTRATION AND COSMETIC PRODUCT LISTING UNDER MOCRA ACT?

According to FDA’s August 2023 draft guidance, following information will be required in Cosmetic Facility Registration:

  1. Owner and/or operator of the facility
  2. Facility Name, Address, Email & Telephone Number
  3. US Agent (for non-US facilities) Name, Email & Telephone Number
  4. FEI number or Facility Registration Number, if previously assigned
  5. Brand names under which cosmetic products are sold
  6. Product category
  7. Responsible person for each cosmetic product
  8. Type of submission (initial, amended, biennial renewal, or abbreviated biennial renewal)

The Cosmetic Product Listing shall contain:

  1. Facility Registration Number of manufacturer
  2. Name of Product
  3. Responsible person Name & Telephone Number
  4. Product Category
  5. Ingredient List
  6. Product listing number, if any, previously assigned by the FDA.
  7. Type of submission (initial, update, abbreviated renewal)

The above information may change once FDA releases final guidance on MoCRA. Please visit our website for most updated information.

Liberty Management Group Ltd. provides assistance with MoCRA submissions.

Namrata

Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

MOCRA – Modernization of Cosmetics Regulation Act of 2022

Recently US Congress passed the Consolidated Appropriations Act, bringing changes to how cosmetic products are regulated in the US. MOCRA or the Modernization of Cosmetics Regulation Act of 2022 provides regulatory authority to US FDA over cosmetic industry. Key requirements of MOCRA are as below:

Manufacturers and processors must register their facilities with the FDA and renew such registration biennially. FDA no longer accepts VCRP registrations so Facilities that were registered under the VCRP program will have to register again under the new system.

A responsible person must list each marketed cosmetic product and ingredients with the FDA and must renew such listing annually.

  • Good Manufacturing Practices (GMP)

Cosmetic manufacturing and processing facilities must comply with GMP standards.

Cosmetic product labels must adhere to new cosmetic labeling requirements.

  • Adverse Event Report

A responsible person is required to report serious adverse events associated with the use of cosmetic products in the US to the FDA. FDA will have access to adverse event reports during an inspection.

  • Product Safety Substantiation

A responsible person is required to ensure and maintain records supporting adequate safety               substantiation for their products.

  • Mandatory Recall

FDA has the authority to order a mandatory recall, if deemed necessary, if the responsible person refuses to do so voluntarily.

A responsible person means the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label of such cosmetic product in accordance with section 609(a) of the FD&C Act or section 4(a) of the Fair Packaging and Labeling Act.

Liberty Management Group Ltd. can help you with Facility Registration, Product Listing, Label compliance and other FDA regulations.

Namrata

Regulatory Consultant

support@libertymanagement.us

www.fdahelp.us