Category: Cosmetics Regulations

FEI – FDA Establishment Identifier

An FEI is an FDA system generated unique number used to identify a firm, establishment, or facility involved in manufacturing, packing and distribution of FDA-regulated products. The FEI helps the FDA track inspections, facility registrations, and other regulatory activities.

FEI is different from DUNS or EIN.

FEI for Drugs

  • Both US and foreign drug manufacturing or processing facility must register with the FDA and is assigned an FEI after registration.
  • FEI enables FDA to track inspections, regulatory compliance, recalls, and other enforcement actions for that establishment location.

FEI for Medical Devices

  • Manufacturers, contract manufacturers, foreign exporters, initial importers, relabelers, repackagers must register with the FDA and are assigned an FEI upon registration.
  • FEI enables FDA to track inspections, regulatory compliance, recalls, and other enforcement actions for that establishment location.

FEI for Food

  • The FEI helps the FDA with communication, inspection planning, and tracking facility-related activities during food safety investigations.
  • The FEI is distinct from the food facility registration number, which is an 11-digit FDA-assigned number assigned after registration.

FEI for Cosmetics 

  • The FEI is the required facility registration number used by the FDA to identify cosmetic product facilities in its database.
  • Obtaining an FEI is the first step toward registering a cosmetic facility with the FDA. You must have an FEI before submitting a facility registration.
  • The FEI links the facility registration to product listing submissions, which must include the FEI of each facility manufacturing or processing the cosmetic products.
  • The FEI number does not expire. Once assigned, the FEI remains valid and does not require renewal.
  • The FEI is different from cosmetic facility registration, which must be renewed biennially to maintain compliance.

Liberty Management Group Ltd can help facilities with FDA Regulations for all above product categories.

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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.

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Regulatory Consultant

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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.

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What does a US Agent do?

A US FDA Agent acts as a domestic representative for foreign establishments that are engaged in the manufacturing, processing, packaging, or holding of FDA regulated products, such as food, drugs, medical devices &, cosmetics.

The role of the US Agent is primarily to serve as a point of contact between the FDA and the foreign establishment.

Key responsibilities of a US Agent may include:

  1. Assisting FDA to communicate with foreign establishment including responding to inquiries, submitting required documentation, and facilitating inspections.
  2. Serving as a liaison for regulatory compliance matters, including ensuring that the foreign establishment meets FDA regulatory requirements for the products they are dealing in.
  3. Facilitating the submission of required registrations, listings, and other regulatory submissions to the FDA.
  4. Coordinating with the FDA in the event of product recalls, adverse events, or other safety issues related to products manufactured or distributed by the foreign establishment.
  5. Keeping the FDA updated of any changes that are relevant to the foreign establishment’s operations, such as changes in ownership, new manufacturing processes, or product formulations.

The US Agent plays a critical role in helping foreign establishments navigate the regulatory requirements of the FDA and ensuring compliance with US laws and regulations governing the safety and quality of FDA regulated products.

Liberty Management Group Ltd. can be your US Agent and help with registration & other FDA requirements.

Namrata

Regulatory Consultant

support@libertymanagement.ushttp://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.

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Regulatory Consultant

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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

What is SPL?

SPL stands for Structured Product Labeling. SPL is an XML-based document markup standard that provides a consistent way to format and organize information about a drug or cosmetic product, including its ingredients, labels and other details.

Drug & Cosmetic companies are required to submit product information to the FDA in SPL format. SPL is used for various FDA submissions related to FDA regulated products. It is designed to improve the accuracy and consistency of product information and make it easier for healthcare professionals, regulators, and the public to access and understand this information. Some of the key FDA submissions that utilize SPL include:

  1. Drug Establishment Registration – Manufacturers of drug products must register their facilities with the FDA, and SPL is used for this purpose.
  2. Drug Listing – Manufacturers and distributors of drug products are required to list their products with the FDA. SPL is used to provide comprehensive product information for the FDA’s NDC Directory.
  3. Drug Renewals & Listing updates – Annual Drug renewals & any changes to a drug product’s label or listing info, must be submitted to the FDA using SPL.
  4. Cosmetic Facility Registration – Manufacturers & processors of cosmetic products must register their facilities with the FDA, and SPL is used for this purpose.
  5. Cosmetic Product Listing – A responsible person must list the cosmetic products with FDA by way of SPL submissions.
  6. Cosmetic Renewals & Listing updates – Annual Cosmetic renewals & any changes to a cosmetic product’s label or listing info, must be submitted to the FDA using SPL.

Liberty Management Group Ltd can help with SPL preparation & submissions to FDA.

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

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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