Cosmetic Registration – FDA Support

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.

Facility registration
Product listing
Label compliance
Comply with cGMP requirements
Safety substantiation of cosmetic products
Adverse event reporting system

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

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 1^st, 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 1^st, 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 1^st, 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:

Drug Establishment Registration – Manufacturers of drug products must register their facilities with the FDA, and SPL is used for this purpose.
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.
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.
Cosmetic Facility Registration – Manufacturers & processors of cosmetic products must register their facilities with the FDA, and SPL is used for this purpose.
Cosmetic Product Listing – A responsible person must list the cosmetic products with FDA by way of SPL submissions.
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

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:

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

The Cosmetic Product Listing shall contain:

Facility Registration Number of manufacturer
Name of Product
Responsible person Name & Telephone Number
Product Category
Ingredient List
Product listing number, if any, previously assigned by the FDA.
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:

Facility Registration

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.

Product Listing

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.

Product Labeling

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

PROHIBITED AND RESTRICTED INGREDIENTS IN COSMETICS

FDA Registration for Cosmetic Products and Cosmetic Establishments is voluntary and FDA does not approve cosmetic products or ingredients before they go on the market. It is the responsibility of cosmetic manufacturer to ensure the safety of its products.

As per FD&C, it is prohibited by law to distribute any cosmetic containing an ingredient that makes the product harmful when used exactly as per label directions or as per the customary use. The only exception to this rule is for coal tar hair dyes for which FDA cannot take action against as long as the product label contains a special warning statement and also contains directions for a skin test.

Color additives are permitted in cosmetics only if FDA has pre-approved them for the intended use.

FDA specifically prohibits or restricts following ingredients in cosmetics:

Bithionol – Prohibited as it may cause photo contact sensitization
Chlorofluorocarbon propellants – Prohibited for use in cosmetic aerosol products intended for domestic consumption
Chloroform – Prohibited as it causes cancer in animals and is likely to be harmful to human health, too. Except for residual amounts from its use as a processing solvent during manufacture, or as a byproduct from the synthesis of an ingredient
Halogenated salicylanilides (di-, tri-, metabromsalan and tetrachlorosalicylanilide) – Prohibited as it may cause serious skin disorders.
Hexachlorophene – Prohibited because of its toxic effect and ability to penetrate human skin. The HCP concentration in a cosmetic may not exceed 0.1 percent, and it may not be used in cosmetics that are applied to mucous membranes, such as the lips
Mercury compounds – Restricted to eye area products at no more than 0.0065 percent of mercury calculated as the metal and is permitted only if no other effective and safe preservative is available
Methylene chloride – Prohibited as it causes cancer in animals and is likely to be harmful to human health, too
Prohibited cattle materials – These materials include specified risk materials, material from no ambulatory cattle, material from cattle not inspected and passed, or mechanically separated beef
Sunscreens in cosmetics
Vinyl chloride – Prohibited for use as an ingredient of aerosol products, because it causes cancer and other health problems
Zirconium-containing complexes – Prohibited in aerosol cosmetic products because of their toxic effect on lungs of animals, as well as the formation of granulomas in human skin

FDA may take action against any such cosmetic manufacturers or products on the market that do not comply with the law.

Cosmetic labels must always carry directions for use as some cosmetics are safe when used the correct way and unsafe when used the wrong way. Cosmetics must have any directions for use or warning statements needed to make sure people use the products safely. For example; some ingredients are safe on skin if washed off immediately but not if left on skin for hours or some ingredients that are safe for use on hair but not safe when used near eyes.

Liberty Management Group LTD is one of the leading FDA consulting group in the USA. LMG provides assistance with Registrations, Label compliance, and many more FDA regulations.

Namrata

FDA Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

Published on February 27, 2019

Are cosmetics FDA approved?

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

FDA does not approve cosmetics.

Under the law, 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, or against establishments or individuals who violate the law.

It is a legal responsibility of cosmetic manufacturers or distributors to ensure the safety of their products.

All the cosmetics labels must be FDA compliant. Although FDA does not approve cosmetics labels, there are limits that apply to cosmetic labeling claims. As per law, all information on cosmetic labeling including claims must be truthful and not misleading.

FDA encourages cosmetic manufacturers and packers to register themselves by way of VCRP (Voluntary Cosmetic Registration Program) and submit the information of their products currently marketed in US by submitting CPIS (Cosmetic Product Ingredient Statement). Although the submission is voluntary, it provides FDA with an estimate of the information available on cosmetics and their ingredients, the frequency in which they are used and the establishments that are engaged in manufacture, packaging or distribution.

The submission of registration, filing of cosmetic product ingredient, assignment of registration number or CPIS number does not imply that the FDA has approved such establishment or its products.

Liberty Management Group LTD is one of the leading FDA consulting group in the USA. LMG provides assistance with VCRP, CPIS, Label Review and many more FDA regulations.

Namrata

FDA Regulatory Consultant

support@libertymanagement.us

http://www.fdahelp.us

Published on: January 23, 2019