Cosmetic Product Registration Rules (United States FDA)

US laws governing the cosmetic industry changed significantly in recent years. The ‘Modernization of Cosmetics Regulation Act’ (MoCRA) placed new requirements on manufacturers and distributors of cosmetic products in the United States (US). This is Part 2 of FDA compliance resources for cosmetic product regulations (MoCRA).

Key components of the new cosmetic laws in the United States include (1) registration requirements, and (2) Good Manufacturing Practice (GMP) compliance responsibilities, with increased FDA authority over manufacturers and distributors. These laws also give the FDA the authority to mandate a cosmetic product recall when a product is deemed unsafe, is contaminated or otherwise adulterated, and/or includes banned cosmetic ingredients.

Cosmetic Facility & Cosmetic Product Registrations are now mandatory for cosmetics/beauty products being manufactured and/or distributed in the United States. Cosmetics are now regulated more in line with pharmaceuticals, taking a risk-based approach. These law changes were necessary because many types of cosmetic products can cause harm or disfigurement, including eye infections leading to blindness, if they become contaminated or adulterated during manufacturing or distribution.

MoCRA (the updated FDA ‘cosmetic laws’) changed ‘voluntary registration’ to mandatory registration of cosmetic manufacturing facilities and cosmetic products.
The initial compliance deadline for registration (and most other parts of MoCRA) was 29 December 2023.
With the cosmetic industry struggling to comply, the deadline to register cosmetic products and facilities with the US FDA was extended to 1 July 2024.

Unsurprisingly, many manufacturers still haven’t registered their cosmetic products & manufacturing facilities with the FDA, meaning they are in breach of MoCRA. This could feasibly relate to their confusion regarding the complexity of using the Cosmetic Direct system and the MoCRA cosmetic laws, in general.

Delays could also relate to the requirement to list all products and all ingredients.
It is likely that some manufacturers, especially those with extensive product lines, may have out-of-date SOPs and missing chemical safety sheets.
Other companies may rely on suppliers who lack robust quality systems and ISO 22716 compliance.

Help to Understand MoCRA Cosmetic Registration Requirements in the US

In this article, we will help you make sense of the following MoCRA requirements:

How to register cosmetic products US FDA.

Your responsibility to register your cosmetic products and facilities with the FDA if you manufacture or distribute products in the United States.
The key features of Cosmetic Direct (the registration platform) including links to FDA tutorials on ‘how to register cosmetic products and facilities’.
Guidance for cosmetic manufacturers based outside the US.
How the FDA defines ‘Responsible Person’.

If you need project support to update your quality system documentation or product registration data or need help to respond to an audit finding, please enquire about Regulatory Affairs consulting and/or Technical SOP writing experts at PharmOut. Our Global experts can help you learn to comply with GMP and ISO requirements in many different countries.

Key Provisions of MoCRA

MoCRA was signed into law on December 29, 2022, as part of the Consolidated Appropriations Act in the United States of America (US). MoCRA aimed to modernize the oversight of cosmetic products by the US Food & Drug Administration (FDA). This was necessary because there are so many new (and potentially harmful) cosmetic products entering the market, along with new chemical formulations and banned ingredients still being used by some manufacturers.

MoCRA introduces several key provisions:

Mandatory Facility Registration: Every facility manufacturing or processing cosmetic products for distribution in the U.S. must register with the FDA; facility registration renewals are required on a biennial timeframe.
Registration details: The responsible person’s contact information is required in all cosmetic manufacturing facility and product registrations, as well as a US-based Agent’s contact information if the product or facility is not based in the US.
Product Listings: Manufacturers must list all cosmetic products, including disclosing all of their ingredients, and must keep these listings accurate and up-to-date. These listings need to be updated annually.
Good Manufacturing Practices (GMP): Facilities must adhere to GMP guidelines to ensure product safety; the FDA can inspect facilities and records to ensure compliance, just as they do with pharmaceutical and medical device manufacturers.
Adverse Event Reporting: Manufacturers must report to the FDA (within 15 days) any adverse events/adverse reactions to their cosmetic products.
Mandatory Recalls: The FDA now has the authority to enforce recalls of cosmetic products found to be potentially harmful to consumers or the broader public.
Updates: Manufacturers must update product listings and registrations if there are any changes or product discontinuations, etc.; these updates must be completed in the registration portal (Cosmetic Direct) within 60 days of any changes.

Are there any exemptions to complying with MoCRA?

Do you need to register cosmetics with the FDA?

If you manufacture OR distribute cosmetics in the US consumer market, the answer is ‘YES’.

Small Business Exemptions: Small businesses with average gross annual sales under $1 million may qualify for exemptions, provided they do not manufacture certain high-risk products.
To review high-risk cosmetic product types and MoCRA compliance guidance for small businesses, click here.
Some businesses that distribute products as part of their services, such as hotels, hospitals and beauty shops, are also exempt from registering as a facility (the business type exemption list is in the Resources section towards the end of this article).

Did you miss the MoCRA facility registration/product listing deadline?

Cosmetic manufacturers/distributors selling products to US consumers were expected to comply with MoCRA registration requirements by 1 July 2024.
Cosmetic Direct is the FDA’s electronic portal for cosmetic facility data and cosmetic product registrations; it is also used for adverse event reporting, ingredient and registration updates, and biennial registration renewals.

Although the FDA deadline for registration has come and gone, many Cosmetic Manufacturers and Distributors selling their products in the United States market, including Australian cosmetic companies, have not yet registered their cosmetic products and cosmetic facilities in Cosmetic Direct.

You must register your cosmetic products urgently.

To improve your compliance, train your team members, update your quality system or expand your manufacturing and distribution capabilities including global markets, contact the GMP compliance & life science/validation experts at PharmOut. We can also help you create or create or update GMP quality system documents and SOPs.

To learn more about the other regulations and standards that apply to manufacturers and exporters of cosmetic products, consider our online regulatory compliance training courses for your personnel. There are over 70 GMP eLearning courses including a course on Cosmetic Product regulations (e.g., ISO 27716 and MoCRA), suitable for a global audience.

Register your Cosmetic Products & Cosmetic Facilities (or US Agents) with the FDA

MoCRA requires the ‘responsible person’ to register their cosmetic manufacturing facility and cosmetic product(s) with the FDA if selling or distributing cosmetic products in the United States (US).

Do I need to register ‘free samples’ of cosmetic products with the FDA?

Yes, even ‘free cosmetic samples’ must be registered with the FDA via Cosmetic Direct.
An exception may apply if such samples are being used solely for research purposes.

If you’re not sure your product is considered a ‘cosmetic’ by the FDA, scroll down to the Cosmetic Product Definition.

How to Register Cosmetic Products & Cosmetic Facilities via Cosmetic Direct

Facilities Registrations:

Follow the FDA instructions (and helpful hints provided below) to register your cosmetic manufacturing facility/facilities.
You must also list a US-based Agent if your cosmetic manufacturing facility is located outside of the United States.
Facility Registrations must be renewed biennially.

Product registrations (product listings):

All of your cosmetic products must be registered with the FDA.
These products are cross-linked in the system to your Facility registration data.
The Cosmetic Direct User Guide contains detailed instructions, which you should read after finishing this article.

Requirements for Cosmetic Product listings in Cosmetic Direct:

Detailed Ingredient Disclosure: All ingredients, including fragrances and colours, must be listed.
Use of FDA’s Submission Portal: Listings must be submitted electronically via Cosmetics Direct.
Annual Updates: Product listings must be updated annually OR whenever there is a significant change to the product.

Are you in breach of MoCRA registration requirements?

Failure to meet MoCRA requirements including registering your cosmetic manufacturing facilities/agents and cosmetic products being made, sold or distributed in the United States:

Is in breach of the US FD&C legislation.
May lead to serious consequences such as losing access to the US cosmetic market.

Why is protecting exports of cosmetic products from Australia to the United States so important?

Cosmetic Market Worth (Global Statistics)

The global cosmetic industry is expected to be worth $108.4 billion USD in 2024 and is expected to reach a value of $131.86 billion USD by 2029.
The global cosmetic market CAGR is estimated to be ~9.8%.
The Asia-Pacific region is seeing notable cosmetic industry growth rates, including China and India.

US Cosmetic Market CAGR (Growth Statistics)

The United States (as a region) is currently the world’s largest cosmetic market.
The US Cosmetics Market is currently valued at USD $20.13 billion (up to $24 billion).
The US Cosmetic Market has a ~3.85% CAGR (2024-2020).
The combined personal care services and cosmetics sector in the US is currently valued at over $94 billion USD and will soon approach $100 billion USD.

Sources: Statista, OEC reports, other reports

Protecting Australia’s Cosmetic Products Export Market

Australian exports of cosmetic products to the United States market represent a thriving industry. This success should not be jeopardised by manufacturers failing to comply with the facility and product registration requirements outlined in MoCRA and FDA guidance publications.

Australia Cosmetic Exports (Trends)

Beauty Product Exports, Australia

Australia’s cosmetic product /beauty product exports total around $464 million and are growing.

China and New Zealand are Australia’s largest export markets for cosmetics produced in Australia.
There has been a slight decline in exports of cosmetics/beauty products from Australia to New Zealand.

While exporting cosmetics to the US is considerable, we import cosmetics from the United States at 10 times the amount we export ($358M imported cosmetics vs $35M exports of cosmetic products).

Value of Cosmetic Exports from Australia to the United States

Australia exports around $35 million of cosmetic products to the United States.
This cosmetic product export trend to the US market has recently experienced a slight decline.
Further declines in exports could occur if cosmetic manufacturing companies fail to register their facilities and cosmetic products with the FDA in line with MoCRA requirements.

FDA MoCRA Compliance

If you missed the cosmetic product registration deadline, be sure you register your Cosmetic Facilities and Cosmetic Products using the FDA’s electronic system (Cosmetic Direct).

Snapshot of MoCRA Compliance

How do foreign manufacturers comply with MoCRA? They must register their facilities and appoint a US-based agent.

What is the timeline for mandatory registration compliance? Facilities were expected to register by 1 July 2024. Products marketed after 1 July 2024, are to be registered/listed within 120 days of entering the market.

Can small businesses opt out of mandatory registration? Yes, if they meet specific criteria and do not manufacture high-risk products.

What is the role of a responsible person? The Responsible Person ensures compliance with registration, listing, and adverse event reporting requirements.

Are free samples subject to product listing requirements? Yes, unless used exclusively for research and development.

FAQs: Cosmetic Facility Registration and Cosmetic Product Listing Requirements (US FDA)

Detailed summary of FDA MoCRA compliance requirements (FD&C Act).

FAQ 1: What section of the FD&C Act is relevant to MoCRA’s cosmetic product and facility registration requirements?

Section 607[a] of the FD&C Act requires every person that owns or operates a facility that engages in the “manufacturing or processing of a cosmetic product for distribution in the United States” to register each facility with FDA.
Section 607[c] of the FD&C Act requires that for each cosmetic product, the responsible person must submit to FDA “a cosmetic product listing.”

FAQ 2: What is Cosmetics Direct in the United States (FDA)?

Cosmetic Direct is the online platform where the responsible person (of a cosmetic product manufacturer or distributor) can make Electronic Submissions to the US Food & Drug Administration (US FDA).
It is used for registering or renewing cosmetic facilities and cosmetic products; submitting reports on adverse events, product changes and/or market withdrawals according to FDA timeframes, and for uploading/sharing other information and regulatory compliance activities.
The Cosmetic Direct portal allows users (responsible persons) to enter and save data prior to submission; the platform then performs evaluations/validation of the saved data prior to the responsible person being able to click ‘Submit’.

FAQ 3: Which do you register first, your facility or the product?

A cosmetic product listing must include the facility registration number of each facility where the cosmetic product is manufactured or processed.
It is important to register the cosmetic manufacturing facility first (and the US-based Agent, for foreign manufacturers) before listing a cosmetic product in the FDA’s Cosmetic Direct portal; these are two distinct activities within Cosmetic Direct.

FAQ 4: What are key features of the Cosmetics Direct portal?

Cosmetics Direct is a Structured Product Labeling (SPL) authoring tool meaning it:
Contains user-friendly data entry forms,
Is used to create and save draft SPL submissions,
Performs initial validations of the entered data and data formats (which prevents missing data and ensures data is captured in a structured format),
Submits the SPL (product and facility information) to the FDA for internal processing without having to use the Electronic Submissions Gateway (ESG).

FAQ 5: What is meant by ‘SPL’ (Structured Product Labeling)?

The primary purpose of an SPL is to collect and manage data in a structured, well-organised manner.

SPL (Structured Product Labeling) definition: SPL is a standardized document format developed by Health Level Seven (HL7) to exchange product and facility-related information. The FDA has required electronic submissions in XML format compliant with the SPL standard since 2005.
SPL Purpose: It establishes a consistent framework for regulatory guidance and product labelling content exchange, ensuring control over essential product information. In other words, An SPL requires registrants to use a consistent structure and standard terminology when submitting product labels to the FDA.
SPL Benefits: The standard improves patient safety and product usability by providing consistent structure and terminology, enhancing the accuracy and reliability of product information. SPL is crucial for a well-structured, usable dataset (database), providing improved data analysis and trend evaluations.

FAQ 6: Which person or entity is responsible for entering and updating/renewing facility and cosmetic product registrations into Cosmetic Direct?

A responsible person must list each marketed cosmetic product with the FDA, including product ingredients, and provide any updates annually.
The name and contact details of the responsible must be included in the registrations and product listings.
If the manufacturer is overseas (not in the US), they must also enter the information of their Agent (who must be in the United States).

FAQ 7: What is the FDA definition of a ‘responsible person’?

Responsible Person Designation

Per MoCRA, a “Responsible Person” is defined as the manufacturer, packer, or distributor listed on the product’s label.
The “Responsible Person” must:
- Ensure facility registration and product listings are complete.
- Report adverse events to the FDA within 15 business days.
- Maintain records demonstrating product safety.
This designation provides a single point of accountability, streamlining communication with the FDA.

FAQ 8: How often do I have to update cosmetic product listings and facility registrations?

Cosmetic Product Listings & Facility Registrations: Renewals, Updates

Facility Registration: Cosmetic product manufacturers and processors must register their facilities with the FDA (the deadline was 1 July 2024).
Updates to listings: Registrations and product listings must be updated to reflect any changes to their registration information within 60 days of any changes.
Cosmetic Registration renewals: Facility registrations must be renewed every two years (biennially); cosmetic/beauty product listings should be updated within 60 days of changes or otherwise renewed annually.
Abbreviated renewals: There is an abbreviated renewal option for listings (affirming no changes have occurred since the original registration or latest update).
Relisting formerly discontinued products: Cosmetic Direct allows for the relisting of discontinued products brought back into the US market.
Adverse event reports: Adverse event reports must be filed within 15 days.

FAQ 9: Is registering or listing a cosmetic in the US still voluntary or is it mandated?

As of MoCRA, registering your facility and cosmetic products is mandatory.
Registration requires adding a US-based Agent’s contact information if your facility is based outside of the United States.
Possible exemptions exist for small businesses that manufacture or distribute only low-risk cosmetic products.

FAQ 10: Why was the VCRP replaced by more stringent regulations?

The Voluntary Cosmetic Registration Program (VCRP) was established to help the FDA monitor cosmetic products and their manufacturing facilities. As a mechanism for the FDA to track and assess cosmetic safety trends, it simply wasn’t adequate. With the VCRP, participation was encouraged but not legally required. This meant the FDA had limited insight into the cosmetic industry, due to low participation rates.

Key weaknesses of the VCRP included:

Low Participation: Many small businesses and international manufacturers did not participate, leaving gaps in the FDA’s data and making the VCRP ineffective as a safety monitoring tool.
Limited Authority: The FDA previously had limited compliance oversight, relying on manufacturers’ goodwill.
Insufficient Safety Information: Without a complete picture of the cosmetic product industry and product safety trends, assessing potential risks to public health was challenging.

MoCRA, in contrast to VCRP, gives the FDA clearer and more robust oversight authority over the cosmetic industry within the United States, including products being imported to the US from foreign manufacturers. These new cosmetic industry laws mandate that manufacturers register products including all ingredients, and their facilities and US agents. These laws also require compliance with Good Manufacturing Practice (GMP) to ensure cosmetic products do not harm consumers and the environment.

Resources & Article Summary

Resources for Cosmetic Manufacturers & Beauty Product Distributors

Whether you’re a small business or an established manufacturer, understanding how to register your cosmetic products and facilities with the FDA, via the Cosmetic Direct portal, is essential to maintaining compliance and avoiding penalties.

Links to FDA resources and Cosmetic Direct Tutorials.

Cosmetics Direct
Download the User’s Guide (92 pages)
Cosmetics Direct – Facility Registration Tutorial (April 2024)
Cosmetics Direct – Product Listing Tutorial (April 2024)

Cosmetic Product Definition (FDA):

FDA Excerpt: “The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines cosmetics as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body…for cleansing, beautifying, promoting attractiveness, or altering the appearance” [FD&C Act, sec. 201(i)]. Among the products included in this definition are skin moisturizers, perfumes, lipsticks, fingernail polishes, makeup, cleansing shampoos, permanent waves, hair colors, and deodorants, as well as any substance intended for use as a component of a cosmetic product. [FD&C Act, sec. 201(i)]. Among the products included in this definition are skin moisturizers, perfumes, lipsticks, fingernail polishes, makeup, cleansing shampoos, permanent waves, hair colours, and deodorants, as well as any substance intended for use as a component of a cosmetic product.” Tattoo inks are considered to be ‘cosmetic products’ by the FDA, and manufacturers should keep abreast of recent developments regarding tattoo ink safety and pending regulatory changes.

How does the FDA regulate “cosmeceuticals”?

FDA Excerpt: “The FD&C Act does not recognise any such category as “cosmeceuticals.” A product can be a drug, a cosmetic, or a combination of both, but the term “cosmeceutical” has no meaning under the law.”

Exemptions from MoCRA Requirements to Register their Facilities

FDA Excerpt: The following types of facilities, which often distribute cosmetics or personal care products, are exempt from registering their facilities on the Cosmetic Direct platform.

Service-based establishments:
- Beauty shops and salons (unless manufacturing or processing cosmetics on-site).
- Entities like hotels and airlines offering complimentary products as part of their services.
Retailers and distributors:
- Cosmetic product retailers, direct sellers, retail distribution facilities, and pharmacies (unless manufacturing or processing non-direct-to-consumer cosmetics).
Healthcare and public services:
- Hospitals, physicians’ offices, healthcare clinics, public health agencies, and nonprofits providing products directly to consumers.
Non-commercial or sample-based operations:
- Trade shows and other venues distributing free samples.
- Establishments manufacturing cosmetics solely for research, evaluation, or production testing (not for retail).
Specific operations:
- Establishments solely performing labeling, relabeling, packaging, repackaging, holding, or distributing (excluding filling containers).
Small businesses:
- Facilities with average gross annual cosmetic sales in the U.S. under $1,000,000 (adjusted for inflation) and not engaged in certain types of manufacturing or processing.

SPL Coding, new SPL Guidance

Implementing SLP and Validation Protocols (US FDA Cosmetic Facility Registrations and Cosmetic Product Listings)

The FDA’s December 2023 guidance for implementing SPL included validation protocols for cosmetic product facility registrations and product listings.
This updated SPL guidance is not limited to just cosmetics; and includes sections covering drugs, biologics, and medical devices as well.
This is a highly technical document reviewing the line-by-line coding required for this SPL framework.
Click here to read a US FDA media release covering SPLs.