In the United States, cosmetic products and ingredients don’t need any pre-market approval. However, authorities may crack down on products on the market that are noncompliant with applicable laws. They can take action against the products, firms, or individuals violating the law. This makes knowing FDA cosmetic regulations quite important.
This guide explains these regulations and the cosmetic facility registration and product listing process in the USA. This guide also covers requirements for classification, ingredients, labeling, imports, GMP, safety, and post-market compliance.
Cosmetics Regulatory Authority in the USA
The US Food and Drug Administration (FDA) regulates cosmetics sold in the USA. It enforces the Federal Food, Drug, and Cosmetic Act, the Fair Packaging and Labeling Act, and the Modernization of Cosmetics Regulation Act (MoCRA) for these products.
Is FDA Approval for Cosmetics Required?
No. Cosmetics do not need approval from the US Food and Drug Administration before they are sold/marketed, except for some color additives.
There are some things to consider, like the following:
- Certain color additives must be approved for their intended use, and some must also undergo FDA batch certification.
- Claims that cause a cosmetic to meet the drug definition can subject the product to drug requirements.
- Imported cosmetics are subject to the same FDA requirements as domestically manufactured cosmetics.
- Companies should not represent their cosmetics as “FDA approved” merely because they have completed facility registration or product listing. FDA states that cosmetic facility registration and product listing are not an FDA approval program.
MoCRA Requirements
The cosmetic market requirements have increased since MoCRA came into the picture. All facilities are required to be registered and renewed every 2 years, except certain small businesses that are exempted. All cosmetic products must be listed and updated on an annual basis. Safety substantiation records need maintenance. Serious adverse events need reporting within 15 business days. The label must have mandatory adverse event contact information. Authorities can mandate recalls and access records under specified conditions.
FDA Guidelines
FDA does not approve cosmetics prior to sale, except for some color additives. So, cosmetics manufacturers are obliged to make products safe when used as intended, well-labeled, not misleading, compliant with banned and restricted ingredient standards, and supported with sufficient safety substantiation records.
Imported cosmetics must meet the same FDA standards as domestic cosmetics.
US FDA Cosmetics Classification
Cosmetics are classified by the FDA according to their intended use and claims. These products help cleanse, beautify, promote attractiveness, or alter appearance.
They can be rubbed, poured, sprinkled over, sprayed on, or introduced into or applied onto the human body. It covers the following:
- Skin moisturizers
- Perfumes
- Fingernail polishes
- Lipsticks
- Cleansing shampoos
- Eye/facial makeup
- Deodorants
- Permanent waves
- Other products to be used as cosmetics
Products that treat diseases or alter the structure or function of the body can be regulated as drugs or medical devices. A cosmetic claiming to treat acne, protect skin from the sun, reduce wrinkles, help hair grow, or repair skin might be regulated as a drug.
Some products can be both cosmetics and drugs, like shampoos that prevent dandruff or moisturizers having SPF. Soaps are not cosmetics. Some other “personal care products” may also come under dietary supplements or consumer product regulations.
If companies don’t classify cosmetics properly, authorities may issue warning letters, import detentions, relabeling expenses, or commercialization delays.
FDA Cosmetic Facility Registration & Product Listing Process in the USA
Ensuring compliance requires following the steps mentioned below:
Step 1: Classify the Product
Make sure the product is a cosmetic and not a drug by definition, its intended use, and claims.
Step 2: Check Ingredient and Formula Compliance
Look after compliance with prohibited ingredients, restricted substances, and color additives.
Step 3: Take Care of Labeling and Safety Documentation
Keep labels in compliance with FDA requirements and maintain updated safety substantiation records. Although there’s no specific testing regimen for cosmetics, MoCRA requires the responsible person to maintain proper safety-substantiation documents.
Step 4: Get an FDA Establishment Identifier (FEI)
The FEI must be obtained prior to facility registration by manufacturers and processors.
Step 5: Register the Cosmetic Facility with the FDA
Facility registration is submitted via Cosmetics Direct, the Electronic Submission Gateway using SPL, or the applicable paper submission process.
Step 6: Submit Cosmetic Product Listing
The responsible person must list each marketed cosmetic product with the FDA, including the product’s ingredients, and provide required updates annually.
Step 7: Ensure Continued Compliance
Update registration within 60 days of changes. Renew facility registration every 2 years. Update product listings annually. Maintain adverse event and safety-substantiation records. Report serious adverse events within 15 business days. Cosmetic registrations and listings are not approved by the FDA.
Documents Required for Cosmetic Compliance in the USA
Here is the list of documents that cosmetic companies should maintain to show compliance:
Facility Registration Information
Facility registration information depends on the submission and includes the following:
- FDA Establishment Identifier (FEI)
- Name and address of the facility
- Facility contact information
- Owner/operator information
- Information regarding agents in the USA (for foreign facilities)
- Applicable brand name information
Cosmetic Product Listing Information
The responsible person must provide information required for the product listing, including the following:
- Responsible Person details
- Product name & applicable product information
- Ingredient information
- Product label information
- Facility information
- Contact information for adverse events
Supporting Compliance Documentation
Companies should also maintain appropriate records supporting the following:
- Safety substantiation records
- Ingredient and formulation records
- Labeling and artwork files
- Complaint and adverse event procedures
Cosmetics Labeling Requirements in the USA
Cosmetic labels must comply with FDA labeling requirements and must not be false or misleading.
Principal Display Panel Requirements
The principal display panel must include an appropriate identity statement indicating the nature or use of the product and an accurate net quantity of contents statement.
Information Panel Requirements
The label must include the manufacturer, packer, or distributor name and address, distributor statement (if applicable), and ingredients listed in order of predominance.
Additional Requirements
Applicable products must also carry required warnings and caution statements. MoCRA additionally requires the responsible person to provide a domestic address, domestic phone number, or electronic contact information through which adverse-event reports can be received on the label.
If the label or labeling contains representations in a foreign language, required label information must also appear in that language.
Ingredient Regulations and Safety Requirements in the USA
Cosmetics manufacturers are responsible for ensuring that cosmetics sold in the US are safe and compliant.
Key requirements include the following:
- Meeting requirements for prohibited and restricted ingredients
- Use of approved color additives for intended use
- FDA certification for certain color additives
- Appropriate safety substantiation records according to MoCRA
FDA does not require specific cosmetic testing procedures, but responsible persons are required to keep records supporting product safety.
Cosmetic Import Requirements in the USA
Imported cosmetics are subject to the same FDA regulations and laws as domestic cosmetics.
Key import requirements include the following:
- Compliance with FD&C Act, FPLA, and MoCRA requirements
- Registration of foreign facilities subject to MoCRA’s requirements
- Cosmetic product listing by the Responsible Person
- Labeling-requirements compliance
- Compliance with ingredient and color additive requirements
For a foreign facility, FDA’s Cosmetics Direct registration materials require U.S. agent information as part of the facility registration submission. The FDA can refuse entry or detain products that are not compliant with cosmetic regulations.
FDA Cosmetic GMP Requirements
MoCRA requires the FDA to establish Good Manufacturing Practice (GMP) requirements for cosmetic manufacturing and processing facilities. The FDA has issued draft guidance describing its current thinking on cosmetic GMPs and has considered ISO 22716 in developing the guidance. However, FDA guidance is nonbinding unless specific regulatory or statutory requirements are cited.
Product Safety & Post-Market Surveillance
Cosmetic companies are responsible for the safety of products marketed in the US, adequate labeling, and maintaining safety substantiation records.
Key requirements include safety substantiation under MoCRA, tracking complaints and adverse events, reporting serious adverse events within 15 business days, providing required information and records to the FDA under applicable MoCRA authorities, and complying with FDA’s mandatory recall authority where applicable.
FDA does not require specific cosmetic testing procedures, but responsible persons are required to maintain records supporting product safety.
Timeline & Fees for Cosmetic Compliance in the USA
FDA does not publish a general approval timeline for cosmetic facility registration or product listing because these submissions are not premarket approval applications. Submission timing depends on the information required, preparation of the filing, and the submission method. FDA currently encourages electronic submission through Cosmetics Direct and other electronic mechanisms.
At this time, the FDA does not impose official government fees on cosmetic facility registration, product listing, biennial facility renewals, and annual product listing updates.
Businesses can, however, face expenses for FEI preparation, US agent support, safety substantiation and testing, labeling review, GMP implementation, regulatory consulting, and submission support.
Conclusion
The implementation of MoCRA has strengthened the regulatory framework for cosmetics in the United States. Companies subject to its requirements must address facility registration, cosmetic product listing, safety substantiation, serious adverse event reporting, and other applicable compliance obligations.
Successful US market entry also requires attention to product classification, ingredient and color additive requirements, labeling, documentation, and post-market responsibilities.
Artixio provides regulatory support to cosmetic companies seeking to meet applicable US FDA requirements. For more information, contact us at info@artixio.com.
FAQs
1. Does the FDA approve cosmetic products before they are sold in the USA?
No. FDA generally does not preapprove cosmetic products or their ingredients before they are marketed, except for certain color additives. Cosmetic companies are responsible for ensuring that their products are safe and properly labeled. Facility registration and product listing under MoCRA also do not constitute FDA approval.
2. What is the difference between cosmetic facility registration and product listing?
Facility registration applies to a cosmetic product manufacturing or processing facility subject to MoCRA, while product listing is submitted by the responsible person for each marketed cosmetic product. Facility registrations must generally be renewed every two years, while product listings require annual updates.
3. Are small cosmetic businesses exempt from FDA registration and product listing?
Some small businesses are exempt from MoCRA’s facility registration and product-listing requirements, subject to the statutory conditions and exceptions. The exemption does not apply to certain categories of cosmetics, including products that regularly contact the eye’s mucous membrane, are injected, are intended for internal use, or are intended to alter appearance for more than 24 hours under customary conditions of use without consumer removal.
