FDA Q2 2025 Cosmetic Product Facility Registration & MoCRA Listing Data Reveal 681,831 Products | Market Impact on U.S. Cosmetic Surgery Products & Medical Aesthetics Industry

Published on April 29, 2025 | Data as of March 31, 2025

FDA Cosmetic Product Facility Registration & Product Listing Data | Q2 2025 Update

The U.S. Food and Drug Administration (FDA) has released new summary data for the second quarter regarding the mandatory registration of cosmetic product facilities and the listing of cosmetic products under the Modernization of Cosmetics Regulation Act (MoCRA) of 2022. This updated data provides key insights into the progress made by manufacturers and processors in complying with MoCRA requirements.

Key Data & Statistics

Total Number of Unique, Active Cosmetic Product Facilities Registered: 10,820

Total Number of Unique, Active Cosmetic Products Listed: 681,831

These figures reflect the ongoing implementation of MoCRA, which mandates that all manufacturers and processors of cosmetic products intended for distribution in the United States must register their facilities with the FDA and renew their registrations every two years. Furthermore, a responsible person must list each marketed cosmetic product with the FDA, including detailed product ingredients and updates provided annually.

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MoCRA Key Requirements

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) established critical regulatory changes to enhance consumer safety and improve transparency in the cosmetic industry. Here are the essential requirements under the act:

Facility Registration:

All manufacturers and processors of cosmetic products for distribution in the United States must register their facilities with the FDA.

Facility registration must be renewed every two years.

Failure to comply with registration requirements can result in suspension of a facility's registration if the FDA determines the products manufactured or processed at that facility pose a significant risk to consumer health.

Cosmetic Product Listing:

A responsible person-typically the manufacturer, packer, or distributor-must list each marketed cosmetic product with the FDA. This includes detailed information on product ingredients and any updates to the product's formulation.

The product listing must be updated annually.

There are certain exemptions, such as for small businesses and for products or facilities that fall under drug or device regulations.

Exemptions to Registration & Listing Requirements

MoCRA does provide some exemptions to these requirements:

Small Businesses: Certain small businesses may be exempt from registering their facilities or listing their products, subject to specific criteria set by the FDA.

Specialty Products: Products that are regularly intended to come into contact with the mucus membranes of the eye, injected products, or those intended for internal use, are excluded from some of the general requirements.

Drugs and Devices: Facilities and products that are already regulated as drugs or medical devices may not be subject to MoCRA's registration and listing requirements, provided they meet the applicable regulations for those product categories.

Compliance Tools & Resources

The FDA provides several tools and resources to assist companies with facility registration and product listing:

Cosmetics Direct: This is the FDA's official Structured Product Labeling (SPL) authoring tool for cosmetic product facility registration and product listing. The tool helps users create, validate, and submit SPL files electronically.

Electronic Submission Gateway (ESG): The FDA accepts online submissions via the ESG platform. Companies must apply for an account to submit their data electronically. It is recommended to start the registration process early, as account creation may take several weeks.

SPL Xforms: For creating SPL files for product listings, this tool provides a structured approach to submitting information about cosmetic products.

Enforcement & Compliance Timeline

The FDA has provided a compliance timeline for the cosmetic industry:

Enforcement Delay: The FDA has issued a delay in enforcing certain provisions of MoCRA. Companies have until July 1, 2024, to comply with the registration and listing requirements, even though the statutory deadline for compliance was December 29, 2023.

New Facilities & Products: Facilities that begin manufacturing or processing cosmetic products after December 29, 2022, and products first marketed after this date are given a grace period. These new entities must comply by July 1, 2024.

Historical Data Comparison

To illustrate the growth and progress made under MoCRA, here is a comparison with the Voluntary Cosmetic Registration Program (VCRP), which was phased out in March 2023:

The statistics show a significant increase in both facility registrations and product listings, reflecting the growing adoption of MoCRA's regulatory framework.

The data provided by the FDA as of March 31, 2025, highlights the substantial progress in ensuring the safety, transparency, and compliance of the U.S. cosmetic industry under MoCRA. With the growing number of registered facilities and listed products, manufacturers are aligning with the FDA's regulatory requirements. The extended compliance timeline also provides industry stakeholders with a clear path to meet these requirements, ensuring smoother operations and enhanced consumer safety.

Market Impact and Investment Opportunities in the Growing Cosmetic Surgery and Services Market

Impact of MoCRA and FDA Data on Cosmetic Surgery

The FDA's Q2 2025 update reveals that as of March 31, 2025, there are 10,820 unique, active cosmetic product facilities registered and 681,831 unique, active cosmetic products listed. These figures underscore the implementation of MoCRA, which aims to improve the safety, transparency, and regulation of the cosmetic industry, ultimately enhancing consumer confidence and trust.

While MoCRA primarily targets cosmetic products, the benefits of its enforcement resonate throughout the entire cosmetic surgery and services market. For instance, the registration of facilities ensures that only compliant manufacturing and processing facilities are allowed to operate, directly impacting the products used in surgical and non-surgical cosmetic procedures. FDA-compliant products, such as breast implants, dermal fillers, and other medical devices, are essential for cosmetic surgery providers, making the regulatory environment pivotal to the industry's growth.

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Key Regulatory Insights:

Facility Registration & Product Listing:

All cosmetic product manufacturers and processors are required to register their facilities with the FDA, ensuring compliance with safety standards. This applies to both surgical devices used in procedures and non-invasive cosmetic products.

The obligation for annual product listing updates and detailed ingredient disclosure ensures a higher level of product safety, transparency, and traceability, fostering consumer confidence in the procedures performed with FDA-approved products.

Exemptions and Grace Periods:

Small businesses and certain specialty products may be exempt from full compliance, but the overall trend shows an industry-wide push toward standardization. This benefits both patients and providers by ensuring that products used in surgeries and services meet high safety and efficacy standards.

The July 1, 2024 compliance deadline for new entities marks an important milestone, and companies entering the market before this date will have a clear path to regulatory compliance, offering investment stability in the long term.

Market Drivers for Cosmetic Surgery and Services

Rising Demand for Aesthetic Enhancements: The global demand for cosmetic surgery, driven by increasing disposable income and shifting cultural attitudes, continues to rise. Procedures such as breast augmentation, liposuction, rhinoplasty, and non-surgical treatments (e.g., Botox, dermal fillers) are increasingly common.

Aging Population: As the global population ages, the demand for anti-aging procedures is growing, providing a steady market for both invasive and non-invasive treatments.

Technological Advancements: Innovations such as 3D printing, robotic-assisted surgeries, and AI-driven consultations enhance the precision and safety of procedures, attracting more consumers to invest in cosmetic surgery.

Improved Consumer Education and Safety: As the FDA enforces MoCRA regulations, consumers are becoming more knowledgeable about the safety and quality of the products used in cosmetic surgery. This growing consumer awareness is driving the demand for FDA-compliant treatments and products, leading to higher levels of trust in certified cosmetic surgery providers.

Investment Opportunities in the Cosmetic Surgery and Services Market

Investment in Cosmetic Surgery Clinics and Medical Spas: With an increasing number of consumers seeking cosmetic procedures, investing in cosmetic surgery clinics and medical spas provides an attractive opportunity. These centers offer both surgical and non-surgical services, catering to a wide variety of aesthetic preferences.

Market Opportunity: The global medical spa market is expected to grow at a compound annual growth rate (CAGR) of over 20% in the coming years. Clinics offering non-invasive procedures such as Botox, fillers, and laser treatments are particularly well-positioned for growth, particularly in regions like North America and Europe, where consumer demand for such services is high.

Cosmetic Surgery Products and Device Manufacturers: The demand for FDA-approved products, including breast implants, liposuction equipment, and injectables, is expected to increase significantly due to the regulatory oversight under MoCRA. As the FDA's enforcement ensures higher product safety, manufacturers of these products will see steady demand.

Investment Opportunity: Medical device manufacturers that specialize in FDA-approved aesthetic devices are poised for growth. Companies that manufacture injectables, implants, and non-invasive treatment devices stand to benefit as the market for cosmetic surgeries grows in parallel with regulatory standards that ensure product quality.

Medical Aesthetics Technology Providers: With advancements in artificial intelligence (AI), robotic surgery, and 3D printing in cosmetic surgery, there is a growing market for medtech companies that provide these solutions. These technologies enhance the precision, safety, and overall patient experience during procedures, making them highly attractive investment opportunities.

Market Opportunity: AI-driven platforms that assist with virtual consultations, procedure planning, and post-operative monitoring are becoming increasingly important in the cosmetic surgery field. Additionally, robotic-assisted surgeries are improving precision in procedures, reducing recovery time, and lowering risks, leading to greater adoption by consumers and healthcare providers.

Regulatory Compliance Services and Software Providers: As the cosmetic surgery market becomes more heavily regulated under MoCRA, the demand for compliance-related services is growing. Companies providing regulatory technology (RegTech) solutions and consulting services for cosmetic surgery clinics and product manufacturers will experience increased demand.

Investment Opportunity: Regulatory technology companies that offer compliance management software, tools for FDA registration, and solutions for product labeling and ingredient tracking are positioned for growth. This includes software platforms that help cosmetic surgery providers meet FDA compliance standards, creating a strong market for service providers in this space.

Consumer-Focused Digital Platforms: The trend of online consultations, reviews, and virtual procedure planning is on the rise. Platforms offering digital solutions that connect patients with cosmetic surgery providers for consultations, bookings, and post-surgery care are gaining traction.

Investment Opportunity: Cosmetic surgery booking platforms that provide virtual consultations or online patient reviews are a growing niche. These platforms offer convenient access to services and help patients make informed decisions, increasing market adoption.

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