The U.S. Food and Drug Administration (FDA) has significantly expanded its oversight of cosmetics manufacturing, with a new registration system now tracking over 16,000 active cosmetic facilities and 1.3 million product listings. This represents a major shift in how the agency monitors the safety of makeup, skincare, and other beauty products that millions of Americans use daily. The changes stem from the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), the most significant expansion of FDA authority over cosmetics since 1938.

What Changed in FDA Cosmetics Regulation?

For decades, cosmetics manufacturers operated under relatively loose FDA oversight compared to pharmaceutical companies. MoCRA changed that by requiring every cosmetic facility to register with the FDA and renew that registration every two years. The agency recently announced updates to its Cosmetics Direct electronic submission portal to streamline this process, introducing new fields that display registration status and renewal dates for each facility.

This biennial renewal requirement means manufacturers must keep their facility information current or face potential consequences. If the FDA determines that a cosmetic product from a registered facility poses a reasonable risk of serious harm or death, the agency now has the authority to suspend that facility's registration entirely, preventing it from distributing any products in the United States.

How Does the New Registration System Work?

The FDA has created a streamlined process for manufacturers to register and renew their cosmetics facilities. Facilities can submit their information electronically through Cosmetics Direct, which uses Structured Product Labeling (SPL), a standardized format that ensures consistent product information across submissions. The system performs automatic validations and sends email reminders to facility contacts before renewal dates arrive.

Manufacturers have two renewal options when their registration comes due. They can file a full biennial renewal if their facility information has changed, or they can submit an abbreviated renewal if nothing has been updated since their last submission. This flexibility is designed to reduce unnecessary paperwork while maintaining safety oversight.

• Renewal Timeline: Facilities must renew every two years from their initial registration date. For example, a facility that registered on February 20, 2024, would need to renew by February 20, 2026.
• Early Renewal Option: Manufacturers can renew earlier than the two-year mark if they prefer to align their cosmetics registration with other FDA submissions, such as drug establishment registrations.
• Electronic Submission Encouraged: The FDA strongly encourages electronic submissions through Cosmetics Direct rather than paper forms, as this speeds up data processing and ensures more accurate record-keeping.
• Product Listing Requirements: In addition to facility registration, responsible persons (manufacturers, packers, or distributors) must list each marketed cosmetic product with the FDA, including all ingredients, and provide updates annually.

Who Must Register and Who Gets an Exemption?

MoCRA does exempt certain small businesses from facility registration and product listing requirements. However, these exemptions do not apply to manufacturers of products that regularly contact the eye's mucous membranes, injected products, products for internal use, or products designed to alter appearance for more than 24 hours without removal by the consumer. This means that even small companies making eye makeup, lip products, or long-wear foundations must register with the FDA.

As of June 30, 2026, the FDA's database shows 16,398 unique, active cosmetic product facilities registered under MoCRA, with 1,298,361 unique, active product listings. This comprehensive tracking system gives the agency unprecedented visibility into what products are being manufactured and where, enabling faster response to safety concerns.

What This Means for Consumers

The expanded registration and renewal system represents a significant step forward in cosmetics safety oversight. Previously, the FDA had limited authority to inspect facilities or require manufacturers to disclose safety testing. Under MoCRA, the agency can now suspend facilities that fail to maintain safe manufacturing practices, and it has clearer authority to remove dangerous products from the market.

For consumers, this means the makeup and skincare products on store shelves are now subject to more rigorous tracking and accountability. If a product causes harm, the FDA can trace it back to its manufacturing facility and take swift action. The biennial renewal requirement also ensures that facility information stays current, reducing the risk that unsafe or contaminated products slip through the system.

The FDA emphasizes that cosmetics registration and product listing is not an approval program or promotional tool. The agency does not issue certificates for cosmetic registrations, and listing a product does not mean the FDA has verified its safety or efficacy. Instead, the system creates a transparent record that allows the agency to monitor trends, investigate complaints, and take enforcement action when necessary.

Steps to Verify Your Cosmetics Are Registered

• Check the FDA Database: Consumers can search the FDA's cosmetics registration database to verify that products they use are from registered facilities. This transparency allows you to confirm that manufacturers are following federal requirements.
• Review Product Labels: Look for the responsible person's name and address on product labels. This is the manufacturer, packer, or distributor accountable for the product's safety and compliance with FDA regulations.
• Report Safety Concerns: If you experience an adverse reaction to a cosmetic product, report it to the FDA through its MedWatch program. These reports help the agency identify patterns and take action against unsafe products.
• Stay Informed About Recalls: Monitor the FDA's cosmetics enforcement reports and recall announcements. The agency publishes updates on products that have been removed from the market due to safety concerns.

The Modernization of Cosmetics Regulation Act represents a watershed moment for cosmetics safety in the United States. With over 16,000 facilities now registered and required to renew every two years, the FDA has built a system that brings much-needed transparency and accountability to an industry that touches the faces and bodies of millions of Americans daily. As this system matures and the FDA gains more experience with enforcement, consumers can expect stronger protections against unsafe ingredients and contaminated products.