If the July 1, 2024 deadline for compliance with the FDA’s new cosmetic regulations slipped past you, don’t worry—it’s not too late to take action. Under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), companies still have the opportunity to submit late registrations and product listings to align with these groundbreaking requirements. Staying proactive can help avoid potential penalties and keep your business on track.
MoCRA has completely transformed cosmetic regulation in the U.S., creating a framework that prioritizes consumer safety and industry accountability. Even if you missed the deadline, there’s no better time than now to step into compliance. Here’s everything you need to know to catch up.
Who Needs to Act Now?
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Cosmetic Facilities: Facilities that manufacture or process cosmetic products distributed in the U.S. must register with the FDA every two years. This includes establishments involved in production, quality control, and testing.
Excluded entities:
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Retailers, salons, and healthcare facilities offering cosmetics incidentally.
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Nonprofits or agencies distributing cosmetics directly to consumers.
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Businesses limited to labeling, repackaging, or distributing (with narrow exceptions).
Unsure if your business qualifies? Use the FDA’s Decision Tool to verify if registration is necessary.
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Product Manufacturers: If your product is on the U.S. market, it must be listed with the FDA, including all ingredient information. The company listed on the product label (referred to as the “Responsible Person”) is responsible for ensuring compliance.
Why Late Compliance Still Matters
Even though the deadline has passed, late submissions are still accepted by the FDA. Acting now can help you:
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Avoid regulatory fines or enforcement actions.
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Protect your brand reputation.
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Gain consumer trust by demonstrating compliance with safety regulations.
Exemptions That May Apply
Certain small businesses are exempt from facility registration and product listing requirements. To qualify, your cosmetic sales in the U.S. must average less than $1 million annually over the past three years. However, the exemption does not apply if your products:
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Are injected or used internally.
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Contact mucous membranes, such as eye products.
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Alter appearance for over 24 hours without easy removal.
What You Need to Do
Facility Registration:
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Submit your registration as soon as possible if you manufacture or process cosmetics in the U.S. New facilities must register within 60 days of operation.
Product Listing:
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Provide a complete list of marketed products, including detailed ingredient information. Update the listings annually to reflect changes.
Submitting Your Application:
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Use the FDA’s Cosmetics Direct portal for efficient electronic submissions.
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Alternatively, use paper forms (Form FDA 5066 for facility registration and Form FDA 5067 for product listing).
Tips for a Smooth Compliance Process
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Prepare Your Documents: Gather all necessary information about your facility and products, including an FDA Establishment Identifier (FEI) number for facility registration.
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Avoid Further Delays: Start the submission process immediately to reduce the risk of enforcement actions.
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Seek Professional Help: Navigating MoCRA requirements can be complex. Professional guidance ensures your submission meets all regulatory standards.
Why Work With GegaHelix Consulting?
At GegaHelix Consulting, we understand the stress of regulatory compliance. Our team specializes in helping cosmetic businesses like yours get back on track with MoCRA requirements. Whether you missed the deadline or need assistance ensuring your submission is flawless, we’re here to guide you every step of the way.
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Tailored compliance strategies for your unique business needs.
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Expertise in FDA submissions, facility registration, and product listings.
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Proactive support to minimize disruptions to your operations.
The FDA is still accepting late submissions—but time is of the essence. Contact us today to take the first step toward compliance and protect your business’s future.