Your Guide to Cosmetic Facility Requirements

Failing to register your facility with the FDA isn’t just a minor paperwork mistake—it’s a critical error that can halt your entire operation. Under the new MoCRA regulations, non-compliance can get your products refused entry into the U.S. and trigger an FDA registration suspension. Ultimately, it stops you from selling to consumers. Completing your cosmetic facility registration is a non-negotiable part of doing business in the beauty industry. This step protects your brand and maintains market access. Understanding the risks is essential for your business’s survival.

Key Takeaways

Treat Registration as a Requirement, Not a Choice: MoCRA has made cosmetic facility registration mandatory for any business manufacturing or processing products for the U.S. market, replacing the previous voluntary system with a legal obligation.
Organize Your Information Before You File: Avoid common processing delays by gathering all necessary details ahead of time—especially your facility-specific DUNS number, brand names, and product categories—before starting your application in the Cosmetics Direct portal.
Think Beyond the Initial Submission: Compliance doesn’t end once you’re registered. You must renew your facility registration every two years and fulfill ongoing duties like reporting serious adverse events and maintaining detailed safety records.

What Is Cosmetic Facility Registration and Why Does It Matter?

If you own or operate a business that makes or processes cosmetic products, you need to have facility registration on your radar. Simply put, it’s the process of officially notifying the FDA where your cosmetic products are manufactured or handled. Think of it as putting your facility on the FDA’s map. This isn’t a new concept, but it has become much more critical for the industry.

The reason for this shift is the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), a landmark piece of legislation that gives the FDA more authority to regulate cosmetic safety. This is the most significant update to cosmetic laws since 1938, and it transforms facility registration from a voluntary program into a mandatory requirement. For the first time in decades, every company that manufactures or processes cosmetics must register its facilities with the FDA and renew that registration every two years. This change ensures the agency has a clear picture of the industry landscape and can act quickly to protect public health.

The Scale of MoCRA: A Look at the Numbers

To understand just how significant this shift is, consider this: MoCRA is the biggest update to the FDA’s oversight of cosmetics since 1938. For the first time, the agency has mandatory authority to ensure product safety, which includes the power to order recalls. This new law requires every facility that manufactures or processes cosmetics for sale in the U.S. to register with the FDA and renew that registration every two years. The numbers paint a clear picture of this new reality. With initial deadlines passed, the FDA’s portal already reflects over 12,000 compliant facilities. This ongoing cycle means compliance isn’t a one-and-done event. For business owners, staying organized for biennial renewals is key to ensuring your facility remains in good standing.

How MoCRA Is Changing the Game for Cosmetics

Under MoCRA, the old way of doing things is officially over. Previously, companies could participate in the Voluntary Cosmetic Registration Program (VCRP). As the name implies, it was optional. However, MoCRA makes registration a legal obligation for both domestic and foreign facilities. The FDA stopped accepting submissions to the old voluntary program and has rolled out a new electronic portal specifically for these mandatory registrations.

This new framework requires all existing cosmetic facilities to register and to renew their registration every two years. This ensures the FDA’s database remains current and accurate. It’s a fundamental change that moves the cosmetics industry toward greater accountability and transparency, aligning it more closely with other FDA-regulated sectors like food and drugs.

Replacing the Voluntary Cosmetic Registration Program (VCRP)

For years, the cosmetic industry operated under the Voluntary Cosmetic Registration Program (VCRP). The key word there is “voluntary.” Since it wasn’t required, many facilities never registered, leaving the FDA with an incomplete picture of the market. MoCRA has completely changed that dynamic. The VCRP is no more; it has been replaced by a mandatory registration system that applies to every facility manufacturing or processing cosmetics for sale in the United States. This isn’t just a suggestion—it’s a legal requirement designed to give the FDA the oversight it needs to ensure product safety. The agency has even introduced a new electronic portal to handle these required submissions, officially closing the door on the old, optional approach.

Protecting Your Customers and Your Brand Reputation

At its core, this new registration requirement is about safety. By knowing where cosmetic products are made, the FDA can more effectively monitor the industry and respond to potential health risks. But this isn’t just about protecting consumers—it’s also about protecting your brand. Compliance builds trust with your customers and demonstrates your commitment to quality and safety.

MoCRA also gives the FDA significant enforcement power. If the agency determines that a cosmetic product made at a facility has a reasonable probability of causing serious adverse health consequences, it has the authority to suspend that facility’s registration. A suspension means you cannot introduce your products into the market, effectively halting your operations. Staying compliant isn’t just about checking a box; it’s a critical step in safeguarding your business’s reputation and its ability to operate without disruption.

Does Your Cosmetic Facility Need to Register?

With the new regulations from the Modernization of Cosmetics Regulation Act (MoCRA), one of the first questions on every brand owner’s mind is, “Does this apply to me?” The short answer is: probably. The FDA has expanded its oversight, and most cosmetic facilities that manufacture or process products for the U.S. market now need to register. However, there are specific definitions, roles, and even a few exemptions to consider. Let’s walk through who needs to register so you can determine exactly where your business stands.

Are You a “Manufacturer” or “Processor”?

Under MoCRA, the rule is straightforward: any facility that manufactures or processes cosmetic products for sale in the United States must register with the FDA. This includes facilities that create the product from raw materials, combine ingredients, or package the final product. Think of it this way—if your facility is involved in the physical creation or handling of the cosmetic before it’s ready for the consumer, you almost certainly fall into this category. The goal is to give the FDA a clear picture of where cosmetics are being made, ensuring they can act quickly if any safety issues arise.

What If You’re a Contract Manufacturer or Private Labeler?

Many cosmetic brands don’t own their production facilities. If you use a contract manufacturer to produce products for your private label brand, you might wonder who is responsible for registration. The FDA has clarified that only one registration is needed per facility, even if that facility produces for dozens of different brands. The “responsible person”—which is typically the brand owner whose name appears on the label—can register the facility on the manufacturer’s behalf. This collaborative approach prevents duplicate filings and ensures that every facility is accounted for without creating unnecessary administrative work for manufacturers.

Rules for Foreign Facilities and U.S. Agents

If your cosmetic facility is located outside of the United States but sells products to American consumers, you are also required to register. A key part of this process is appointing a U.S. agent. This agent must be a person or a company physically located in the U.S. who acts as your official point of contact for all communications with the FDA. Your U.S. agent is crucial for regulatory correspondence, scheduling inspections, and handling any urgent matters. Choosing a reliable and responsive agent is essential for maintaining compliance and ensuring smooth communication with the agency.

Could Your Small Business Be Exempt?

The FDA recognizes that these new regulations could place a heavy burden on smaller operations. Because of this, MoCRA includes exemptions for some small businesses. To qualify, your company must have had average gross annual sales of cosmetic products in the U.S. of less than $1 million for the previous three-year period. It’s important to note that this exemption does not apply to facilities that manufacture or process certain types of products, such as cosmetics that come into contact with the eye or are intended for injection. You can find more details in the FDA’s draft guidance to confirm if your business qualifies.

Voluntary Registration for Exempt Businesses

Just because your business qualifies for an exemption doesn’t mean you’re barred from registering. MoCRA allows exempt small businesses to register their facilities on a voluntary basis. Why would you do this? For some brands, it’s a strategic move. Voluntarily registering can signal to consumers and retail partners that you are committed to transparency and high safety standards, even when not legally required. It can also be a smart way to prepare for future growth. If you anticipate your sales will eventually exceed the $1 million threshold, registering early can help you establish compliance practices before it becomes mandatory, ensuring a smoother transition as your business scales.

Who Is Exempt from Registration?

While MoCRA’s registration requirements are broad, they aren’t universal. The FDA has carved out specific exemptions to avoid placing an undue burden on certain types of businesses that are not primarily involved in manufacturing or are already subject to other forms of regulatory oversight. These exemptions generally fall into a few key categories. The most significant is for small businesses with less than $1 million in average annual U.S. cosmetic sales over the previous three years. This is designed to protect smaller, independent brands from being overwhelmed by the new administrative requirements.

Beyond the small business exemption, MoCRA also excludes entities where cosmetics are not manufactured but are instead sold or applied. This includes places like beauty salons, spas, and retail stores. The logic here is that these businesses are at the end of the supply chain, not the beginning. Additionally, facilities that are already registered with the FDA as drug or medical device establishments are exempt from duplicating their registration for cosmetics. Understanding these categories is the first step in determining whether your facility is required to register or if it falls under one of these specific exemptions.

Beauty Salons, Retailers, and Other Entities

If your business primarily sells cosmetics to consumers or uses them to provide services, you likely don’t need to register your facility. MoCRA specifically exempts establishments like beauty salons, spas, and retail stores. It also excludes clinics, hospitals, and research institutions where cosmetics might be used but not manufactured for public sale. The key distinction is your facility’s function. The registration requirement is aimed at the source—the places where cosmetics are made and processed. If your salon simply uses professional products on clients or your shop sells pre-packaged goods, you are not considered a manufacturer or processor under these rules.

Facilities Regulated as Drugs or Medical Devices

To prevent redundant paperwork, MoCRA exempts facilities that are already registered with the FDA as a drug or medical device establishment. Many products, like anti-dandruff shampoos or moisturizers with SPF, are classified as both cosmetics and over-the-counter drugs. If your facility manufactures these types of products and is already compliant with drug establishment registration requirements, you do not need to register a second time as a cosmetic facility. However, it’s important to remember that while the facility is exempt, you are still required to complete the cosmetic product listing for any applicable products you manufacture.

Using the FDA’s Decision Tool

Feeling a little unsure about where your business fits in? You’re not alone. The lines between manufacturing, processing, and selling can sometimes feel blurry, especially for businesses that handle multiple functions. To help bring some clarity, the FDA has created resources to help you determine your obligations. On its main cosmetic registration and listing page, you can find a step-by-step guide and interactive tools designed to walk you through the requirements. Think of it as a short questionnaire that helps you assess whether your facility’s activities trigger the need for registration.

This tool is an excellent first step for any business owner trying to understand their responsibilities under MoCRA. It can quickly confirm if you need to register or if you likely qualify for an exemption. While the tool is a fantastic starting point, every business is unique. If your operations involve complex supply chains, contract manufacturing agreements, or products that fall into multiple regulatory categories, you might find that your situation isn’t so clear-cut. If you’re still uncertain after using the tool, getting expert advice can provide the clarity you need to move forward confidently.

What Information Does the FDA Require for Registration?

Getting your cosmetic facility registered with the FDA means giving them a clear and detailed snapshot of your operations. Think of it less like filling out a simple form and more like creating a comprehensive profile. The goal of the Modernization of Cosmetics Regulation Act (MoCRA) is to improve transparency and safety across the industry, and that starts with knowing who is making what, and where. The FDA needs specific information to track products, manage safety reports, and communicate effectively with manufacturers.

Before you even log into the registration portal, it’s smart to gather all the necessary documents and details in one place. This preparation will make the actual submission process much smoother and help you avoid errors that could cause delays. The required information covers everything from your facility’s physical location and ownership to the specific types of products you create. Each piece of data helps the FDA build a complete picture of the cosmetic landscape in the U.S. Let’s walk through exactly what you’ll need to have on hand.

Providing Your Facility and Owner Information

First up, the basics. The FDA requires fundamental contact information for both the facility owner and the facility itself. You’ll need to provide the facility’s name, physical address, email address, and telephone number. This information must be precise and current, as it’s how the FDA will contact you with any questions or official notices. If you have an operator who is different from the owner, you’ll need to provide their contact information as well. Accuracy is key here, so double-check every detail before you submit.

Why You Need a DUNS Number

This is a big one: every facility that manufactures or processes cosmetic products for sale in the U.S. must have a unique Facility Registration Number. To get this, you first need a specific Data Universal Numbering System (DUNS) number. This isn’t just any DUNS number for your parent company; it must be for the specific physical location of the facility you are registering. A DUNS number is a unique nine-digit identifier for businesses, and the FDA uses it to maintain accurate records for each location. If you don’t have one for your facility yet, you’ll need to request one from Dun & Bradstreet before you can complete your registration.

Listing Your Product Categories and Brands

Next, you’ll need to provide information about the products you handle. This includes a list of all brand names under which cosmetic products are sold from your facility. You don’t have to list every single product, but you do need to identify the product categories for everything you manufacture or process. The FDA provides a list of established categories to choose from, such as skin care, hair care, makeup, and fragrances. This helps the agency understand the scope of your operations and the types of products associated with your facility.

Understanding Your Product Listing Requirements

It’s important to understand the difference between facility registration and product listing. While they are related, they are two separate requirements under MoCRA. The facility registration tells the FDA where products are made. The product listing tells them what those products are. This duty falls to the “Responsible Person,” which is typically the manufacturer, packer, or distributor whose name appears on the product label. This person or entity must submit a detailed listing for each cosmetic product they market, including its ingredients.

How to List Products with Minor Variations

What if your best-selling lipstick comes in twenty different shades, or your popular body lotion is available in five unique scents? Under MoCRA, you can’t just group these together under a single product listing. Each variation—even if the difference is as minor as a color, fragrance, or flavor—must be accurately documented. The “Responsible Person” is accountable for ensuring every version is detailed in the product listing submission. This means specifying the exact ingredients, color additives, or fragrances that make each one unique. This level of detail is crucial for transparency and allows the FDA to have a precise understanding of every product on the market, which is fundamental to protecting consumer safety.

How to Register Your Cosmetic Facility: A Simple Guide

Now that you know what the FDA requires, let’s walk through the actual registration process. While it might seem like a lot of steps, breaking it down makes it manageable. The key is to be prepared. The FDA has streamlined the submission process with a dedicated online portal, which is the required method for sending in your information. Think of it as your central hub for getting and staying compliant under the Modernization of Cosmetics Regulation Act (MoCRA).

Before you even open your web browser, your first goal should be to gather every piece of information you’ll need. This preparation is the single best thing you can do to ensure a smooth process. Having all your details—from facility addresses to brand names—ready to go will prevent delays and help you avoid common submission errors. We’ll cover exactly what you need in the checklist below. Getting this right from the start saves you time and headaches, and it’s the first major step toward securing your facility’s compliant status with the FDA.

First Step: Get Your FDA Establishment Identifier (FEI) Number

Before you can even think about submitting your facility registration, you need to secure a critical piece of information: your FDA Establishment Identifier (FEI) number. This unique number is how the FDA tracks your specific facility, and you can’t complete the registration without it. To get your FEI, you first need a Data Universal Numbering System (DUNS) number. This is a crucial detail—the DUNS number must be for the exact physical location of the facility you are registering, not your corporate headquarters. Once you have the correct DUNS number, you can find or request your FEI through the FDA’s official FEI Search Portal. Think of the FEI as your facility’s official ID in the FDA’s system; it’s the foundation for both your facility registration and your future product listings.

Getting Started with the Cosmetics Direct Portal

The FDA requires electronic submissions for facility registration and product listing, and the tool you’ll use is the Cosmetics Direct portal. The agency strongly encourages everyone to use this platform, as it’s specifically designed to handle MoCRA requirements. This portal is an updated version of the previous system for voluntary registrations, now built to manage the new mandatory submissions. You’ll create an account, enter your facility and product information, and submit everything in one place. It’s a fairly intuitive system, but it’s important to familiarize yourself with the interface before you begin to ensure you’re entering data into the correct fields. This is your official channel for communicating registration details to the FDA.

Choosing Your Submission Method

When it comes to submitting your cosmetic facility registration, you have a few different paths you can take. The FDA has made it clear that they prefer electronic submissions, as they are faster, more accurate, and easier to process. While there are a couple of digital options and a paper-based alternative, they aren’t all created equal. Your choice can impact how quickly your registration is processed and how easily you can manage your compliance information moving forward. Let’s break down the options so you can decide which one makes the most sense for your business.

Using Cosmetics Direct, ESG, or Paper Forms

The FDA strongly recommends using Cosmetics Direct, an online portal designed specifically for cosmetic facility registration and product listing. It’s the most straightforward and user-friendly option, guiding you through the process step-by-step. Another electronic option is the FDA Electronic Submissions Gateway (ESG), which is a more complex system typically used by larger firms that handle multiple types of FDA submissions. While it’s a valid method, it has a steeper learning curve. The FDA also provides paper forms as a last resort, but submitting by mail can lead to significant processing delays and potential errors. For a smooth and efficient registration, Cosmetics Direct is your best bet.

Important Note on ESG Account Setup Time

If you’re considering using the Electronic Submissions Gateway (ESG), you absolutely cannot wait until the last minute. Setting up an ESG account is not an instant process. It requires several steps, including applying for an account, conducting connectivity tests, and getting everything validated by the FDA. This setup can take anywhere from one to three weeks, and sometimes even longer. If you’re up against a deadline, this delay could put you at risk of non-compliance. This lengthy setup time is another major reason why most cosmetic facilities will find the Cosmetics Direct portal to be the more practical and timely choice.

Is There a Fee for Registration?

Here’s some good news: there is no fee to register your cosmetic facility or list your products with the FDA. The entire submission process through the Cosmetics Direct portal is completely free. This is a welcome relief for businesses of all sizes, especially smaller brands that are working to align with the new MoCRA requirements. While the registration itself doesn’t cost anything, it’s important to remember that ensuring your submission is accurate and complete from the start is an investment in itself. Taking the time to get it right helps you avoid potential compliance issues, which can be far more costly down the road.

Your Step-by-Step Registration Checklist

The registration process follows a clear sequence. Your very first step, before even accessing the portal, is to secure a DUNS number for your facility’s physical location. This is a unique nine-digit identifier for businesses, and the FDA requires it for registration. If you don’t have one, you can request a DUNS number for free. Once you have it, you can create your Cosmetics Direct account. From there, you’ll fill out the facility registration form with your company details, brand names, and product categories. After you’ve entered all the required information and double-checked it for accuracy, you’ll be ready to submit it to the FDA.

Gathering Your Required Documents

To make your submission as smooth as possible, gather all your information beforehand. Think of this as your prep list. You’ll need to have these details on hand when you sit down to register your facility:

The facility owner and/or operator’s name, address, phone number, and email.
The contact information for the U.S. agent if it’s a foreign facility.
The facility’s DUNS number.
All brand names under which products are sold.
The product category or categories for all cosmetics manufactured or processed at the facility.
The name and contact information of the “responsible person” for each product.

Having this information organized and ready will prevent you from having to stop and start the application, reducing the chance of errors.

Common Mistakes to Avoid During Registration

One of the biggest hurdles businesses face is a simple one: processing delays caused by incomplete or inaccurate applications. To avoid this, meticulously review every piece of information before you hit “submit.” Ensure the address matches your DUNS record exactly and that all required fields are filled. Another common issue is what some call a “facility registration bottleneck,” where brands wait on their contract manufacturers to register, causing delays across the board. If you use a third-party manufacturer, communicate with them early to confirm they are on track with their own registration. Proactive communication and careful data entry are your best defenses against these preventable setbacks.

Important Deadlines for Registration and Renewal

Meeting deadlines is a non-negotiable part of FDA compliance, and with MoCRA, the cosmetic industry has a new set of dates to circle on the calendar. These timelines for facility registration and product listing are mandatory. Missing them isn’t just a minor slip-up; it can lead to serious compliance issues that could disrupt your ability to sell your products. Think of these deadlines as your roadmap to staying in good standing with the FDA and keeping your business running smoothly. It’s crucial to understand that these are not suggestions but firm requirements under the new law.

It’s not just about the initial registration, either. MoCRA establishes an ongoing cycle of renewals and updates to ensure your information remains accurate over time. This shift from a voluntary system to a required one means you need a solid plan for managing these dates. Getting them on your calendar now is the first step to building a sustainable compliance strategy for your business. Below, we’ll break down the specific timelines for initial registration, biennial renewals, and annual updates so you know exactly what to expect and can avoid any last-minute scrambles. Staying ahead of these requirements is key to maintaining market access and consumer trust.

Mark Your Calendar: Initial Registration Deadlines

The first set of deadlines depends on when your facility started operating and when your products hit the market. For facilities that were already in business before December 29, 2022, the deadline to register was December 29, 2023. If you launched your facility after that date, you have 60 days from when you start operations to get registered. For products, the timeline is similar. Existing products sold before December 29, 2022, needed to be listed by the end of 2023. For new products, you have 120 days from their market launch to complete the listing. The FDA provides detailed guidance on registration and listing to help clarify these timelines.

Understanding the Enforcement Discretion Deadline

While the original statutory deadline for registration was December 29, 2023, the FDA gave the industry some breathing room to adapt to the new system. The agency announced a grace period, delaying enforcement to give businesses more time to get their submissions in order. However, that window is closing. The FDA has set July 1, 2024, as the date when it will begin enforcing the new registration and listing requirements under MoCRA. This means any facility not registered by this date could face significant consequences, including having its registration suspended or its products refused entry into the U.S.

Deadlines for New Facilities and Products

Compliance isn’t a one-time task; it’s an ongoing responsibility, especially for new businesses and product lines. For any facility that began manufacturing or processing cosmetics after December 29, 2022, the rule is straightforward: you must register within 60 days of starting operations. This ensures the FDA’s database remains current as the industry evolves. Similarly, if you launch a new cosmetic product, you are required to submit its product listing within 120 days of its market introduction. These rolling deadlines are designed to create a complete and up-to-date picture of the cosmetic landscape, allowing the agency to act quickly if safety concerns arise with new products or facilities.

How to Handle Your Biennial Renewal

Under MoCRA, your initial registration isn’t a one-and-done task. The FDA now requires all registered cosmetic facilities to renew their registration every two years. This ensures that the agency’s database stays current and reflects the active players in the industry. Think of it like renewing a business license—it’s a routine check-in to confirm your facility is still operating and compliant. The renewal window will occur every other year, so it’s a good idea to set a recurring reminder well in advance. This biennial renewal is a cornerstone of the new regulations, helping the FDA maintain effective oversight of the cosmetics market.

What Happens When Your Facility Information Changes?

Beyond the biennial facility renewal, you also have an annual responsibility to keep your product listings up to date. Each year, you’ll need to review and update the information for every product you’ve listed with the FDA. This isn’t just for adding new products to your portfolio; it’s also your chance to formally notify the FDA if a product has been discontinued. Keeping this information current is essential for maintaining an accurate record with the agency. An annual review helps ensure your product catalog is correctly represented in the FDA’s database, which is a key part of your ongoing compliance duties under MoCRA.

Common Registration Challenges (and How to Solve Them)

Getting your cosmetic facility registered with the FDA is a huge step, but the path isn’t always straightforward. With new regulations under the Modernization of Cosmetics Regulation Act (MoCRA), many business owners run into similar hurdles, from confusing paperwork to unexpected delays. Think of these challenges not as stop signs, but as checkpoints. With a little preparation and the right information, you can handle them smoothly and keep your business on track.

Let’s walk through some of the most common issues that pop up during the registration process and, more importantly, how you can solve them.

What to Do If Your Registration Is Delayed

Few things are more frustrating than a processing delay when you’re working against a deadline. Most of the time, these delays happen because of simple errors or missing information in the submission. The FDA’s system is designed to process complete and accurate applications, so any mistake can send yours to the back of the line.

The best way to prevent this is to be meticulous from the start. Before you even open the registration portal, create your own checklist of every single piece of information required. Double-check names, addresses, and registration numbers. When you’re ready to submit, go through your application one last time. Ensuring you submit all necessary information accurately is the surest way to avoid getting stuck in administrative limbo.

Ensuring You Have the Correct Documentation

Having all your paperwork in order before you begin is essential for a smooth registration. One of the most critical pieces of information you’ll need is a Data Universal Numbering System (DUNS) number. This unique nine-digit identifier is used to track businesses, and you need one for the specific physical location of the facility you’re registering.

This requirement can sometimes cause issues, as you need to ensure the number corresponds to the correct address. The best approach is to request your DUNS number well in advance of the FDA’s deadline, as it can take some time to be assigned. Confirming you have the right number for the right facility will save you a major headache when you’re ready to file.

Feeling Overwhelmed by New Regulations?

New federal regulations can feel like learning a new language. MoCRA has introduced significant changes, and it’s completely normal to feel a bit overwhelmed by the details. The FDA provides resources like its Draft Guidance on Registration and Listing to help businesses understand their new responsibilities.

These documents explain who needs to submit, what information to include, how to submit it, and when it’s due. Instead of trying to absorb everything at once, focus on the sections that apply directly to your business. The FDA also publishes Q&A pages that address common points of confusion in plain language. Taking the time to review these materials can clarify your obligations and build your confidence.

Will Your Registration Information Be Made Public?

Submitting detailed information about your facility and products to a government agency naturally brings up questions about privacy. Many brand owners worry that their registration data could become public through the Freedom of Information Act (FOIA), potentially exposing sensitive business information.

Industry associations have raised these concerns with the FDA, advocating for the protection of confidential commercial information. While the FDA operates under transparency laws, certain proprietary details are typically shielded from public disclosure. It’s wise to understand what information falls under this protected category. If you have specific concerns about your trade secrets or product formulations, consulting with a regulatory expert can help you understand the boundaries and ensure your sensitive data remains secure.

What Information the FDA Keeps Confidential

It’s a valid question, and thankfully, the FDA has provided some clarity on what stays private. The agency has confirmed that certain key identifiers will not be released to the public. Specifically, your product listing number and your facility registration number (when it’s part of a product listing) are kept confidential. This helps protect the specific links between a product and its manufacturing site from your competitors. While these crucial numbers are shielded, it is important to know that other information from your registration and listing might be made public through FOIA requests. Understanding this distinction can help you file with confidence, knowing your most sensitive operational data is secure.

Resources to Make Your Registration Easier

You don’t have to go through the registration process alone. Plenty of resources are available to guide you, from official FDA publications to expert advice. Knowing where to find reliable information can make a huge difference in ensuring your submission is accurate and timely. Here’s a breakdown of the best places to look for help as you prepare your cosmetic facility registration.

Official FDA Guidance and Documentation

Your first stop for information should always be the source itself. The FDA provides official guidance to help businesses understand and comply with MoCRA’s new requirements. Their guidance on Registration and Listing of Cosmetic Product Facilities and Products is an essential read. This document clearly outlines who is responsible for submitting, what information you need to include, how to format it, and when your deadlines are. Think of it as your official instruction manual for the entire process. Keeping a copy handy will help you answer many of your own questions along the way and ensure you’re following the correct procedures from the start.

Answers Directly from the FDA: Q&A Resources

As with any new regulation, questions are bound to come up. The FDA often releases Q&A materials to address common concerns and clarify gray areas. For example, after receiving feedback from industry associations, the FDA provided answers regarding whether registration and listing information would be protected from public disclosure under the Freedom of Information Act (FOIA). Following these official Q&A updates can give you insight into how the agency is interpreting the rules and help you stay informed on specific issues that might affect your business. It’s a great way to get clarity on nuanced topics.

Tips and Best Practices from Industry Experts

Sometimes the most helpful advice comes from those who are in the trenches. One of the biggest hurdles businesses face is a simple processing delay, which is often caused by incomplete or incorrect applications. To avoid this, make sure you submit all the necessary information right from the start. A great best practice is to create your own internal checklist based on the FDA’s requirements. Before you hit submit, double-check that every field is filled out correctly and all your documents are in order. This simple step can prevent significant headaches and keep your registration on track, saving you valuable time and resources.

When to Call a Regulatory Consultant

If you’re feeling stuck or overwhelmed, it might be time to call in a professional. Many brands run into challenges like a facility registration bottleneck or confusion navigating the Cosmetics Direct portal. Instead of spending countless hours trying to solve these issues yourself, working with a regulatory expert can streamline the entire process. A consultant can help you troubleshoot problems, ensure your submission is flawless, and give you the peace of mind that comes with knowing your business is fully compliant. It’s a smart investment to avoid costly mistakes and potential business disruptions down the road.

What Happens If You Don’t Register?

Skipping your cosmetic facility registration isn’t just an oversight—it’s a direct violation of federal law with serious consequences. The FDA established these rules under the Modernization of Cosmetics Regulation Act (MoCRA) to ensure product safety and transparency. Failing to comply can put your entire business operation at risk, leading to blocked sales, legal trouble, and significant financial losses. Let’s walk through exactly what can happen if you don’t complete this critical step.

Registration Is Not FDA Approval

It’s crucial to understand that registering your cosmetic facility with the FDA does not mean your products are “FDA approved.” This is one of the most common misconceptions in the industry. The FDA is very clear on this point: registering a facility or listing a product is a mandatory administrative step, not a stamp of approval. The agency does not issue certificates for registration, and you cannot use the FDA logo on your products to imply that your facility’s registration means your products have been deemed safe or effective by the government.

So, what is the purpose of registration? Think of it as a tool for accountability. Under MoCRA, registration gives the FDA the visibility it needs to monitor the market and protect public health. The agency has the authority to suspend a facility’s registration if it determines a product made there poses a reasonable risk of serious harm. This enforcement power underscores the true nature of registration: it’s a baseline requirement for legal operation, not a guarantee of product quality from the FDA’s perspective. Compliance keeps you on the market, but it doesn’t equal an endorsement.

Facing Issues with Imports and Market Access

For businesses located outside the United States, registration is your ticket to the American market. If a foreign facility that is required to register fails to do so, the FDA and U.S. Customs and Border Protection (CBP) have the authority to refuse your products entry into the country. Your shipments can be detained at the border, leaving your inventory in limbo and halting your revenue stream. This creates a major operational bottleneck, damages relationships with distributors and retailers, and effectively shuts down your access to U.S. consumers until you become compliant.

The Consequences of FDA Enforcement Actions

Non-compliance can trigger direct enforcement actions from the FDA. The agency has the power to issue warning letters, request mandatory recalls, or even suspend your facility’s registration. A suspension is particularly severe, as it prohibits you from distributing any cosmetic products in the U.S. The FDA can take this step if it believes a product from your facility could cause serious harm. These enforcement activities are public, which can damage your brand’s reputation with both consumers and retail partners who expect their suppliers to follow the law.

Avoiding Costly Business Disruptions

Failing to register your facility is a direct threat to your business continuity. Beyond having your products detained or being forced to stop sales, non-compliance creates a cascade of problems. Retailers may cancel orders and refuse to stock your products to avoid their own legal risks. The time and resources required to resolve these issues—from hiring legal help to paying for stalled inventory—can be immense. Proactively managing your regulatory compliance is the only way to prevent these costly disruptions and protect the long-term health of your business.

You’re Registered! What Comes Next?

Congratulations, you’ve successfully registered your cosmetic facility with the FDA. That’s a huge and necessary step, but it’s important to see it as the starting line, not the finish line. Your registration is the foundation of your compliance, and now you need to build upon it with consistent, ongoing practices. The Modernization of Cosmetics Regulation Act (MoCRA) didn’t just create a registration requirement; it established a new framework for accountability. This means your work continues long after you receive your registration number.

Staying on top of these ongoing responsibilities is crucial for keeping your business in good standing and avoiding potential FDA enforcement actions, like warning letters or import refusals. It’s about integrating compliance into the very fabric of your operations. Think of it as building good habits—once they’re established, they become second nature. This proactive approach not only protects you from regulatory headaches but also reinforces consumer trust in your brand. When customers know you’re committed to safety and transparency, it strengthens your reputation in a competitive market. From tracking safety data and maintaining meticulous records to keeping your facility information current, these post-registration duties are fundamental to operating a responsible and successful cosmetics brand. Let’s break down exactly what you need to do.

Your Guide to Adverse Event Reporting

Under MoCRA, your company is now required to have a system for receiving and processing reports of adverse events related to your products. More importantly, you must report any serious adverse events to the FDA within 15 business days of receiving the information. A serious adverse event can include things like a significant disfigurement, infection, or any experience that requires medical intervention. You’ll need to maintain records of all adverse events—serious or not—for six years (or three years for some small businesses). This isn’t just about paperwork; it’s a critical part of monitoring your product’s real-world safety and protecting consumers.

Setting Up Your Record-Keeping System

Your responsibility for documentation goes hand-in-hand with safety reporting. The FDA now has the authority to access and inspect your records related to product safety. This means you must keep detailed and organized files for every product, substantiating its safety. This includes records of any adverse events, formulation details, testing data, and manufacturing controls. Think of your records as the official story of your product’s safety journey. If the FDA ever has a question or concern, clear and complete documentation is your best tool for demonstrating compliance and due diligence. Keeping these records organized is essential for a smooth FDA inspection.

The Ongoing Duty to Update Your Information

Your registration isn’t a “set it and forget it” task. You are required to renew your facility registration every two years. Additionally, you must update your product listings annually. This includes providing any new information or confirming that the existing information is still accurate. You also need to notify the FDA of any significant changes, such as a change in your facility’s name or address, within 60 days. Keeping your information current through the Cosmetics Direct portal ensures the FDA has an accurate picture of your operations and the products you have on the market. It’s a simple but vital part of maintaining your registration.

Staying Compliant with Good Manufacturing Practices (GMP)

While the FDA is still working on finalizing the specific GMP rules for cosmetics under MoCRA, adhering to established GMP is a fundamental expectation. Good Manufacturing Practices are the systems and procedures that ensure your products are consistently produced and controlled according to quality standards. This covers everything from the cleanliness of your facility and the calibration of your equipment to raw material handling and employee training. Following GMP minimizes the risk of contamination, mix-ups, and errors, ensuring the final product is safe for consumers. Proactively implementing a robust quality management system now will put you ahead of the curve for when the final rule is published.

Frequently Asked Questions

What’s the difference between facility registration and product listing? Think of it this way: facility registration tells the FDA where your cosmetics are made, while product listing tells them what you are making. Registration is about the physical location of your manufacturing or processing operations. Product listing is a separate requirement where the brand owner provides detailed information about each specific product, including its ingredients. Both are mandatory under MoCRA, but they are two distinct submissions.

My products are made by a contract manufacturer. Who is responsible for registering the facility? The facility where the products are physically manufactured or processed is the one that needs to be registered. This means your contract manufacturer is responsible for ensuring their facility is on the FDA’s list. However, as the brand owner, you can also complete the registration on their behalf. The key is to communicate with your manufacturing partner to confirm who will handle the submission, as only one registration is required per facility.

Do I still need to register if I run a small business? You might be exempt, but you need to check the details carefully. MoCRA provides an exemption for businesses whose average gross annual sales of cosmetic products in the U.S. were less than $1 million for the previous three years. This exemption does not apply if you manufacture certain products, such as cosmetics that are injected or come into contact with the eye. Always confirm your status with the official FDA guidance before assuming you don’t need to register.

What happens if I miss the registration deadline? Failing to register your facility can bring your business to a halt. The FDA has the authority to suspend your registration, which legally prevents you from selling your products in the U.S. If you import your products, they can be detained at the border and refused entry into the country. This isn’t just a paperwork issue; it’s a direct threat to your ability to operate and can lead to significant financial and reputational damage.

Is the information I submit to the FDA going to be made public? This is a valid concern for many brand owners. While the FDA operates under transparency laws, it also protects confidential commercial information and trade secrets from public disclosure. Basic details like your facility’s name and address may become public, but sensitive information related to your specific product formulas is generally shielded. If you have deep concerns about proprietary data, consulting with a regulatory expert can provide more specific guidance.