MoCRA: Protecting Beauty Professionals and Enthusiasts by Regulating Cosmetics

New Cosmetic Act Regulating Cosmetics

The important parts for you and your business, a deep dive into the details, and what you can do to ensure compliance.

Introduction

Cosmetics are everywhere in our daily life – in fact, the average person uses between 6-12 cosmetics every day! But with so many products available, which ones are safe and how do you know? As a lash artist or beauty enthusiast, you already know how important it is to use high-quality, safe products to keep your lash clients looking fabulous and feeling confident. But did you know that there's a new law in place that’s making it easier for everyone – from manufacturers to beauty professionals like you – to ensure that the products you use are safe by being compliant with regulations?

The Modernization of Cosmetics Regulation Act (MoCRA) – signed into law on December 29, 2022 – is a long-awaited update for the beauty industry. It’s the first significant update to U.S. cosmetics regulation since the 1930s. And while MoCRA’s primary goal is to protect consumers and enhance transparency, it has some pretty important implications for lash artists, beauty professionals, and business owners in the industry. If you’ve ever wondered about the safety of the products you use or the rules you need to follow, you'll be able to get the basic details right here.

In this blog, we’ll break down everything you need to know about MoCRA: what it is, how it affects you, and the steps you need to take to ensure compliance and keep your clients safe. Let’s get started!

 

MoCRA (Modernization of Cosmetics Regulation Act) covers a wide range of personal care and beauty products, including hair and hair removal products, makeup, nail products, soaps and lotions, and tanning products.

Why It Matters for Lash Artists or Beauty Professionals:

You might be asking yourself, “How does MoCRA affect me?” While it primarily targets manufacturers, there are important aspects for you to pay attention to. For lash artists, any products that touch the eye, such as lash glue, lash primer, and cleansers, are regulated. While you may not need to register any products as a manufacturer, it's important to track the compliance of the products you use to ensure safety and meet MoCRA standards.

Here’s how MoCRA’s provisions can affect your practice:

1. Facility Registration & Product Listing

Under MoCRA, all cosmetic manufacturers and processors must register their facilities with the FDA and list their products. For you, this means that the brands and products you use for lash extensions should be FDA-compliant, with their facilities registered and products listed. This helps ensure that the products you’re using are safe, traceable, and meet the necessary standards.

What you need to do:

• Check if your suppliers are complying: When purchasing products for your lash business, check that the brands you use are complying with MoCRA's registration and product listing requirements. This ensures that the products meet necessary safety standards and can be traced back to compliant sources. And if you're sourcing your glue directly from a manufacturer, check with them to make sure that they have registered.

2. Adverse Event Reporting

If a client has a reaction to a product – whether it’s irritation, swelling, or any other serious side effect – it’s essential that you report it. MoCRA mandates that manufacturers report serious adverse events to the FDA within 15 business days. As a lash artist, you need to be aware of any adverse events linked to the products you use.

What you need to do:

• Be aware and report: If you notice any issues or side effects related to a product you use, you should report it to the FDA via MedWatch. Additionally, keep an eye out for any adverse event reports from manufacturers. Being proactive about this ensures your clients' safety and helps you avoid known issues before they happen to you.

3. Safety Substantiation and Testing

MoCRA places a responsibility on manufacturers to ensure the safety of their products before they hit the market. This means that the products you use should be tested for safety. While MoCRA doesn’t specify which tests are required, it encourages companies to substantiate the safety of their products, which is especially important for products used around sensitive areas like the eyes.

What you need to do:

• Choose reputable brands: Make sure that the products you use for lash extensions come from reputable brands that have a clear safety substantiation process in place.

4. Product Labeling Requirements

All cosmetic products must have clear labeling. For products used in professional settings, such as lash extensions, MoCRA requires that they are labeled accordingly, indicating that they are meant for professional use only. They also need to have all ingredients listed, potential allergens (such as fragrances, preservatives, extracts), contact information for a responsible person, warnings and directions for use, and expiration dates. These requirements help you as a lash artist to ensure you are using products in the correct manner and warn you against anything that may cause sensitivities.

What you need to do:

• Check labels: Always double-check the labeling of the products you use. Look for any specific instructions related to professional application and make sure the product is intended for the type of service you offer.

5. Transparency and Trust

MoCRA has made it easier for consumers, including lash artists, to trace the products they use back to their sources. This enhanced transparency helps foster trust between manufacturers, distributors, and consumers. As a lash artist, knowing where your products come from, how they’re made, and the regulations they’re subject to can give you peace of mind and confidence in your services.

What you need to do:

• Build trust with your clients: By choosing products from manufacturers that comply with MoCRA’s requirements, you are reinforcing your commitment to safety and transparency. This is important for building long-term relationships with your clients, who trust you to use products that keep them healthy and safe.

Make sure that you know about your products so you can talk to your clients about the products that you're using on them if they have concerns.

Breaking it Down: What is MoCRA?

MoCRA, or the Modernization of Cosmetics Regulation Act, is a major update to U.S. cosmetics regulations that was signed into law on December 29, 2022. It’s the first significant change to cosmetics regulation in the United States since the 1930s. This law aims to improve consumer safety by enhancing transparency, increasing oversight, and ensuring that cosmetics are safe for use.

Basically, MoCRA gives the FDA (U.S. Food and Drug Administration) more authority over cosmetic products, enabling the agency to track, regulate, and take action on unsafe cosmetics more effectively. Under MoCRA, the FDA can now better monitor the ingredients in products, where they are made, and the manufacturers involved. It also requires cosmetic manufacturers to be more transparent about the products they put on the market. It also allows the FDA to take action against anything that is reported as potentially hazardous or has safety concerns.

For lash artists, beauty professionals, and business owners in the industry, this means a greater level of accountability and safety. MoCRA directly impacts the products you use, the brands you trust, and the rules you follow to keep your clients safe.

Here’s a breakdown of what MoCRA is and why it matters for you:

• Expanded FDA Authority: MoCRA gives the FDA greater oversight and enforcement powers, allowing them to inspect facilities, enforce regulations, and recall products that don't meet safety standards.
• Consumer Protection: The law emphasizes product safety, ensuring that only properly tested and proven safe products reach the consumer market.
• Transparency and Accountability: Manufacturers are now required to register their facilities and list their products with the FDA, helping to keep the entire supply chain transparent. This means that you’ll have a better idea of where the products you use are coming from and whether they’re complying with safety regulations.

For lash artists, it’s essential to understand how MoCRA impacts your practice. While the law focuses on the manufacturers and distributors of products, it will help you in the end to ensure that what you're using on your clients is safe.

 

Key Provisions of MoCRA

MoCRA brings some important changes to how the beauty industry operates, with provisions that affect both manufacturers and beauty professionals. As a lash artist, knowing these key provisions will help you stay compliant with the law and ensure the safety of your clients.

Let’s break down the most significant parts of MoCRA that will impact you and your practice:

1. Facility Registration

One of the core requirements under MoCRA is that all manufacturers and processors of cosmetic products must register their facilities with the FDA. This registration has to be renewed every two years.

• Why it matters for you: While you may not directly register your facility as a lash artist, knowing that the products you use come from FDA-registered facilities ensures that the brands you trust are held to safety standards. The more transparent manufacturers are, the safer you can feel about the products you're using on your clients.

2. Product Listing

Manufacturers must also list each cosmetic product marketed in the U.S. with the FDA, providing details about the product’s ingredients and updating this information annually.

• Why it matters for you: When you're choosing products for your lash business, it’s important to check that they are listed with the FDA. This shows that the product has been properly tested and is in compliance with the necessary regulations.

3. Adverse Event Reporting

Under MoCRA, manufacturers are required to report any serious adverse events (SAEs) related to their products to the FDA within 15 business days. This is a critical safety measure for the beauty industry because it helps quickly identify any safety concerns with cosmetics.

• Why it matters for you: As a lash artist, being aware of any adverse events related to the products you use is essential. If you notice a serious reaction in a client (such as an allergic reaction or irritation from a lash extension product), it’s important to report these incidents. This helps the FDA keep track of potential hazards and makes the industry safer for everyone.

4. Safety Substantiation

Manufacturers must ensure that their products are safe for use. While MoCRA doesn’t require specific safety tests, it does require that manufacturers have adequate safety data to support their claims about their products.

• Why it matters for you: As a lash artist, you want to be confident that the products you use are safe. Make sure the brands you work with have robust safety testing processes in place, especially for products that come into direct contact with your client’s skin and eyes.

5. Product Labeling Requirements

MoCRA also sets clear rules for labeling, requiring cosmetics to include contact information for the responsible party (such as a domestic address or phone number) to facilitate adverse event reporting. For products intended for professional use, like lash extension adhesives, the labeling must clearly indicate that the product is meant for use only by licensed professionals.

• Why it matters for you: When you purchase professional-grade products for your lash business, always check the labels to make sure they’re intended for licensed professionals. It’s also a good practice to verify that the contact information is listed in case you need to report any adverse reactions or get more information about the product.

6. Compliance with Additional Regulations

MoCRA also empowers the FDA to implement additional regulations, including Good Manufacturing Practices (GMP) and specific requirements for detecting asbestos in talc-containing products. Manufacturers must also label fragrance allergens if they are present in their products.

• What are Good Manufacturing Practices (GMP)? GMP refers to a set of guidelines that manufacturers must follow to ensure that their products are consistently produced and controlled according to quality standards. These practices help minimize the risks involved in production that cannot be eliminated through testing the final product alone. Essentially, GMP ensures that products are made safely, without contamination, and with the correct ingredients.
• Why it matters for you: While you may not directly be involved in the manufacturing process, it’s important to understand that products manufactured under GMP guidelines are held to a higher standard of quality and safety. For example, GMP covers areas like:
• Proper hygiene in production facilities
• Ensuring the right ingredients are used in the right quantities
• Testing products for contaminants before they are sold
• Maintaining a clean environment during production

When purchasing products for your lash business, choose those from manufacturers that follow GMP regulations. This way, you can feel confident that the products you use are made in safe, controlled environments, reducing the risk of harmful ingredients or contamination.

 

Key Dates and Deadlines for MoCRA Compliance

MoCRA is now fully in effect. While the FDA initially indicated that it would delay enforcement of facility registration and product listing requirements for companies and products established or marketed after December 29, 2022, this enforcement pause ended on July 1, 2024. Here are the important dates of when MoCRA went into effect:

Facility Registration Deadlines

• Existing Facilities:
  Cosmetic facilities in operation as of December 29, 2022, were required to register with the FDA by December 29, 2023. This requirement ensures that all facilities involved in cosmetic manufacturing or processing are known to the FDA, supporting traceability and consumer safety.
• New Facilities:
  Facilities established after December 29, 2022, must register within 60 days of either December 29, 2023, or the start of their cosmetic manufacturing or processing activities, whichever is later.

Product Listing Requirements

• By December 29, 2023, all cosmetic manufacturers were required to submit a list of their products to the FDA, including details such as product names, ingredients, and intended uses. For lash artists, this means that the products you use should now be listed with the FDA by the brands or manufacturers that supply them, ensuring greater transparency and better ability to find where issues are coming from.

Lynk-Gel, and all illumino products, are made at a MoCRA-compliant facility so you can apply lashes knowing that your products are safe to use.

Steps Lash Artists Can Take to Ensure MoCRA Compliance

As a lash artist, while you may not be directly responsible for MoCRA compliance, understanding how to work within these guidelines can help keep your clients safe and protect your business. Here are some things you can do:

1. Verify Your Suppliers’ Compliance

• Why It Matters: The products you use should come from manufacturers who are compliant with MoCRA regulations, ensuring they meet the FDA’s safety and transparency requirements.
• What You Can Do: When purchasing products, including adhesives, check with your suppliers to confirm that their facilities and products are registered and listed with the FDA. Most reputable suppliers will be transparent about their compliance status.

2. Stay Informed on Product Safety Updates

• Why It Matters: MoCRA requires manufacturers to report adverse events and maintain transparent records. Staying updated on any safety recalls or reports linked to the products you use helps you avoid potential risks.
• What You Can Do: Regularly check FDA updates on the products you use, or sign up for alerts related to cosmetic product safety. You can also ask your suppliers if they notify clients about product recalls or safety issues.

3. Understand Labeling Requirements and Directions for Use

• Why It Matters: MoCRA mandates clear labeling, including all ingredients, potential allergens, expiration dates, and warnings. Proper labeling helps you make informed choices about the products you use and provides clients with safe, high-quality results.
• What You Can Do: Always read product labels carefully and look for any special instructions, warnings, or professional-use-only labels.

4. Create a System for Monitoring Adverse Reactions

• Why It Matters: If a client experiences an adverse reaction, having a system for tracking and reporting it can help protect your clients and demonstrate your commitment to safety.
• What You Can Do: Keep records of products used and any adverse reactions clients may have to specific products, and report serious reactions to the FDA through MedWatch if necessary. This record-keeping is also valuable if any legal issues arise with clients.

5. Build Trust with Transparency

• Why It Matters: By choosing products from MoCRA-compliant manufacturers and educating your clients on the safety standards you uphold, you build trust and loyalty.
• What You Can Do: Communicate with clients about the steps you take to ensure product safety and compliance.

By taking these steps, you can help prevent problems before they happen. This can help give both you and your clients peace of mind about the safety of the products you use.

 

Exemptions and Exceptions Under MoCRA

MoCRA has set requirements for facility registration and product listing, but several exemptions and exceptions exist. Understanding these provisions is crucial for compliance.

Exemptions to Know:

1. Small Business Exemption:

• Small businesses with lower revenue or manufacturing output may be exempt from certain MoCRA requirements. However, this exemption does not apply to products that are injected, alter appearance for over 24 hours, or come into contact with the eye. For lash artists, this means any product you use that touches the eye, such as adhesives, must still comply with MoCRA’s registration and listing requirements.

2. Products Regulated as Drugs or Devices:

• Products regulated as drugs or medical devices, such as certain lash serums or devices with therapeutic claims, are exempt from MoCRA’s cosmetic-specific registration and listing requirements. These products may be subject to different FDA standards.

3. Products for Professional Use Only:

• Certain products intended exclusively for professional use, like lash adhesives, may have special regulatory considerations under MoCRA. While MoCRA does not change how these products are regulated, they must be clearly labeled as "for professional use only."

 

Voluntary Listings Under MoCRA

In addition to mandatory registration and listing requirements, manufacturers can voluntarily list their products with the FDA. Voluntary listings show a manufacturer’s commitment to product safety and transparency.

Why It Matters for Lash Artists:

Although voluntary listings are not required, they offer additional peace of mind. Products with voluntary FDA listings are more likely to have undergone thorough safety testing, providing extra assurance regarding their quality and safety.

 

Wrapping Up: How  MoCRA Affects You and Your Business

MoCRA introduces several important changes to cosmetic regulations. Here's a quick recap of the key points that directly affect you as a beauty professional:

• Mandatory facility and product registration with the FDA
• Following Good Manufacturing Practices (GMPs) to ensure safe production
• Reporting adverse events related to products
• Providing proof of safety for products
• New labeling requirements for transparency
• Increased enforcement powers for the FDA to regulate and monitor products

Understanding these regulations will help you maintain a safe business and feel more confident in the products that you choose. Keeping open lines of communication with your manufacturer is important to make sure that they are properly registered and compliant. If you ever have any concerns, make certain that you report them, or at least reach out to the FDA to get clarification. These updates will help you protect your clients and your business, without you having to worry about products that are subpar from shady factories. MoCRA is the first update in many years to keep us safe, but there may be more. Keep your eyes out and ears open for any future laws or updates.

 

Frequently Asked Questions (FAQ)

1. Do I need to register my facility with the FDA as a lash artist? No, MoCRA requires that manufacturers and processors of cosmetic products register their facilities with the FDA. As a lash artist, your focus should be on ensuring that the products you use come from registered and compliant facilities.
2. What types of products are exempt from MoCRA? Certain products, like those that are regulated as drugs or medical devices (such as lash serums with therapeutic claims or sunscreen), are exempt from MoCRA’s cosmetic-specific regulations, but may have other regulations. Additionally, small businesses and products only used for professional applications (like professional-grade lash glue) may have specific exemptions, though products that come into contact with the eye must still comply.
3. What happens if I use a non-compliant product in my lash business? Using non-compliant products can put your clients at risk, potentially leading to safety issues like allergic reactions or infections. It may also harm your business reputation and lead to legal consequences if safety standards are not met and there are any adverse effects.
4. How can I stay updated on MoCRA regulations and compliance? Sign up for FDA updates and subscribe to alerts from your suppliers about any changes, recalls, or new product listings. Staying informed helps you maintain compliance and keep your clients safe.
5. Are there any penalties for non-compliance? Yes, manufacturers that fail to comply with MoCRA may face penalties, including product recalls, fines, and legal action. As a lash artist, using non-compliant products could also expose your business to potential liability.

Written By: J. Thorn