The Modernization of Cosmetics Regulation Act (MoCRA) has brought significant changes to the cosmetic industry, requiring manufacturers, packers, and distributors to comply with updated safety and regulatory standards. Among these changes is the introduction of mandatory cosmetic product listing with the U.S. Food and Drug Administration (FDA).

Product listings aim to enhance consumer safety, improve transparency, and ensure that the FDA maintains an accurate inventory of cosmetics marketed in the United States. This process benefits both the industry and consumers by fostering accountability and enabling better oversight of potential safety concerns.

In this article, we’ll break down MoCRA’s product listing requirements, outline the steps for submission, and provide tips to ensure compliance.

The Purpose of Product Listing

MoCRA’s product listing requirements aim to establish greater accountability and transparency within the cosmetics industry. By requiring detailed submissions for every product marketed in the U.S., the FDA can monitor trends, address safety concerns, and respond to emergencies more effectively.

Why Product Listings Are Essential

• Consumer Safety: Product listings help the FDA quickly identify and recall hazardous products if safety issues arise.
• Regulatory Oversight: They provide the FDA with comprehensive data on products, ingredients, and their manufacturers or distributors.
• Industry Accountability: Listings ensure companies adhere to MoCRA’s requirements, promoting fair competition and trust in the market.

Broader Impacts of Product Listing

• Improved Public Health: Accurate product data enables better risk management and safety assessments.
• Streamlined Communication: The FDA can reach companies faster regarding compliance, recalls, or ingredient safety concerns.
• Global Market Access: Meeting MoCRA’s listing standards reinforces a brand’s reputation and facilitates access to other regulated markets.

Who Must Submit a Product Listing?

Under MoCRA, cosmetic product listing requirements apply to specific entities involved in the production or marketing of cosmetics in the United States. Understanding who is responsible for compliance is critical to meeting FDA regulations.

Responsible Parties

• Manufacturers: Entities that produce cosmetics for distribution in the U.S. are required to submit product listings.
• Packagers: Companies responsible for packaging cosmetics must ensure that all packaged products are properly listed if they are also the manufacturers.
• Distributors: Firms that market cosmetics under their brand name, even if another entity manufactures the product, are responsible for submitting product listings.
• Contract Manufacturers: Third-party manufacturers producing private-label cosmetics must collaborate with brand owners to ensure accurate product listing submissions.

Exemptions

While most cosmetics marketed in the U.S. fall under MoCRA’s product listing requirements, there are key exemptions:

• Small Businesses: Companies with less than $1 million in annual gross sales of cosmetics, excluding sales from affiliates or related entities, are exempt from the listing requirements.
• Certain Categories of Cosmetics: Products classified as soap (meeting specific FDA definitions) or cosmetics not intended for marketing in the U.S. are excluded.

Collaboration Between Entities

For companies with complex supply chains:

• Brand Owners: Typically hold primary responsibility for submitting listings, especially if multiple entities are involved.
• Manufacturers and Distributors: Should collaborate to ensure all necessary product details, including ingredients and labels, are accurately provided.

With a clear understanding of who is required to submit listings, the next section will focus on Information Required for Product Listings.

Information Required for Product Listing

Submitting a compliant cosmetic product listing under MoCRA requires providing specific details about the product, its ingredients, and associated facilities. Ensuring accuracy and completeness is vital, as incomplete or inaccurate listings can result in non-compliance and potential regulatory scrutiny.

For each cosmetic product, companies must identify the product by its marketed name and its category, such as skincare, makeup, or fragrance. Additionally, a full list of ingredients must be provided, using the International Nomenclature of Cosmetic Ingredients (INCI) naming conventions. While the concentration of ingredients is not typically required, the FDA may request additional details in specific circumstances. Accurate ingredient information not only ensures compliance but also supports consumer safety.

Manufacturing or processing facilities associated with the product must be clearly identified in the listing. This includes the facility’s name, address, and its MoCRA-assigned registration number. This linkage between products and facilities strengthens accountability across the supply chain.

The product label must also be submitted as part of the listing. This includes a digital copy or image showing essential details such as the brand name, net quantity, directions for use (if applicable), and any warnings or precautions, such as allergen notifications. This requirement ensures transparency and compliance with labeling standards.

Additionally, the entity responsible for the listing must provide their name and contact information, allowing the FDA to address inquiries or concerns directly. For new products, the initial listing must be submitted within 120 days of marketing the product in the U.S. Updates to the listing, such as ingredient changes or label modifications, must be made annually or whenever significant changes occur.

Including all required information in the listing demonstrates a commitment to compliance with MoCRA and ensures smoother interactions with the FDA. In the next section, we’ll explore the process of Submitting Product Listings to the FDA, including tools and tips for efficiency.

Submitting Product Listings to the FDA

Under MoCRA, submitting cosmetic product listings is a key compliance step, requiring businesses to accurately provide product and facility information to the FDA. This process is managed through the Cosmetic Direct portal, a dedicated platform designed for ease and security in regulatory submissions.

Steps for Submission:

The FDA has developed Cosmetics Direct, an electronic submission portal designed for the registration and listing of cosmetic product facilities and products. This user-friendly tool allows for the creation, validation, and submission of Structured Product Labeling (SPL) files without the need for the Electronic Submissions Gateway (ESG).

1. Accessing Cosmetic Direct:

• Companies must register for an account with the FDA and gain access to the Cosmetic Direct portal. This registration process ensures secure transmission of sensitive information.
• Before submission, ensure all required documentation and information are complete to avoid delays.

1. Required Submission Details:

• Product Information: Include the marketed product name, intended use (e.g., skincare, makeup), and all ingredients listed by their International Nomenclature of Cosmetic Ingredients (INCI) names.
• Manufacturing Facility Details: Provide the facility name, address, and FDA registration number for each facility where the product is manufactured.
• Label Images: Submit clear, high-resolution digital images of the product’s label, displaying all required information, including brand name, ingredients, and any warnings or usage instructions.
• Responsible Person’s Information: Identify the person or entity responsible for ensuring MoCRA compliance, along with their contact details.

1. Updates and Amendments:

• Product listings must be kept up-to-date. If a product is reformulated or its labeling changes, the Responsible Person must submit an update within 120 days of the change.
• An annual update is also required to confirm the accuracy of previously submitted information.

Submission Tools and Guidance: The FDA provides step-by-step instructions and resources for using Cosmetic Direct, including templates and detailed guidance for data formatting. Utilizing these resources minimizes submission errors and ensures compliance with MoCRA’s strict requirements.

Benefits of Accurate Submission: Submitting accurate and complete product listings not only fulfills MoCRA requirements but also reflects a company’s dedication to consumer safety and regulatory transparency. By leveraging Cosmetic Direct effectively, businesses can streamline their compliance processes and maintain a strong position in the marketplace.

Maintaining Compliance and Meeting Deadlines

Ensuring compliance with MoCRA’s product listing requirements demands vigilance and attention to regulatory timelines. Since the enactment of MoCRA, key deadlines have shaped how companies approach their responsibilities.

Past Deadlines Under MoCRA:

• December 29, 2023: By this date, all existing cosmetic products marketed in the U.S. prior to MoCRA’s enactment were required to be listed with the FDA. Businesses that failed to meet this initial deadline may now face additional scrutiny or penalties.
• March 29, 2024: This date marked the deadline for facilities to register with the FDA, ensuring that all manufacturing locations were accounted for under MoCRA’s requirements.

Ongoing and Future Obligations:

• Annual Updates: As of 2024, companies are required to update their product listings annually to ensure accuracy. These updates must confirm or revise information related to product formulations, labeling, and manufacturing facilities.
• 120-Day Updates for Changes: For any significant product or facility changes—such as reformulations, rebranding, or new manufacturing locations—the Responsible Person must submit an updated product listing within 120 days of the change.

Consequences of Non-Compliance:

Failure to comply with these deadlines can result in:

• FDA-issued Warning Letters or requests for corrective action.
• Delays in market access or restrictions on sales.
• Damage to brand reputation and consumer trust.

Best Practices for Ongoing Compliance:

1. Schedule Regular Reviews:

• Create a compliance calendar to track submission deadlines, including the annual update and any anticipated product changes.
• Periodically audit product labels and formulations to ensure they align with submitted information.

1. Leverage Technology:

• Utilize tracking tools or compliance software to maintain accurate records of product formulations, facility registrations, and submissions.
• Assign automated reminders for submission deadlines to avoid oversight.

1. Engage a Compliance Team:

• Designate qualified personnel to oversee MoCRA-related submissions and updates.
• Partner with consultants or legal advisors familiar with FDA requirements to navigate complex regulatory scenarios.

1. Maintain Transparent Communication:

• Collaborate with suppliers and manufacturers to ensure data accuracy and timeliness.
• Notify the FDA promptly of any issues that could delay submissions or updates.

By adhering to these practices and staying ahead of submission deadlines, businesses can confidently navigate MoCRA’s regulatory landscape while building consumer trust through their commitment to safety and transparency.

Key Takeaways for Product Listing Compliance

Navigating MoCRA’s product listing requirements is essential for cosmetic companies aiming to maintain compliance and consumer trust. The following key points summarize the critical elements of effective compliance:

Understanding MoCRA’s Scope

MoCRA introduced a new regulatory framework for cosmetics, requiring product listings and facility registrations to enhance transparency and safety across the industry. Compliance is mandatory for both domestic and foreign manufacturers marketing in the U.S.

Meeting Submission Deadlines

• Initial submissions for existing products were due by December 29, 2023, while facilities had to register by March 29, 2024.
• Annual updates are now required, and changes must be submitted within 120 days to maintain accurate records.

Preparing and Submitting Listings

• The Responsible Person must ensure submissions include key details like:
  • Product name and intended use.
  • Ingredient list and formulation.
  • Facility information for each product.
• Submissions are managed electronically through the FDA’s Cosmetics Direct portal, streamlining the listing process.

Avoiding Non-Compliance Penalties

Failure to comply can result in enforcement actions, restricted market access, and reputational damage. Staying proactive is critical for avoiding unnecessary risks.

Best Practices for Compliance Success

1. Maintain accurate and up-to-date records for all product formulations and facilities.
2. Utilize technology to streamline submissions and monitor deadlines.
3. Regularly audit internal processes and labeling to ensure alignment with FDA requirements.
4. Seek professional guidance when needed, particularly for navigating complex regulatory changes.

By staying informed, embracing technological tools, and fostering a culture of compliance, companies can meet MoCRA’s requirements while demonstrating their dedication to product safety and transparency. Compliance not only fulfills regulatory obligations but also strengthens consumer confidence, paving the way for long-term success in the competitive cosmetics market.