Introduction
The Modernization of Cosmetics Regulation Act of 2022 (MOCRA) has been a major update to the U.S. beauty and cosmetics industry, marking the most significant regulatory update in the U.S. since the Federal Food, Drug and Cosmetic Act of 1938.
MOCRA introduced a completely new framework for cosmetic safety and quality control. It places greater responsibility on manufacturers, producers, distributors, and brand owners of beauty products and cosmetics in general.
Our goal with this handbook is to highlight critical compliance obligations as well as suggest compliance best practices for beauty brand owners.
Frequently Asked Questions
Brand owners are responsible for choosing adequate product development and manufacturing partners that can ensure adequate safety substantiation for their products as well as ensure proper labeling requirements are met.
Brand owners, if not exempt, are required to list their products with the FDA and maintain the listings updated.
Brand owners are required to report adverse events to the FDA.
In a private label or white label arrangement, brand owners, if not exempt, are responsible for listing their products with the FDA.
While brand owners are not required to maintain production records, they may be required to present them.
The FDA was given broad authority to request information and documentation from brands.
To ensure compliance, brand owners should partner-up with manufacturers that observe best practices in documentation and record-keeping so they can be properly supported when and if needed.
In a private label or white label arrangement, cosmetic labels should include the name and contact information of the brand owner (e.g. “Distributed by MY BRAND NAME LLC”).
Brand owners should look for MOCRA-compliant product development and manufacturing partners, registered with the FDA and able to provide all the necessary information and documentation to support the brand obligations.
Need help transitioning your products into a MOCRA-compliant facility? Reach out to us today.
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Table of Contents
Understanding MOCRA
Key terms
Responsible Person (RP): the link in the supply chain that is closest to the end consumer. This could be the manufacturer, packer, distributor, or, most commonly, the brand owner.
The name and contact information of the RP must be included on all product labels.
The FDA defines key responsibilities for brand owners:
- Listing their products with the FDA;
- Handling adverse events;
- Ensuring product safety;
- Ensuring proper product labeling.
Adverse Event: Any health-related negative effect associated with using a cosmetic product.
Serious Adverse Event: A health event that results in: death, life-threatening experiences, hospitalization, long-term disability, birth defects, infections, disfigurement (e.g., severe rashes, burns, hair loss, medical or surgical intervention to prevent any of the above.
What is considered a cosmetic product?
The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines cosmetics as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body … for cleansing, beautifying, promoting attractiveness, or altering the appearance” [FD&C Act, sec. 201(i)].
MOCRA amended the FD&C Act to include “cosmetic product” which is defined as “a preparation of cosmetic ingredients with a qualitatively and quantitatively set composition for use in a finished product” [FD&C Act, sec. 361].
It is important to note that cosmetic products may not be labeled or marketed as “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” or “intended to affect the structure or any function of the body of man or other animals” [FD&C Act, sec. 201(g)(1)].” as that would meet the criteria of a drug, and would require a completely different set of rules.
For this guide we will focus solely on beauty and cosmetic products.
MOCRA exemption for small businesses
Small businesses, defined as those with average annual U.S. sales under $1,000,000 are exempt from some MOCRA requirements.
ⓘ As a small brand owner, it is important to partner with distributors and manufacturing partners that will be able to help you transition into the necessary compliance processes later, when you cross through the small business threshold as your brand grows.
It’s easier to start the business compliant and scale it from there than it is to transition later.
Cosmetic product listing
For non-exempt businesses, the brand owner or responsible person must submit a product listing for each cosmetic product, as required by the FDA.
The listing must be submitted within 120 days of first entering interstate commerce.
- All product listings must be submitted through Cosmetics Direct, the FDA’s electronic portal;
- Listings must be updated annually;
Each product listing will include:
- FDA Facility registration number(s) where the product is manufactured or processed;
- Name and contact details of the responsible person and the product name as shown on the label;
- Applicable cosmetic categories;
- A complete list of ingredients (including flavors, colors, and fragrances);
- Product listing number (if previously assigned).
ⓘ To stay compliant as a brand owner, you should partner exclusively with manufacturers that are registered with the FDA and able to provide you their registration number.
Note: a single submission (flexible listing) can cover multiple cosmetic products with identical formulations, differing only in flavor, color, fragrance, or quantity.
Upon registration or listing, the FDA will assign a product listing number. The product listing number will not be made public.
For further information on how to submit a product listing, the FDA has made available a step-by-step tutorial.
Cosmetic product labeling
Cosmetic product labels must include a domestic address, phone number, or electronic contact (such as a website or a QR code) that allows the responsible person to receive reports of adverse events.
There are no regulations or requirements under current United States law that require cosmetic manufacturers to print expiration dates on the labels of cosmetic products.
All required information must be displayed prominently and in reasonably simple terms. Ingredients must be listed accurately, under their commonly accepted scientific name, in reverse order of concentration. Learn more about labeling guidelines and required labeling information for cosmetics.
Adverse event reporting and record-keeping access
The responsible person must report any serious adverse event associated with a cosmetic product in the U.S. to the FDA.
Reports must be submitted via the MedWatch online form within 15 business days from receiving the serious adverse event report and must include a copy of the product label from the retail packaging.
Adverse event records must be kept for six years, or three years if the responsible person qualifies as a small business and does not handle certain high-risk products.
In the event that the FDA suspects a cosmetic product may be adulterated or may pose a serious health risk, responsible persons and facilities may be required to provide access to a wide range of records. This applies to the product under investigation and any other products the FDA reasonably believes could be similarly affected.
Records include, but are not limited to manufacturing records, records of testing and results of testing, product development records, product or ingredient documentation, among others.
The FDA’s authority under MOCRA allows even broader record-keeping and inspection beyond these specific requirements.
In general terms, the FDA has the authority to request a very wide range of documentation regarding ingredients and their sources, as well as manufacturing records. As a brand owner, be prepared to comply.
ⓘ As a brand owner it is critical to partner up with manufacturing partners that are able to provide proof of good documentation practices and able to maintain all the necessary records on your behalf.
Manufacturers that are GMP-certified by a reputable auditing entity are more likely to have the necessary tools to support your compliance as a brand owner.
Safety substantiation
Cosmetic products must have adequate substantiation of safety, meaning there is sufficient evidence to prove the product is safe for consumers when used as directed.
This includes maintaining records of product development, manufacturing records, product and ingredient tests, studies, research, and expert analyses that can support the product’s safety.
ⓘ A reputable manufacturing partner will be a critical component of maintaining compliance as a brand owner.
To stay compliant, you should work with manufacturers that adopt best practices in record-keeping and will be able to provide any necessary documentation if and when needed.
While not a guarantee, a reputable GMP-certification is a good indication of a reliable record-keeping process.
Although brands are ultimately responsible for the safety of the products they bring to market, manufacturers that take the regulatory landscape seriously will be able to provide all necessary support for safety substantiation.
A few key indicators of a reliable manufacturing partnership, from the brand owner perspective:
- You have an established routine of reviewing and approving finished product specification sheets for each production batch with your manufacturer.
- Your product is consistent from batch to batch.
- Your manufacturer is able to quickly provide Certificate of Analysis upon request.
- Your manufacturer is registered with the FDA.
- Your manufacturer is GMP-certified by a reputable auditing agency.
While these items are not sufficient to ensure MOCRA compliance, their presence is a sign of a positive manufacturing partnership and their absence should be a topic of concern.
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Conclusion
By understanding the requirements set forth by MOCRA, from cosmetic product listing and labeling to safety substantiation, record-keeping and adverse event reporting, brands can better navigate the complexities of this new regulatory environment.
Establishing a partnership with reputable manufacturers who uphold Good Manufacturing Practices (GMP) is crucial for maintaining compliance and ensuring product safety.
In this changing landscape, being proactive rather than reactive will be the key to thriving under MOCRA.
By embracing these guidelines, beauty brand owners can confidently create innovative products that resonate with consumers while ensuring their ability to comply with all regulations and ensure product safety and quality.
Disclaimer: This article was written by FormuNova – We are a MOCRA-compliant cosmetics contract manufacturing company.
