Business & Commercial LitigationFDA Issues Final Guidance on Cosmetic Product Facility Registrations and Product Listings

On December 18, 2023, the U.S. Food and Drug Administration (FDA) announced new regulations over cosmetic facility registration and cosmetic product listing requirements, adding to the Modernization of Cosmetics Regulations Act of 2022 (MoCRA). Applicable organizations have until July 1, 2024 to determine what actions they must take to be compliant, as that is when the Agency has stated it will begin enforcing requirements. Below, a product liability defense lawyer from Fee, Smith & Sharp LLP explains what this could mean for your organization.

Organizations Required to Report for Industry Compliance

Any individual who owns or operates a facility that manufactures or processes cosmetics for sale or distribution within the U.S. should submit the appropriate information for compliance with FDA-required reporting. Applicable organizations will have to submit every relevant facility for registration and individual cosmetic product listings for review by the FDA. If your organization manufactures, packages, or distributes cosmetics, you most likely will need to report.

Some exceptions apply, including certain small businesses and certain entities such as an establishment that manufactures or processes cosmetics used for research that are not offered for retail sale. Either an owner / operator or another responsible individual whose products are manufactured or processed at a facility may submit the report. Reports must be renewed every two years.

Small businesses not required to report are those whose average gross annual sales of cosmetic products for the previous 3-year period is less than $1,000,000 adjusted for inflation and who do not manufacture or process cosmetic products described in Section 612(b) of the Federal Food, Drug and Cosmetic Act (FDCA). These products are defined as any of the following:

1. Cosmetic products that are designed to regularly come into contact with the mucous membrane of the eye
2. Injectable cosmetic products
3. Cosmetic products intended for internal use
4. Cosmetic products that are intended to customarily alter the appearance for more than 24 hours and are typically not intended to be removed by the customer

Cosmetics Direct Submission Portal

The FDA has provided a guidance document, which includes recommendations and instructions for the cosmetic industry to follow on submitting product listings and facility registrations as required under Section 607 of the FDCA.

During the FDA’s announcement, it revealed its new electronic submission portal, Cosmetics Direct, which is designed to make the registration and product listing submissions more efficient and user-friendly. Referred to as a Structured Product Labeling authoring tool, this portal provides easy-to-use data entry forms, performs initial validations, drafts and saves the product labeling information, and submits it to the FDA for internal processing. Paper forms are available, if necessary, but using the portal will speed up the approval process for all involved.

Information Cosmetic Industry Companies Need to Submit

Each cosmetic industry organization is required to submit a registration for each individual facility that handles cosmetics. They should submit the following for a facility registration:

• Their facility registration number or FDA Establishment Identifier
• Parent company name, if applicable
• Name of the owner / operator of the facility
• Address of the facility and contact information
• List all brand names that are manufactured, processed, or packaged at that facility
• List of the individuals responsible for each product
• Product category of each product
• The Facility’s Data Universal Numbering System (DUNS) number
• Additional contact information for anyone associated with registering

Each cosmetic industry organization should submit a product listing including:

• Facility registration number where it is manufactured or processed
• Name and contact information for the individual responsible for the product
• Name of the cosmetic product as it appears on the label
• Product category information
• List of ingredients in the cosmetic product, including fragrances, flavors, or colors
• Parent company name (if applicable)
• Type of business, whether manufacturer, packager, or distributor
• Image of the product label
• Product website URL
• Whether the cosmetic product is for professional use only
• Name of the individual responsible and the DUNS number for the address on the product label

A Note Regarding Privacy Concerns

In an attempt to increase honesty and visibility, the FDA has announced that it intends to share any relevant information with the public as it is allowed by law. This includes information requested by a Freedom of Information Act Request. However, the Agency will not release brand names that were associated with the facility registration submission, facility registration numbers, or product listing numbers that were assigned during the submission process.

Compliance Policy and Reporting

MoCRA regulations are intended to regulate the cosmetics industry to ensure the safety of their products. Cosmetic products include makeup, nail polishes, shaving cream, perfumes, cleansers for the face or body, hair products, moisturizers, injectable treatments, and many other products used by consumers on a daily basis. These guidelines allow the FDA the authority to shut down a facility or institute other penalties if they determine a product is likely to cause serious adverse health consequences for consumers.

A serious adverse event is defined as one that results in death, a life-threatening experience, inpatient hospitalization, an infection, significant disfigurement, or requires a medical or surgical intervention to prevent one of those severe reactions from occurring. If a product is determined with reasonable probability to mislead or cause a serious adverse health event, the FDA has the authority to order a mandatory recall if the organization refuses to do so on its own. Industry-responsible individuals are required to report adverse events 15 days after finding out by taking the following steps:

1. Download the MedWatch: FDA Safety Information and Adverse Event Reporting Program Mandatory (PDF).
2. Complete the form and include any additional product information possible, including scans of labels and images and medical records of the serious adverse event.
3. Email to cosmeticAERS@fda.hhs.gov, or;
4. Mail to:

FDA CDER Mail Center
Attn: Cosmetics MedWatch Reports
White Oak Campus, Building 22, G0207
10903 New Hampshire Ave.
Silver Spring, MD 20993

If you are struggling to understand the regulatory requirements now being issued for the cosmetics industry or simply need some help, come to Fee, Smith & Sharp LLP for legal advice. Our team is experienced in a wide variety of business law matters and can help ensure you do not have to deal with penalties for missing deadlines. Contact us today to speak to one of our business law attorneys and get started.