The FDA Modernization of Cosmetics Regulation Act: What You Need To Know

The Consolidated Appropriations Act of 2023 was signed into law on December 29, 2022. Contained within the act was the Modernization of Cosmetics Regulation Act, 2022 (MoCRA). The new cosmetics act is the biggest change in the regulation of cosmetic products since the 1938 Federal Food, Drug, and Cosmetic Act. Ten years in the making, it gives the FDA additional authority to regulate cosmetic products.

What requirements will cosmetic manufacturers and processors need to comply with?

1. Good manufacturing practices (GMPs)
2. Safety substantiation
3. Adverse event reporting
4. Record-keeping requirements
5. Mandatory recall authority for the FDA
6. Additional labelling

As part of the rollout of the new regulation, the FDA will be required to publish new regulations to establish GMP requirements for facilities that manufacture or process cosmetic products. Like the GMP requirements in a pharmaceutical context, the FDA will have the authority to inspect a company’s records and facility to establish compliance with good manufacturing practices.

Companies must start working to ensure that their cosmetic manufacturing or processing facilities comply with MoCRA. To help with compliance, NSF provides certification services to NSF/ANSI 455-3, the industry-aligned GMP certification standard for cosmetics. NSF/ANSI 455-3 is the existing GMP standard with the greatest utility to maximise benefits and minimise limitations. It has the versatility and national control to meet the current and future needs of consumers, manufacturers, and regulators, domestically and globally.

MoCRA establishes an exemption from cosmetic GMP requirements for small-scale manufacturers or processors. Companies with average gross sales of less than $1 million per year over three years (this figure will be adjusted for inflation) will be exempt. However, it must be noted that companies manufacturing or processing certain high-risk products will not be covered under the exemption. These exempted products include:

• Injectables
• Products intended for internal use
• Products that come into contact with the mucus membrane of the eye

The manufacturer or processor will be required to appoint a Responsible Person to substantiate the safety of the products. This can be the product’s manufacturer, packer, or distributor whose name appears on the label. Substantiation will require tests, studies, and/or research analyses to assess the product’s safety.

Following the lead set by the pharmaceutical industry, manufacturers or processors will be required to submit adverse event reports within 15 business days of an event being reported to them. This will be the ultimate responsibility of the Responsible Person. After this, for a year after the initial adverse event report, the RP must submit to the FDA any new or relevant medical information related to the initial adverse event within 15 business days. Records of all events must be maintained for six years unless a small business exemption applies.

The role of the Responsible Person is, perhaps, one of the standout changes in the Modernization of Cosmetics Regulation Act. Companies will need to identify an individual or individuals who will serve in this role and ensure that they are fully trained in the duties and responsibilities of the Responsible Person.

Section 607 of the act requires all facilities to register with the FDA. Each facility will need to renew its registrations every two years, and changes within the facility will need to be notified to the FDA within 60 days.

According to draught guidance issued by the FDA in August 2023, information that must be submitted in the facility registration includes:

• The name of the owner and/or operator of the facility;
• The facility’s name, physical address, email address, and telephone number;
• With respect to any foreign facility, the contact for the United States agent of the facility (name and phone number), and, if available, the electronic contact information (email);
• The facility registration number, if any, previously assigned;
• All brand names under which cosmetic products manufactured or processed in the facility are sold;
• The product category or categories and Responsible Person for each cosmetic product manufactured or processed at the facility; and
• Type of submission

The following optional information may also need to be included:

• Parent company name (if applicable);
• Facility DUNS Number; and
• Additional contact information for individuals associated with the registration.

The Responsible Person will be required to list each cosmetic product with the FDA and is expected to attest to the accuracy and veracity of the information submitted. In each case, the product listing will need to include the following:

• The facility registration number of each facility where the cosmetic product is manufactured or processed;
• The name and contact number of the Responsible Person and the name for the cosmetic product, as such name appears on the label;
• The applicable cosmetic category or categories for the cosmetic product (refer to Appendix A below);
• A list of ingredients in the cosmetic product, including any fragrances, flavours, or colours, with each ingredient identified by the name, as required under section 701.3 of title 21, Code of Federal Regulations (or any successor regulations), or by the common or usual name of the ingredient;
• The product listing number, if any previously assigned; and type of submission (initial, update to content (annual), abbreviated renewal). Optional information expected to be included:
• Parent company name (if applicable);
• Type of business (as listed on the label), i.e., manufacturer, packer, or distributor;
• Image of the label;
• Product webpage link;
• Whether the cosmetic product is for professional use only;
• Responsible Person DUNS Number for address listed on product label;
• Unique Ingredient Identifiers (UNIIs); and
• Additional contact information for individuals associated with the listing.

Listings must be updated annually, while existing product listings must be submitted by December 29th, 2024.

As stated at the beginning of this article, MoCRA marks the most significant change in regulating cosmetic products since 1938. One of the most significant elements of the new act is that it will provide the FDA with enforcement powers. These include:

• Facility Suspension: if a product manufactured at that plant has a reasonable probability of causing serious harm or death.
• Access to Records: The FDA will have the power to access records if they believe the ingredients pose a serious threat of adverse health consequences.
• Misbranding: The agency will have the power to recall a product if it is adulterated, misbranded, or, again, poses a serious threat to human health.

The FDA will also be able to provide the Responsible Person with the opportunity to cease distribution and recall the product voluntarily. If this does not happen, the FDA will issue an order to cease distribution and institute a product recall. Companies should note that in the case of a mandatory FDA-requested recall, the agency will issue a press release and an image of the product to alert users of the recall, and this might have significant reputational consequences for the manufacturer or processor.

Existing regulations relating to labelling fragrances in cosmetic products will not change. However, MoCRA adds a new requirement for the manufacturer or processor to include fragrance allergens in the product.

Finally, the new act contains a pre-emption that prevents individual states in the United States from enacting or maintaining a requirement not identical to this Federal law.

MoCRA is the biggest cosmetic regulatory development in nearly a century. Companies are already preparing for the forthcoming GMP requirements. We are working with many companies – both brands and retailers - to help them to prepare. Contact NSF Nutrition and Wellness Certification today to speak with a member of our expert team and start on the path to MoCRA compliance.