[interview] U.S. FDA on MoCRA: New Authority, Fragrance Allergens, Animal Testing and More

The Modernization of Cosmetic Regulation Act of 2022 (MoCRA) is the most significant expansion of the FDA’s authority to regulate cosmetics since the Federal Food, Drug and Cosmetic (FD&C) Act of 1938. In this interview, the FDA describes its new MoCRA-mandated authorities, 5 requirements for industry (and how it will enforce them), the mandate for listing fragrance allergens, why animal testing was omitted from MoCRA, how the FDA is assisting companies with compliance and more.

Learn about a new tool for MoCRA's adverse event reporting mandates.

"In the United States, federal laws are enacted by Congress, which authorizes certain government agencies, such as the Food and Drug Administration (FDA), to create regulations," the FDA writes, framing the following discussion. "The Office of Legislation (OL) directs and manages FDA’s interactions with Congress and ensures that Congress has the most accurate and up-to-date information regarding FDA regulatory actions.

"On December 29, 2022, President Biden signed into law the Modernization of Cosmetic Regulation Act of 2022 (MoCRA), which expands FDA’s authority over cosmetics and the ingredients in them. MoCRA is the most significant expansion of FDA’s authority to regulate cosmetics since the Federal Food, Drug, and Cosmetic (FD&C) Act was passed in 1938. [It] provides new authorities to FDA, directs FDA to issue certain regulations, and establishes new requirements for industry."

Learn what MoCRA got wrong, according to one reader's opinion.

Reporting Requirements Before MoCRA 

As the FDA outlines, prior to MoCRA:

• Manufacturers were not required to register their cosmetic facilities or file their product listings;
• The FDA published nonbinding recommendations in a draft guidance on cosmetic Good Manufacturing Practices; and
• The industry was not required to submit adverse event reports (including serious adverse event reports) to the FDA.

2 New MoCRA-mandated FDA Authorities

Now, new FDA authorities provided by MoCRA, include:

1. Records access: "If certain conditions are met, the FDA can access and copy certain records related to a cosmetic product, including safety records," the FDA explains.
2. Mandatory recall authority: "If the agency determines there is a reasonable probability that a cosmetic is adulterated or misbranded and the use of or exposure to the cosmetic will cause serious adverse health consequences or death, FDA has the authority to order a mandatory recall if the responsible person refuses to do so voluntarily," the agency continues.

MoCRA also requires that FDA establish regulations for:

• Good Manufacturing Practice (GMP) requirements for facilities that manufacture cosmetic products;
• Fragrance allergen labeling requirements (described below); and
• Standardized testing methods for detecting and identifying asbestos in talc-containing cosmetic products.

5 New MoCRA Mandates for Industry

According to the FDA, besides providing the agency with new authorities, new requirements for industry are mandated by MoCRA. These include the following.

1. Adverse event reporting: A responsible person is required to report serious adverse events associated with the use of cosmetic products in the United States to FDA within 15 business days;
2. Facility registration: Manufacturers and processors must register their facilities with FDA and renew their registration every two years;
3. Product listing: A responsible person must list each marketed cosmetic product with FDA, including product ingredients, and provide any updates annually;
4. Safety substantiation: For safety substantiation, under U.S. law, cosmetic products and ingredients do not need FDA approval before they go on the market. The one exception is certain color additives, which must be approved for their intended use. Companies and individuals who market cosmetics have a responsibility to ensure the safety of their products. MoCRA does not change this requirement, however under MoCRA, a responsible person is now required to ensure and maintain records supporting adequate safety substantiation of their cosmetic products. Manufacturers can use relevant safety data that is already available to support the safety of their products. Animal testing is not a requirement for marketing a cosmetic product. It’s important, however, that all data used to support the safety are derived from scientifically robust methods; and 
5. Product labeling: Cosmetics must be labeled properly as per the FD&C Act and the Fair Packaging and Labeling Act (FPLA). MoCRA establishes that cosmetic labeling must include contact information such as domestic address, phone number or electronic contact so that the responsible person can receive adverse event reports.
• Cosmetic products for professional use must include a clear and prominent statement that the product shall be administered or used only by licensed professionals, and it also must include the same information on its label required of cosmetic products intended for consumers.

How will the FDA Prioritize, Monitor and Enforce MoCRA Checks and Balances?

"FDA monitors cosmetics through surveillance, inspections and compliance programs," the agency writes. "FDA’s enforcement actions include product seizures, injunctions and prosecution. We prioritize removing products from the market that pose a risk to public health."

The agency adds, "Businesses should follow our social media handle, @FDACosmetics on X (formerly Twitter), and subscribe to email updates at the Cosmetics News & Events | FDA Web page to stay up to date as we continue to make more announcements related to MoCRA."

Requirement to List Fragrance Allergens:
In Progress

The FDA explains the requirement to list fragrance allergens: "Currently, if a cosmetic is marketed on a retail basis to consumers, it must have a list of ingredients. In most cases, each ingredient must be listed individually. But under U.S. regulations, fragrance and flavor ingredients can be listed simply as 'Fragrance' or 'Flavor' because the FPLA is not allowed to be used to force a company to tell 'trade secrets.'

"Fragrance and flavor formulas are complex mixtures of many different natural and synthetic chemical ingredients, and they may include cosmetic components in mixtures that are most likely to be 'trade secrets.' To learn more, see Fragrances in Cosmetics | FDA."

The agency continues, "FDA has been working with industry and the major cosmetic trade organizations to have manufacturers voluntarily label any known allergens found in their products. Some firms that market their cosmetics in the United States list fragrance ingredients on the product labels, especially if the fragrance ingredients are known allergens. To learn more about the common allergens found in cosmetic products and what consumers can do, see Allergens in Cosmetics | FDA.

"However, MoCRA adds several new authorities to chapter VI of the FD&C Act for FDA, including explicit authority to require manufacturers to list specific fragrance allergens in the ingredient list on the product label, which would include the listing of a fragrance allergen that might be found within the allowable 'Fragrance' or 'Flavor' declaration. Specifically, MoCRA requires that FDA establish regulations for fragrance allergen labeling requirements. FDA is developing these regulations."

Was the Definition for What Constitutes a Cosmetic Reconsidered?

"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)]," the FDA reminds us. "Among the products included in this definition are skin moisturizers, perfumes, lipsticks, fingernail polishes, makeup, cleansing shampoos, permanent waves, hair colors and deodorants, as well as any substance intended for use as a component of a cosmetic product.

"The FD&C Act defines drugs, as 'articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease' and 'articles (other than food) intended to affect the structure or any function of the body of man or other animals'. Some products meet the definitions of both cosmetics and drugs.

"MoCRA did not change the definition of cosmetic but 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 did not change the definition of cosmetic in the FD&C Act."

Why Was No Animal Testing Ban Included in MoCRA?

"At this time, neither the law nor FDA regulations require specific tests to demonstrate the safety of cosmetic products or ingredients. As such, animal testing is not a requirement by FDA for marketing a cosmetic product. MoCRA states that it is the sense of the Congress that animal testing should not be used for the purposes of safety testing on cosmetic products and should be phased out with the exception of appropriate allowances.

"FDA has a long-standing commitment to the replacement, reduction and refinement (the 3Rs) of animal testing, including by promoting the development and use of new technologies to better predict human and animal responses to substances whose uses are relevant to our regulatory mission.

"In December 2017, FDA released the Agency’s FDA's Predictive Toxicology Roadmap | FDA. In January 2021, FDA published the report Advancing New Alternative Methodologies at FDA providing examples of alternative methodologies being investigated at FDA and, in some cases, in partnership with others. More information, including examples of FDA programs and projects to advance alternative methods, can be found on the Advancing Alternative Methods at FDA | FDA Web page.

"While FDA supports the development and use of alternative methods that are backed by science and provide the necessary data showing whether products are safe, it is important to recognize that animal testing may still be necessary, in certain circumstances, to thoroughly evaluate certain health risks of products used on people."

How is the FDA Helping Companies Comply with MoCRA?

Lastly, C&T wondered what the FDA is doing to help assure companies are complying with MoCRA mandates. The FDA outlines several measures.

"... On December 18, 2023, FDA issued a final guidance for industry on cosmetic product facility registrations and product listings, as mandated by MoCRA. The guidance assists stakeholders with cosmetic product facility registration and product listing submissions to FDA by describing who is responsible for making the registration and listing submissions, what information to include, how to submit, when to submit and certain exemptions to the registration and listing requirements.

"In November 2023, FDA issued guidance on its intent to delay enforcement of the requirements for cosmetic product facility registration and cosmetic product listing requirements under MoCRA for six months until July 1, 2024, to help ensure that industry has sufficient time to submit facility registration and product listing information.

"To help industry comply with MoCRA’s registration and listing requirements, FDA has developed multiple platforms by which owners or operators of facilities that manufacture or process cosmetic products can register their facilities, and by which manufacturers, packers, and/or distributors can list their products. For more information, see https://www.fda.gov/cosmetics/registration-listing-cosmetic-product-facilities-and-products."