Did you know that the average person uses six to 12 cosmetics daily? That was what the data reported as of 2023, according to the FDA. If you’re reading this article, chances are you’re a beauty lover in the upper part of that range. And, it’s important to understand the regulation behind those products. Who is making sure that what you’re using is safe, properly packaged and transparent about ingredients? On December 29, 2022, President Biden signed into law the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). If you follow any beauty influencers on social media, chances are you’ve heard this acronym before. Here, we outline all the details of the law, and how it impacts the products we love.
What Is MoCRA?
On December 29, 2022, President Biden signed into law the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). This law was established to expand the U.S. Food and Drug Administration’s (FDA) authority over cosmetics and their ingredients. “MoCRA is the most significant expansion of the FDA’s authority to regulate cosmetics since the Federal Food, Drug and Cosmetic (FD&C) Act was passed in 1938,” an FDA representative tells us. “Under MoCRA, the agency will have more information about which cosmetics are being manufactured and distributed in the U.S. It will also have increased information about what is in the products being sold.”
Does MoCRA Cover All Categories in the Beauty Industry?
“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)],” says an FDA representative. “Among the products included are skin moisturizers, perfumes, lipsticks, fingernail polishes, makeup, cleansing shampoos, permanent waves, hair colors, and deodorants. This also includes any substance intended for use as a component of a cosmetic product.”
Additionally, the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) amended the FD&C Act to include “cosmetic product.” According to an FDA representative, a cosmetic product 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]. This new term applies to these amendments of the FD&C Act.” Sunscreen is not included in MoCRA because the FDA considers it a drug, not a cosmetic. For more information on which products are considered cosmetics under the law, click here.
The Primary Goals of MoCRA
MoCRA provides new authorities to the FDA including records access and mandatory recall authority. Regarding records access, under certain conditions, the FDA can access and copy certain records related to a cosmetic product. This includes safety records. Regarding recalls, the FDA now has the authority to order a mandatory recall if the responsible person refuses to do so. This would happen “if the agency determines that there is a reasonable probability that a cosmetic is adulterated or misbranded. And, if the use of exposure to the cosmetic will cause serious adverse health consequences or death.”
The “responsible person” is defined by the FDA as “the manufacturer, packer or distributor of a cosmetic product whose name appears on the label of such cosmetic product in accordance with section 609(a) of the FD&C Act or section 4(a) of the Fair Packaging and Labeling Act.”
New Requirements for Cosmetic Brands Under MoCRA
According to the FDA, MoCRA establishes new requirements for the beauty industry, as listed below.
- 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 the FDA within 15 business days.
- Facility Registration: Manufacturers and processors must register their facilities with the FDA and renew their registration every two years.
- Product Listing: A responsible person must list each marketed cosmetic product with the FDA, including product ingredients, and provide any updates annually.
- Safety Substantiation: Companies and individuals who manufacture or market cosmetics have a responsibility to ensure the safety of their products. Neither the law nor FDA regulations require specific tests to demonstrate the safety of individual products or ingredients.
- Product Labeling: Cosmetics must be labeled properly as per 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. This is so that the responsible person can receive adverse event reports. Cosmetics products for professional use must include a clear and prominent statement that the product shall be administered or used only by licensed professionals. It also must include the same information on its label required of cosmetic products intended for consumers.
MoCRA also requires that cosmetic brands comply with other regulations that the FDA will establish. These include requirements for Good Manufacturing Practice (GMP) and fragrance allergen labeling. Another regulation is standardized testing methods for detecting and identifying asbestos in talc-containing cosmetic products. Talc has been linked to both cancer and asbestos contamination. Though many products are now talc-free, it’s still out there. It’s often utilized in products to absorb moisture, increase the opacity of makeup or improve the feel of a product.
What’s Next From MoCRA That We Can Expect?
“July 1, 2024 is an important upcoming date for registration and listing,” says an FDA representative. “The FDA announced that we do not intend to enforce the requirements related to cosmetic product facility registration and cosmetic product listing for an additional six months after the December 29, 2023, statutory deadline, or until July 1, 2024, to provide regulated industry additional time to comply with these requirements.”
The FDA also announced that it does not intend to enforce the registration requirement for owners or operators of facilities that first engaged in manufacturing or processing a cosmetic product after December 29, 2022, or the listing requirement for cosmetic products first marketed after December 29, 2022, until July 1, 2024.
