Jason Velligan
Associate Editor
Loyola University Chicago School of Law, JD 2024
The Food Drug & Cosmetic Act (FDCA) has been relatively unchanged regarding cosmetics since 1938. The United States cosmetics industry is primarily self-policing compared to the food, drugs, or medical device industries. CNN recently noted that around 5,000 adverse events relating to cosmetics are reported to the Food & Drug Administration (FDA), and 25% are considered serious. On December 22, 2022, Joe Biden signed the Modernization of Cosmetic Regulation Act of 2022 (MoCRA) to overhaul the cosmetics regulatory regime. The FDA’s oversight and policing of the cosmetics will belatedly resemble that of food, drugs, and medical devices.
Cosmetics
A “cosmetic” is an article intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance. Strangely, soap is excluded from this definition and is regulated by the Consumer Product Safety Council (CPSC).
MoCRA
MoCRA’s first major changes became effective on December 23, 2023. Manufacturers must register their facilities and submit their product listings to the FDA, ensure and substantiate the safety of their products, maintain adverse event records, and report them to the FDA. The FDA now has the authority to mandate cosmetics recalls. In mid-2024, the FDA must propose a rule identifying substances that are fragrance allergens. On December 29, 2024, companies must include their contact information on product labels through which they can receive adverse event reports. On December 29, 2025, the FDA must publish the final rule for current good manufacturing practices for cosmetics facilities and a report assessing PFAS and the safety and risks associated with its use.
Unpacking MoCRA
The FDA regulates food, drugs, and medical devices, similar to what MoCRA intends to do for the cosmetics industry. For many years, the FDA required food, drug, and medical device manufacturers to register their facilities. For decades, the FDA has required drug and medical device manufacturers to report adverse events concerning the safety of these products. The quality systems for FDA-regulated products are identified as current good manufacturing practices (CGMPs). These regulations outlining cGMPs for manufacturers ensure that products are manufactured with an eye toward safety for the individuals that will use or need the product. Food, drugs, and medical devices all require some form of label to be included with the product. The Agency for Toxic Substances and Disease Registry (ASTDR) has already identified many health risks related to PFAS. Does the FDA really need to do a report?
Why Now?
Cosmetics, with few exceptions, come into contact with or are directly applied to the skin, the largest organ of the human body. The average adult uses 12 cosmetics a day. The FDCA was untouched for 80 years when it came to cosmetics, and MoCRA is an attempt to fix the cosmetics regulatory conundrum.
MoCRA was introduced and signed into law in 2022. Thousands of lawsuits have been ongoing relating to Johnson & Johnson’s talcum powder, which is claimed to contain asbestos and cause ovarian cancer. Just over 8,000 lawsuits against multiple manufacturers of hair relaxers are being pursued by women who used the cosmetics and subsequently developed uterine cancers. Chemical companies that manufactured and sold PFAS or PFOAs for years have paid out $11.5 billion dollars relating to environmental damage related to them. The lawsuits exemplify when private individuals took it upon themselves to hold a small subset of individual cosmetics manufacturers accountable. MoCRA is needed to assure consumers of product safety and guidelines for cosmetic industry conduct in their manufacturing of these products.
Associate Editor
Loyola University Chicago School of Law, JD 2024
The Food Drug & Cosmetic Act (FDCA) has been relatively unchanged regarding cosmetics since 1938. The United States cosmetics industry is primarily self-policing compared to the food, drugs, or medical device industries. CNN recently noted that around 5,000 adverse events relating to cosmetics are reported to the Food & Drug Administration (FDA), and 25% are considered serious. On December 22, 2022, Joe Biden signed the Modernization of Cosmetic Regulation Act of 2022 (MoCRA) to overhaul the cosmetics regulatory regime. The FDA’s oversight and policing of the cosmetics will belatedly resemble that of food, drugs, and medical devices.
Cosmetics
A “cosmetic” is an article intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance. Strangely, soap is excluded from this definition and is regulated by the Consumer Product Safety Council (CPSC).
MoCRA
MoCRA’s first major changes became effective on December 23, 2023. Manufacturers must register their facilities and submit their product listings to the FDA, ensure and substantiate the safety of their products, maintain adverse event records, and report them to the FDA. The FDA now has the authority to mandate cosmetics recalls. In mid-2024, the FDA must propose a rule identifying substances that are fragrance allergens. On December 29, 2024, companies must include their contact information on product labels through which they can receive adverse event reports. On December 29, 2025, the FDA must publish the final rule for current good manufacturing practices for cosmetics facilities and a report assessing PFAS and the safety and risks associated with its use.
Unpacking MoCRA
The FDA regulates food, drugs, and medical devices, similar to what MoCRA intends to do for the cosmetics industry. For many years, the FDA required food, drug, and medical device manufacturers to register their facilities. For decades, the FDA has required drug and medical device manufacturers to report adverse events concerning the safety of these products. The quality systems for FDA-regulated products are identified as current good manufacturing practices (CGMPs). These regulations outlining cGMPs for manufacturers ensure that products are manufactured with an eye toward safety for the individuals that will use or need the product. Food, drugs, and medical devices all require some form of label to be included with the product. The Agency for Toxic Substances and Disease Registry (ASTDR) has already identified many health risks related to PFAS. Does the FDA really need to do a report?
Why Now?
Cosmetics, with few exceptions, come into contact with or are directly applied to the skin, the largest organ of the human body. The average adult uses 12 cosmetics a day. The FDCA was untouched for 80 years when it came to cosmetics, and MoCRA is an attempt to fix the cosmetics regulatory conundrum.
MoCRA was introduced and signed into law in 2022. Thousands of lawsuits have been ongoing relating to Johnson & Johnson’s talcum powder, which is claimed to contain asbestos and cause ovarian cancer. Just over 8,000 lawsuits against multiple manufacturers of hair relaxers are being pursued by women who used the cosmetics and subsequently developed uterine cancers. Chemical companies that manufactured and sold PFAS or PFOAs for years have paid out $11.5 billion dollars relating to environmental damage related to them. The lawsuits exemplify when private individuals took it upon themselves to hold a small subset of individual cosmetics manufacturers accountable. MoCRA is needed to assure consumers of product safety and guidelines for cosmetic industry conduct in their manufacturing of these products.