Articles & Alerts
What Does the Newly-Enacted Modernization of Cosmetics Regulation Act of 2022 Mean for the Beauty Industry?
In the ever-evolving Beauty industry, staying abreast of regulatory changes is essential to a company’s success. The Modernization of Cosmetics Regulation Act of 2022, which Congress enacted on December 29th of last year to replace Chapter VI of the Federal Food, Drug, and Cosmetic Act, has given the federal government more oversight over the Beauty industry through the Food and Drug Administration (FDA).
Below are the key components of the Act that will affect Beauty companies’ operations in various stages following the enactment of the Act.
- Adverse Events Reporting – The Act requires the responsible person, who is defined as “the manufacturer, packer, or distributor of a cosmetic product whose name appears on the label of such cosmetic product,” to submit to the FDA any report received of a serious adverse event associated with the use of a cosmetic product manufactured, packed, or distributed by such person in the United States. A serious adverse event is defined as “an adverse event that results in death, a life-threatening experience, inpatient hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, a serious infection or significant disfigurement.” This report must be accompanied by a copy of the label on or within the retail packaging of the product no later than 15 business days after the report is received by the responsible person.
- Good Manufacturing Practices – By December 29, 2024, and no later than December 29, 2025, the FDA will propose a ruling on good manufacturing practices for facilities intended to protect the public health and ensure that cosmetic products are not adulterated.
- Registration and Product Listing – The Act requires existing companies and contract manufacturers to register their facility with the FDA, with a biennial renewal, and provide a cosmetic product listing within one year after the enactment. The cosmetic product listing must include a list of ingredients including any fragrances, flavors or colors with each ingredient identified by the name and product listing number. Any updates to this list must be submitted on an annual basis.
- Safety Substantiation – Companies must maintain records supporting that there is adequate substantiation of the safety of their products, which includes tests or studies, research, analyses, or other evidence by a person or a Company with scientific training and experience.
- Labeling – Labels should include a domestic address, phone number or electronic contact information to receive adverse event reports from consumers. Fragrance allergens should also be identified on the label. Any product used by a professional, which includes cosmetologists, nail technicians, barbers, or estheticians, should clearly state on the label of the product that it shall only be administered or used by licensed professionals. This requirement shall take effect two years after the date of enactment of this Act.
- Mandatory Recall Authority – The Company will have the option to voluntarily recall or no longer sell or distribute a product that has a reasonable probability that it is adulterated or misbranded, and use will cause serious adverse health consequences or death. If a voluntary recall is not done, then the FDA will require the immediate recall of the product and the public must be made aware of this recall. This requirement shall take effect one year after the date of the enactment of this Act.
- Talc and Perfluoroalkyl and Polyfluoroalkyl Substances (“PFAS”) Regulations – Proposed regulations will be established to require standardized testing methods for detecting and identifying asbestos in talc-containing cosmetic products. The proposed regulations will be communicated within one year of the enactment of this Act and no later than 180 days after the comment period closes for the final regulations. For PFAS in cosmetics, the FDA has no longer than three years from the enactment date of the Act to assess the use, safety, and risks associated with PFAS in cosmetics.
While this regulation affects all Beauty companies, the resulting challenges and implications for each company will be unique. To learn about the ways that Anchin can help your company, contact Carolyn Naporlee-Cipolla or Megan Klingbeil, co-leaders of Anchin’s Beauty, Health & Wellness Group.