A New Era of Cosmetics Regulation

Updated Regulations
14 FEBRUARY 2023

Overview

The Federal Food, Drug, and Cosmetic Act (FDCA) is the fundamental law that governs everything that comes into contact with humans or animals. However, cosmetics have largely been excluded from the FDA's regulatory program since 1938. As 2022 comes to a close, the fact that the cosmetics industry was largely unregulated by the FDA also comes to an end. At the end of 2022, President Biden signed Omnibus Spending bill, including the Modernization of Cosmetics Regulation Act of 2022 (MOCRA), which strengthens the FDA's oversight of cosmetics. This is the first update to federal cosmetic law in over 80 years. Previously, the FDA could issue warning letters to illegal products or companies and refuse entry of cosmetics at the ports, but it had no right to order a mandatory recalls of unqualified cosmetics. Companies also registered facilities and recorded products on a voluntary basis. The MOCRA Act has raised product safety to new heights and established a series of cosmetic product safety standards and enterprise production specifications. It affects all cosmetic categories, including professional salon products, personal care products, and intimate care products.

Enterprises need to focus on:

Cosmetic Facility Registration - All facilities engaged in the manufacture or processing of cosmetics must be registered with the FDA by December 31, 2023, and every two years thereafter.
Product Filing - Product-specific information, such as ingredients, must be submitted to the FDA.
Cosmetic Label Specifications - All cosmetic products must label fragrance allergens and require ingredient labeling in professional cosmetics only used by salon workers.
Good Manufacturing Practices - Manufacturers must comply with good manufacturing practices.
Adverse Health Event Reporting - Manufacturers must report serious adverse health events caused by cosmetics and keep records of adverse events for six years.
Recall Authority - The FDA has the authority to enforce recalls of misbranded and/or adulterated products.
Asbestos Testing - The FDA must propose testing regulations to detect asbestos in talc-containing cosmetics by January 2024.
PFAS Assessment - The FDA must issue an assessment report on Per- and polyfluoroalkyl substances (PFAS) in cosmetics by January 2026.
State Preemption - Preempts states from passing more stringent laws related to registration, product listing, good manufacturing practice, records, recalls, adverse event reporting or safety substantiation.

The following are the two regulations in detail:

Labeling of Professional Salon Products - Previously, products sold "for professional use only" were not required to list ingredients on the label like retail cosmetics. MOCRA now requires professional cosmetics to meet the same requirements as other cosmetics. California bill AB 2775, signed into law in 2018, was the first bill in the United States to require ingredient labeling of professional salon products. This provision is now included in MOCRA, allowing salon staff to clearly see important ingredient information on the labels of the products they use. However, manufacturers can still keep most of the ingredients in fragrances confidential.

Mandatory Reporting of Adverse Health Events - MOCRA defines an adverse health event as death, life-threatening experience, inpatient hospitalization, persistent or significant disability or incapacity, congenital anomaly or birth defect, infection, significant disfigurement (serious or persistent rashes, second or third degree burns, hair loss, or persistent or significant alteration of appearance), or an event which requires medical intervention to prevent the health outcomes listed above. MOCRA requires manufacturers to submit adverse event reports they receive to the FDA within 15 days. Previously, manufacturers were not required to inform the FDA if they received reports and could keep information confidential. This is no longer the case, and the FDA will have a more comprehensive view of whether certain products or product ingredients pose a risk.

Today, when the market and regulations are constantly updated, manufacturers can speed up the process of product development by cooperating with third-party institutions. As an experienced cosmetic testing expert, Creative BioMart has the ability to make the optimal decisions for clients on cosmetic regulatory matters with the support of an excellent regulatory affairs team and toxicology department. Our structured approach to regulatory support for cosmetics helps clients simplify the regulatory compliance process and allow their products access to market in the fastest and most cost-effective way.
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