The U.S. Food and Drug Administration (FDA) just gave itself real teeth to regulate the cosmetics industry for the first time in nearly a century. The Modernization of Cosmetics Regulation Act of 2022, commonly called MoCRA, represents the most substantial expansion of FDA authority over cosmetics since the Federal Food, Drug, and Cosmetic Act passed in 1938. Since the average person uses 6 to 12 cosmetic products daily, from foundation and mascara to moisturizers and shampoo, this shift could meaningfully change how companies develop, test, and report on the safety of the products sitting in your bathroom cabinet.

What Exactly Changed Under the New Cosmetics Law?

For decades, cosmetics manufacturers operated under a relatively loose regulatory framework. Unlike pharmaceuticals, cosmetics didn't require FDA approval before hitting store shelves, and companies had minimal obligation to report when consumers experienced adverse reactions. MoCRA flipped that script by introducing several mandatory requirements that manufacturers must now follow.

The law establishes a framework that holds companies accountable in real time. If a consumer experiences a serious adverse event, the responsible person (the manufacturer, packer, or distributor whose name appears on the label) must report it to the FDA within 15 business days. This includes any health-related event that results in death, hospitalization, persistent disability, birth defects, infections, or significant disfigurement beyond what's intended during normal use. If additional medical information surfaces within a year of the initial report, companies must submit that too.

Beyond adverse event reporting, manufacturers must now register their facilities with the FDA and renew that registration every two years. They also must list each marketed cosmetic product with the FDA, including all ingredients, and update that information annually. Perhaps most importantly, companies are required to maintain records demonstrating that their products are adequately safe, a practice known as safety substantiation.

How Does Safety Substantiation Actually Work?

One of the most significant shifts under MoCRA is the formalization of safety substantiation requirements. Previously, there was no explicit mandate for companies to prove their products were safe before selling them. Now, responsible persons must ensure and maintain records supporting adequate safety substantiation of their cosmetic products.

The good news: companies don't need to conduct brand-new animal testing to meet this requirement. Manufacturers can use relevant safety data that's already available, including published research, historical data, and other scientifically robust methods. The key is that all data used to support safety claims must be derived from scientifically sound methods, not marketing hype or untested assumptions.

The FDA has also introduced Good Manufacturing Practice (GMP) requirements for facilities that manufacture cosmetic products, standardized testing methods for detecting asbestos in talc-containing cosmetics, and fragrance allergen labeling requirements. These additions create a more transparent and safer supply chain from factory to shelf.

What Happens If a Company Refuses to Comply?

MoCRA gives the FDA enforcement powers it never had before. If the agency determines that a cosmetic is adulterated or misbranded and poses a serious risk to health or death, the FDA can now order a mandatory recall even if the company refuses to do so voluntarily. Additionally, if a facility's registration is suspended because products manufactured there have a reasonable probability of causing serious adverse health consequences, it becomes illegal to distribute or sell those products in the United States.

The FDA can also access and copy safety records related to cosmetic products during inspections, giving regulators visibility into the data companies are using to justify their safety claims. This transparency mechanism is crucial for identifying patterns of harm that might not be obvious from individual reports.

Steps to Understanding Your Cosmetics' Safety Profile

• Check the FDA Adverse Event Monitoring System: The FDA created a user-friendly, interactive web-based tool called the FDA Adverse Event Monitoring System (AEMS) Public Dashboard for Cosmetic Products, which allows consumers to query the database and see what adverse events have been reported for specific products or brands.
• Review Product Ingredient Lists: Under MoCRA, all cosmetic products must now be listed with the FDA, including complete ingredient information. You can request this information from manufacturers or look for transparency on company websites.
• Look for Safety Substantiation Documentation: Ask cosmetics companies directly about the safety data supporting their products. Reputable manufacturers should be willing to share summaries of their safety substantiation records, even if they don't disclose proprietary formulation details.
• Monitor FDA Recalls and Warnings: The FDA's new mandatory recall authority means that if a product poses a serious risk, you're more likely to hear about it quickly through official channels rather than discovering it through word-of-mouth or social media.

What About PFAS in Cosmetics?

One of the most pressing safety questions MoCRA required the FDA to address involves per- and polyfluoroalkyl substances, commonly known as PFAS. These are synthetic chemicals used in some cosmetics, particularly waterproof and long-wear formulas, because they help products resist water and maintain their appearance. PFAS are sometimes called "forever chemicals" because they don't break down naturally in the environment or the human body.

In December 2025, the FDA published a comprehensive report titled "Report on the Use of PFAS in Cosmetic Products and Associated Risks," which summarizes the agency's assessment of PFAS in cosmetics and the scientific evidence regarding their safety. This report represents the first major regulatory examination of PFAS in beauty products and signals that the FDA is taking the issue seriously enough to investigate and report publicly.

Who Gets a Pass, and Who Doesn't?

MoCRA does exempt certain small businesses from some requirements, including Good Manufacturing Practice standards, facility registration, and product listing requirements. However, these exemptions don't apply to manufacturers of products that regularly come into contact with sensitive areas like the eyes, lips, or skin, or products marketed for use by children. This means that even small indie cosmetics brands making eyeshadow, lipstick, or children's products must comply with the full suite of MoCRA requirements.

The practical effect is that the regulatory burden falls most heavily on companies making the products that pose the greatest potential for harm if something goes wrong, which is exactly where consumer protection should focus.

MoCRA represents a watershed moment for cosmetics safety in the United States. For the first time, the FDA has real authority to investigate, track, and enforce safety standards across the industry. While the law doesn't eliminate all risks, it creates a system where companies are accountable, adverse events are documented, and consumers have access to information about product safety. As the FDA continues to implement MoCRA's requirements and publish reports like the PFAS assessment, the cosmetics industry will likely become more transparent and, by extension, safer for the millions of people who use these products every single day.