The FDA now has unprecedented power to pull unsafe cosmetics off shelves, require companies to prove their products are safe, and track adverse reactions in real time. These changes stem from the Modernization of Cosmetics Regulation Act (MoCRA), the most significant overhaul of U.S. cosmetics law since 1938, which continues to reshape how beauty products are manufactured, tested, and monitored.

For decades, the FDA had limited authority over cosmetics compared to drugs and food. That changed dramatically when MoCRA passed in 2022. Now, as the agency phases in new requirements throughout 2026 and beyond, both consumers and manufacturers are navigating a landscape where transparency, safety documentation, and regulatory scrutiny have become non-negotiable.

What New Powers Does the FDA Have Over Cosmetics?

MoCRA granted the FDA several game-changing authorities that didn't exist before. Most significantly, the agency can now mandate recalls of cosmetic products that are adulterated or misbranded and pose a serious health risk. In December 2025, the FDA issued draft guidance explaining exactly when it will use this power and what companies must do to comply.

The agency also requires cosmetic manufacturers to maintain detailed records proving their products are safe. This isn't just about having a safety study on file; the FDA defines "adequate substantiation of safety" as evidence that would convince experts qualified by scientific training and experience that a product is genuinely safe to use. Companies can't simply rely on existing published research if that research doesn't specifically address their formulation.

Additionally, MoCRA mandates that all cosmetic facilities register with the FDA and that every product sold in the U.S. be listed in a federal database. As of January 2026, the FDA's system reflects 14,299 active facility registrations and 992,907 active product listings. This level of visibility means the FDA now knows who is making what, where it's being made, and can track problems much more effectively.

How Is the FDA Making Cosmetics Safety More Transparent?

One of the most consumer-friendly changes is the new FDA Adverse Event Reporting System (FAERS) Public Dashboard for Cosmetic Products, which launched in September 2025. This dashboard gives the public real-time access to safety complaints and adverse reactions linked to specific cosmetic products. Anyone can now see what problems other consumers have reported, whether it's skin irritation, allergic reactions, or other health concerns.

This transparency shift has major implications. Consumers, salon professionals, healthcare providers, and even lawyers can now monitor product-specific safety issues as easily as regulators can. Manufacturers are advised to regularly check the FAERS dashboard for trends involving their own products and competitors' offerings, and to develop internal procedures to investigate and respond to public safety data.

Steps to Understand Your Cosmetics' Safety Profile

• Check the FAERS Dashboard: Visit the FDA's Adverse Event Reporting System for cosmetics and search for any products you regularly use. Look for patterns in reported reactions, especially if multiple people report similar issues.
• Review Product Listings: The FDA's cosmetics database now contains detailed ingredient and manufacturing information for nearly 1 million products. You can search for your favorite brands to see what the FDA has on file about their formulations and where they're made.
• Look for Safety Substantiation Claims: When a brand claims a product is "safe," "non-toxic," or "all natural," ask yourself whether they've provided specific testing data. Under MoCRA, companies must have documented evidence from qualified experts that their formulation is safe, not just general claims about ingredients.

What Does This Mean for Cosmetics Manufacturers?

The regulatory landscape is tightening significantly for companies that make and sell cosmetics. The FDA is expected to issue final Good Manufacturing Practice (GMP) regulations for cosmetics, which will set minimum standards for how products are manufactured, processed, packed, and stored. These rules will likely become a cornerstone of FDA inspections and enforcement, similar to how the agency oversees food and drug manufacturing.

Companies are also being signaled through warning letters that they need to strengthen their quality systems now, before final GMP rules are published. This means cosmetics manufacturers will need to adopt more formal, auditable processes for quality control, documentation, and employee training. The interim period before final rules are issued is the industry's best opportunity to comment on draft guidance and shape what those final regulations will look like.

The stakes for non-compliance are rising. Incomplete or inaccurate product listings can trigger FDA enforcement action or cause imported products to be delayed or rejected at the border. Customs and Border Patrol will increasingly rely on product listing data during import screenings, making accuracy essential.

Why Should You Care About These Changes?

These regulatory shifts represent a fundamental shift in how cosmetics are overseen in the United States. For consumers, it means greater visibility into product safety, more rigorous testing requirements, and faster FDA action if a product proves dangerous. The days of cosmetics operating in a regulatory gray zone are ending.

The emphasis on safety substantiation also matters for anyone concerned about ingredients like heavy metals, per- and polyfluoroalkyl substances (PFAS), or other contaminants that have been found in some cosmetics. Companies can no longer make vague safety claims; they need documented evidence that their specific formulation is safe. This creates pressure for more thorough testing and transparency about what's actually in your makeup, skincare, and other beauty products.

As MoCRA continues to roll out over the next few years, expect to see more FDA guidance documents, stricter enforcement, and potentially more product recalls. The cosmetics industry is being held to a higher standard, and that standard ultimately benefits consumers who want to know that the products they're putting on their skin have been properly tested and monitored.