In the United States, the Food and Drug Administration (FDA) is the primary federal agency responsible for regulating cosmetics. But the FDA doesn’t work alone. The Federal Trade Commission (FTC) oversees cosmetic advertising claims, an industry-funded panel reviews ingredient safety, and individual states have started passing their own stricter laws. The regulatory landscape changed significantly in December 2022, when Congress passed the first major update to federal cosmetics law in over 80 years.
The FDA’s Role Before and After 2022
For decades, the FDA’s authority over cosmetics was surprisingly limited. Unlike drugs and medical devices, cosmetics did not require pre-market approval. Companies could introduce new products without registering them, listing their ingredients with the agency, or proving they were safe. The FDA could act against a product only after it was already on shelves and causing harm, and even then it lacked the power to order a recall.
The Modernization of Cosmetics Regulation Act of 2022, known as MoCRA, changed that. This law gave the FDA a set of tools it had never had for cosmetics:
- Facility registration. Manufacturers and processors must now register their facilities with the FDA and renew that registration every two years.
- Product listing. Companies must list every cosmetic product they sell with the FDA, including a full ingredient list, and update it annually.
- Mandatory recall authority. If a cosmetic has a reasonable probability of causing serious health consequences or death and the company won’t voluntarily recall it, the FDA can now order a recall.
- Records access. Under certain conditions, the FDA can access and copy a company’s safety records for a cosmetic product.
- Facility suspension. If the FDA determines that a product from a registered facility could cause serious harm, and the problem may extend to other products made there, it can suspend that facility’s registration. Once suspended, the facility cannot legally sell cosmetics in the U.S.
MoCRA also requires companies to report serious adverse events to the FDA within 15 business days. A “serious adverse event” includes outcomes like death, hospitalization, significant disfigurement (serious rashes, second- or third-degree burns, significant hair loss), birth defects, infections, or any reaction requiring medical intervention to prevent those outcomes.
What the FDA Still Doesn’t Do
Even after MoCRA, cosmetics do not require FDA approval before they go on sale. There is no pre-market safety review the way there is for prescription drugs. Companies are responsible for ensuring their own products are safe, and the FDA steps in after the fact if problems arise. This is a fundamental difference from how pharmaceuticals are regulated.
There is one notable exception: color additives. Any color additive used in a cosmetic must be approved by the FDA before use, and certain categories must be batch-certified, meaning the FDA physically analyzes each manufactured batch before it can be sold. Manufacturers must label these certified colors with the FDA-assigned lot number and any usage limitations. This makes color additives the only cosmetic ingredients subject to true pre-market approval.
The FTC and Advertising Claims
The FDA regulates what goes into a cosmetic product and how it’s labeled. The Federal Trade Commission handles how that product is advertised. Under federal law, advertising claims must be truthful, cannot be deceptive or unfair, and must be backed by evidence. This applies to claims like “anti-aging,” “clinically proven,” or “all-natural” that appear in commercials, online ads, or social media promotions. If a company can’t substantiate a marketing claim with solid proof, the FTC can take enforcement action.
Industry Self-Regulation Through CIR
A significant portion of cosmetic ingredient safety review happens outside of government entirely. The Cosmetic Ingredient Review (CIR) program, established in 1976 by the cosmetics industry trade association, conducts independent safety assessments of cosmetic ingredients. The FDA and the Consumer Federation of America both participate in the process, but CIR is funded by the industry itself.
CIR operates through an expert panel that reviews available safety data in open, public meetings. Any unpublished studies submitted by companies become part of the public record once summarized. After review and public comment, the panel issues a final safety assessment published in the peer-reviewed International Journal of Toxicology. As of its most recent tally, CIR has evaluated 1,194 individual cosmetic ingredients. Of those, 683 were found safe as currently used, 388 were found safe with specific qualifications, 9 were deemed unsafe, and 114 lacked sufficient data to make a determination.
CIR’s findings are not legally binding. Companies are not required to follow them. But the assessments carry weight in the industry and serve as a reference point when questions about ingredient safety arise.
How Many Ingredients Are Actually Banned
The FDA explicitly prohibits or restricts roughly 11 categories of ingredients in cosmetics. These include chloroform and methylene chloride (both linked to cancer in animal studies), mercury compounds (limited to eye-area products at very low concentrations when no safer alternative exists), hexachlorophene (restricted to 0.1 percent due to its ability to penetrate skin), chlorofluorocarbon propellants, and certain cattle-derived materials to prevent mad cow disease transmission.
The European Union, by comparison, has banned or restricted over 1,300 cosmetic ingredients. This gap is one of the most commonly cited criticisms of U.S. cosmetics regulation and a driving force behind state-level laws that go further than federal requirements.
State Laws That Go Further
Several states have passed their own cosmetics regulations that exceed federal standards. California’s Cosmetic Fragrance and Flavor Ingredient Right to Know Act, which took effect in January 2022, is one of the most detailed. It requires manufacturers selling cosmetics in California to disclose fragrance and flavor ingredients that appear on designated hazard lists to the state’s Department of Public Health. Companies must also disclose any fragrance allergens listed under EU cosmetics regulations when those allergens are present above specific thresholds: 100 parts per million in rinse-off products and 10 parts per million in leave-on products.
The law protects trade secrets by not requiring companies to reveal the amount of each ingredient or how the product is formulated. But it does require disclosure of the chemical identity of flagged ingredients, something federal law has not mandated. Other states, including Maryland, Washington, and Oregon, have passed laws banning specific chemicals like certain PFAS compounds or formaldehyde-releasing preservatives from cosmetics sold within their borders.
How This Affects What You Buy
The practical result of this multi-layered system is that no single authority reviews every cosmetic product before it reaches you. The FDA now has better visibility into what’s being manufactured and sold, along with stronger tools to act when something goes wrong. But the initial responsibility for product safety still rests with the company making it. Advertising claims are policed separately by the FTC. Ingredient safety reviews are largely conducted by an industry-funded panel. And depending on where you live, your state may impose additional requirements that provide a higher standard of transparency or safety than federal law alone.