In the United States, cosmetics are regulated primarily by the Food and Drug Administration, with the Federal Trade Commission handling advertising claims and individual states adding their own ingredient rules on top. A 2022 law called the Modernization of Cosmetics Regulation Act, or MoCRA, gave the FDA far more authority than it had held for the previous eight decades.
What the FDA Controls
The FDA’s authority over cosmetics comes from the Federal Food, Drug, and Cosmetic Act, signed in 1938.1Food and Drug Administration. Part II: 1938, Food, Drug, and Cosmetic Act Under that law, a cosmetic is any product applied to the body to cleanse, beautify, or alter appearance. Selling a cosmetic that is “adulterated” (unsafe or contaminated) or “misbranded” (labeled in a false or misleading way) in interstate commerce is prohibited.2Office of the Law Revision Counsel. 21 US Code 362 – Misbranded Cosmetics
Here is what surprises most people. The FDA does not approve cosmetic products or their ingredients before they reach store shelves. The one exception is color additives, which must be approved by the FDA and, in many cases, certified batch by batch before they can be used in any cosmetic.3Food and Drug Administration. FDA Authority Over Cosmetics: How Cosmetics Are Not FDA-Approved, but Are FDA-Regulated4Food and Drug Administration. Color Certification Beyond color additives, manufacturers may use any ingredient they choose as long as the finished product is safe, properly labeled, and free of any banned substance. The legal responsibility for safety sits with the company, not the agency.
The FDA also enforces cosmetic labeling rules under both the FD&C Act and the Fair Packaging and Labeling Act.5U.S. Food and Drug Administration. Cosmetics Labeling Guide A cosmetic label must state the name and place of business of the manufacturer, packer, or distributor, the net contents, and a list of ingredients in descending order of predominance.2Office of the Law Revision Counsel. 21 US Code 362 – Misbranded Cosmetics False or misleading labeling makes a product legally misbranded, and the FDA can respond with warning letters, injunctions, and product seizures.
A short list of ingredients is outright banned or restricted, including mercury compounds, chloroform, vinyl chloride, methylene chloride, chlorofluorocarbon propellants, and hexachlorophene.6U.S. Food and Drug Administration. Cosmetics Safety Q&A – Prohibited Ingredients Everything else is fair game so long as the finished product is not harmful under its intended use.
How MoCRA Expanded FDA Authority in 2022
The Modernization of Cosmetics Regulation Act of 2022 was the most significant expansion of FDA cosmetic authority since 1938.7U.S. Food and Drug Administration. Modernization of Cosmetics Regulation Act of 2022 Before MoCRA, the FDA could not require companies to register their facilities, list their products, report safety problems, or follow specific manufacturing standards. That changed.
Facility Registration and Product Listing
Manufacturers and processors must now register their facilities with the FDA and renew the registration every two years. A designated “responsible person” must list every marketed cosmetic with the FDA, including its ingredients, and update that listing annually.8Food and Drug Administration. Registration and Listing of Cosmetic Product Facilities and Products The FDA began enforcing these requirements on July 1, 2024.9Food and Drug Administration. Deadline for Registration and Listing of Cosmetic Product Facilities and Products Companies averaging less than $1 million in annual gross cosmetic sales over the prior three years generally qualify as small businesses and are exempt from registration and listing, though that exemption drops away for higher-risk product categories such as eye-area products, injectables, and semi-permanent hair dyes.
Adverse Event Reporting
Companies must report any serious adverse event tied to their cosmetic products to the FDA within 15 business days of learning about it. Additional medical information about the same event received within a year triggers another 15-business-day update.7U.S. Food and Drug Administration. Modernization of Cosmetics Regulation Act of 2022 Records of adverse event reports must be kept for six years, or three for qualifying small businesses.
Mandatory Recall Authority
Before MoCRA, the FDA had no power to force a cosmetic recall. It relied on companies to pull unsafe products voluntarily. MoCRA now lets the agency order a mandatory recall when it determines there is a reasonable probability that a cosmetic is adulterated or misbranded, exposure will cause serious health consequences or death, and the company refuses to act on its own.10Food and Drug Administration. FDA Recall Policy for Cosmetics
Good Manufacturing Practices
MoCRA directed the FDA to write formal Good Manufacturing Practice regulations covering facility design, sanitation, personnel training, and quality control. The statute set a December 2025 deadline for a final rule. As of early 2026, the FDA has moved that rulemaking to its long-term actions list, so the formal GMP regulations remain unfinished. Existing FDA GMP guidance documents are still the practical reference point, but they do not carry the force of law.
The FTC and Cosmetic Advertising
The FDA’s authority stops at the package. Advertising claims made on television, in print, online, or through social media fall under the Federal Trade Commission.11Food and Drug Administration. Cosmetics Labeling Claims The FTC requires cosmetic advertising to be truthful, not misleading, and supported by adequate evidence. The two agencies coordinate when marketing crosses the line, but the split means a single product can face separate action from the FDA for its label and from the FTC for its commercial.
State Rules on Top of Federal Law
Federal law sets a floor, not a ceiling. States can and do impose their own cosmetic regulations, and the result is a patchwork. The most active area of state activity in recent years has been restrictions on per- and polyfluoroalkyl substances, or PFAS. As of 2025, roughly fourteen states had enacted laws restricting intentionally added PFAS in cosmetics, with compliance deadlines running from 2025 through 2032. There is no equivalent federal ban on PFAS in cosmetics.
Some states also impose their own facility permitting or inspection requirements on cosmetic manufacturers, and those rules vary. A company selling in multiple states may have to meet different registration, labeling, or ingredient rules in each one, even after satisfying every federal requirement.
When a Cosmetic Is Also a Drug
Not every product marketed as beauty or personal care is regulated only as a cosmetic. If a product is intended to cleanse or beautify but also claims to treat or prevent a disease, or to affect the structure or function of the body, federal law treats it as a drug in addition to a cosmetic.3Food and Drug Administration. FDA Authority Over Cosmetics: How Cosmetics Are Not FDA-Approved, but Are FDA-Regulated Anti-dandruff shampoos, sunscreens, anti-acne washes, and fluoride toothpastes all fall into this dual category.12Food and Drug Administration. How Can I Tell if My Product Is a Cosmetic, a Drug, or Both? Products in this category must meet drug rules, including premarket approval or monograph compliance, on top of the cosmetic labeling and safety requirements. Marketing language can push a product across the line: calling a moisturizer “anti-aging” is generally treated as a cosmetic claim, but claiming it “reduces wrinkles” has drawn FDA warning letters as a drug claim.11Food and Drug Administration. Cosmetics Labeling Claims
Reporting a Bad Reaction to a Cosmetic
If you have a bad reaction to a cosmetic, you can report it directly to the FDA through the MedWatch safety reporting program. Consumer reports can be submitted online or through Form 3500B, which is written for patients and consumers rather than professionals.13Food and Drug Administration. MedWatch Forms for FDA Safety Reporting Those reports help the FDA spot patterns across products and ingredients and decide where to focus enforcement. Combined with the mandatory adverse event reports that companies must now file under MoCRA, they form the agency’s early warning system for unsafe cosmetics on the market.