How Cosmetics Are Regulated in the United States

Most people assume that a product on a store shelf has been cleared by someone in a lab coat. For cosmetics in the United States, that assumption is wrong in an interesting way. The rules are real, but they work differently from the rules for drugs.

Cosmetics and drugs are separate categories

Federal law splits these products by intended use. A cosmetic is meant to clean, beautify, or change appearance. A drug is meant to treat or prevent disease, or to affect the structure or function of the body. The same tube can be both. A shampoo is a cosmetic; an anti-dandruff shampoo is a cosmetic and a drug. Sunscreen sold in the United States is regulated as an over-the-counter drug.

That split matters because drugs go through a pre-market approval or monograph process. Cosmetics do not. There is no FDA review before a lipstick is sold.

What “FDA approved” does and does not mean

The FDA does not approve cosmetics or their ingredients, with one narrow exception: color additives. Nearly every color used in a cosmetic must be listed by the agency, and some batches must be certified by FDA before use. That is why a claim like “FDA approved formula” on a face cream is marketing language, not a regulatory status. No such approval exists for the formula.

What the agency can do is act after a product reaches the market. A cosmetic must not be adulterated or misbranded. If it contains a harmful substance, if it is made in filthy conditions, or if the label lies, it is illegal to sell.

What MoCRA changed in 2022

The Modernization of Cosmetics Regulation Act, signed at the end of 2022, was the first major update to US cosmetics law since 1938. It gave the FDA authority it did not have before. The main pieces:

• Facility registration and product listing. Manufacturers and processors must register their facilities and list their products and ingredients with the FDA.
• Safety substantiation. A company must keep records showing adequate substantiation of safety for each product.
• Adverse event reporting. Serious adverse events must be reported to the FDA, and companies must keep records of reports they receive.
• Mandatory recall authority. The FDA can order a recall rather than ask for a voluntary one.
• Good manufacturing practice. The agency was directed to write binding manufacturing rules.
• Fragrance allergen labeling. The agency was directed to require disclosure of certain fragrance allergens on labels.

Several of these pieces depend on rulemaking that has moved slowly, so what is written in the statute and what is enforceable on a given date are not always the same thing. Small businesses are exempt from some requirements.

What this means when you shop

Read the law as a floor, not a guarantee. Registration is not a safety review. A listed product has not been tested by the government. What has improved is traceability: the agency now knows who makes what, can demand the safety file, and can pull a product off shelves.

The practical work is still yours. Read the ingredient list, watch how your own skin responds, and treat dramatic claims with suspicion. If a product promises a drug-level result, such as reversing a medical condition, it is either an illegal drug claim or an exaggeration.

For anything stronger than a shelf product, the oversight changes again. Prescription-strength retinoids, chemical peels above certain strengths, and device-based treatments run under clinical supervision, which is one reason people take those to a clinician or a Knoxville med spa rather than trying to replicate them at home.