FDA

What Is the FDA?

The Food and Drug Administration (FDA) is a U.S. federal agency within the Department of Health and Human Services. It regulates a wide range of products, including foods, drugs, medical devices, biologics and cosmetics.

For cosmetics, the FDA's authority is primarily based on the Federal Food, Drug, and Cosmetic Act and the Fair Packaging and Labeling Act. The regulatory approach is different from the European Union, where cosmetic products are governed by Regulation (EC) No 1223/2009 and require a formal safety assessment and notification before being placed on the market.

Does the FDA Approve Cosmetics?

Generally, no.

Cosmetic products and cosmetic ingredients do not require FDA approval before they are marketed in the United States. The important exception is color additives, which generally must be approved for their intended cosmetic use before they can be used.

Companies that market cosmetics are responsible for ensuring that their products are safe under their labelled or customary conditions of use and that the products are properly labelled.

The FDA has significant post-market enforcement authority. If the agency has reliable information indicating that a cosmetic is adulterated or misbranded, it can take regulatory action.

FDA and Cosmetic Ingredients

Most cosmetic ingredients do not require individual FDA approval before being used in cosmetics. However, they must comply with applicable U.S. requirements and must be safe for their intended or customary conditions of use.

The FDA also maintains information concerning ingredients that are prohibited or restricted in cosmetics. Therefore, checking whether an ingredient is permitted is only one part of evaluating a formulation.

An additional consideration is the intended use and claims of the finished product. A product marketed with claims that meet the legal definition of a drug may be regulated as a drug rather than solely as a cosmetic.

For example, certain products marketed for sun protection are regulated as drugs in the United States. A cosmetic product that combines cosmetic and drug claims can therefore be subject to both regulatory frameworks.

Color Additives

Color additives are subject to a different regulatory system.

With the exception of coal-tar hair dyes, color additives used in cosmetics generally must be approved by FDA for their intended use. The applicable regulations specify where and under what conditions a particular color may be used.

Some approved color additives are also subject to batch certification by FDA. Others are exempt from certification but must still comply with the applicable specifications and restrictions.

This means that simply purchasing a pigment or colourant that is commonly used in Europe does not necessarily mean that it can be used in the same way in a cosmetic product marketed in the United States.

MoCRA – Modernization of Cosmetics Regulation Act

A major change in U.S. cosmetic regulation came with the Modernization of Cosmetics Regulation Act of 2022 (MoCRA).

MoCRA significantly expanded FDA's authority over cosmetics and introduced several new requirements for the U.S. cosmetics industry.

Facility Registration

Manufacturers and processors of cosmetic products that are subject to the requirements must register their facilities with FDA and renew the registration every two years.

There are exemptions for certain small businesses, although these exemptions do not apply to all types of cosmetic products or activities.

Cosmetic Product Listing

A responsible person must list each marketed cosmetic product with FDA and provide the required information, including product ingredients. Product listings must be updated annually.

The responsible person is generally the manufacturer, packer or distributor whose name appears on the product label.

Safety Substantiation

MoCRA also strengthened the responsibility of companies to maintain adequate safety substantiation for their cosmetic products.

This is important because the absence of a pre-market FDA approval requirement does not mean that a company can market an unsafe cosmetic product.

FDA Registration Is Not FDA Approval

A particularly important distinction for cosmetic companies is that FDA facility registration and cosmetic product listing do not constitute FDA approval.

The FDA explicitly states that assigning a facility registration number or product listing number does not indicate that FDA has approved the facility or the cosmetic product. FDA also does not issue certificates confirming cosmetic facility registration or product listing.

Therefore, statements such as “FDA approved cosmetic” can be misleading when they refer only to facility registration or product listing.

FDA vs. EU Cosmetic Regulation

The U.S. and EU approaches differ significantly.

The two systems therefore should not be treated as interchangeable. A cosmetic product that complies with EU requirements may still require additional regulatory review before being marketed in the United States.

FDA Requirements for Cosmetic Product Development

When developing a cosmetic product for the U.S. market, several areas should be reviewed:

Formulation: Ingredients must comply with applicable U.S. requirements and the finished product must be safe for its intended use.

Claims: Marketing claims must be reviewed carefully because certain claims can cause a product to fall within the U.S. drug definition.

Labelling: Cosmetic labelling must comply with applicable U.S. requirements.

Colorants: Any color additives must be permitted for the specific intended cosmetic use, with certification requirements assessed where applicable.

Facility registration: Facilities subject to MoCRA must be registered with FDA and renewed as required.

Product listing: The responsible person must list applicable marketed cosmetic products and update the information annually.

Safety documentation: Companies must maintain appropriate evidence supporting the safety of their cosmetic products.

FDA in Cosmetic Product Development

For a cosmetic brand planning to enter the U.S. market, FDA compliance should be considered from the early formulation and product-development stage, rather than only immediately before launch.

Ingredient selection, colourants, product claims, intended use, labelling, manufacturing arrangements and MoCRA requirements can all affect the regulatory status of the final product.

The key point is that FDA regulation of cosmetics is not an approval system equivalent to the EU CPNP system. Most cosmetics are not individually approved by FDA before entering the U.S. market, but companies remain legally responsible for product safety and compliance, and FDA has substantial post-market enforcement authority.

References

U.S. Food and Drug Administration (FDA). Cosmetic Products.

U.S. Food and Drug Administration (FDA). Registration & Listing of Cosmetic Product Facilities and Products.

U.S. Food and Drug Administration (FDA). Cosmetic Ingredients.

U.S. Food and Drug Administration (FDA). Color Additives and Cosmetics: Fact Sheet.

U.S. Food and Drug Administration (FDA). Does the FDA approve cosmetics before they go on the market?