FDA Authority & Cosmetics: What You Need to Know

Cosmetics and other beauty products are obviously not food or drugs so it might be surprising to some that the FDA has authority over these products. Since these health and beauty products will be put on people’s faces and bodies, it was deemed important to have an authority verifying the safety of the ingredients. 



The products that will be marketed and sold in the United States are mainly regulated under two laws: the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA).

What does this regulation look like and which cosmetics are affected by this?

A major distinction to understand in comparison to the FDA’s usual approval mechanisms is that the law currently does not require the ingredients or products that are considered cosmetic to be approved by the FDA before going onto the market. 

There is one exception to this rule, any color additives used in cosmetic products will need approval by the FDA.



With FDA’s regulatory authority over cosmetics, they do have the right to pursue enforcement action against a company or individual, and their products on the market, who violate any laws. This enforcement is pursued through the Department of Justice.

To know which cosmetics fall in this category, you first need to know how the FD&C Act defines cosmetics: “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body...for cleansing, beautifying, promoting attractiveness, or altering the appearance”.

This definition can include deodorants, perfumes, facial makeup, lipsticks, fingernail polishes, moisturizers, hair colors, and any other substance used as a part of a cosmetic product. The FDA’s definition of cosmetic does not include soap. 



If the product’s purpose is for any type of therapeutic use, it will most likely be considered a drug and fall under a different regulation and approval process than cosmetics. 

When a cosmetic product is released on the market, the labeling of it becomes very important because this can be one of the main reasons for the FDA to pursue enforcement action against a product. 

The FD&C Act lays out what incorrect labeling, or misbranding, could look like:
 

• The label has false or misleading information
• The label does not include all information that is legally required
• The required information is hidden on the label or not prominent enough
• How the container is built or filled is misleading
• The color additive doesn’t meet regulations

Also, any product that does not comply with the FPLA is considered misbranded under the FD&C Act. In these cases, the FDA can take action against the product and the company or individual who markets them. 

We offer a 3-day course on everything about US cosmetic manufacturing regulations. The course is designed for professionals in the personal care, cosmetic, and pharmaceutical industries who engage in all phases of product development. 

Have questions? Get in touch with a member of the CfPIE team by calling 1-610-648-7550 or emailing [email protected].