What is the role of the Food and Drug Administration (FDA) in the cosmetic industry? What are “cosmeceuticals?”


What is the role of the Food and Drug Administration (FDA) in the cosmetic industry?

A cosmetic maker can sell products without FDA approval. FDA does not review or approve cosmetics, or their ingredients, before they are sold to the public. But FDA urges cosmetic makers to do whatever tests are needed to prove their products are safe. Cosmetics makers must put a warning statement on the front labels of products that have not been safety testing, which reads, “WARNING-The safety of this product has not been determined.”

FDA does require safety testing for color additives used in cosmetics. Cosmetics may only contain approved and certified colors. You’ll find FD&C, D&C, or external D&C listed on cosmetic labels.

FD&C – color that can be used only in foods, drugs, and cosmetics
D&C – color that can be used only in drugs and cosmetics
external D&C – color that can be used only in drugs applied to the surface of the skin and cosmetics

A cosmetic maker also does not have to report product injuries. FDA collects this information on a voluntary basis only. Cosmetic makers that want to be a part of this program send reports to the FDA.

Product recalls are voluntary actions taken by cosmetic makers too. FDA cannot require cosmetics recalls. But FDA does monitor cosmetic makers that do a recall. FDA must first prove in court that a cosmetic product is a danger or somehow breaks the law before it can be taken off the market.

What are “cosmeceuticals?”

Some products can be both cosmetics and drugs. This may happen when a product has two uses. For example, a shampoo is a cosmetic because it’s used to clean the hair. But, an anti-dandruff treatment is a drug because it’s used to treat dandruff. So an antidandruff shampoo is both a cosmetic and a drug. Other examples are:

toothpastes that contain fluoride
deodorants that are also antiperspirants
moisturizers and make-up that provide sun protection

These products must meet the standards for both cosmetics (color additives) and drugs.

Some cosmetic makers use the term “cosmeceutical” to refer to products that have drug-like benefits. FDA does not recognize this term. A product can be a drug, a cosmetic, or a combination of both. But the term “cosmeceutical” has no meaning under the law.

While drugs are reviewed and approved by FDA, FDA does not approve cosmetics. If a product acts like a drug, FDA must approve it as a drug.