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Research Involving Cosmetics: What you Need to Know

The Food and Drug Administration (FDA) is a U.S. public health authority within the Department of Health and Human Services (HHS). The FDA is responsible for protecting public health by overseeing the development, marketing, and consumer use of certain medical and personal care products.

The products the FDA regulates can generally be grouped into eight regulatory classifications. The level of FDA oversight varies between the regulatory categories. These regulatory classifications are defined in the federal Food, Drug, and Cosmetic Act (FD&C). These eight areas are:

In this blog, we will discuss how the FD&C defines cosmetics. We’ll also explore how a test article might be subject to multiple FDA regulatory frameworks.

  1. The FD&C defines a cosmetic as an “[article] 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.
    • Common products meeting the FD&C definition of a cosmetic include lotion, lipstick, and makeup.
  2. Considerations for determining whether and how a cosmetic (or any other product) is regulated by the FDA include (but are not limited to):
    • The product’s intended use
    • The product’s intended purpose
    • The marketing (or other) claims made to potential product consumers
  3. FDA-regulated products can fit into more than one classification. When this happens, the FDA requirements for all relevant product types apply.
  4. Some cosmetics may also be regulated as, for example, a drug.
    • Consider a skin lotion claiming to moisturize skin and mitigate the effects of cystic acne. This lotion would meet the definition of a cosmetic because it is an article intended to be used on the human body for cleansing, beautifying, promoting attractiveness, or altering appearance.
    • This lotion would also meet the FD&C definition of a drug because it is intended for use in the treatment or mitigation of disease.
    • In this example, both the FDA drug and cosmetic regulations would apply.

When research is submitted to Advarra for IRB review, reviewers assess each submission to determine: (1) whether any test article used in the research is FDA-regulated; and if so, (2) what regulatory requirements may apply.

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