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The Food and Drug Administration (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 are grouped into eight regulatory classifications; oversight varies between each regulatory category.
The eight classifications defined in the federal Food, Drug, and Cosmetic Act (FD&C) are:
- Drugs
- Vaccines, blood, and biologics
- Medical devices
- Radiation-emitting products
- Foods (includes dietary supplements)
- Cosmetics
- Tobacco products
- Animal and veterinary products
This blog outlines how the FD&C defines cosmetics and explore how a test article might be subject to multiple FDA regulatory frameworks.
Definition
According to the FD&C, a cosmetic is 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.” Lotions and makeup are two examples of products falling under this definition. Determining whether and how the FDA regulates a cosmetic includes, but isn’t limited to:
- The product’s intended use
- The product’s intended purpose
- The marketing (or other) claims made to potential product consumers
Classification
Some FDA-regulated products may fit into more than one classification. In this case, the FDA requirements for all relevant product types apply. For example, a skin lotion claiming to mitigate the effects of cystic acne and moisturize skin may be regulated as a drug and a cosmetic. It would be classified as a drug because of its intent to treat and mitigate a disease, and it would be classified as a lotion because of its intent to cleanse and beautify the human body, promoting attractiveness or altering appearance.
When research is submitted to Advarra’s institutional review board (IRB), reviewers assess submissions to determine whether any test article used in the research is FDA-regulated, and if so, what regulatory requirements may apply.
Understanding the definition of a cosmetic and its classification can greatly impact how it fits into the regulatory guidelines. Since oversight varies by each regulatory category, if you have any questions on the classifications, don’t hesitate to reach out to your IRB.
Author: Lauren Hartsmith, JD, CIP, Director, Regulatory Affairs
