What are Cosmeceuticals?

The term “cosmeceutical” has become a popular buzzword in the beauty industry—used to describe products that seem to bridge the gap between cosmetics and drugs. However, according to the U.S. Food and Drug Administration (FDA), there is no legal definition or regulatory category for cosmeceuticals under U.S. law.

What Counts as a Cosmetic vs. a Drug

Under the Federal Food, Drug, and Cosmetic Act (FD&C Act):

• Cosmetics are products applied to the body for cleansing, beautifying, promoting attractiveness, or altering appearance.
• Drugs are products intended to diagnose, treat, mitigate, or prevent disease or that affect the structure or function of the body.

A product can be both a cosmetic and a drug if it serves both purposes. For example, a moisturizing lotion that also claims to treat eczema must meet drug requirements because it makes a therapeutic claim.

Why “Cosmeceutical” Is a Marketing Term

Although the term cosmeceutical is often used by marketers to suggest enhanced benefits, the FDA does not recognize it as a distinct category. Products labeled this way are still classified as either cosmetics, drugs, or both depending on their intended use and claims.

Using the term cosmeceutical doesn’t exempt a company from FDA regulations. In fact, if a product marketed as a cosmetic makes drug-like claims—such as “restores collagen,” “heals acne,” or “repairs sun damage”—it may be subject to additional drug approval requirements.

The Role of Product Claims

What truly determines how the FDA classifies a product is its intended use, which is often inferred from the product’s claims—the words used on labels, packaging, advertising, and social media. Claims that imply a physiological change or therapeutic effect can shift a product from a cosmetic into the drug category, triggering different labeling, testing, and premarket approval obligations.

Why This Matters for Brands

For manufacturers and marketers, understanding this distinction is essential. Mislabeling a product or making unapproved drug claims can result in FDA warning letters, seizures, or recall actions. Staying compliant means carefully reviewing product claims and avoiding terminology that could be misleading or imply medical benefits without proper authorization.

Final Thoughts

While “cosmeceutical” may sound appealing, it holds no official meaning under FDA law. Every product must still meet the standards for either cosmetics, drugs, or both. Companies should focus on accurate, compliant claims—and consumers should recognize that the term cosmeceutical is purely promotional, not regulatory. (FDA Sources)