March 13, 2000. This document is current. It is updated only as needed.
Fragrance products are sometimes marketed with claims or implications that their use will improve personal well-being in a variety of ways, such as "strengthening the body's self-defense mechanisms." These are also known as "behavioral fragrance" or "aromatherapy" products.
Traditionally, perfumes have been considered cosmetics by FDA. The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines cosmetics in part as articles intended to be applied to or introduced into the human body "for cleansing, beautifying, promoting attractiveness, or altering the appearance" (FD&C Act, Section 201).
On the other hand, articles intended for use in the diagnosis, mitigation, treatment, or prevention of disease, and intended to affect the structure or any function of the body, are considered to be drugs -- with all "new drugs" requiring FDA's premarket approval.
While cosmetics and drugs both are under FDA's jurisdiction, the legal requirements applying to them differ. A claim that a perfume's aroma makes a person feel more attractive, in general, is a cosmetic claim not requiring FDA approval before a product is sold. But if someone tries to market a scent suggesting effectiveness as an aid in quitting smoking, as a sleeping aid, or to treat or prevent any other condition or disease, or otherwise affect the body's structure or function, such a claim may cause the product to be regulated as a drug, requiring premarket approval. The agency will make judgments on a case-by-case basis.
Claims made in advertising but not on product labeling are regulated by the Federal Trade Commission, although advertising claims can be used to establish a product's intended use. Room fragrance systems (deodorizers, odor control) are the Consumer Product Safety Commission's responsibility.
For more information, see Is It a Cosmetic, a Drug, or Both? (or Is It Soap?)