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U. S. Food and Drug Administration
FDA Fact Sheet
T86-28 April 23, 1986


A new category of aroma products is being introduced 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." What are called "behavioral fragrance" products are beginning to be marketed. The following may be used to answer inquiries.

Traditionally, perfumes have been considered cosmetics by FDA. The Food Drug and Cosmetic Act defines cosmetics as articles to be introduced into or otherwise applied to the body to cleanse, beautify, promote attractiveness or alter appearance.

On the other hand, articles intended for use in the diagnosis, treatment or prevention of disease, and intended to affect the structure or any function of the body, usually 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 is good or beneficial, in general, is a cosmetic claim not requiring FDA approval before a product is sold. But if someone tries to market a scent with labeling "for treatment or prevention of allergies" or other condition or disease, presumably this could be found after investigation to be a new drug claim, requiring premarket approval. The agency will make judgements on a case-by-case basis.

Claims made in advertising but not on product labeling are regulated by the Federal Trade Commission. Room fragrance systems (deodorizers, odor control) are the Consumer Product Safety Commission's responsibility.

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