Q: What is aromatherapy?


 A:

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.

For more information, see Is It a Cosmetic, a Drug, or Both? (or Is It Soap?)

Source: Excerpted from Office of Cosmetics and Colors Fact Sheet, March 13, 2000: Aromatherapy


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