15 U.S.C. § 55 — Additional definitions

(a) False advertisement: This subsection defines "false advertisement" for sections 52 through 54. (1) An advertisement (other than labeling) is a "false advertisement" if it is misleading in a material way. To decide whether it's misleading, you look at more than just what the ad directly states, you also look at what it suggests through words, design, sound, pictures, or any combination of these. You also look at whether the ad leaves out facts that matter, either about what it's claiming, or about what could happen if someone uses the product the way the ad describes or the way people usually use it. There's an exception for drug ads aimed only at doctors and other medical professionals. Such an ad isn't "false" if it makes no false statement of a material fact, and if it includes, or comes with, a truthful statement of the drug's formula, listing the amount of each ingredient. (2) For oleomargarine or margarine, an ad is misleading in a material way if it claims or suggests, through words, grade names, designs, symbols, sounds, or any combination, that the product is a dairy product. That said, nothing stops a truthful, accurate, complete list of the product's ingredients in the ad. (b) Food: "Food" means: food or drink for people or animals; chewing gum; and articles used as parts of those items. (c) Drug: "Drug" means: articles listed in the official U.S. Pharmacopoeia, the official Homoeopathic Pharmacopoeia, the official National Formulary, or a supplement to any of them; articles meant to diagnose, cure, ease, treat, or prevent disease in people or animals; articles (other than food) meant to affect the structure or function of the body of a person or animal; and articles meant to be used as a part of any of those. "Drug" does not include devices, or their parts or accessories. (d) Device: Except when the word is used in subsection (a), "device" means an instrument, tool, machine, implant, in vitro reagent, or similar article (including its parts and accessories) that is: listed in the official National Formulary or U.S. Pharmacopeia or a supplement; meant for diagnosing disease or other conditions, or for curing, easing, treating, or preventing disease, in people or animals; or meant to affect the structure or function of the body of a person or animal. To count as a "device," the article must not achieve its main purpose through chemical action in or on the body, and it must not need to be metabolized (broken down by the body) to achieve its main purpose. (e) Cosmetic: "Cosmetic" means: articles rubbed, poured, sprinkled, or sprayed on, or otherwise applied to, the human body, meant to clean, beautify, promote attractiveness, or change appearance; and articles meant to be used as a part of those. Soap is not included. (f) Oleomargarine or margarine: For this section and for section 347 of title 21, "oleomargarine" or "margarine" includes: everything known as oleomargarine or margarine; and any substance, mixture, or compound with a consistency like butter's, made with edible oils or fats other than milk fat, if it's made to imitate or resemble butter.