
From the U.S. Code Online via GPO Access
[wais.access.gpo.gov]
[Laws in effect as of January 2, 2001]
[Document not affected by Public Laws enacted between
  January 2, 2001 and January 28, 2002]
[CITE: 15USC55]

 
                      TITLE 15--COMMERCE AND TRADE
 
   CHAPTER 2--FEDERAL TRADE COMMISSION; PROMOTION OF EXPORT TRADE AND 
               PREVENTION OF UNFAIR METHODS OF COMPETITION
 
                 SUBCHAPTER I--FEDERAL TRADE COMMISSION
 
Sec. 55. Additional definitions

    For the purposes of sections 52 to 54 of this title--

(a) False advertisement

    (1) The term ``false advertisement'' means an advertisement, other 
than labeling, which is misleading in a material respect; and in 
determining whether any advertisement is misleading, there shall be 
taken into account (among other things) not only representations made or 
suggested by statement, word, design, device, sound, or any combination 
thereof, but also the extent to which the advertisement fails to reveal 
facts material in the light of such representations or material with 
respect to consequences which may result from the use of the commodity 
to which the advertisement relates under the conditions prescribed in 
said advertisement, or under such conditions as are customary or usual. 
No advertisement of a drug shall be deemed to be false if it is 
disseminated only to members of the medical profession, contains no 
false representation of a material fact, and includes, or is accompanied 
in each instance by truthful disclosure of, the formula showing 
quantitatively each ingredient of such drug.
    (2) In the case of oleomargarine or margarine an advertisement shall 
be deemed misleading in a material respect if in such advertisement 
representations are made or suggested by statement, word, grade 
designation, design, device, symbol, sound, or any combination thereof, 
that such oleomargarine or margarine is a dairy product, except that 
nothing contained herein shall prevent a truthful, accurate, and full 
statement in any such advertisement of all the ingredients contained in 
such oleomargarine or margarine.

(b) Food

    The term ``food'' means (1) articles used for food or drink for man 
or other animals, (2) chewing gum, and (3) articles used for components 
of any such article.

(c) Drug

    The term ``drug'' means (1) articles recognized in the official 
United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the 
United States, or official National Formulary, or any supplement to any 
of them; and (2) articles intended for use in the diagnosis, cure, 
mitigation, treatment, or prevention of disease in man or other animals; 
and (3) articles (other than food) intended to affect the structure or 
any function of the body of man or other animals; and (4) articles 
intended for use as a component of any article specified in clause (1), 
(2), or (3); but does not include devices or their components, parts, or 
accessories.

(d) Device

    The term ``device'' (except when used in subsection (a) of this 
section) means an instrument, apparatus, implement, machine, 
contrivance, implant, in vitro reagent, or other similar or related 
article, including any component, part, or accessory, which is--
        (1) recognized in the official National Formulary, or the United 
    States Pharmacopeia, or any supplement to them,
        (2) intended for use in the diagnosis of disease or other 
    conditions, or in the cure, mitigation, treatment, or prevention of 
    disease, in man or other animals, or
        (3) intended to affect the structure or any function of the body 
    of man or other animals, and

which does not achieve any of its principal intended purposes through 
chemical action within or on the body of man or other animals and which 
is not dependent upon being metabolized for the achievement of any of 
its principal intended purposes.

(e) Cosmetic

    The term ``cosmetic'' means (1) articles to be rubbed, poured, 
sprinkled, or sprayed on, introduced into, or otherwise applied to the 
human body or any part thereof intended for cleansing, beautifying, 
promoting attractiveness, or altering the appearance, and (2) articles 
intended for use as a component of any such article; except that such 
term shall not include soap.

(f) Oleomargarine or margarine

    For the purposes of this section and section 347 of title 21, the 
term ``oleomargarine'' or ``margarine'' includes--
        (1) all substances, mixtures, and compounds known as 
    oleomargarine or margarine;
        (2) all substances, mixtures, and compounds which have a 
    consistence similar to that of butter and which contain any edible 
    oils or fats other than milk fat if made in imitation or semblance 
    of butter.

(Sept. 26, 1914, ch. 311, Sec. 15, as added Mar. 21, 1938, ch. 49, 
Sec. 4, 52 Stat. 114; amended Mar. 16, 1950, ch. 61, Sec. 4(a), (b), 64 
Stat. 21; Pub. L. 94-295, Sec. 3(a)(1)(B), May 28, 1976, 90 Stat. 575.)


                               Amendments

    1976--Subsec. (d). Pub. L. 94-295 expanded definition of ``device'' 
to include implements, machines, implants, in vitro reagents, and other 
similar or related articles, added recognition in the National Formulary 
or the United States Pharmacopeia, or any supplement to the Formulary or 
Pharmacopeia, to the enumeration of conditions under which a device may 
qualify for inclusion under this chapter, and inserted requirements that 
a device be one which does not achieve any of its principal intended 
purposes through chemical action within or on the body of man or other 
animals and which is not dependent upon being metabolized for the 
achievement of any of its principal intended purposes.
    1950--Subsec. (a). Act Mar. 16, 1950, Sec. 4(a), designated existing 
provisions as par. (1) and added par. (2) relating to oleomargarine.
    Subsec. (f). Act Mar. 16, 1950, Sec. 4(b), added subsec. (f).


                    Effective Date of 1950 Amendment

    Amendment by act Mar. 16, 1950, effective July 1, 1950, see note set 
out under section 347 of Title 21, Food and Drugs.

                  Section Referred to in Other Sections

    This section is referred to in title 21 sections 347b, 352.
