[Federal Register: August 11, 1995 (Volume 60, Number 155)]
[Notices]
[Page 41467-41470]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]

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[[Page 41467]]

I. CIGARETTES AND SMOKELESS TOBACCO PRODUCTS ``AFFECT THE STRUCTURE OR
ANY FUNCTION OF THE BODY'' BECAUSE THEY HAVE PHARMACOLOGICAL EFFECTS
AND LEAD TO ADDICTION

    The definition of drug in the Food and Drugs Act of 1906 included
only articles ``intended to be used for the cure, mitigation, or
prevention of disease.'' Pub. L. No. 59-384, 34 Stat. 768 Sec. 6.
Congress added section 201(g)(1)(C) <SUP>2 when it enacted the Federal
Food, Drug, and Cosmetic Act of 1938 in order to expand the reach of
the drug definition to encompass products that escaped regulation under
the 1906 act. Section 201(g)(1)(C) and the parallel section 201(h)(3),
governing devices, reach products that do not have therapeutic uses but
have, or are promoted as having, significant pharmacological or
physiological effects. As House Report 2139 explained:

    \2\ Section 201 of the Federal Food, Drug, and Cosmetic Act is
now codified at 21 U.S.C. Sec. 321.
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[t]he definition of drug is expanded to include * * * articles other
than food intended to affect the structure or any function of the
body of man or other animals. These expansions are needed to give
jurisdiction over a great number of drugs which are not amenable to
control under the present law.

H.R. Rep. No. 2139 at 3, reprinted in 6 Legislative History 300, 302
(emphasis added). The principal example given in the legislative
history of products ``intended to affect the structure or any function
of the body'' is weight management products. The ``structure or any
function'' language was needed because obesity and extreme thinness
were not considered diseases. Congress was concerned with both the
egregious nature of the claims for some of these products as well as
the health risks associated with their use. See 78 Cong. Rec. 8960 (73d
Cong., 2d Sess., May 16, 1934) (prepared statement of Senator
Copeland), reprinted in 2 Legislative History at 831.

[[Page 41468]]

    While Congress' primary focus in 1938 was on products intended for
weight management, it adopted language that included all products that
affect the structure or function of the body. This expansion of the
drug definition was ``needed to protect the consumer * * * against a
multiplicity of abuses not subject to the [1906 act].'' S. Rep. No.
646, 74th Cong. 1st Sess. 1, reprinted in 4 Legislative History at 93.
As one court explained:

    The legislative history of the 1938 Act discloses that * * * the
law which broadened the drug definition was enacted in part, and
perhaps in important part, to control fraudulent remedies for
obesity and leanness. But it also discloses that the expansion of
the drug definition was not aimed solely at these remedies. They
were merely illustrative of a comprehensive class of preparations
which were intended to affect the structure or function of the body
to which the legislation was directed.

United States v. Article Consisting of 36 Boxes * * * ``Lineaway,
Temporary Wrinkle Smoother'', 284 F. Supp. 107, 110 (D. Del. 1968),
aff'd, 415 F.2d 369 (3d Cir. 1969) (emphasis added) (citations
omitted).
    Consistent with the statutory language and Congress' intent to
insure that FDA has the authority to regulate products with non-
therapeutic, but pharmacological effects, FDA has interpreted the
provisions to encompass products that intrinsically have
pharmacological or physiological effects, even though they are not
promoted for therapeutic purposes. Examples of such products are
topical hormones, sunscreens, and tanning booths. See Appendix to Legal
Analysis. Judicial constructions of sections 201(g)(1)(C) and 201(h)(3)
are consistent with this interpretation. See, e.g., E.R. Squibb & Sons,
Inc. v. Bowen, 870 F.2d 678, 683 (D.C. Cir. 1989) (summarizing cases);
United States v. Undetermined Quantities of Cal-Ban 3000, 776 F. Supp.
249, 253 (E.D.N.C. 1991) (``[T]he term 'drug' should be interpreted
broadly and not limited to only products which are commonly known as
drugs.'').

[[Page 41469]]

    Courts have been careful to distinguish between remote physical
effects which arguably might fall within the literal language of
section 201(g)(1)(C) or section 201(h)(3) and significant effects on
structure or function which clearly fall within the provisions' ambit.
``[R]emote physical effect[s] on the body'' are not covered by the
structure or function provision. E.R. Squibb & Sons, 870 F.2d at 682.
On the other hand, products intended to prevent pregnancy, thus
affecting the reproductive function of the human body, fall within that
definition. Id. at 682-83.
    For example, a product intended to reduce the number of bacteria in
an animal's digestive system and oral cavity is a drug within the
meaning of section 201(g)(1)(C) because it ``was intended to alter a
function of the animal's body.'' United States v. Undetermined
Quantities * * * ``Pet Smellfree, 22 F.3d 235, 240 (10th Cir. 1994).
Similarly, liquid solutions intended to cause hair growth and prevent
hair loss are drugs within the meaning of section 201(g)(1)(C) because
the hair growth process is a function of the human body. United States
v. Kasz Enterprises, Inc., 855 F. Supp. 534, 540 (D.R.I. 1994),
judgment modified on other grounds, 862 F. Supp. 717 (D.R.I. 1994).
Likewise, an apparatus containing oxygen that is intended to improve
athletic performance by increasing a tired athlete's intake of oxygen
falls within sections 201(g)(1)(C) and 201(h)(3) because enhanced
oxygen absorption alters a bodily structure or function. United States
v. Eighteen Units, More or Less Of An Article of Drug * * * ``SPORTS
OXYGEN * * *'', Civ. No. 89-2085 (D.N.J. October 27, 1992), reprinted
in Food, Drug, and Cosmetic Act Judicial Record, 1991-92 115. Cocaine
and similar substances with parallel addictive and psychoactive effects
also fall within the drug definition because

[[Page 41470]]
they ``affect the structure or any function of the body.'' <SUP>3

    \3\ In fact, the Controlled Substances Act, 21 U.S.C. Secs. 801-
904, which prohibits the sale of drugs such as cocaine, defines
``drug'' by reference to section 201(g)(1) of the FDCA. 21 U.S.C.
Sec. 802(12).
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    In each of these cases, a significant pharmacological effect on the
body can bring a substance within the drug definition, even when the
product has no therapeutic effect. On numerous other occasions, the
Agency has reached similar conclusions and has taken regulatory action.
See Appendix to Legal Analysis for examples. As is discussed at p. 22,
et seq., it is now widely accepted that nicotine has pharmacological
effects on both the structure and function of the central nervous
system, particularly the brain. Addiction is a direct result of
nicotine's effects on the structure and function of the body. Id. Based
on the record before the agency, cigarettes and smokeless tobacco
products ``affect the structure or any function of the body'' within
the meaning of sections 201(g)(1)(C) and 201(h)(3).