I
103D CONGRESS
1ST SESSION
H. R. 2923
To amend the Federal Food, Drug, and Cosmetic Act to revise the regulation
of dietary supplements.
IN THE HOUSE OF REPRESENTATIVES
AUGUST 6, 1993
Mrs. COLLINS of Illinois introduced the following bill; which was referred to
the Committee on Energy and Commerce
A BILL
To amend the Federal Food, Drug, and Cosmetic Act to
revise the regulation of dietary supplements.
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled,
SECTION 1. SHORT TITLE; REFERENCE.
This Act may be cited as the ‘‘Dietary Supplement
Consumer Protection Act of 1993’’.
(b) REFERENCE.—Whenever in this Act an amend-
ment or repeal is expressed in terms of an amendment
to, or repeal of, a section or other provision, the reference
shall be considered to be made to a section or other provi-
sion of the Federal Food, Drug, and Cosmetic Act
SEC. 2. DEFINITIONS.
Section 201 (21 U.S.C. 321) is amended by adding
at the end the following:
‘‘(gg) The term ‘dietary supplement’ means an article
that is—
‘‘(1) intended to supplement the diet,
‘‘(2) is, or contains, a vitamin, mineral, or an
herb or similar nutritional substance, including a
concentrate or extract of a vitamin, mineral, or other
nutritional substance, and
‘‘(3)(A) is intended for ingestion in a form de-
scribed in paragraph (1)(B)(i) or (2) of section
411(c) or in another similar form, or
‘‘(B) complies with section 411(c)(1)(B)(ii).
‘‘(hh) The term ‘dietary ingredient’ means a vitamin,
mineral, or herb or other similar nutritional substance the
intended use of which results, or may reasonably be ex-
pected to result, directly or indirectly, in its becoming a
component or otherwise affecting the characteristics of
any dietary supplement.’’.
SEC. 3. DEFINITIONS AND STANDARDS OF IDENTITY.
Section 401 (21 U.S.C. 341) is amended—
(1) in the first sentence, by inserting ‘‘or die-
tary supplement’’ after ‘‘establishing for any food’’,
and
(2) in the fourth sentence, by inserting ‘‘or die-
tary supplement’’ after ‘‘any food’’ and by inserting
‘‘or dietary supplements’’ after ‘‘class of food’’.
SEC. 4. ADULTERATION.
Section 402 (21 U.S.C. 342) is amended—
(1) by inserting ‘‘or dietary supplement’’ after
‘‘food’’ before paragraph (a), and
(2) by adding at the end the following:
‘‘(f) If it is a dietary supplement and it is, or con-
tains, any dietary ingredient which is unsafe within the
meaning of section 413.
‘‘(g) If it is a dietary supplement and it does not meet
the quality factor requirements prescribed by the Sec-
retary under this paragraph. The Secretary shall, by regu-
lation, establish requirements for quality factors for die-
tary supplements as appropriate.
‘‘(h)(1) If it is a dietary supplement and the process-
ing of such dietary supplement is not in compliance with
the good manufacturing practices and the quality control
procedures established by the Secretary under subpara-
graph (2).
‘‘(2) The Secretary shall, by regulation, establish
good manufacturing practices for dietary supplements, in-
cluding quality control procedures that the Secretary de-
termines are necessary to assure that a dietary supple-
ment—
‘‘(A) provides the vitamin, mineral, or herb or
other nutritional substance it claims to provide in its
label or labeling, and
‘‘(B) is manufactured in a manner designed to
prevent adulteration.’’.
SEC. 5. MISBRANDING.
Section 403 (21 U.S.C. 343) is amended—
(1) by inserting ‘‘or dietary supplement’’ after
‘‘food’’ before paragraph (a),
(2) in paragraph (a)(2), by inserting ‘‘or die-
tary supplement’’ after ‘‘food’’,
(3) in paragraph (b), by inserting ‘‘or dietary
supplement’’ after ‘‘another food’’,
(4) in paragraph (g), by inserting ‘‘or dietary
supplement’’ after ‘‘food’’ each place it occurs,
(5) in paragraph (h), by inserting ‘‘or dietary
supplement’’ after ‘‘food’’ each place it occurs,
(6) in paragraph (i)(1), by inserting ‘‘or dietary
supplement’’ after ‘‘food’’,
(7) in paragraph (r)(1), by inserting ‘‘or dietary
supplement’’ after ‘‘food’’ each place it occurs and
by inserting ‘‘or dietary ingredient’’ after ‘‘nutrient’’
each place it occurs,