§ 350. — Vitamins and minerals.
[Laws in effect as of January 24, 2002]
[Document not affected by Public Laws enacted between
January 24, 2002 and December 19, 2002]
[CITE: 21USC350]
TITLE 21--FOOD AND DRUGS
CHAPTER 9--FEDERAL FOOD, DRUG, AND COSMETIC ACT
SUBCHAPTER IV--FOOD
Sec. 350. Vitamins and minerals
(a) Authority and limitations of Secretary; applicability
(1) Except as provided in paragraph (2)--
(A) the Secretary may not establish, under section 321(n), 341,
or 343 of this title, maximum limits on the potency of any synthetic
or natural vitamin or mineral within a food to which this section
applies;
(B) the Secretary may not classify any natural or synthetic
vitamin or mineral (or combination thereof) as a drug solely because
it exceeds the level of potency which the Secretary determines is
nutritionally rational or useful;
(C) the Secretary may not limit, under section 321(n), 341, or
343 of this title, the combination or number of any synthetic or
natural--
(i) vitamin,
(ii) mineral, or
(iii) other ingredient of food,
within a food to which this section applies.
(2) Paragraph (1) shall not apply in the case of a vitamin, mineral,
other ingredient of food, or food, which is represented for use by
individuals in the treatment or management of specific diseases or
disorders, by children, or by pregnant or lactating women. For purposes
of this subparagraph,\1\ the term ``children'' means individuals who are
under the age of twelve years.
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\1\ So in original. Probably should be ``paragraph''.
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(b) Labeling and advertising requirements for foods
(1) A food to which this section applies shall not be deemed under
section 343 of this title to be misbranded solely because its label
bears, in accordance with section 343(i)(2) of this title, all the
ingredients in the food or its advertising contains references to
ingredients in the food which are not vitamins or minerals.
(2) The labeling for any food to which this section applies may not
list its ingredients which are not dietary supplement ingredients
described in section 321(ff) of this title (i) except as a part of a
list of all the ingredients of such food, and (ii) unless such
ingredients are listed in accordance with applicable regulations under
section 343 of this title. To the extent that compliance with clause (i)
of this subparagraph is impracticable or results in deception or unfair
competition, exemptions shall be established by regulations promulgated
by the Secretary.
(c) Definitions
(1) For purposes of this section, the term ``food to which this
section applies'' means a food for humans which is a food for special
dietary use--
(A) which is or contains any natural or synthetic vitamin or
mineral, and
(B) which--
(i) is intended for ingestion in tablet, capsule, powder,
softgel, gelcap, or liquid form, or
(ii) if not intended for ingestion in such a form, is not
represented as conventional food and is not represented for use
as a sole item of a meal or of the diet.
(2) For purposes of paragraph (1)(B)(i), a food shall be considered
as intended for ingestion in liquid form only if it is formulated in a
fluid carrier and it is intended for ingestion in daily quantities
measured in drops or similar small units of measure.
(3) For purposes of paragraph (1) and of section 343(j) of this
title insofar as that section is applicable to food to which this
section applies, the term ``special dietary use'' as applied to food
used by man means a particular use for which a food purports or is
represented to be used, including but not limited to the following:
(A) Supplying a special dietary need that exists by reason of a
physical, physiological, pathological, or other condition, including
but not limited to the condition of disease, convalescence,
pregnancy, lactation, infancy, allergic hypersensitivity to food,
underweight, overweight, or the need to control the intake of
sodium.
(B) Supplying a vitamin, mineral, or other ingredient for use by
man to supplement his diet by increasing the total dietary intake.
(C) Supplying a special dietary need by reason of being a food
for use as the sole item of the diet.
(June 25, 1938, ch. 675, Sec. 411, as added Pub. L. 94-278, title V,
Sec. 501(a), Apr. 22, 1976, 90 Stat. 410; amended Pub. L. 103-417,
Secs. 3(c), 7(d), Oct. 25, 1994, 108 Stat. 4328, 4331.)
Amendments
1994--Subsec. (b)(2). Pub. L. 103-417, Sec. 7(d), redesignated
subpar. (A) as par. (2), substituted ``dietary supplement ingredients
described in section 321(ff) of this title'' for ``vitamins or
minerals'', and struck out former subpar. (B), which read as follows:
``Notwithstanding the provisions of subparagraph (A), the labeling and
advertising for any food to which this section applies may not give
prominence to or emphasize ingredients which are not--
``(i) vitamins,
``(ii) minerals, or
``(iii) represented as a source of vitamins or minerals.''
Subsec. (c)(1)(B)(i). Pub. L. 103-417, Sec. 3(c)(1), inserted
``powder, softgel, gelcap,'' after ``capsule,''.
Subsec. (c)(1)(B)(ii). Pub. L. 103-417, Sec. 3(c)(2), struck out
``does not simulate and'' after ``in such a form,''.
Effective Date of 1994 Amendment
For provision that dietary supplements may be labeled after Oct. 25,
1994, in accordance with amendments made by section 7(d) of Pub. L. 103-
417, and shall be so labeled after Dec. 31, 1996, see section 7(e) of
Pub. L. 103-417, set out as a note under section 343 of this title.
Amendment of Inconsistent Regulations by Secretary
Section 501(b) of Pub. L. 94-278, as amended by Pub. L. 96-88, title
V, Sec. 509(b), Oct. 17, 1979, 93 Stat. 695, provided that: ``The
Secretary of Health and Human Services shall amend any regulation
promulgated under the Federal Food, Drug, and Cosmetic Act [this
chapter] which is inconsistent with section 411 of such Act [section 350
of this title] (as added by subsection (a)) and such amendments shall be
promulgated in accordance with section 553 of title 5, United States
Code.''
Section Referred to in Other Sections
This section is referred to in sections 321, 343 of this title.
