21 U.S.C. § 350 : US Code - Section 350: Vitamins and minerals

Search 21 U.S.C. § 350 : US Code - Section 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.
(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.