§ 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;
(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
(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—
(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.
[1] So in original. Probably should be “paragraph”.