Sec. 411. [21 USC §350] Vitamins and Minerals
（a）（1） Except as provided in paragraph （2）—
（A） the Secretary may not establish, undersection 201（n）, 401, or 403, 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 201（n）, 401, or 403, 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 inpiduals 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 inpiduals who are under the age of twelve years.
（b）（1） A food to which this section applies shall not be deemed under section 403 to be misbranded solely because its label bears, in accordance with section 403（i）（2）, 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 201（ff） （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 403. 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）（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 403 （j） 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.
更多有关《联邦食品、药品和化妆品法》的内容，请点击《联邦食品、药品和化妆品法》第II章及第IV章食品法规汇总。
更多国外法规翻译，请联系食品翻译中心
编辑：foodlaw
