Unit of measurement

Lower

U.S. Upper Lower U.S. Upper Lower U.S. limit RDA limit limit RDA limit limit RDA

"When labeled for use by infants, a dietary supplement shall contain not less than the lower limit designated for a nutrient in this set of columns, nor more than 100 percent of the infant U.S. RDA for a nutrient as prescribed in sec. 125.1(b) of this chapter except that the level of biotin, when used, shall be 0.05 mg daily recommended quantity.

Optional for adults and children 4 or more years of age.

'Optional for liquid products.

5

40

.5

4.0

200

400

400

0.225

.150

.300

.450

.300

.300

.600

5.0

7.5

5.0

10.0

15.0

10.0

10.0

20.0

.800 1.200

.125 1.000

1.500

.125

1.300

2.000

(4) In addition to the nutrients listed in paragraph (d)(1) of this section, other vitamins and minerals recognized as essential or probably essential in human nutrition in their biologically active forms but for which no U.S. RDA's have been established are: vitamin K, choline, and the minerals chlorine, chromium, fluorine, manganese, molybdenum, nickel, potassium, selenium, silicon, sodium, tin, and vanadium.

(e) Exemption from limitations on inclusion of ingredients and from maximum potency restrictions for certain dietary supplements. (1) Pursuant to section 411(a)(1) of the act, the limitations established by paragraphs (b) and (d) of this section and by § 105.60(b)(5) with respect to the inclusion of vitamins, minerals, and other ingredients in dietary supplements, and the maximum limits on potency established by paragraphs (c) and (d) of this section shall not apply to a food for special dietary use, defined in § 105.3(a)(1), which is or contains any vitamin or mineral and which complies with the following criteria:

(i) The preparation is intended for ingestion in tablet, capsule, or liquid form, or, if not intended for ingestion in such a form, does not simulate and is not represented as conventional food and is not represented for use as

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CHCON.O.P

CHIN,O,S
C.H,,NO,

a sole item of a meal or of the diet; and

(ii) The preparation is not represented for use by individuals in treatment or management of specific diseases or disorders, by children, or by pregnant or lactating women.

(2) For purposes of paragraph (e)(1) of this section: 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; and the term "children" means individuals who are under the age of 12 years.

(3) The exemption provided by section 411(a)(1) of the act and paragraph (e)(1) of this section does not apply to minimum potency requirements established by this section. Whenever a vitamin or mineral for which a U.S. RDA has been established is included in a dietary supplement, the supplement shall provide in the recommended daily quantity at least the lower potency limit for the vitamin or mineral established by the table in paragraph (d)(1) of this section.

(4) The exemption provided by section 411(a)(1) of the act and paragraph (e)(1) of this section does not apply to restrictions on maximum potency imposed by the act or by regula

(5) Copper-See § 182.5260 of this chapter.

(6) Fluorine-See § 170.45 of this chapter.

(7) Potassium-See § 201.306 of this chapter.

(8) Any vitamin or mineral which is included in a dietary supplement and which is not generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown to be safe under the conditions of its intended use is a food additive within the meaning of section 201(s) of the act; and pursuant to sections 402(a)(2)(C) and 409 of the act, such inclusion is illegal in the absence of a food additive regulation approving such inclusion. A listing of some of the vitamins, minerals, and compounds with vitamin and/or mineral properties which are generally recognized as safe, and which thus may lawfully be included in a dietary supplement without a food additive regulation, appears at Subpart F of Part 182 of this chapter.

(g) Acceptable ingredient sources for dietary supplements: (1) A vitamin or mineral used in a dietary supplement may be supplied by any suitable substance which is not a food additive as defined in section 201(s) of the act; or if it is a food additive as so defined, it shall be used in conformity with regulations established pursuant to section 409 of the act.

(2) Any safe and suitable substance may be used as preservative, stabilizer, flavor, sweetener, color, seasoning, carrier, base, or vehicle, or to facilitate preparation of vitamin or mineral sub

stances. A dietary supplement shall be prepared so that any such substance contained therein does not exceed the amount reasonably required to accomplish its intended physical or technical effect, and so that the biological availability of the vitamin(s) and mineral(s) is not impaired by the presence of such substance. Any such substance shall not be a food additive or color additive as defined in section 201 (s) or (t) of the act; or if it is a food additive or color additive as so defined, it shall be used in conformity with regulations established pursuant to section 409 or 706 of the act.

(h) Nomenclature. (1) The name of a dietary supplement shall consist of a term descriptive of the vitamin and/or mineral composition of the product, as established in paragraph (h)(2) of this section, together with a phrase or phrases designating the group(s) for which the supplement is intended, as established in paragraph (h)(3) of this section, e.g., "multivitamin and multimineral supplement for children under 4 years of age"; "dietary supplement of vitamin C and E for adults". The name of the dietary supplement shall appear prominently and conspicuously on the principal display panel(s) of the label. The letters or phrase(s) designating the consumer group(s) for which the product is represented shall be no less than onethird the size of those used in the term descriptive of the composition of the product. In addition to the name prescribed by this paragraph, a dietary supplement may be labeled with a proprietary name: Provided, That it is not false or misleading in any particular.

(2) The terms used to describe the vitamin and/or mineral composition of dietary supplements shall be as follows:

(i) "Multivitamin and multimineral supplement" for a dietary supplement containing all vitamins and minerals identified as "mandatory," for the group(s) for which the supplement is offered, in the table in paragraph (d)(1) of this section.

(ii) "Multivitamin supplement" for a dietary supplement containing all vitamins identified as "mandatory," for the group(s) for which the supplement

(iii) “Multimineral supplement" for a dietary supplement containing all minerals identified as "mandatory," for the group(s) for which the supplement is offered, in the table in paragraph (d)(1) of this section.

(iv) “Multivitamin and iron supplement" or "multivitamin supplement with iron" for a dietary supplement containing all vitamins identified as "mandatory," for the group(s) for which the supplement is offered, in the table in paragraph (d)(1) of this section and the mineral iron.

(v) " —— supplement" for a dietary supplement containing a single vitamin or mineral listed in paragraph (d) of this section (the blank to be filled in with the name of the vitamin or mineral).

(vi) "Dietary supplement of vitamins A, D, and C" for a preparation complying with paragraph (b)(1)(v) of this section, provided that if vitamin E is included, the term shall read “* • • vitamins A, D, C, and E ** and that if iron is included, the term shall conIclude with “*** with iron" or 440 and iron."

(vii) If, pursuant to section 411(a)(1) of the act and paragraph (e)(1) of this section, the dietary supplement contains more than one vitamin or mineral but does not meet the criteria for any of the preparations identified in paragraph (h)(2) (i) through (vi) of this section, the preparation shall bear as a part of the name an appropriately descriptive term: Provided, That the term "multivitamin” shall not be used to describe a product which fails to provide all of the vitamins identified as "mandatory," for the group(s) for which the supplement is offered, in the table in paragraph (d)(1) of this section, except as provided in the second proviso clause of paragraph (b)(1) of this section with respect to a liquid multivitamin preparation that does not include folic acid: And provided further, That the term "multimineral" shall not be used to describe a product that fails to provide all of the minerals identified as "mandaLory," for the group(s) for which the

paragraph (d)(1) of this section.

(3) The phrases used to designate the group(s) for which a dietary supplement is intended shall be as follows:

(i) "For infants."

(ii) "For children under 4 years of age."

(iii) "For adults and children 4 or more years of age."

(iv) "For pregnant or lactating women."

(v) If, pursuant to section 411(a)(1) of the act and paragraph (e)(1) of this section, a dietary supplement does not comply with the formulation and potency criteria established in paragraphs (b) and (c) of this section, the supplement may not be offered for any of the groups identified in paragraph (h)(3)(i) through (iv) because the exemption from formulation and potency restrictions authorized by section 411(a)(1) of the act and paragraph (e)(1) of this section does not apply to preparations offered for use by persons under 12 years of age or by pregnant or lactating women. Such a preparation shall accurately identify the group for which it is offered, e.g., "For adults" or "For persons 12 years of age or older, other than pregnant or lactating women."

(i) Format for listing vitamins and minerals. (1) Immediately following the name of the dietary supplement (i.e., the term descriptive of the vitamin and/or mineral composition of the product together with the phrase or phrases designating the group(s) for which the supplement is intended, as required by paragraph (h) of this section) on the principal display panel, or on the information panel pursuant to § 101.2 of this chapter if insufficient space is available on the principal display panel, the label shall bear a listing in tabular form of each of the vitamins and/or minerals supplied by the specified daily quantity of the dietary supplement, such daily quantity being specified at the top of the list. (In the event a dietary supplement is offered for more than one group, the specified daily quantity and listing of vitamins and/or minerals for each group shall be stated separately on the label.) The

vitamins and/or minerals shall be described by the names appearing in paragraph (d) of this section and shall be grouped and identified separately as "vitamins" and/or "minerals" without reference to “mandatory” or “optional." Within each category (i.e., “vitamins” and “minerals”), the vitamins or minerals shall appear in the order listed in paragraph (d) of this section. The quantity of each vitamin and/or mineral present in a specified daily quantity of the dietary supplement shall be stated as a part of this list and expressed in percentage of the U.S. RDA for each group for which the supplement is offered. The quantity of each vitamin and/or mineral present in the specified daily quantity of the dietary supplement shall also appear in the tabular listing in terms of the unit of measure specified in paragraph (d)(1) of this section: Provided, That if

the dietary supplement includes a vitamin or mineral for which no U.S. RDA has been established, the listing shall state the quantity in standard metric units of weight of each such nutrient supplied by the food when consumed in the specified quantity during a period of 1 day, accompanied by the statement "No U.S. Recommended Daily Allowance (U.S. RDA) has been established for this nutrient," or followed by an asterisk referring to another asterisk placed at the bottom of the table and followed by that statement.

(2) For determining the percentage contents of the U.S. RDA's present in the dietary supplement, the quantitative content of the following vitamins shall be calculated in terms of the following chemically identifiable reference forms:

in liquid form and contains alcohol, the label shall state the percent-byvolume of alcohol present.

(1) Expiration date. A dietary supplement containing one or more nutrients subject to deterioration below the labeled value before consumption shall bear on its outside wrapper or container, as well as on the label of its immediate container, the statement: "Expiration date," the blank to be filled in with a month and year. The expiration date shall be the date selected by the manufacturer, packer, or distributor of the dietary supplement on the basis of tests or other information showing that the dietary supplement, until that date, under the conditions of handling, storage, and use prescribed by directions appearing on its label, or, in the absence of such pre