Source: https://www.law.cornell.edu/cfr/text/21/101.36
Timestamp: 2020-08-06 08:28:18
Document Index: 401529024

Matched Legal Cases: ['§ 101', '§ 101', '§ 101', '§ 101', '§ 101', '§ 101', '§ 101', '§ 101', '§ 101', '§ 101', '§ 101', '§ 101', '§ 101', '§ 101', '§ 101', '§ 101', '§ 101', '§ 101', '§ 101', '§ 101', '§ 101', '§ 101', '§ 101', '§ 101', '§ 101', '§ 101', '§ 101', '§ 101', '§ 101', '§ 101']

21 CFR § 101.36 - Nutrition labeling of dietary supplements. | CFR | US Law | LII / Legal Information Institute
Subpart C. Specific Nutrition Labeling Requirements and Guidelines
Section 101.36. Nutrition labeling of dietary supplements.
21 CFR § 101.36 - Nutrition labeling of dietary supplements.
(1) Serving size.
(i) The subheading “Serving Size” shall be placed under the heading “Supplement Facts” and aligned on the left side of the nutrition label. The serving size shall be determined in accordance with §§ 101.9(b) and 101.12(b), Table 2. Serving size for dietary supplements shall be expressed using a term that is appropriate for the form of the supplement, such as “tablets,” “capsules,” “packets,” or “teaspoonfuls.”
(2) Information on dietary ingredients that have a Reference Daily Intake (RDI) or a Daily Reference Value (DRV) as established in § 101.9(c) and their subcomponents (hereinafter referred to as “(b)(2)-dietary ingredients”).
(i) The (b)(2)-dietary ingredients to be declared, that is, total calories, total fat, saturated fat, trans fat, cholesterol, sodium, total carbohydrate, dietary fiber, total sugars, added sugars, protein, vitamin D, calcium, iron, and potassium, shall be declared when they are present in a dietary supplement in quantitative amounts by weight that exceed the amount that can be declared as zero in nutrition labeling of foods in accordance with § 101.9(c). Calories from saturated fat, polyunsaturated fat, monounsaturated fat, soluble fiber, insoluble fiber, and sugar alcohol may be declared, but they shall be declared when a claim is made about them. Any (b)(2)-dietary ingredients that are not present, or that are present in amounts that can be declared as zero in § 101.9(c), shall not be declared (e.g., amounts corresponding to less than 2 percent of the RDI for vitamins and minerals). Protein shall not be declared on labels of products that, other than ingredients added solely for technological reasons, contain only individual amino acids.
(B) The names of dietary ingredients that are declared under paragraph (b)(2)(i) of this section shall be presented in a column aligned on the left side of the nutritional label in the order and manner of indentation specified in § 101.9(c), except that calcium and iron shall follow choline, and sodium and potassium shall follow chloride. This results in the following order for vitamins and minerals: Vitamin A, vitamin C, vitamin D, vitamin E, vitamin K, thiamin, riboflavin, niacin, vitamin B6, folate and folic acid, vitamin B12, biotin, pantothenic acid, choline, calcium, iron, phosphorus, iodine, magnesium, zinc, selenium, copper, manganese, chromium, molybdenum, chloride, sodium, potassium, and fluoride. The (b)(2)-dietary ingredients shall be listed according to the nomenclature specified in § 101.9 or in paragraph (b)(2)(i)(B)(2) of this section.
(A) The amounts shall be expressed in the increments specified in § 101.9(c)(1) through (7), which includes increments for sodium.
(B) The amounts of vitamins and minerals, excluding sodium, shall be the amount of the vitamin or mineral included in one serving of the product, using the units of measurement and the levels of significance given in § 101.9(c)(8)(iv), except that zeros following decimal points may be dropped, and additional levels of significance may be used when the number of decimal places indicated is not sufficient to express lower amounts (e.g., the RDI for zinc is given in whole milligrams (mg), but the quantitative amount may be declared in tenths of a mg). The amount of vitamin D may, but is not required to, be expressed in IUs, in addition to the mandatory declaration in mcg. Any declaration of the amount of vitamin D in IUs must appear in parentheses after the declaration of the amount of vitamin D in mcg.
(iii) The percent of the Daily Value of all dietary ingredients declared under paragraph (b)(2)(i) of this section shall be listed, except that the percent Daily Value for protein, when present, shall be calculated using the corrected amount of protein as specified in § 101.9(c)(7)(ii); no percent of the Daily Value shall be given for subcomponents for which DRVs or RDIs have not been established (e.g., total sugars). Additionally, the percentage of the RDI for protein shall be omitted when a food is purported to be for infants through 12 months of age.
(B) The percent of Daily Value shall be calculated by dividing the quantitative amount by weight of each (b)(2)-dietary ingredient by the RDI as established in § 101.9(c)(8)(iv) or the DRV as established in § 101.9(c)(9) for the specified dietary ingredient and multiplying by 100, except that the percent of Daily Value for protein, when present, shall be calculated as specified in § 101.9(c)(7)(ii). The quantitative amount by weight of each dietary ingredient in this calculation shall be the unrounded amount, except that for total fat, saturated fat, cholesterol, sodium, potassium, total carbohydrate, and dietary fiber, the quantitative amount by weight declared on the label (i.e, rounded amount) may be used. The numerical value shall be followed by the symbol for percent (i.e., %).
(3) Information on dietary ingredients for which RDI's and DRV's have not been established.
(i) Dietary ingredients for which FDA has not established RDI's or DRV's and that are not subject to regulation under paragraph (b)(2) of this section (hereinafter referred to as “other dietary ingredients”) shall be declared by their common or usual name when they are present in a dietary supplement, in a column that is under the column of names described in paragraph (b)(2)(i)(B) of this section or, as long as the constituents of an other dietary ingredient are not listed, in a linear display, under the heavy bar described in paragraph (e)(6) of this section, except that if no (b)(2)-dietary ingredients are declared, other dietary ingredients shall be declared directly beneath the heading “Amount Per Serving” described in paragraph (b)(2)(i)(A) of this section.
(B) For any dietary ingredient that is a liquid extract from which the solvent has not been removed, the quantity listed shall be the volume or weight of the total extract. Information on the condition of the starting material shall be indicated when it is fresh and may be indicated when it is dried. Information may be included on the concentration of the dietary ingredient and the solvent used, e.g., “fresh dandelion root extract, x (y:z) in 70% ethanol,” where x is the number of milliliters (mL) or mg of the entire extract, y is the weight of the starting material and z is the volume (mL) of solvent. Where the solvent has been partially removed (not to dryness), the final concentration, when indicated, shall be stated (e.g., if the original extract was 1:5 and 50 percent of the solvent was removed, then the final concentration shall be stated as 1:2.5). Where the name of the solvent used is not included in the nutrition label, it is required to be listed in the ingredient statement in accordance with § 101.4(g).
(d) The source ingredient that supplies a dietary ingredient may be identified within the nutrition label in parentheses immediately following or indented beneath the name of a dietary ingredient and preceded by the words “as” or “from”, e.g., “Calcium (as calcium carbonate),” except that manner of presentation is unnecessary when the name of the dietary ingredient (e.g., Oriental ginseng) or its synonym (e.g., ascorbic acid) is itself the source ingredient. When a source ingredient is identified in parentheses within the nutrition label, or when the name of the dietary ingredient or its synonym is the source ingredient, it shall not be required to be listed again in the ingredient statement that appears outside of the nutrition label. When a source ingredient is not identified within the nutrition label, it shall be listed in an ingredient statement in accordance with § 101.4(g), which shall appear outside and immediately below the nutrition label or, if there is insufficient space below the nutrition label, immediately contiguous and to the right of the nutrition label.
(1) Source ingredients shall be identified in accordance with § 101.4 (i.e., shall be listed by common or usual name, and the listing of botanicals shall specify the part of the plant from which the ingredient is derived) regardless of whether they are listed in an ingredient statement or in the nutrition label.
(i) The quantitative amount by weight (or volume, if permitted) and the percent of Daily Value of each dietary ingredient may be presented on a “per unit” basis in addition to the “per serving” basis required by paragraphs (b)(2)(ii) and (b)(2)(iii) of this section for (b)(2)-dietary ingredients and (b)(3)(ii) and (b)(3)(iv) of this section for other dietary ingredients. If “per unit” information is provided, it must be presented in additional columns to the right of the “per serving” information and be clearly identified by appropriate headings.
(1) Compliance with this section will be determined in accordance with § 101.9(g)(1) through (g)(8), (g)(10), and (g)(11), except that the sample for analysis shall consist of a composite of 12 subsamples (consumer packages) or 10 percent of the number of packages in the same inspection lot, whichever is smaller, randomly selected to be representative of the lot. The criteria on class I and class II nutrients given in § 101.9(g)(3) and (g)(4) also are applicable to other dietary ingredients described in paragraph (b)(3)(i) of this section. Reasonable excesses over labeled amounts are acceptable within current good manufacturing practice.
(2) When it is not technologically feasible, or some other circumstance makes it impracticable, for firms to comply with the requirements of this section, FDA may permit alternative means of compliance or additional exemptions to deal with the situation in accordance with § 101.9(g)(9). Firms in need of such special allowances shall make their request in writing to the Office of Nutrition and Food Labeling (HFS-800), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740.
(g) Except as provided in paragraphs (i)(2) and (i)(5) of this section, the location of nutrition information on a label shall be in compliance with § 101.2.
(2) Section 101.9(j)(18) for foods that are low-volume products (that is, they meet the requirements for units sold in § 101.9(j)(18)(i) or (j)(18)(ii)); that, except as provided in § 101.9(j)(18)(iv), are the subject of a claim for an exemption that provides the information required under § 101.9(j)(18)(iv), that is filed before the beginning of the time period for which the exemption is claimed, and that is filed by a person, whether it is the manufacturer, packer, or distributor, that qualifies to claim the exemption under the requirements for average full-time equivalent employees in § 101.9(j)(18)(i) or (j)(18)(ii), and whose labels, labeling, and advertising do not provide nutrition information or make a nutrient content or health claim;
(1) Dietary supplements are subject to the special labeling provisions specified in § 101.9(j)(5)(i) for foods other than infant formula, represented or purported to be specifically for infants through 12 months of age and children 1 through 3 years of age.
(iii) When the nutrition information is presented on any panel under § 101.9(j)(13)(ii)(D), the ingredient list shall continue to be located immediately below the nutrition label, or, if there is insufficient space below the nutrition label, immediately contiguous and to the right of the nutrition label as specified in § 101.4(g).
(5) Section 101.9(j)(17) for foods in packages that have a total surface area available to bear labeling greater than 40 square inches but whose principal display panel and information panel do not provide sufficient space to accommodate all required label information, except that the ingredient list shall continue to be located immediately below the nutrition label, or, if there is insufficient space below the nutrition label, immediately contiguous and to the right of the nutrition label as specified in § 101.4(g).
(j) Dietary supplements shall be subject to the misbranding provisions of § 101.9(k).