Dietary Supplement Regulation in the United States by Taylor C. Wallace Douglas MacKay Rend Al-Mondhiry Haiuyen Nguyen & James C. Griffiths

Author:Taylor C. Wallace, Douglas MacKay, Rend Al-Mondhiry, Haiuyen Nguyen & James C. Griffiths
Language: eng
Format: epub
Publisher: Springer International Publishing, Cham

1.4.1.3 Ingredients Statement

If a dietary supplement includes ingredients not listed on the Supplement Facts box, these ingredients must be listed under the heading "Other Ingredients," in accordance with §101.4(g). These ingredients may include the source of dietary ingredients that have not been identified in the Supplement Facts box (e.g., rose hips as the source of vitamin C), other food ingredients (e.g., water and sugar), and technical additives or processing aids (e.g., gelatin, excipients, starch, colors, stabilizers, preservatives, and flavors).

Unlike labeling for conventional foods, if all of the ingredients that are sources of the dietary ingredients are identified in the Supplement Facts box, and there are no other ingredients such as excipients or fillers, an ingredients statement is not necessary. For example, if calcium appears in the Supplement Facts box as “Calcium (as calcium carbonate),” this ingredient may be omitted from the ingredients statement. If the source of the dietary ingredient is not listed in the Supplement Facts box, it must be listed under the heading “Ingredients,” in accordance with §101.4(g). For ingredients with multiple sources, all of the sources should be listed within parentheses in descending order by weight. Source ingredients should be identified using their common or usual name, and the listing of botanicals should specify the part of the plant from which the ingredient is derived.

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