Disclosure of Added Constituents in Dietary Supplements - Botanical Ingredients

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Mar. 8, 2001
Sept. 2018

The following information on botanical ingredients (sold as an herb or other botanical, or as a concentrate; metabolite; constituent; or extract of an herb or other botanical) should be included in either a bulk botanical raw material specification sheet (for business-to-business transactions) or finished product labeling (when selling directly to consumers):

For Bulk Botanical Raw Materials (Not Directly Sold to Consumers)

Bulk botanical raw materials not intended to be sold directly to consumers (i.e., not labeled for consumer use) should include the following standardized information for the purposes of assessing labeling requirements

  • In the ingredient declaration of a bulk botanical raw material, declare all ingredients by their common or usual name and in order of predominance, including but not limited to botanical extractives; excipients; fillers; binders; solvents that have not been removed; and added constituents;
  • Specification sheets for bulk botanical raw materials should indicate for each such ingredient the percentage, or range of percentages, of the entire raw material represented by the ingredient, so that finished product manufacturers can determine the order of ingredients in a finished product containing the raw material;

For Bulk Botanical Raw Materials or Finished Products (As Applicable)

In the labeling of either a bulk botanical raw material to which a constituent has been added, or of a finished product containing any such ingredient, include the common name of the botanical raw material in the form of: botanical; plant part; form; "with added" constituent (e.g., "guarana seed extract with added caffeine," "goldenseal leaf powder with added berberine");

For Finished Products

Manufacturers and marketers of finished products containing any botanical raw material should label such products to include all ingredients listed in order of predominance except incidental additives (per 21 CFR 101.100(a)(3)) present in the supplement at insignificant levels and that do not have any technical or functional effect in that supplement.