Food Labeling: Ingredient Labeling of Dietary Supplements That Contain Botanicals

The Food and Drug Administration (FDA) is amending its regulation on declaring botanical ingredients in dietary supplements to incorporate by reference the latest editions of two books. Currently, the regulation incorporates by reference Herbs of Commerce (1992) and the International Code of Botanical Nomenclature (Tokyo Code) 1994. FDA is replacing the references to these editions with the 2000 editions of the same books. This action is intended to provide industry with current and more comprehensive references to use in identifying on product labels the common or usual name of each botanical ingredient contained in dietary supplements. In addition, FDA is incorporating new statutory restrictions on the use of the word "ginseng" in dietary supplement labeling. Finally, FDA is making minor wording changes in its regulation on declaring botanical ingredients in dietary supplements. These changes are intended to improve the reader's understanding, consistent with the principles of plain English, or to be more technically accurate, consistent with internationally accepted botanical terminology. FDA is issuing a direct final rule for this action because FDA expects there will be no significant adverse comments on the rule. Elsewhere in this issue of the Federal Register, FDA is publishing a companion proposed rule through the usual notice- and-comment rulemaking process. If FDA receives significant adverse comment on either rule, FDA intends to withdraw the direct final rule and proceed with the rulemaking. The companion proposed rule and direct final rule are substantively identical.