The Food and Drug Administration (FDA) has proposed to amend its regulation on declaring botanical ingredients in dietary supplements to incorporate by reference the latest editions of two books.
Published in the August 28 edition of the Federal Register , the regulation incorporates the 1992 edition of Herbs of Cotimerce (1992) and the 1994 edition of the International Code of Botanical Nomenclature (Tokyo Code). The FDA proposed this week that the new regulation would replace the references to these editions with the 2000 editions of the same books.
The motivation behind the move is to bring industry into line with current andmore comprehensive references to use in identifying on product labels thecommon or usual name of each botanical ingredient contained in dietarysupplements.
'These proposed 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,' said the FDA in a statement this week.
The proposed rule would also incorporate new statutory restrictions on the use of the word 'ginseng' in dietary supplement labeling and implement minor wording changes in its regulation on declaring botanical ingredients in dietary supplements.
Written or electronic comments will be accepted up to 75 days after the proposed rule is published. Written comments can be submitted to the Division of Dockets Management (HFA-305), FDA, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Electronic comments can be sent via www.fda.gov/dockets/ecomments. Include the docket number (2003 n-0346) with comments. If no significant comments against the proposed rule are received, FDA will publish the final rule 1 January, 2006.