Fda reference herbs of commerce

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Federal Register - 68 FR 51693, August 28, 2003: Food Labeling: Ingredient Labeling of Dietary Supplements That Contain Botanicals: Direct Final Rule
[Federal Register: August 28, 2003 (Volume 68, Number 167)]
[Rules and Regulations]
[Page 51693-51704]From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr28au03-9]

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DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

21 CFR Part 101

[Docket No. 2003N-0346]


Food Labeling: Ingredient Labeling of Dietary Supplements That
Contain Botanicals

AGENCY: Food and DrugAdministration, HHS.

ACTION: Direct final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending its
regulation on declaring botanical ingredients in dietary supplements to
incorporateby 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 industrywith
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
botanicalterminology. 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...