On August 28, 2003, the U.S. Food and Drug Administration (FDA) published a direct final rule in the Federal Register¹ to amend its regulations on labeling of botanical ingredients in dietary supplements by incorporating the current edition of AHPA’s Herbs of Commerce.² The new rule becomes effective on January 1, 2006, consistent with FDA’s published policy on uniform effective dates for food labeling regulations.

FDA also updated its reference sources to include the current edition of the International Code of Botanical Nomenclature (St. Louis Code) 2000 (ICBN). The ICBN is accepted by the worldwide taxonomic community as "the rules that govern scientific naming in botany" as determined and "revised at Nomenclature Section meetings at successive International Botanical Congresses. The present edition of the International code of botanical nomenclature embodies the decisions of the XVI International Botanical Congress held in St Louis in 1999 and supersedes the Tokyo Code, published six years [earlier, in 1994,] subsequent to the XV International Botanical Congress in Yokohama."³

Current FDA regulations⁴ require that the common or usual name of botanical ingredients in dietary supplements be consistent with the names standardized in the first edition of Herbs of Commerce (published by AHPA in 1992). The current rules also allow dietary supplement products to omit the Latin name of those herbal ingredients that are included in this book, whereas the Latin name is required on the label to identify all other herbal ingredients (i.e., those herbs that are not listed in the AHPA book). In addition, all Latin names must conform to international rules on nomenclature and the 1994 edition of the ICBN (Tokyo Code) is identified as an authoritative reference.

FDA’s new rule replaces both of these references with their current editions. Because the second edition of Herbs of Commerce includes almost 1,500 additional plants (2,048 separate species as opposed to approximately 550 in the original), many additional ingredients will be required to use standardized common names and will no longer have to provide Latin names on product labels. The updated Herbs of Commerce also changed the standarized common names of about 140 species. The new rule also clarifies the regulation’s language on the meaning of this rule to specify that only "standardized common names" listed in Herbs of Commerce, not "other common names," are to be used on product labels. For example, eleuthero (Eleutherococcus senticosus (Rupr. & Maxim.) Maxim., Araliaceae) may not be labeled "Siberian ginseng," or any of its other names, but only eleuthero.

"I am pleased that FDA has incorporated AHPA’s work," said Michael McGuffin, AHPA’s president. "This is how things are supposed to work: experts in the field provide valuable and authoritative information to the regulator, and the regulator then adopts and endorses this information as policy." McGuffin served as the book’s managing editor, assisted by three of the nation’s preeminent experts on botanical nomenclature: John T. Kartesz, Albert Y. Leung, and Arthur O. Tucker.

AHPA published Herbs of Commerce in 1992 as self-governing guidance for its members to reduce confusion in labeling botanical ingredients. FDA incorporated the document by reference in 1997 as the agency initiated rulemaking to implement the Dietary Supplement Health and Education Act of 1994 (DSHEA).

Over the past few years, AHPA has often requested that FDA revise the regulations to incorporate the second edition of Herbs of Commerce. The agency has now initiated the rulemaking process by issuing this direct final rule. In the Federal Register, FDA explained that it initiated rulemaking in this manner instead of the usual notice-and-comment process as it does not expect to receive significant adverse comments on the proposal. The agency, nevertheless, simultaneously published a virtually identical proposed rule in the event that significant adverse comments are received.

–Mark Blumenthal