AHPA requests FDA update federal regulation to reference Herbs of Commerce, 3rd Edition
November 16, 2023
On November 14, 2023, the American Herbal Products Association (AHPA) submitted a Citizen Petition amendment requesting that the U.S. Food and Drug Administration (FDA) amend the federal regulation referencing the first edition of AHPA's Herbs of Commerce (1992) to reflect the updated, third edition published this year. AHPA's Herbs of Commerce provides guidance on consistent naming of botanical ingredients on product labels, especially those marketed in the United States as dietary supplements.
Specifically, AHPA's updated request seeks to have FDA issue a direct final rule to amend 21 C.F.R. § 101.4(h) to remove the reference to the 1992 edition of Herbs of Commerce and require that the common or usual name of ingredients in dietary supplements that are botanicals (including fungi and algae) be consistent with the standardized common names in Herbs of Commerce, 3rd Edition (2023).
This request amends the Citizen Petition that AHPA submitted in 2017, in which the association also sought to have FDA remove the reference to the first edition of Herbs of Commerce and replace it with the latest edition at the time. In a 2018 response to AHPA's Citizen Petition, FDA stated that the agency “ha[d] not reached [a] decision on your petition due to competing agency priorities” and that the “petition is currently under active evaluation by our staff.” To AHPA's knowledge, FDA has not taken any subsequent action in response to the 2017 Citizen Petition.
AHPA published the first edition of Herbs of Commerce in 1992 as self-governing guidance to reduce confusion associated with labeling botanical ingredients and establish a single “standardized” common name for each listed herb. The publication took the force of federal law when it was incorporated by reference in 1997 as FDA completed rulemaking regarding the labeling of dietary supplements to implement the Dietary Supplement Health and Education Act (DSHEA) of 1994. AHPA's third edition of Herbs of Commerce added standardized common names for approximately 800 more botanicals than included in the second edition referenced in AHPA's initial Citizen Petition and over 2,000 more botanicals than included in the 1992 edition currently referenced in 21 C.F.R. § 101.4(h).
“The third edition of Herbs of Commerce reflects the most current taxonomic nomenclature for botanicals used as dietary ingredients in dietary supplements marketed in the United States,” said AHPA President Michael McGuffin. “Responsible marketers clearly and accurately label herbal ingredients to help consumers make well-informed decisions about the products they buy. We encourage FDA to amend the regulation to require use of the most current and accurate botanical names for dietary ingredients.”
Herbs of Commerce, 3rd Edition is available for purchase now.