11.16.23
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, which was published in 1992, to reflect updates found in the third edition which was published this year.
AHPA specifically requests that FDA issue a direct final rule to amend 21 C.F.R. § 101.4(h) to remove 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 standardized common names found in the third edition.
The request amends a Citizen Petition AHPA originally submitted in 2017, in which the association initially requested that the agency make the same changes but in reference to the second edition, which was the most recent at the time.
FDA reported to AHPA in 2018 that it hadn’t yet reached a decision “due to competing priorities,” and the agency hasn’t taken any subsequent action since.
Herbs of Commerce was first published in 1992 as a self-governance tool to reduce confusion in labeling botanical ingredients, and establish standardized common names for each listed herb. It was incorporated by reference into federal law in 1997 as FDA completed rulemaking related to dietary supplement labeling, implementing the Dietary Supplement Health and Education Act (DSHEA).
The third edition of Herbs of Commerce added 800 more botanicals than what was included in the second edition, and over 2,000 more botanicals than what is included in the first edition currently referenced in federal law.
“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.”
AHPA specifically requests that FDA issue a direct final rule to amend 21 C.F.R. § 101.4(h) to remove 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 standardized common names found in the third edition.
The request amends a Citizen Petition AHPA originally submitted in 2017, in which the association initially requested that the agency make the same changes but in reference to the second edition, which was the most recent at the time.
FDA reported to AHPA in 2018 that it hadn’t yet reached a decision “due to competing priorities,” and the agency hasn’t taken any subsequent action since.
Herbs of Commerce was first published in 1992 as a self-governance tool to reduce confusion in labeling botanical ingredients, and establish standardized common names for each listed herb. It was incorporated by reference into federal law in 1997 as FDA completed rulemaking related to dietary supplement labeling, implementing the Dietary Supplement Health and Education Act (DSHEA).
The third edition of Herbs of Commerce added 800 more botanicals than what was included in the second edition, and over 2,000 more botanicals than what is included in the first edition currently referenced in federal law.
“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.”
