Michael McGuffin, President, American Herbal Products Association09.22.15
The American Herbal Products Association (AHPA) strongly supports consumer access to complete and accurate information about the dietary supplements they purchase. The names used on supplement labels must therefore correctly identify contained ingredients, including herbal ingredients.
On Sep. 9, the office of the New York Attorney General (NYAG) issued demands for 13 supplement companies to cease and desist from marketing, distribution, and sale of products labeled as "devil's claw" and reported by the NYAG to contain Harpagophytum zeyheri. Devil's claw root is a botanical article derived from one of two species of the genus Harpagophytum, either H. zeyheri or H. procumbens.
Relevance of Herbs of Commerce in FDA's Labeling Rules
AHPA's Herbs of Commerce, 1st edition was published in 1992 to provide guidance in selecting the most appropriate common or usual names for botanical ingredients. The document was incorporated by reference in the Food and Drug Administration's (FDA) rules for labeling dietary supplements in 1997. This regulation, codified at 21 CFR 101.4 (h), states in relevant part:
"The common or usual name of ingredients of dietary supplements that are botanicals (including fungi and algae) shall be consistent with the names standardized in Herbs of Commerce, 1992 edition, which is incorporated by reference in accordance with 5 U.S.C. 552 (a) and 1 CFR part 51."
This sentence clearly applies to the botanicals that are included in Herbs of Commerce, 1992 edition and is silent on the matter of the common or usual names of botanical dietary ingredients that are not so included. But since there are not any "names standardized in Herbs of Commerce, 1992 edition" for plants that are not in this text, there is no rational basis to extrapolate the regulatory application of this reference for selecting common names to plants that are not included in it.
Of additional relevance is a 2003 Federal Register notice in which FDA issued a proposed rule to replace the first edition of Herbs of Commerce with the second edition, published by AHPA in 2000, as the incorporated reference in 21 CFR 101.4 (h).[1] This notice also proposed to replace the 1994 edition of International Code of Botanical Nomenclature with the then-current 2000 edition of that text as the incorporated reference in 21 CFR 101.4 (h)(1)(ii). In the preamble of this notice FDA notes that the 2000 editions of Herbs of Commerce and of the International Code of Botanical Nomenclature "have been updated and now the 2000 editions supersede the earlier ones." The preamble also states:
"Botanical nomenclature is an evolving science that is influenced by new discoveries and the correction of past misidentifications of plants." 68 FR 51739.
FDA has neither finalized this proposed rule nor withdrawn it.[2] This cited statement, which is an official advisory opinion binding on the agency under FDA's regulations, can be read to acknowledge the legitimacy of authoritative changes in the nomenclature of common and scientific names for plant species.
Common Names for Other Plant Species
For plants not in Herbs of Commerce, 1992 edition, marketers may label these with a common or usual name, as established by common usage, to comply with the long-established broader regulation on "common or usual name for nonstandardized food," as follows:
"The common or usual name of a food, which may be a coined term, shall accurately identify or describe, in as simple and direct terms as possible, the basic nature of the food or its characterizing properties or ingredients. The name shall be uniform among all identical or similar products and may not be confusingly similar to the name of any other food that is not reasonably encompassed within the same name." 21 CFR 102.5 (a).
Thus, when a common name accurately describes a plant that is not listed in Herbs of Commerce, 1992 edition and is the same as a standardized common name used in Herbs of Commerce, 1992 edition to identify another plant, that same common name should be able to be used to name the unlisted plant on a dietary supplement label so long as it is not confusingly similar to the name of any other food that is not reasonably encompassed within the same name.
Authoritative References Establish Devil's Claw Species as Interchangeable
Actions by the NYAG were apparently based in part on a view that assignment in AHPA's Herbs of Commerce 1st edition (1992) of a standardized common name to any one particular plant species does not permit its use for any other species. But though there is, in fact, an intention expressed in the introduction to this book to have each standardized common name "apply to only one taxon." This reference also specifies exceptions to that intention, including instances "where a commodity is represented by more than one taxa in an official compendium."
Thus, for any herbal commodity that is reported in an official compendial reference to be obtained from more than one species, Herbs of Commerce 1st edition would allow the same common name to be used for either (or any) such interchangeable species.[3]
Devil's claw root is identified in the current edition of the European Pharmacopoeia as derived from either Harpagophytum procumbens or Harpagophytum zeyheri.[4] In addition, a final community monograph was issued in 2008 by the European Medicines Agency for an article described as, "Harpagophytum procumbens D.C. and/or Harpagophytum zeyheri Decne; Harpagophyti radix; devil's claw root."[5] This official compendial reference and monograph clearly establish that "devil's claw" is a common or usual name for either of these species and that the two species are reasonably encompassed within this name.
Use of Latin Names on Herbal Supplement Labels
FDA's labeling rule for botanical ingredients in dietary supplement requires at 21 CFR 101.4 (h)(2) those not included in Herbs of Commerce, 1992 to be labeled to include the Latin binomial name of the plant, whereas those that are included in the incorporated reference do not need to include these Latin names on labels. Thus, a product that contains only Harpagophytum procumbens root could identify the ingredient with the common name "devil's claw" and inclusion of the Latin name would be optional. On the other hand, identification of Harpagophytum zeyheri root in a dietary supplement could be identified with the common name "devil's claw" and also with the Latin name.
Note: The information presented here does not constitute legal advice or a legal opinion. This document is not a substitute for the actual labeling regulations discussed here, and this information is not intended to replace or supersede FDA regulations. While AHPA believes that all of the information here is accurate, any company that chooses to use this information does so as its own choice, and is advised to discuss all aspects related to this subject matter with a qualified attorney.
References
[1] 68 FR 51738, August 28, 2003.
[2] FDA issued a Direct Final Rule on the same date that would have accomplished the same replacement of Herbs of Commerce 1st edition with Herbs of Commerce 2nd edition as the incorporated reference in 21 CFR 101.4 (h) (68 FR 51693). This Direct Final Rule was subsequently withdrawn (70 FR 76684).
[3] The second edition of Herbs of Commerce (2000) carries forward this exception but states it as "when several taxa are accepted as interchangeable" without reference to the limitation of "an official compendium." As noted elsewhere in this document, however, although FDA in 2003 issued a proposed rule to replace the 1992 reference with its 2000 update this rule was never finalized so it is the first edition that is directly relevant to this labeling rule.
[4] European Directorate for the Quality of Medicines & Healthcare (EDQM). 2013. Devil's claw root - Harpagophyti radix. European Pharmacopoeia 8.0 01/2011:1095: 1226-1227.
[5] European Medicines Agency, Committee on Herbal Medicinal Products. 2008. Final community monograph on Harpagophytum procumbens DC. and/or Harpagophytum zeyheri Decne, radix. Doc. Ref.: EMEA/HMPC/251323/2006.
On Sep. 9, the office of the New York Attorney General (NYAG) issued demands for 13 supplement companies to cease and desist from marketing, distribution, and sale of products labeled as "devil's claw" and reported by the NYAG to contain Harpagophytum zeyheri. Devil's claw root is a botanical article derived from one of two species of the genus Harpagophytum, either H. zeyheri or H. procumbens.
Relevance of Herbs of Commerce in FDA's Labeling Rules
AHPA's Herbs of Commerce, 1st edition was published in 1992 to provide guidance in selecting the most appropriate common or usual names for botanical ingredients. The document was incorporated by reference in the Food and Drug Administration's (FDA) rules for labeling dietary supplements in 1997. This regulation, codified at 21 CFR 101.4 (h), states in relevant part:
"The common or usual name of ingredients of dietary supplements that are botanicals (including fungi and algae) shall be consistent with the names standardized in Herbs of Commerce, 1992 edition, which is incorporated by reference in accordance with 5 U.S.C. 552 (a) and 1 CFR part 51."
This sentence clearly applies to the botanicals that are included in Herbs of Commerce, 1992 edition and is silent on the matter of the common or usual names of botanical dietary ingredients that are not so included. But since there are not any "names standardized in Herbs of Commerce, 1992 edition" for plants that are not in this text, there is no rational basis to extrapolate the regulatory application of this reference for selecting common names to plants that are not included in it.
Of additional relevance is a 2003 Federal Register notice in which FDA issued a proposed rule to replace the first edition of Herbs of Commerce with the second edition, published by AHPA in 2000, as the incorporated reference in 21 CFR 101.4 (h).[1] This notice also proposed to replace the 1994 edition of International Code of Botanical Nomenclature with the then-current 2000 edition of that text as the incorporated reference in 21 CFR 101.4 (h)(1)(ii). In the preamble of this notice FDA notes that the 2000 editions of Herbs of Commerce and of the International Code of Botanical Nomenclature "have been updated and now the 2000 editions supersede the earlier ones." The preamble also states:
"Botanical nomenclature is an evolving science that is influenced by new discoveries and the correction of past misidentifications of plants." 68 FR 51739.
FDA has neither finalized this proposed rule nor withdrawn it.[2] This cited statement, which is an official advisory opinion binding on the agency under FDA's regulations, can be read to acknowledge the legitimacy of authoritative changes in the nomenclature of common and scientific names for plant species.
Common Names for Other Plant Species
For plants not in Herbs of Commerce, 1992 edition, marketers may label these with a common or usual name, as established by common usage, to comply with the long-established broader regulation on "common or usual name for nonstandardized food," as follows:
"The common or usual name of a food, which may be a coined term, shall accurately identify or describe, in as simple and direct terms as possible, the basic nature of the food or its characterizing properties or ingredients. The name shall be uniform among all identical or similar products and may not be confusingly similar to the name of any other food that is not reasonably encompassed within the same name." 21 CFR 102.5 (a).
Thus, when a common name accurately describes a plant that is not listed in Herbs of Commerce, 1992 edition and is the same as a standardized common name used in Herbs of Commerce, 1992 edition to identify another plant, that same common name should be able to be used to name the unlisted plant on a dietary supplement label so long as it is not confusingly similar to the name of any other food that is not reasonably encompassed within the same name.
Authoritative References Establish Devil's Claw Species as Interchangeable
Actions by the NYAG were apparently based in part on a view that assignment in AHPA's Herbs of Commerce 1st edition (1992) of a standardized common name to any one particular plant species does not permit its use for any other species. But though there is, in fact, an intention expressed in the introduction to this book to have each standardized common name "apply to only one taxon." This reference also specifies exceptions to that intention, including instances "where a commodity is represented by more than one taxa in an official compendium."
Thus, for any herbal commodity that is reported in an official compendial reference to be obtained from more than one species, Herbs of Commerce 1st edition would allow the same common name to be used for either (or any) such interchangeable species.[3]
Devil's claw root is identified in the current edition of the European Pharmacopoeia as derived from either Harpagophytum procumbens or Harpagophytum zeyheri.[4] In addition, a final community monograph was issued in 2008 by the European Medicines Agency for an article described as, "Harpagophytum procumbens D.C. and/or Harpagophytum zeyheri Decne; Harpagophyti radix; devil's claw root."[5] This official compendial reference and monograph clearly establish that "devil's claw" is a common or usual name for either of these species and that the two species are reasonably encompassed within this name.
Use of Latin Names on Herbal Supplement Labels
FDA's labeling rule for botanical ingredients in dietary supplement requires at 21 CFR 101.4 (h)(2) those not included in Herbs of Commerce, 1992 to be labeled to include the Latin binomial name of the plant, whereas those that are included in the incorporated reference do not need to include these Latin names on labels. Thus, a product that contains only Harpagophytum procumbens root could identify the ingredient with the common name "devil's claw" and inclusion of the Latin name would be optional. On the other hand, identification of Harpagophytum zeyheri root in a dietary supplement could be identified with the common name "devil's claw" and also with the Latin name.
Note: The information presented here does not constitute legal advice or a legal opinion. This document is not a substitute for the actual labeling regulations discussed here, and this information is not intended to replace or supersede FDA regulations. While AHPA believes that all of the information here is accurate, any company that chooses to use this information does so as its own choice, and is advised to discuss all aspects related to this subject matter with a qualified attorney.
References
[1] 68 FR 51738, August 28, 2003.
[2] FDA issued a Direct Final Rule on the same date that would have accomplished the same replacement of Herbs of Commerce 1st edition with Herbs of Commerce 2nd edition as the incorporated reference in 21 CFR 101.4 (h) (68 FR 51693). This Direct Final Rule was subsequently withdrawn (70 FR 76684).
[3] The second edition of Herbs of Commerce (2000) carries forward this exception but states it as "when several taxa are accepted as interchangeable" without reference to the limitation of "an official compendium." As noted elsewhere in this document, however, although FDA in 2003 issued a proposed rule to replace the 1992 reference with its 2000 update this rule was never finalized so it is the first edition that is directly relevant to this labeling rule.
[4] European Directorate for the Quality of Medicines & Healthcare (EDQM). 2013. Devil's claw root - Harpagophyti radix. European Pharmacopoeia 8.0 01/2011:1095: 1226-1227.
[5] European Medicines Agency, Committee on Herbal Medicinal Products. 2008. Final community monograph on Harpagophytum procumbens DC. and/or Harpagophytum zeyheri Decne, radix. Doc. Ref.: EMEA/HMPC/251323/2006.
