Suggested changes to USP naming convention could help clear confusion over botanical IDs, experts say
In a recent stimulus article published by the United States Pharmacopeial Convention (USP), titled 41(6) Stimuli to the Revision Process: Guideline for Assigning Titles to USP Dietary Supplement Monographs, the authors note that the issue of what to call items of botanical origin has been around for a long time; the authors of the original 1820 edition of the Pharmacopoeia of the United States wrestled at that time with how best to refer to these complex substances.
“The 1820 volume discussed a guide for developing botanical monograph titles and indicated that USP would adapt a nomenclature that was simple, with the intent that the monograph title would be brief and explicit, expressing the medical meaning and nothing else. This Stimuli article presents a new guideline for formulating titles of dietary supplement monographs. The intent of this article is to initiate a discussion on this new proposed guideline,” the authors wrote.
The authors noted that the landscape for names changed when DSHEA was enacted, as that legislation specifies how ingredients should be named, using Herbs of Commerce as a basic reference.
Specificity on plant parts, powders
The authors of the stimulus article propose a number of changes, much of them aimed at being specific about the precise plants parts the monograph refers to that are relevant to dietary supplement manufacture. For example, they suggest ‘Andrographis’ should be changed to ‘Andrographis Stem and Leaf’ and ‘Valerian’ be changed to ‘Valerian Rhizome, Root and Stolon.’
But even more significant are the changes proposed to how powdered ingredients are identified. The proposed change would differentiate a powder that produced via the milling of a whole botanical ingredient and a powder that is the result of a drying process for an extract. The change would use the word ‘powder’ in the first case and the term ‘dry extract’ in the second.
The situation of many potential names for the same ingredient has led to potential confusion, and has been identified as a potential vulnerability for the industry as it interacts with regulators, legislators and the plaintiffs bar. And in this era of more interest in DNA testing technologies, it becomes more important than ever to know exactly which botanical is being referred to.
“There are a lot of unsettled issues with what you call things,” Steven Dentali, PhD, Research Fellow with Herbalife, told NutraIngredients-USA. “It goes back to the beginning of USP. This stimulus article was a collective effort from a joint committee I was on at USP.”
Dentali said that as the way in which botanical ingredients are used, and the ever wider variety of manufacturing techniques used to turn them into dietary supplement ingredients, the old naming convention wasn’t keeping up with the times. In the case of aloe (a big ingredient in Herbalife’s stable of products) a recent issue came up with what to call this botanical, especially considering that an improperly manufactured aloe ingredient can include some potentially harmful chemicals contained in the layer immediately under the skin of the leaves. So being as specific as possible can be crucial, depending on the botanical in question.
“It used to be that herbs used as drugs had a single name. For example, if you look up aloe, you find the drug of antiquity, a laxative drug that is no longer approved for use in the US. Aloe can refer to the plant and it can refer to the dried latex. Then there is the whole leaf gel, which is used topically for burns,” Dentali said.
Intent not to limit names
“I totally agree with direction they are taking. This is the standard used internationally, with the one exception that most pharmacopoeias use the pharmaceutical nomenclature for herbs, whereas Herbs of Commerce had often adopted the horticultural name, not the medicinal name,” said Roy Upton, founder and executive director of the American Herbal Pharmacopoeia.
“I don’t think the intent here is to limit the names that are used, but to more appropriately use those names. I don’t anyone really cares about how many names are used as long as we are sure about what we are referring to,” he said.
“This is probably the biggest change to nomenclature since USP started in 1820. These proposed changes are a tool that could be used by industry. There are other useful tools out there and I think this could add to those. The more that people use these tools to provide clarity as to what products really are the more trust consumers can put into them,” Dentali said.