By Mike Montemarano, Associate Editor 11.04.21
The American Herbal Products Association (AHPA), a trade association representing the herbal and botanical products industry, has published a reference document designed to provide clear definitions for terminology unique to cultivating, regulating, labeling, and marketing hemp-based products.
The Hemp Lexicon was intended to be a reference tool for the hemp industry and federal, state, tribal, and other jurisdictions that oversee the industry to provide guidance and encourage clear, consistent communication. The document was developed by a working group of the AHPA Cannabis Committee, which includes growers, manufacturers, processors, and product marketers.
The Lexicon is also intended to be updated as the industry matures, and as matters are settled regarding how terms may differ between the hemp/CBD industry and the larger herbs and botanicals industry. Broadly, it covers different types of extracts, extraction methods, chemical complexity of extracts, and other terms related to the potency and purity of products.
“This was a two-year process in which every iota of hemp terminology was debated,” said Patricia Kim, legal counsel for Papa and Barkley Essentials. “The goal is a uniform vocabulary for U.S. and even foreign governments, and to reduce consumer confusion while allowing the industry itself to define terms.” Likewise, Kim said, the guidance document is not meant to exist in a vacuum, and is intended to evolve over time and remain in cohesion with other industry guidance documents.
Even terms such as “broad-spectrum hemp extract” aren’t yet widely understood, Kim said, but are especially important. For example, THC levels are of concern especially to those who are drug-tested for work.
“Language still has to become clear regarding which extracts have actual plant constituents fully represented, and which extracts have THC or are THC-free,” she said. “Lexicon labeling implications are where the rubber is going to meet the road.”
AHPA: ‘We’ve Got History’
AHPA President Michael McGuffin said that as a trade association in the herbs and botanicals industry, AHPA has long served as a guide for the industry, consumers, and regulators when it comes to identifying botanical ingredients.
“Consumers who have been using herbal products for decades are now using hemp products, and we want to make sure that they have clear and consistent terms to help understand hemp products,” McGuffin said. “AHPA was busy defining terms like full- and broad-spectrum 20 years ago.”
Following the publication of Herbs of Commerce in 1992, for example, the U.S. Food and Drug Administration incorporated it as a reference for federal regulations. Other international regulatory authorities have also relied on AHPA guidance documents. The organization’s ambition to do the same for the hemp industry is lockstep with past achievements, McGuffin said.
“The Lexicon is brought to you by the same people who made ‘aerial parts’ a part of FDA’s list of definitions, and defined rational labeling for liquid product proportions. Because of AHPA, herbal tinctures are now codified by volume today. AHPA helped bring herbs into the definition of compliance for the National Organic Program, crop groups 25 and 26 [which have specific EPA pesticide regulations attached to them], and pushed back against trademarking of the word ‘herbalist.’ Rarely if ever has AHPA worked in isolation, and whether we work with herbal companies, industry groups, or government agencies, AHPA has played a role in every significant measure, so we’ve been there before.”
Regulatory Importance
According to McGuffin, it still makes sense for hemp and CBD companies to model the industry in a way that conforms broadly to dietary supplement regulations, even amid ongoing uncertainty about the statuses of CBD isolate and broad- and full-spectrum hemp extracts. Further, it will aid in the work being done to clarify CBD’s regulatory status as an ingredient which consumers use similarly to other
herbal supplements.
While FDA seems less than inclined to establish a legal pathway to market for CBD-containing products, clarity in terminology will help both the agency and elected officials understand how these products differ from a CBD isolate, McGuffin said. “There is a shared view that FDA will throw up obstacles to progress for the inclusion of hemp ingredients in foods and supplements. We need to work with both the agency and Congress directly to elaborate on their understandings of the terms ‘broad-’ and ‘full-spectrum’ in relation to CBD, but also in relation to herbal products generally. Now is the time to do this, especially with hemp sales flat or soft, with continued resistance from regulators, and with interest from people in Congress.”
Much of the inconsistency behind hemp and CBD terminology is rooted in the fact that there are no current federal regulations on labeling, marketing, or manufacturing of hemp products containing CBD, said Debby Miran, consultant at Miran Consulting and former commissioner of the Maryland Medical Cannabis Commission. With industry-led guidance, the Lexicon can potentially be a source to make federal regulations consistent and with fewer gray areas.
“It’s because states were forced to create their own rules that we have to deal with a patchwork of definitions and terminology,” Miran said. “Hemp can be legally grown in all 50 states, but CBD products are only allowed in 15 states, with 15 other states legalizing CBD products per statute. Eighteen states are completely silent about CBD-containing products.”
Miran pointed to the fact that in state statutes, there are inconsistencies in the definitions of the word “cannabidiol” itself. Some of these more recently-formed definitions, crafted to prohibit the sales of delta-8 THC products, conflate the terms psychoactive with intoxicating, which could be concerning in the future.
AHPA’s definition of cannabidiol, specifically, is its exact chemical formula and structure. However, Florida’s definition is a “compound by the same name derived from the hemp variety of Cannabis sativa L.”
Meanwhile, New York’s definition is “naturally occurring hemp-derived cannabinoids, but does not include synthetic cannabidiol.” Michigan’s definition, “a substance derived from the cannabis plant that does not have any psychoactive effects,” is perhaps the broadest in any state statute, Miran said.
“Definitions can be difficult to finish, and certain terms can have multiple definitions,” Miran said. “We thought to create consistency in the hemp space with established herbal and botanical terms wherever possible. But the industry also often uses terms for marketing purposes, including certain terms which are nonsensical, such as “PCR,” which stands for phytocannabinoid-rich and has no true definition.”
Mike Montemarano has been the Associate Editor of Nutraceuticals World since February 2020. He can be reached at MMontemarano@RodmanMedia.com.
The Hemp Lexicon was intended to be a reference tool for the hemp industry and federal, state, tribal, and other jurisdictions that oversee the industry to provide guidance and encourage clear, consistent communication. The document was developed by a working group of the AHPA Cannabis Committee, which includes growers, manufacturers, processors, and product marketers.
The Lexicon is also intended to be updated as the industry matures, and as matters are settled regarding how terms may differ between the hemp/CBD industry and the larger herbs and botanicals industry. Broadly, it covers different types of extracts, extraction methods, chemical complexity of extracts, and other terms related to the potency and purity of products.
“This was a two-year process in which every iota of hemp terminology was debated,” said Patricia Kim, legal counsel for Papa and Barkley Essentials. “The goal is a uniform vocabulary for U.S. and even foreign governments, and to reduce consumer confusion while allowing the industry itself to define terms.” Likewise, Kim said, the guidance document is not meant to exist in a vacuum, and is intended to evolve over time and remain in cohesion with other industry guidance documents.
Even terms such as “broad-spectrum hemp extract” aren’t yet widely understood, Kim said, but are especially important. For example, THC levels are of concern especially to those who are drug-tested for work.
“Language still has to become clear regarding which extracts have actual plant constituents fully represented, and which extracts have THC or are THC-free,” she said. “Lexicon labeling implications are where the rubber is going to meet the road.”
AHPA: ‘We’ve Got History’
AHPA President Michael McGuffin said that as a trade association in the herbs and botanicals industry, AHPA has long served as a guide for the industry, consumers, and regulators when it comes to identifying botanical ingredients.
“Consumers who have been using herbal products for decades are now using hemp products, and we want to make sure that they have clear and consistent terms to help understand hemp products,” McGuffin said. “AHPA was busy defining terms like full- and broad-spectrum 20 years ago.”
Following the publication of Herbs of Commerce in 1992, for example, the U.S. Food and Drug Administration incorporated it as a reference for federal regulations. Other international regulatory authorities have also relied on AHPA guidance documents. The organization’s ambition to do the same for the hemp industry is lockstep with past achievements, McGuffin said.
“The Lexicon is brought to you by the same people who made ‘aerial parts’ a part of FDA’s list of definitions, and defined rational labeling for liquid product proportions. Because of AHPA, herbal tinctures are now codified by volume today. AHPA helped bring herbs into the definition of compliance for the National Organic Program, crop groups 25 and 26 [which have specific EPA pesticide regulations attached to them], and pushed back against trademarking of the word ‘herbalist.’ Rarely if ever has AHPA worked in isolation, and whether we work with herbal companies, industry groups, or government agencies, AHPA has played a role in every significant measure, so we’ve been there before.”
Regulatory Importance
According to McGuffin, it still makes sense for hemp and CBD companies to model the industry in a way that conforms broadly to dietary supplement regulations, even amid ongoing uncertainty about the statuses of CBD isolate and broad- and full-spectrum hemp extracts. Further, it will aid in the work being done to clarify CBD’s regulatory status as an ingredient which consumers use similarly to other
herbal supplements.
While FDA seems less than inclined to establish a legal pathway to market for CBD-containing products, clarity in terminology will help both the agency and elected officials understand how these products differ from a CBD isolate, McGuffin said. “There is a shared view that FDA will throw up obstacles to progress for the inclusion of hemp ingredients in foods and supplements. We need to work with both the agency and Congress directly to elaborate on their understandings of the terms ‘broad-’ and ‘full-spectrum’ in relation to CBD, but also in relation to herbal products generally. Now is the time to do this, especially with hemp sales flat or soft, with continued resistance from regulators, and with interest from people in Congress.”
Much of the inconsistency behind hemp and CBD terminology is rooted in the fact that there are no current federal regulations on labeling, marketing, or manufacturing of hemp products containing CBD, said Debby Miran, consultant at Miran Consulting and former commissioner of the Maryland Medical Cannabis Commission. With industry-led guidance, the Lexicon can potentially be a source to make federal regulations consistent and with fewer gray areas.
“It’s because states were forced to create their own rules that we have to deal with a patchwork of definitions and terminology,” Miran said. “Hemp can be legally grown in all 50 states, but CBD products are only allowed in 15 states, with 15 other states legalizing CBD products per statute. Eighteen states are completely silent about CBD-containing products.”
Miran pointed to the fact that in state statutes, there are inconsistencies in the definitions of the word “cannabidiol” itself. Some of these more recently-formed definitions, crafted to prohibit the sales of delta-8 THC products, conflate the terms psychoactive with intoxicating, which could be concerning in the future.
AHPA’s definition of cannabidiol, specifically, is its exact chemical formula and structure. However, Florida’s definition is a “compound by the same name derived from the hemp variety of Cannabis sativa L.”
Meanwhile, New York’s definition is “naturally occurring hemp-derived cannabinoids, but does not include synthetic cannabidiol.” Michigan’s definition, “a substance derived from the cannabis plant that does not have any psychoactive effects,” is perhaps the broadest in any state statute, Miran said.
“Definitions can be difficult to finish, and certain terms can have multiple definitions,” Miran said. “We thought to create consistency in the hemp space with established herbal and botanical terms wherever possible. But the industry also often uses terms for marketing purposes, including certain terms which are nonsensical, such as “PCR,” which stands for phytocannabinoid-rich and has no true definition.”
Mike Montemarano has been the Associate Editor of Nutraceuticals World since February 2020. He can be reached at MMontemarano@RodmanMedia.com.
