Hemp Lexicon, a guide to the use of hemp-related vocabulary, was published on 5.4.21 by AHPA(American Herbal Products Association), the association representing the herbal products supply chain in the US. (1)
The paper aspires to promote the use of shared and appropriate terms, based on the scientific bibliography, in various areas of communication. Technical standards and best practices, legislation and government relations, public and commercial information.
The widely shared goal is to foster the sustainable development of an ecological supply chain that lends itself, better than many others, to implementing circular economy models.
Hemp supply chain and botanicals. A shared lexicon
The versatility of Cannabis Sativa L. is amazing. Its seeds, flowers and stems can be used to make consumer goods such as food, beverages and personal care products, textile materials, bioplastics, raw materials for green building and the paper industry. A shared vocabulary is needed to remove ambiguities in the often overstated business language and established practices in the technical field, in the vast field of
botanicals
.
Sharing a vocabulary consistent with botany and technology is the basis for defining good business and information practices to be applied in B2B-between farmers and processors, laboratories and research centers, authorities, traders-and B2C(business to consumers). Where, in part because of the difficulties of monitoring the countless hemp and hemp-derived ecommerce sites, there is a recurrence of disproportionate and misleading news about the potential salite benefits associated with them.
Cannabis Sativa L., the lexicon
Hemp. Botanically, hemp (hemp) and marijuana come from the same plant species(Cannabis sativa L.) but from different varieties or cultivars. Hemp freely permitted for cultivation, possession and sale in the U.S. must have a THC content <0.3 percent on a dry matter basis. Marijuana, which is distinguished there by THC concentrations >0.3 percent, on the other hand, is classified as a psychotropic substance (the cultivation, possession and sale of which are punished as federal crimes, subject to any liberalizations defined in individual states).
Product derived from hemp. A product other than hemp that contains or is derived from hemp and is intended for food, inhalation, or specific industrial use.
Isolated hemp. A chemical constituent such as cannabidiol (CBD) that has been isolated from hemp. May contain THC impurities <0.3%, traces of other builders and moisture.
Tetrahydrocannabinol or THC. It is the cannabinoid with chemical formula C21H30O2, also referred to as Delta-9-tetrahydrocannabinol (left structure).
Tetrahydrocannabinolic acid or THCA is the cannabinoid with chemical formula C22H30O4, and precursor to THC (right). The two cannabinoids are substances with psychotropic effects.
Cannabidiol or CBD is the cannabinoid with chemical formula C21H30O2 (left).
Cannabidiolic acid or CBDA is the cannabinoid with chemical formula C22H30O4 (right), a precursor to CBD that is obtained by its decarboxylation (by heat) of acid. Unlike THC, CBD and CBDA have no psychoactive power.
Compounds, general categories
Compounds are the chemical constituents of botanicals or botanical preparations (class of constituents). They can be traced to three categories:
– active compound. Its application always offers the same biological response when tested in isolation and within a preparation. Its function is dose-dependent,
– Co-active compound. Within a botanical preparation, the co-active compound works in synergy with the other compounds. Its biological response is more pronounced than when it is tested individually,
– marker compound. It is used with technical function, such as for measuring content uniformity, stability assessment or identity of activities and/or compounds.
Cannabinoids and ‘cannabimimetics’
Cannabinoids. They are the class of C21 or C22 terpo-phenol compounds found in cannabis. They can be extracted naturally or synthesized in the laboratory. Cannabimimetics, on the other hand, are compounds that do not have the chemical structure of cannabinoid but have similar biological activity because they too interact directly or indirectly with the human body’s endocannabinoid receptors.
1. Phytocannabinoid. Structural cannabinoid compound, naturally produced by Cannabis sativa L.
2. Cannabinoid synthesized. Generic definition to identify cannabinoids produced in the laboratory through synthetic chemistry or biosynthesis. Artificial (or ‘natural identical‘) cannabinoids are synthesized cannabinoids.
– Artificial cannabinoid. Synthesized cannabimimetic having the same effects as a structural cannabinoid on cannabinoid receptors but whose molecular structure does not exist in nature,
– Cannabinoid identical in nature. Synthesized structural cannabinoid, having the same molecular structure as naturally occurring cannabinoids.
3. Endocannabinoid: cannabimimetic compound produced physiologically by humans or an animal (lipid messengers) that interact with cannabinoid receptors.
Since the term ‘cannaibinoid’ is often also used to refer to structurally unrelated compounds (such as cannabimimetics), APHA recommends the use of the terminology specified above, reserving the term ‘cannabinoid’ for only the structural cannabinoids produced by Hemp sativa L. (phytocannabinoids), their acids, and products derived from them.
Abstracts, general criteria
The Lexicon defines extract as ‘the complex, multicomponent mixture obtained by dissolving, by solvent, the components of the plant mass.’ (3) Extracts can be in liquid, semisolid or dry form. The addition of excipients with specific functionalities (e.g., improve stability, regulate concentration, limit microbial development) is allowed. They can be obtained by infusion, maceration, distillation, percolation or decoction.
Depending on the degree of processing, they are distinguished:
– Crude extract, not subjected to further processing (e.g. concentration or removal of constituent botanicals ) following the initial extraction. Those treatments that do not change the botanical composition such as filtration, pressing, solvent removal and blending with excipients are allowed.
– Native extract, consisting exclusively of the botanical components endogenous to the biomass or formed during extraction. Unlike the crude extract, the native extract does not contain excipients or other substances not originally present in the biomass,
– fortified extract. It is the native extract fortified by addition of exogenous botanical components of the same nature. AHPA recommends that fortification be disclosed on the label, declaring the fortification constituent as a separate ingredient.
Hemp extracts
Extracts are the basis of many hemp-based products. They are widely used, among other things, as cosmetic ingredients (also finally readmitted in the European Union) and supplements for pet food. The lexicon refers to:
– Full-spectrum hemp CBD extract. It is the resinoid hemp extract composed of a wide range of hemp constituents (including natural THC, cannabinoids, and terpenes), the processing of which did not involve intentional removal of compounds and constituted with maximum amount of THC <0.3%. AHPA recommends this claim to the hemp industry, as it is more accurate than ‘full-spectrum hemp extract‘,
– Hemp CBD extract-not THC. Like its predecessor, it is an extract composed of a wide range of hemp constituents, but subjected to a special process to remove THC, therefore undetectable (<0.01%). AHPA urges the hemp industry to use this designation, which is more accurate than ‘broad-spectrum hemp extract,’ which in itself does not express THC purification and removal.
For both extracts, ‘CBC’ can be replaced with another more accurate descriptor, such as resinoid or cannabinoid, or by another cannabinoid.
– Hemp (plant) extract. It is the extract produced from biomass including some or all parts of the hemp plant. It contains no added synthesized cannabinoids or additional components from an exogenous source other than hemp. AHPA points out the term is not equivalent to ‘hemp oil‘ (to follow).
Resins
Resin is defined by Lexicon as a solid or highly viscous, chemically complex, nonwater-soluble substance that exudes from the bark or flowers of some plants, such as Hemp sativa L. It is defined as live when it is extracted from fresh, undried hemp biomass.
Among the resinoid substances derived from the Cannabis Sativa L. there is theHash (better known as hashish) consisting of mechanically separated resin and fragments of plant material, specifically, trichomes (from Greek ϑρίξ τριχός “hair, hair,” are crystalline filaments produced by the epidermal secretions of the plant’s flowers and capable of producing the resin from which THC and CBD are made) that are obtained by rubbing the plant between the hands or sifting the dried plant. Special preparations involve the use of ice water or frozen plant material.
Hemp in the U.S., favorable legislation and triple-digit growth
The Farm Bill-in its latest update signed by President Donald Trump, effective 12/20/18(Agricultural Improvement Act, Pub. L. 115-334)-marked the beginning of a new era for the U.S. hemp industry. The federal government has changed the rules for producing and marketing products that have been excluded from the Controlled Substances Act (CSA) tables, i.e., the federal drug control system. Hemp-unlike marijuana-is thus permanently taken off the black list of narcotic substances.
Hemp è ‘the plant Cannabis sativa L. and any part of that plant, including its seeds and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a concentration of tetrahydrocannabinol delta-9 not exceeding 0.3 percent on a dry weight basis‘.
Hemp production is now subject to the regulation and oversight provided for any agricultural commodity by the U.S. Department of Agriculture (USDA). The Farm Bill also stipulated, however, that products containing cannabis or compounds derived from it remain under the authority of the Food and Drug Administration (FDA) under the Food, Drug and Cosmetic Act and Section 351 of the Public Health Service Act.
Meanwhile, the U.S. hemp market is growing in triple digits. According to the Hemp business Journal, in 2019 the value of legal cannabis sales was $13.6 billion, created 258,437 legal jobs and attracted $11.0 billion in funding. While from 2018 to 2019, the area under hemp cultivation increased by 479 percent. (3)
Hemp in the U.S., permissible uses for consumer products
Hemp-based drugs and cosmetics
The sale of the drugs in the US is subject to FDA approval. In 2018, the FDA approvedEpidiolex, the first and only drug legally on the market with a cannabinoid as its active ingredient. It is allowed for the treatment of epileptic seizures associated with Lennox Gastaut syndrome and Dravet syndrome, its active ingredient is highly purified CBD (first of THC), and it is available by prescription only. Any other drug containing CBD or THC from hemp is illegal.
On the other hand, cosmetics made from hemp and containing hemp extracts can be freely marketed without prior authorization, with only therapeutic claims prohibited. In 2019, FDA had sent a warning to a company that marketed a CBD body butter online attributing to it neuroprotective, antidepressant and even cancer and diabetes preventive properties. (4)
Hemp and hemp derivatives in foods
In general, food products can be marketed in the U.S. without prior approval, provided they are safe, conform to good manufacturing practices, are properly labeled and do not contain harmful substances. Conversely, food additives are subject to pre-market approval, subject to the application of thegenerally recognized as safe (GRAS) criterion, in relation to substances generally recognized as safe among qualified experts under the intended conditions of use.
The use of CBD in food is not (yet) permitted, as it is a pharmacological active ingredient subject to Epidiolex authorization. Instead, FDA granted GRAS status in 2018 to hulled hemp seeds, (5) hemp seed protein powder, and hemp seed oil. These products can be legally used by the U.S. food industry, as they do not naturally contain THC or CBD (any traces are solely due to contact the seeds may have during harvest or processing with other parts of the plant).
Hemp-based foods, AHPA’s definitions
AHPA proposes to use uniform terms for hemp-based foods as well. In particular:
– Hemp oil. Oil extracted from hemp or made from an isolate dissolved in a fixed oil. That is, in a non-volatile oil, other than an essential oil, (6)
– Hemp seed oil. Fixed edible oil obtained by pressing hemp seeds or extracted with a solvent,
– Pressed vegetable oil. Generic term for any fixed oil obtained by mechanical pressure of botanical material. AHPA points out the non-equivalence of the term “extract” often used by the hemp industry to refer to the same preparations. He therefore recommends its replacement with “pressed oil.”
– juice. Liquid substance obtained by mechanical pressing of botanical material, without the use of solvents. It can be used as obtained, dried to powder or concentrated by subtraction of water(input raw botanical material used, output finished substance obtained).
Hemp and dietary supplements
Dietary supplements in the U.S. can be released for free circulation without prior authorization and yet cannot contain active pharmaceutical ingredients. FDA has therefore affirmed on several occasions the ban on marketing CBD as a dietary supplement or its ingredient. (7)
The general rule does not apply if the supplement contains anew dietetic ingredient (new dietetic ingredient, NDI, i.e., a substance not marketed as a supplement before 10/15/94. In such a case, notification to FDA providing evidence of safety under the recommended and labeled conditions of use is required. However, no notification as an NDI has been received by FDA today for the use of ingredients derived from hemp plant parts that do not contain THC and CBD.
Dario Dongo and Giulia Orsi
Notes
(1) AHPA, Hemp Lexicon, March 2021. To consult the full Lexicon http://www.ahpa.org/News/LatestNews/TabId/96/artmid/1179/articleid/1617/AHPA-publishes-Hemp-Lexicon.aspx
(2) Ten intriguing statistics from 2019, Hemp Business Journal https://www.hempbizjournal.com/ten-intriguing-statistics-2019/
(3) AHPA, Guidance for manufacture and sale of bulk botanical extracts, 2001. http://www.ahpa.org/Portals/0/PDFs/HempLexicon/01_AHPA_Guidance-Mfr_and_Sale_of_Bulk_Botanical_Extracts.pdf
(4) FDA. Warning Letter: Rooted Apothecary LLC, October 10, 2019, https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/rooted-apothecary-llc-585312-10102019
(5) Dario Dongo and Laura Pontassuglia, Superfood, hemp. GIFT(Great Italian Food Trade). 9.03.18 https://www.greatitalianfoodtrade.it/mercati/superfood-canapa
(6) Hemp oil, excellent properties. GIFT(Great Italian Food Trade). 17.6.16 https://www.greatitalianfoodtrade.it/canapa/olio-di-canapa
(7) FDA. Statement by FDA Commissioner Scott Gottlieb, MD, on the signing of the Agricultural Improvement Act and the agency’s regulation of products containing cannabis and cannabis-derived compounds. 12/20/18, https://www.fda.gov/newsevents/newsroom/pressAnnouncements/ucm628988.htm.
Dario Dongo, lawyer and journalist, PhD in international food law, founder of WIISE (FARE - GIFT - Food Times) and Égalité.
Graduated in Law at the University of Bologna, now enrolled in the master of law of agri-food markets at the University of Turin. She is a practicing lawyer.
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