Presenter: Dharati Szymanski
This presentation will provide attendees with a working knowledge of the current regulatory framework surrounding CBD products and their status in the practice of veterinary medicine. It will review how those regulatory frameworks differ at the federal and state level as well as between individual states. We will discuss practical challenges that veterinarians face, as well as liability concerns regarding the clinical application of such products. We will briefly review safety issues pertaining to quality control standards and potential toxicoses as well as the clinical research investigating veterinary therapeutic potential.
Presenter: Charlotte Conway
There is increasing interest in the marketing of ingredients derived from hemp for use in animal food. Animal food includes food for both food producing species, such as aquaculture and livestock, and companion animals. Food falls under the regulatory authority of the US Food and Drug Administration (FDA). Within FDA, the Center for Veterinary Medicine (CVM) regulates both food and drugs intended for animals. The Division of Animal Feeds is responsible for regulating substances used in, or as, animal food. Substances added to a food must be safe and achieve their intended purpose. For food producing species, the safety of human food obtained from the animals must also be addressed. Two regulatory pathways are available for new substances. The food additive petition process is described in section 571 in Title 21 of the Code of Federal Regulations (21 CFR 571). When FDA approves a food additive petition, a regulation in 21 CFR 573 is established addressing the proposed use of the substance in animal food. The second pathway is for qualified experts to determine that a substance in animal food is exempt from the premarket requirements of the Federal Food, Drug, and Cosmetic Act because this use is generally recognized as safe (GRAS) for an intended use. A GRAS conclusion generally demands the same quantity and quality of data/ information needed for a food additive approval with the added requirement that this information be in the public domain. Sponsors can notify CVM about a GRAS conclusion through the animal food GRAS notification program. CVM maintains an internet list of animal food GRAS notices and CVM’s conclusions about each notice. More information about these processes is available at http://www.fda.gov/SafeFeed. Another pathway for substances that raise no apparent safety concerns is provided by the Association of American Feed Control Officials and involves establishing an ingredient definition in its Official Publication.
Presenter: Charlotte Lacroix
Modification of the endocannabinoid system likely promises significant therapeutic benefit but all therapeutic products must follow federal guidelines for New (Animal) Drug Approval (NDA/NADA) through the Food and Drug Administration (FDA). Current marketing and sale of unapproved cannabidiol (CBD) supplements for animal use is not legal federally, but may be allowed or overlooked by state or regional organizations. Veterinarians and business owners must carefully consider the legal, ethical, and financial ramifications of discussing, prescribing, selling, or promoting an unapproved CBD product.
Presenter: Falina Hutchinson
Hemp has been utilized for thousands of years as food, feed for animals, and in industrial and textile uses. We will discuss what events took place that banned hemp from production and how it became an illegal drug. We will also discuss what is currently happening with hemp on the federal regulatory level.
Presenter: Ahna Brutlag
A retrospective analysis was performed on 2 years of animal poison center data with the goal of characterizing the signalment, clinical signs, dose-response, severity, and veterinary referral rates of animals exposed to CBD-predominant products. Cases were examined to gain an understanding of the types of CBD products pets were exposed to and how those products correlated with clinical signs and severity.
Presenter: Bill Bookout
Products containing hemp and CBD are the hottest in the industry right now, with new product announcements hitting our news feeds daily. But significant misunderstanding continues to exist around the status of these types of products, as well as risk assumed by suppliers and retailers. This presentation provides an overview of the landscape since the passing of the 2018 Farm Bill, and a status update on this dynamic and inconsistent business and regulatory environment. What are the primary concerns of FDA? What is the status for approval of Hemp in animal feed? What are the risks, what does the future look like, and how can you help?
Presenter: Emmett McGregor
The hemp processing industry has seen a rapid ramp-up in technical innovation as strong competition has forced down commodity prices. Join SciPhy Systems CEO Emmett McGregor to review the market landscape of industrial hemp commodities, and the state of the art in refined hemp processing technology. Extraction, purification, separation, and solvent recovery will be surveyed, with an emphasis on the impact of ultrafiltration and nanofiltration membranes on cannabinoid ingredient manufacturing, and an overview of approaches to cannabinoid separation and THC remediation from hemp extract ingredients.
Presenter: Tao Fei
Different organic solvents including diethyl ether, pentane, and ethanol were tested for the Abstract: Extraction of terpenoids and cannabinoids from hemp inflorescence. The effect of pretreatment such as grinding and extraction conditions such as the number of extractions, temperature, and soaking time was evaluated. The chemical profile of the extracts obtained from extraction by the different solvents under various conditions was characterized. Grinding to reduce the particle size of the inflorescence did not dramatically increase the total extraction yield from three sequential extractions, however, significantly increased the extraction yield of the terpenoids and cannabinoids of the first extraction. Among the three solvents, ethanol resulted in the highest total extraction yield (18.6 wt %) from the ground samples, while diethyl ether and pentane had better selectivity towards the terpenoids and cannabinoids. Increase the extraction temperature from 4 to 20 ºC improved the total extraction yield for all three solvents, however, further increasing the extraction temperature to 30 °C did not result in further improvement. The majority of the compounds can be extracted by the first extraction at a temperature of 20 °C. While at 4 and 30 °C, a second extraction was necessary for an equal total extraction yield.
Presenter: Francisco Leyva-Gutierrez
The chemical compositions of by-products from commercial cannabidiol (CBD) extraction were characterized and quantitated by employing gas chromatography mass spectrometry (GC−MS) and GC flame-ionization detection (GC−FID). The four major by-products included an ethanol-wax suspension (WAX), terpenoid distillate (DIST-A), tar-like residue (TAR), and red resin (RES). The composition of WAX consisted of ∼28 wt % n-alkanes and ∼33−38 wt % cannabidiolic acid and CBD combined. The DIST-A consisted of ∼40 wt % sesquiterpenoids and ∼58 wt % cannabinoids. The DIST-A terpenoid profile was compared to dried unprocessed inflorescences (HEMP) to observe changes in monoterpene content after the distillation process. The TAR was composed of ∼5−9 wt % higher n-alkanes and up to 91 wt % cannabinoids, while RES consisted of up to 99 wt % cannabinoids. Several impurities including cannabidibutol and dehydroabietic acid were identified in commercial CBD samples. Compositional information of these by-products may provide manufacturers with the opportunity to optimize processing conditions.
Presenter: Jack Henion
‘Pet Parents’ often seek alternative therapies for pain relief in their favorite companion animals. Instead of routine NSAID treatment there is a trend toward trying hemp-based products rich in cannabinoids. There are increasing numbers of companies producing hemp-based oils enriched with various mixtures of cannabinoids for pain and other maladies including seizures, cancer, and anxiety. These products post labels attesting to the composition in the product, usually labeling for cannabidiol (CBD) concentrations in their products but often with confusing concentration units which make it difficult for the pet owner to know what dose to give the pet. In addition, accurate reference to other cannabis-derived chemicals (terpenes, flavonoids, etc.) are often not mentioned on the label. Importantly, there often is little reference to potential known toxins such as pesticides, aflatoxins, residual solvents, or heavy metals provided on the package label. These trends result because there are currently no federal regulations which producers must adhere to which can ensure safe and effective products.
This presentation will overview the issues that pertain to safe cannabis-derived products and describe the chemical analysis of commercial veterinary products where it has been demonstrated that many of these products do not adhere to accurate labeling of their products. The importance of independent chemical analysis from a high-quality third-party laboratory which provides a detailed certificate of analysis (COA) for the product contents will be described.
Presenter: Kangming Ma
Understanding the THC/CBD content through the supply chain is critical to ensure the yield and high quality products. Traditional HPLC and wet chemistry methods are time consuming and require technical skills. The analyses are limited in the lab environment. Infrared methods are rapid and portable, an ideal tool where the analysis needs to be done in real time. The presentation offers a scientific review of the challenges and the considerations to implement reliable NIR/IR operations. The difference of the various NIR/IR technologies, methods development, performance SOP, keys to ensure the methods accuracy and precision, practical application for crop monitoring and manufacturing processes. Multiple varieties of hemp/cannabis material from growing regions across North America were used in the study. All of the samples were scanned using FT-NIR spectrometers and primary data for the model building and model validation was obtained by HPLC method. Chemometric modeling using the FT-NIR spectra proved to be very effective resulting in RMSEP of 0.03% when compared to HPLC results for CBDA, CBD, THCA, THC-D9. Multiple blind validations have since been completed resulting in a viable test method for rapid analysis of hemp/cannabis materials without the need for solvent extraction of the sample.
Presenter: Grace Bandong
Testing requirements for contaminants in hemp and hemp-derived products vary from state to state and can be confusing to manufacturers and producers. People often wonder if it is necessary to test these products for contaminants. Questions on which residues to test and how to test them are the most often asked. The talk will address these questions and look at a risk based approach that can help build confidence in materials and products.
Presenter: Christopher Hudalla
The hemp industry is currently one of the fastest growing industries worldwide. This growth is fueled by recent revelations of the nutritional and therapeutic benefits of hemp-based products. One challenge that has emerged is the ability to ensure consumer safety, providing accurate dosing and products that are free from potential contaminants. Analytical testing is a necessary component to ensure consumer safety for products that are being consumed both for nutrition as well as therapeutics. Yet, most jurisdictions have minimal or no regulations in place to require analytical testing. In regions where analytical testing is mandated, there is little synchronicity between requirements from one region to another. In an effort to address this, several organizations have begun to develop and validate methods that can be used as a basis for this testing. These methods not only encompass testing for the active phytochemical constituents (cannabinoids and terpenes), but also for potential contaminants including heavy metals, residual solvents (VOCs), pesticides, mycotoxins, and microbiological contaminants. The methodologies that are being used to meet these testing requirements include a wide variety of chromatographic techniques in addition to mass spectrometry and variety of approaches to address microbiological contaminants. Standardization of these methods for the industry will give regulators the resources they need to include sensible requirements for regulation and legislation that is being crafted to monitor and control the distribution of hemp and hemp-based products.
Presenter: Joe Wakshlag
The use of cannabinoid rich hemp products is growing in veterinary medicine. There are few clinical trials in dog or other species to date, however small clinical pilot studies have been appearing in the literature. The focus of this lecture will be to review published and unpublished clinical investigations on a variety of disease processes including osteoarthritis, atopic dermatitis, anxiety disorders and seizure management. Deciphering the doses used and the potential indications for these disorders will be discussed in detail trying to fully understand the clinical utility so more informed discussions can be had between client and veterinarian.
Presenter: Igor Koturbash
Cannabidiol (CBD) is the major non-psychotropic phytocannabinoid present in Cannabis sativa. In 2018, Congress designated select C. sativa cultivars as “hemp” removing them from the DEA’s list of controlled substances. As a result, CBD-containing hemp extracts and other CBD products are now widely available and heavily marketed, yet their FDA regulatory status is still hotly debated. Further complicating the debate is CBD’s vastly under-researched safety profile. Safety concerns yet to be adequately addressed include CBD’s drug interaction potential and its effect on the gut microbiome. Using acetaminophen (APAP), the most commonly ingested over-the-counter pain medication, we demonstrated that CBD-rich cannabis extract (CRCE) poses a significant drug interaction risk. Mice exposed to both CRCE and APAP developed severe liver injury. This hepatotoxicity, however, was not observed when either CRCE or APAP were administered separately. Importantly, this injury was observed in two different strains of mice with susceptibilities seemingly linked to sex (female) and age (older animals). Furthermore, both beneficial and adverse effects of CRCE on the gut microbiome were observed. Specifically, CRCE exposure increased the relative abundance of the beneficial gut microbe, Akkermansia muciniphila, however, an overall decrease in the relative abundance of all gut bacterial species was noted. This decrease was paralleled by numerous pro-inflammatory responses in the proximal jejunum and colon. Taken together, these findings raise significant concerns about the safety of widespread CBD usage and underlines the need for additional well-designed studies into its safety and efficacy.
Presenter: Aaron Rozental
This lecture will present results from recent in vivo studies with cannabidiol (CBD) that have been performed at Colorado State University. This includes pharmacokinetic studies in dogs evaluating the pharmacokinetics of different delivery methods of CBD, as well as the effect of a single dose of CBD on phenobarbital concentrations. Results from a published pilot study utilizing CBD for the treatment of idiopathic epilepsy in will also be presented. Finally, we will delve into our pharmacokinetic study utilizing escalating doses of CBD oil in cats.
Presenter: Dawn Boothe
The plethora of dietary supplements containing hemp-related extracts puts the veterinary practitioner in an uncomfortable position. The popularity of this emerging therapeutic intervention cannot be ignored, but the science is not easily found. On the one hand, the potential medical attributes of these therapeutic interventions is exciting, but the complexity of the physiology and pathophysiology that they are targeting is profound. The endocannabinoid system is ancient and integrated. It influences all and is influenced by many. The diseases to be targeted clearly include those impacting the neurologic system, but will include those involving metabolic pathways, immunomodulation and others. Response will vary and establishing a therapeutic range to target with therapy will be complicated. Manipulation of this system offers multiple targets with the use of exogenous compounds being the most popular. Hemp extracts currently available as dietary supplements are not approved and minimally regulated. Indeed, the regulations themselves are dynamic. This contributes to variability in the products themselves as has been demonstrated in regards to cannabinoid content. This in turn will influence patient response. The disposition of the target compounds – cannabinoids- will vary among the species, breeds, physiology, and products, as has been demonstrated by our lab, making it more difficult to establish an effective dose. The role of therapeutic drug monitoring may offer a means of standardizing protocols.
Presenter: Daniele Piomelli
The major psychoactive constituent of cannabis, D9-tetrahydrocannabinol (THC), produces its pharmacological effects by activating cannabinoid receptors in the brain and peripheral tissues. In my talk, I will provide a brief outline of the history of cannabis as a medicine, the pharmacology of THC, and the key properties of the endogenous signaling complex THC hijacks – the endocannabinoid system. I will also describe other plant-derived cannabinoids that do not activate cannabinoid receptors, with special focus on cannabidiol.
Presenter: Vermont Dia
Non-drug varieties of Cannabis sativa L, commonly referred to as hemp, are widely cultivated for industrial use and harvested for seed, oil, meal, and fiber. Despite the fact that it has long been used as a source of edible oil and consumed as a food throughout history, its cultivation has been prohibited in numerous countries because of the presence of Δ9-tetrahydrocannabinol (THC). The ban to cultivate, transform and commercialize specific hemp varieties containing less than 0.3% THC has been lifted in the United States. Hempseed contains over 30% edible oil and about 25% easily digestible protein. This talk will give an overview if industrial hempseed, and will focus on the characterization of hempseed meal after oil and protein removal. We called this ca-product hempseed meal after protein isolation (HM-PI). HM-PI contained over 70% protein and had similar or higher level of essential amino acids than recommended values for human adults. Osborne fractionation indicated that glutelin was the most dominant fraction in HM-PI. Freeze-dried HM-PI has a significant lower surface hydrophobicity and higher in vitro protein digestibility than oven-dried HM-PI and vacuum oven-dried HM-PI. Freeze-dried HM-PI demonstrated better functional properties. Pepsin-pancreatin digestion of HM-PI resulted in comparable and considerable antioxidant and anti-inflammatory properties. HM-PI could serve as a novel food protein ingredient resulting in increased utilization of hempseed.
Presenter: James House
Cold-pressed processing of hemp (Cannabis sativa L.) seeds can result in various products including whole hemp seed (HS), hemp seed hulls (HH), dehulled hemp seed, hemp seed oil (HO), hemp seed cake/meal (HC/HM), HS protein concentrate (50% protein), coarse HS protein (<35% protein), and screenings. However, currently, hemp-derived products are not approved as feed ingredients in Canada, in part, because the safety and efficacy of these derivatives for use in animal feeds have not been evaluated by regulatory bodies. Hemp seeds-derived products such as HS, HO, HC/HM, and to some extent HH, have been evaluated in feeding various animals including poultry, swine, ruminants and aquaculture. These studies showed results that do not negatively influence animal health indicators or animal performance, moreover, they enhanced animal products (egg, meat and milk) with health benefiting bioactive components such as omega-3 fatty acids, GLA, and CLA. The studies also suggest that the main active cannabinoid, Δ9-tetrahydrocannabinol levels in Canadian hemp containing products are below the guidelines of 10–20 mg/kg. Although more supporting evidence from literature on the safety and efficacy may have focused on whole HS, HO, HC/HM for use in animal feeds, other hemp seed-derived fractions such as dehulled hemp seed, HS protein concentrate (50% protein), coarse HS protein (<35% protein) not used for human consumption, could be valuable for animals. Hence, within prescribed limits, hemp seed-derived products can be safe and effective feed ingredients and suitable alternatives to the conventional ingredients for inclusion in the animal rations.
Presenter: Serkan Ates
The 2018 Farm Bill removed hemp (Cannabis sativa) from the Controlled Substances Act, classifying it as an agricultural product. This has led to a flourishing hemp industry, with Oregon among the leading hemp producing states especially for the cultivation of hemp for cannabidiol (CBD) extraction. The extraction process of CBD yields large quantities of spent hemp biomass (SHB). The chemical composition of SHB suggests that it could be included in animal diets. However, the use of SHB in animal diets is not yet approved by FDA. In order to move forward with approval, FDA requires data on cannabinoids residuals in animal products and the effect on animal health, production, and product quality. Thus, we conducted a study to investigate the effect of inclusion level and withdrawal period of SHB in place of alfalfa in finishing lamb diets. Our findings indicated that SHB can be included in ruminant diets without causing any detrimental effect on animal performance with a possible positive effect on feed intake when 10% SHB is included in the diet.
Presenter: Raj Kasula
Hemp seed and hemp seed products such as Hemp Seed Cake (HSC) have shown to increase unsaturated fatty acid (FA) profile in eggs, including linoleic and α-linolenic fatty acids. However, the use of hemp products in animal feed is still a concern due to the potential residues of the of Δ-9 tetrahydrocannabinol (THC), a psychoactive substance present in the hemp plant; thus, research to explore the subject is justified. A multi-parameter research was carried out to characterize the chemical composition and the safety of feeding HSC to commercial laying hens; its effects on layer performance, egg quality, systemic parameters, organs and tissues; and the residues of cannabinoids in organs and tissues. Eight hundred (800) Bovan caged hens in lay at 30 weeks of age were distributed into 4 treatments of 200 hens per treatment based on the inclusion levels (0%, 10%, 20% and 30%) of HSC. Each treatment comprised of 8 cages of 25 hens each that served as replicates. The study was carried out for 16 weeks following a 3-week acclimation. The results showed consistency in nutritional, mycotoxin and heavy metal values of HSC while the cannabinoids were below levels detectable by laboratory analyses, demonstrating levels well under the legal limits of 0.3%. Performance parameters such as feed intake, body weights, hen-day production, feed conversion and livability were not consistently affected. In terms of egg quality, egg weight and egg mass were not impacted, while eggshell strength, the linoleic and linolenic fatty acids were improved. HSC also improved egg lutein, yolk pigmentation and Haugh units. The cannabinoids residues in eggs was below the detectable level. Systemic parameters such as blood pH, blood profile, total protein and the mineral profiles were not consistently affected, and no effect was observed on tissues and organ health parameters. The cannabinoid residues in eggs, blood, breast meat, body fat, liver, kidneys, and spleen were below detectable levels. The results of the study showed that feeding HSC in laying hens did not affect the health and performance nor caused residues in their products even up to 30% inclusion.