The hemp conundrum chta-presentation-beta

The Hemp Bioactives Conundrum –A Simplified Solution

- Nutraceutical potential has been limited due to perception that hemp bioactives may be regulated as

Schedule F drugs

- Generic nature of the science discourages proprietary pharmaceutical commercialization

within pharma parameters due to generic economics

- - Canadian Patent 2,921,553 describes the methods to enable all components

- - Multiple sector-networked supply chains maximize the value

- - Bioactive applications are embodied as formulations in products

- - Developers are the hemp bioactives industry innovators

The Hemp Bioactives Conundrum –A Simplified Solution

• - The solution is to create a robust set of networked, interdependent generic hemp based supply chains with

mass commercialization of affordable products

• - The solution is Innovation via Intellectual Property that can be broadly licensed as opposed to

simple silos with isolated regulations which discourage innovation and commercialization of

all silos in an interactive, integrated manner

• - The solution is a control tower operating system that licenses compatible applications and capitalizes

on the economies of scale

Grow a healthy , clean crop and swath it

Bales are a better way to quickly preserve the crop and extend harvest season without exposure to the elements.

Bales can store 15-20 percent moisture crop until combining

Patent Pending Harvesting system preserves the crop integrity beginning in the field

Check the bales for moisture so the can be safely stored, monitor them in storage for changes in temperatureand dry them to 9-12 % with a bale drier, if required

Assemble bales at storage and store at processing hubs in preparation for drying , then combining

At some locations “in field” primary processing is done in the field, when weather and time constraints permit

Similar to the Mcloed Harvest system , the crop comes to the harvester to complete the combining

All non-grain waste and Straw is conveyed to a pile and removed as required

Straw is burned if no fibre processor expresses interests, alternatively the straw can be re-baled to run a bale dryer

to dry bales to a uniform moisture prior to combining

Harvested grain is not simply separated from the stalks…. aggressive threshing methods are the first milling step

to render the grain a non viable derivative as an integral part of harvesting operations

At commercial scale large pieces of stalk are scalped out of grain and the primary milled grain is remilled to a fine flour

suitable to be transformed into secondary derivatives, or used as is

Milling creates a uniform, pure and consistent quality flour

Flour can be heat treated to dry pasteurize it

The Hemp Bioactives Conundrum – Enabling Development

- Government control has focused on tracking THC, a component hemp is bred to have a very low level of while ignoring the

bioactive entourage

- Other cannabinoids and terpenes exist in biomass; regulations stifle commercialization of these compounds due to lack of clarity

- Intellectual property innovated to fill this vacuum via utilization of a loophole in regulation which allows biomass to be converted to

derivatives as a “bin run” raw material

- Once derivatives are created only the THC limits are currently tracked

- Intellectual property can be licensed to allow governments to collect excise taxes on any specific hemp bioactive (eg CBD) in

compliance with future laws and regulations

- Royalties allow the IP owners to place strategic investments to fill the gaps

in areas they see as bottlenecks for hemp bioactivesindustry expansion

- Patents can provide generic licensing opportunities to ramp up the industry

The Hemp Bioactives Conundrum – Supply Chains

- Patented harvest method enables on farm production of derivatives as a part of harvest

- Mechanical separations, solvent extractions, fractionations create supply chains for custom-compounding raw materials

- - Terpenes, and cannabinoids, are listed in several food, NHP and pharma schedules so derivatives are targeted to appropriate applications which match uses to regulations

- - Intellectual Property controls and tracks supply more effectively than centralized regulatory policing and

facilitates regulatory compliance

- - Pharmaceutical, nutraceutical, medical marijuana licensed producers, unlicensed dispensaries and food processors all

have applications utilizing derivatives as feedstock


• - Secondary derivatives include dietary fibre, protein powder, oilseed granules, full bioactive nutraceutical flour, residual bioactive food flours, oils with various bioactive profiles, nutraceutical bioactive-rich protein powder and utility flour concentrates

• - Tertiary derivatives include edibles with varied bioactive profiles with food, nutraceutical and medical applications, dermal preparations in cosmetics and cosmeceuticals, highly refined bioactives concentrates with various profiles for food, flavor, aroma, supplement and medical formulations.


• - A supply-chain patent tracks the bioactives disposition when it gathers one royalty at the farm-gate and a second royalty at the retailer (checksum of inventory).

• - Farmers, as growers, are paid a premium to manage crops to maximize bioactive content

• - Contracting of farm supply as part of Intellectual Property licensing guarantees supply chain players a continuing supply of product profile-specific ingredients

All the separate cannabis supply chains are beginning to meet to solve common concerns

Industrial hemp is trying to find its place in the matrix of cannabis derived businesses

The Hemp Bioactives Conundrum – The Food Sector

- Current products include protein powder, edible oils ,oilseed powders and granules

- Future products include

edibles with hemp bioactive content

cooking flours and oils with bioactive content

- Food categories include:

margarines, soda pop, candies, beverages, baked goods, soups, cakes and pastries to name a few

Regulations have and will continue to set the allowable bioactive parameters of the finished consumer goods

which are formulated with bioactive concentrates

and hemp derivatives

Commercial flours rich in CBD can find their way into common food products

Beer wine , juice and soda pop flavored with hemp bioactivesfortify the nutritional value

of simple beveragesmuch as feeding flax to chickens produces omega 3 eggs.

The Hemp Bioactives Conundrum – The Nutraceutical Sector

- Concentrated derivatives and bioactives formulations in powder and oil and tinctures can be used as starting

materials for single and compounded formulations including:

- dry capsules and tablets

- gel capsules

- dermal formulations

- flavorings

- compounded multi-component herbal products

Nutraceuticals present hemp bioactives to the food supplement market. The one on the left purports to be some kind of medical marijuana containing CBD when it actually only contains 40 PPM , while the

one on the right has 6000 PPM CBD but makes no claims for containing CBD. It is ironic that black market products clearly list the CBD content on labeling more accurately than nutraceuticals

Nutraceuticals or doggie treats complement the lineup

Concentrated tertiary derivative extracts based on the chemistry of hemp flour

are now available

Cosmeceutical and pet nutraceuticals are derived from hemp bioactive concentrates

SOME CANADIAN HEMP PRODUCTS Deliberately Mislead consumers to associate HEMP WITH MARIJUANA…..

This understandably puts regulators on edge

Hemp contains non-traditional cannabinoids

Caryophyllene

is a cannabinoid found in

Hops, pepper, cloves and oregano

It is a fallacy that cannabinoids are

only found in cannabis

Health benefits of Cannabinoid Family Members

The Hemp Bioactives Conundrum –The Licenced Producer Sector

- Persons with prescriptions for medical marijuana require marijuana formulations high in hemp bioactives

other than THC, especially:

- cannabidiol, minor cannabinoids including caryophylleneand caryophyllene oxide

- bioactive terpenes including myrcene, linalool, alpha pinene, humulene, limonene

The Hemp Bioactives Conundrum –The Licenced Producer Sector

• - licensed producers can authorize and contract processing by GMP, site-licensed pharma and nutraceutical manufacturers to create products of pharmaceutical quality suitable not only for DTC but also pharmacy dispensed products, liquor and other specialty vendors and export to USA and countries where CBD is an over-the-counter compound.

• - licensed producers can purchase generic hemp derivatives to include as base material for their cannabis products

• - licensed producers can focus on THC, and outsource CBD, so as to maximize the productivity of indoor production capacity and capital management

Licensed Producers have a full spectrum of THC and CBD profilesin both dry and oil formulations

The Hemp Bioactives Conundrum –The Pharmaceutical Sector

- Pharmaceutical companies globally researching pharmaceutical formulations need a reliable source of raws

or contract manufactured ingredients

to proceed to commercial products

- In countries where CBD is not regulated as a drug, such as Switzerland, pharma companies desire to receive hemp

bioactives and derivatives of all sorts.

- In the USA where CBD is widely marketed, it is likely a market for products formulated by GMP, Site Licensed

Canadian facilities would meet with

no objections from Federal Regulators

USA and EU have a much more developed market for CBD supplements with negligible THC content

2010 Humanity+ futurist conference at Harvard is the first time healthspan and lifespan became associated with hemp …. Hemp has great utility in the multidisciplinary approach to transforming crisis and palliation driven medicine to preventative, regenerative and enhancement medicine. I spoke on health information management systems with hemp as a side note. A nice icebreaker when having beers at an after-party with scientists Maria Konovalenko and Aubrey De Grey ….

https://www.fightaging.org/archives/2016/09/a-visual-introduction-to-sens-rejuvenation-research/http://longevitycookbook.io/

The Hemp Bioactives Conundrum – The Dispensary Sector

- Although dispensaries may or may not be properly licensed or regulated so are considered illegally operating

- They embody the provision within the Natural Health Product regulations that exempts businesses who

manufacture custom compounded formulations

for customers on the orders of an

alternative health practitioner with or without

dispensation by a licensed compounding pharmacist

- Dispensaries also carry edibles and novel formulations from which to use to formulate custom compounded products

-

The Hemp Bioactives Conundrum – The Dispensary Sector

• Dispensaries are within the hemp industry, the equivalent of the farmers market in the commercial food industry,

so are an evolving sector. It is in the best interests of regulators to use collaboration

instead of confrontation in assisting and working with

the dispensary sector as it matures into a long term player that fits a niche of its own creation

• - The entire industry has watched the dispensaries and learned what works, and what does not, from their

experiences

Dispensaries are the leading edge , evidenced by the way they have reached out to hemp as a product

Hemp derivatives find their way into some very sophisticated concentrates and dermal products

The Hemp Bioactives Conundrum – The Black Market Sector

- Currently all sorts of businesses procure amounts of hemp from farmers and sell everything from dispensary products to highly manufactured high concentration crystal high CBD for domestic or export sale, as well as converting CBD from

hemp using acid, time and temperature into THC products, without any regard for law or regulation

- Patent holders working together with Health Canada and CHTA would then back-track these supply chains and to bring

this production into legally-approved channels engaging in regulated and approved transactions.

The Hemp Bioactives Conundrum – The Black Market Sector

• - Over the last 3 years, several CHTA-member hemp farmers and processors have begun to supply the dispensary and black market with substantial quantities of hemp bioactivesdestined for the medical marijuana and recreational markets.

• A hemp-industry-driven authorization to supply emerging legal supply chains would remove the economic incentive for diverting bioactives to unapproved applications more effectively than the perceived punishments which

currently are not curbing these transactions.

The marijuana black market has developed CBD based formulations

Black market consumer products have also combined CBD into products

The Hemp Bioactives Conundrum –The Health Canada Regulatory Statement

• The Industrial Hemp Regulations (IHR) establishes a framework for the authorization of specific activities with industrial hemp. However, certain activities with industrial hemp are not within the scope of the IHR and cannot be authorized by an industrial hemp licence; these include the production of derivatives, such as oil, from whole industrial hemp plants, including sprouts, or the leaves, flowers or bracts of those plants, as per subsection 2(2) of the IHR which states:

• (2) These Regulations do not apply to• (a) the importation, exportation, sale or provision of whole industrial hemp

plants, including sprouts, or the leaves, flowers or bracts of those plants;• (b) the importation, exportation, sale, provision or production of any derivative or

product made from whole industrial hemp plants, including sprouts, or the leaves, flowers or bracts of those plants; or

• (c) the importation, exportation, sale or provision of any derivative of seed, viable grain or non-viable cannabis seed, or product made from that derivative,


• Under the current framework of the IHR, the use of whole industrial hemp plant parts (which includes sprouts, leaves, flowers or bracts of those plants) is not authorized.

• Activities outside of the scope of the IHR are subject to the prohibitions set out in Part I of the Controlled Drugs and Substances Act unless otherwise authorized under the regulations.


• However, an existing regulatory regime and exemption under the CDSA does allow for the cultivation of cannabis and the production of cannabis oil by licensed producers. That regime is established in the Access to Cannabis for Medical Purposes Regulations (ACMPR) and in section 56 of the CDSA. Please contact the Office of Medical Cannabis at [email protected] should you require more information. Further, it is possible to produce a derivative made from whole industrial hemp plants, including sprouts, leaves, flowers or bracts of those plants with a section 9 licence under the Narcotic Control Regulations. Please contact the Controlled Drugs Section at controlled_drugs_office@hcsc. gc.ca for information on a section 9 licence application

The Hemp Bioactives Conundrum –The Health Canada Compliant Solution

The Hemp Bioactives Conundrum – Patent Excerpts

• [0026] One of the problems which could be addressed in the right circumstances with a method of this type is the notion that industrial hemp bracts , leaves and stems when they occur separately are disallowed to be processed or sold as hemp in an any form as they are classified as "controlled substances" by government regulators. Grain is allowed to be processed into a wide range of food derivatives with the only requirement that it contain less than certain amounts of THC , starting with less than .3% in the raw materials. In agriculture, grain is defined as anything exceeding 50% or more of the principal grain and less than 50% of other grains, chaff and other biomass materials. The novel idea is that if the grain definition is applied to hemp that the result is that a mixture of hemp grain and biomass either in "bin run" or milled into an inseparable mixture that is not defined by regulators as a "controlled substance". This enables the industry to access large quantities of raw materials from farmers in a manner that is not prohibited by regulation.

The Hemp Bioactives Conundrum – patent excerpts

• [0006] One example of this type of a regulatory scenario in which it is believed that an enhanced production method which would accommodate these types of raw crop material or finished crop products regulatory restrictions is the production of crops that have regulated active ingredients, such as hemp. Over the last hundred years, hemp has evolved from a widely available multi-use crop to a highly regulated poorly utilized crop. This invention seeks to remove dysfunctionality from the state of the art of commercial activity that centers on the non THC cannabinoid and terpene bio-actives originating in the industrial hemp plant. Currently non-THC cannabis terpenes and cannabinoids science cannot be commercialized to the extent that consumers demand. Industrial hemp cannabis bio-actives when not presented as drugs containing THC, present as food, nutritional supplements, medicinal foods, natural health products, cosmetics, animal supplements and such other categories that government regulators choose to place them within.

The Hemp Bioactives Conundrum – patent excerpts

• [0007] A control tower production method could be developed that would accomodate many of the issues associated with these types of complicated agricultural production scenarios. A control tower production method is a method of manufacture or production used in many different industries that centers around controlling all of the key or critical control points in a manufacturing process to guarantee process performance or product quality or output. In the particular context of hemp production, there are several supply chain critical control points in an integrated field to consumer industrial hemp cannabis bio-actives supply chain that could benefit from the application of a control tower management methodology, including to minimize incursion by government regulators into such activities. These critical control points include supply contracts for the production and delivery of crop material, prescribed crop management practices including harvesting methods, novel processing and extraction methods and consumer/consumer representative driven field to consumer supply contracts. Management using these critical control points will enable cannabinoid and terpene bioactive commercialization in foods AND non-drug formulations within existing government regulations.

The Hemp Bioactives Conundrum – CBD in Hemp Products

• The original intent of the IHR was to prevent THC derived from Industrial Hemp from entering the marijuana marketplace. Any interpretation to the contrary is in error.

• There is no requirement for grain to be conditioned or cleaned prior to milling. And grain with 50.1 percent of the named grain denotes the description of the resulting flour. For 3 years, It entered the USA as milled oilseed. It was tested for THC by Border Protection agents and passed each time.


• At the time of Combining anywhere between 1 and 20 percent percent of stalk, and biomass from the crop , milled and damaged hemp seeds, and weed seeds comprises what is taken to storage as “bin run” grain. The quoted regulation applies to leaves and plant material which the combine removes and is blown out onto the ground behind the combine. The key way to determine the intent is the use of the word retting. There is no reason to believe it means that the grain must be conditioned or run through a grain cleaner prior to storing in a grainary.

“Hemp for Horses” - 2007

“Hemp for Horses” - 2007


• What is governed by IHR is outside the scope of the CDSA. Therefor if CBD, which is controlled under the CDSA, is part of a product controlled directly or indirectly by the IHR, it is out of the scope of the CDSA and thus, unless specifically exempted from the IHR, is within its scope.

• An example of this is THC, which is governed under the CDSA but exempted within certain specified limits by the IHR. This makes hemp oil or derivatives containing CBD controlled by the IHR.


• When a Licensed Producer buys hemp oil from those producing it under the IHR, the CBD content is neither allowed nor disallowed so it can be deemed as being part of a product produced under the IHR and properly received by Licensed Producers as hemp oil or derivative. Once received by a Licensed Producer, then the rules that govern operation of Licensed Producers apply to hemp grain or derivatives. Those regulations allow them to possess both CBD and THC, thus the CBD is brought within the scope of these permitted activities.


• All hemp derivatives in Canada contain measurable amounts of hemp bio-actives which do not occur in the seed itself. These impurities which include microscopic pieces of the whole plant or grain impregnated with juices derived from herbaceous plant parts during the process of combine harvesting are transmitted into all known hemp derivatives. The proof of this is that all hemp derivatives contain a measurable amount of both THC and CBD which originates not in the seed but in the whole plant.

• Let me also refer to a situation that speaks to trace amounts of hemp plant parts in hemp derivatives. The USA, at one time, had a zero tolerance for THC in hemp derivatives and banned entry of these products for importation into the USA. Canadian exporters responded and the solution was to deem zero to not be zero but a measurable number rounded down to zero.


• If I were to interpret the words of the regulations as stated all hemp products produced in Canada since 1999, namely every single pound of grain and derivative, would be deemed outside the scope of the IHR and thus not permissible by your definition of the scope of the IHR. That would mean that the entire Canadian industrial hemp industry as we know it today would fall outside the scope of the IHR.

• In this case bin run grain may contain all sorts of dockage which may find their way into derivatives. There are no IHR provisions within the law or regulations to address this situation as either permitted or prohibited.


• Within the IHR there are no specific references to any crop production techniques which could remove 100.0 % of the whole plant. Manitoba Harvest, a large producer of hemp derivatives, has published online statements that all of their hemp products contain measurable traces of whole plant parts (CBD) … but they state also that the exact amounts of the CBD marker compound in their products are known to them, but will not be made public.


• The IHR does not specify that the grower, who also converts grain to oil or meal or flour, must remove any impurities from bin run grain unless HC has approved that grower to be licensed as a conditioner. For 17 years HC has licensed both growing as well as creation of derivatives on one license. HC issues licenses for farmers to convert grain to derivatives without requiring them also to be licensed as conditioners, or use the services of conditioners or even set permissable levels of residual materials ; therefor, it can be reasonably expected that bin run grain could be used as the input grain material for all Canadian farmers.


• Nowhere in the regulations does it state that grain must be conditioned, nor what the standards for conditioned grain must be prior to conversion into derivatives.

• There has been a misinterpretation by the IHR as to the terminology defining impurities in hemp e.g. plant part terms. CBD as a reliable chemical fingerprints of the presence of hemp plant parts in all hemp derivatives … indicating that all known hemp grain derivatives contain miniscule amounts of whole hemp plant parts.


• The intent of the regulatory scope of the IHR may not apply to the whole plant nor its named parts nor does it place limits on the incidental content of these in derivatives exists except controlling for the THC limits which are derived from plant part content. The regulations place no specifications as to incidental minor inclusions into hemp grain as far as content of any other bioactive. All Hemp derivatives contain other bio-actives of which CBD is a good indicator of the presence of whole plant parts or the residue thereof.

CBD in hemp products is detailed in peer reviewed papers

• Cannabis sativa L. in Foodstuffs: the Italian Case and the Need for

• EU Harmonised Limits for THC Unavoidable Contamination

• Sabino A. Bufo, Simone Milan, Luigi Milella, Laura Scrano and Cesare Varallo*

• Reports European Food & Feed Law Review 1|2016 pgs 52-57

• “Cannabis seeds have been extensively described in the scientific literature, and some traces of cannabinoids has been occasionally found in seed-derived oils, mainly due to external contaminants such as resin adherent to the seed or plant parts’ residues”


• The Composition of Hemp Seed Oil and Its Potential as an Important Source of Nutrition

• Cary Leizer, David Ribnicky, Alexander Poulev, SlavikDushenkov, Ilya Raskin

• Journal of Nutraceuticals, Functional & Medical Foods Vol. 2(4) 2000

• 2000 by The Haworth Press, Inc. All rights reserved. Pg 35-53

• “Although previously identified only in the essential oils of the Cannabis plant (Hendriks et al., 1978), terpenoid compounds have been identified as being present within the seed oil. Health benefits may be gained from their presence even at concentrations similar to that of CBD. As is the case with CBD, the presence of these terpenes is most likely the result of contamination from glandular hairs during oil processing.


• “The cultivation of modern day industrial hemp crops in more northern latitudes will show a gross chemotype of high CBD/low THC. With these ‘‘unripe’’ varieties, it will be possible to take advantage of the relatively high levels of CBD as compared to THC, and exploit the many benefits of CBD without risk of psychoactivity. The oil which was subjected to investigation here was Canadian grown. It has significant concentrations of CBD but no detectable THC. These results are consistent with the predicted cannabinoid content of northern-grown plants.”


• To clarify, the 46 page document entitled "Control Tower Production Method for Crop Fractions and Derivatives" , patent 2, 902, 766 :

• Put simply , when hemp is grown , processed and marketed as described in my patent and demonstrated in this presentation it is covered by my patent and is compliant with the Industrial Hemp Regulations. Thus all CBD found in the resulting derivatives as is already the case with all hemp derivatives on the market are to be treated equally as not within the scope of the CDSA and wholly within the scope of the Industrial Hemp Regulations

The Hemp Bioactives Conundrum –Summary : 15 November 2016

“There is a globally emerging healthspan and lifespan extension market which most of the players can target-market to. This developing market can grow what is a 2,000 acre biomass acreage in 2016 to about 20,000 acres in 2018 and 200,000 acres by 2022. The economc benefit to both

public and private sectors is obviously significant. It is critical that Canada be a first mover in this industry. 2 cents per milligram of CBD in multiple formulations, if delivered at a consolidated daily dose of 100 mg

a day as a dietary delivered supplement for 25 million people, would consume 16,000 acres and generate a gross market value of 2 billion CAD annually. Canada, with a default public medicare system, has the moral

hazard that health-supporting ingredients which are not fully commercialized in a timely fashion cost medicare and the taxpayer for

avoidable Crisis Management and Palliative Care resource allocations. “

Morris Johnson holds title to the aforementioned IP and is the author of this presentation.

Morris Johnson / Lifespan Pharma Inc.

24-1035 Boychuk Drive, Saskatoon, Sask., S7H-5B2

1-306-716-7822

[email protected]

REBRAND CANADIAN HEMP AS AN ANTI- AGING INGREDIENT

Hemp has an identity crisis in the minds of many today

Health & Medicine

The hemp conundrum chta-presentation-beta