If cannabis had a slogan, it might be “the more the merrier”. That’s because of its highly synergistic nature. The cannabinoids—or active agents—in the cannabis plant work in tandem with terpenes, which are the aromatic molecules that give the plant its signature smell and also produce different physiological effects. Together, cannabinoids and terpenes enhance the therapeutic benefits of cannabis in what is known as “the entourage effect”.

The entourage effect was introduced in 1998 by Israeli scientists Shimon Ben-Shabat and Raphael Mechoulam. Their theory was that cannabinoids within the cannabis plant were more effective together than by themselves. The strongest case for this theory is made by the two most famous cannabinoids in the cannabis plant—THC and CBD. Evidence shows that CBD actually mitigates the psychotropic effects of THC by blocking some of the THC receptors in our bodies. The end result of this relationship is that patients get the same therapeutic benefits with fewer unwanted symptoms.

Studies on the entourage effect have led the medical marijuana industry to move away from isolating and extracting THC to adopting a “whole plant” approach. For example: Marinol, a pure, synthetic form of THC, was introduced in the mid 1980s as a medically identical substitution for the cannabis plant. However, it soon became evident that patients were not responding to Marinol the same way they did when ingesting or smoking naturally grown cannabis. This led researchers to the conclusion that compounds like CBD and terpenes were necessary to realize the full power of THC.

In short, the entourage effect is the cannabis plant’s way of reminding us that sometimes the whole is greater than the sum of its parts, and that sticking together can bring about better results.

Written for Greenway by Sarcoxie Nursery

For more than a century, Sarcoxie Nursery was known as one of the world’s highest-quality growers and purveyors of fine flowers. In 2020, the nursery will bloom once again as a groundbreaking medical marijuana facility with dispensaries across Missouri, bringing healing to patients within our communities. Sarcoxie Nursery is a Missouri owned vertically integrated license applicant. 

Visiting a dispensary for the first time can be intimidating, Feel State and Emma Chasen are here to help.

 

 

 

Emma Chasen of Eminent Consulting on behalf of Feel State

Emma Chasen has a mission to educate people on the science behind cannabis so that they may take charge of their own healing.  A graduate of Brown University in 2014 with a degree in Medicinal Plant Research, Emma has made a huge impact in the cannabis community and has quickly become a recognized expert in the field. Chasen now co-owns and operates Eminent Consulting.

Feel State is a Missouri based dispensary brand focused on helping better connect individuals to themselves, each other, and their communities through the use of cannabis.

By Brandon Dunn

Tuesday evening members of previous advisory committees met together at the Truman Office Building in Jefferson City to discuss scoring and measurement of applications for medical marijuana facilities.

The committee, moderated by General Counsel Richard Moore and composed of Kelly Dyer, Missouri Chamber of Commerce, Lt. Mike Halford, Department of Public Safety, Kimberly Grinston, Missouri Board of Pharmacy, Ken Palermo, Department of Health and Senior Services Division of Community and Public Health, Eric Hueste, Department of Health and Senior Services Bureau of Environmental Health Services, Hwei Ying Johnson Department of Health and Senior Services Division of Community and Public Health, received a series of emails over a 36 hour period containing 5 documents for review.

The committee was asked to approve the questions as presented or provide alternatives and score the weights of questions and topics themselves.

The committee approved and adopted the Evaluation Criteria Scoring Table as presented.

The department stated they had synthesized or corrected questions to harmonize the form and avoid unnecessary repetition. No one on the committee had any opposition to the questions as received, with the exception of Hwei Ying Johnson.

Ms. Johnson requested that question 97’s weight be changed from 3 to 8. Ms Johnson also requested changing the weight of question 98 from 3 to 8, and increasing the weight of question 99 from 4 to 5.

Ms. Johnson also recommended the addition of another question following question 100.

The agreed upon version of that question and the modified version of question 116 now read as, “Describe plans for waste storage, waste management, waste nutrient recycling and destruction.” Both questions were assigned a weight of 7.

The committee denied the motion to change the weight of question 97.

The committee approved the motion to change the weight of questions 98 and 99 respectively.

The scoring scale, and questions as modified and weighted were unanimously approved and adopted.

Moving to assigning weight for categories, Ms Johnson made a motion to increase the weight of application specific categories, ie dispensary, manufacturing, etc. from .20 to .30. That motion failed before the committee.

The category weights remained the same as originally presented by the department.

Categories weighted as follows:

Medical Marijuana Scoring Advisory Committee

By Brandon Dunn

Wednesday morning the final of 10 advisory committees established by DHSS met at the Governor’s Office Building in Jefferson City to determine the weight and measure of nearly 50 questions related to the business plans of aspiring medical marijuana licensees in the state of Missouri.

The committee, comprised of Kelly Dyer with Missouri Chamber of Commerce and Industry, Rick Nichols, President of River Region Credit Union, Leslie Tanner with Central Bank, and Michael Lanahan from the Department of Economic Development, joined moderator Richard Moore to review, amend, and finalize questions 19-75 of the Facility License Application Questions Draft.

The approved and finalized text of the questions follows, original text of questions can be found here:

19 Provide documentation of sources of capitalization to demonstrate that you have sufficient liquid assets to successfully carry out the activities described in the application. Any capitalization claimed, may not be committed for another facility license application or any other purpose. Without evidence showing a lower amount of capitalization is adequate for your facility, the following amounts shall be considered satisfactory.

* For cultivation facility applicants – $300,000 * For dispensary applicants – $150,000* For infused product manufacturing facility applicants – $150,000* For transportation applicants – $150,000* For testing applicants – $200,000

(Critically Important)

20 Will the business have professional liability insurance? If yes, describe the anticipated insurer, policy terms, and limits. (Important)

21 Will the business have product liability insurance? If yes, describe the anticipated insurer, policy terms, and limits. (Important)

22 Will the business have business interruption insurance?  If yes, describe the anticipated insurer, policy terms, and limits. (Slightly Important)

23 Will the business have property insurance, not including insurance to cover marijuana loss? If yes, describe the anticipated insurer, policy terms, and limits. (Slightly Important)

24 Will the business have property insurance to cover marijuana loss? If yes, describe the anticipated insurer, policy terms, and limits. (Slightly Important)

25 If a license is granted, does the business have a legal right (own, option to buy, lease, contingent agreement, etc.) to operate at the proposed location? If yes, describe and provide evidence.  Include the length of time you have secured the business location and submit acknowledgement from the building owner if you do not own the premise. (Highly Important)

26 Describe your plan to address diversity, such as individuals belonging to a racial minority group as defined in section 37.013 RSMo, women, and/or veterans in ownership and/or staffing.  (Important)

27 Describe your plan to maintain an adequate supply of marijuana? (Important)

28 Describe your plan to ensure safety and security of Qualifying Patients and the community. (Highly Important)

29 Describe your procedures to prevent diversion of medical marijuana into the illegal market. (Critically Important)

30 Describe your plan for making medical marijuana available to low income Qualifying Patients.  (Highly Important)

*Per Richard Moore, low income info will be made available via patie...

By Brandon Dunn

Tuesday afternoon, the Advisory Committee on Site Security met at the Truman building in Jefferson City to review and approve questions 76-85 of the Facility License Application Questions Draft.

The committee is listed as including Greene County Sheriff and President of the Missouri Sheriff’s Association, Jim Arnott, Lt. Mike Halford of the Missouri Department of Public Safety, and Tim Reagan. Reagan did not attend.

Richard Moore, General Counsel at the Department of Health and Senior Services, acted as moderator and the committee handled the meeting expeditiously, approving all questions as read.

Questions graded as: Sightly Important, Important, Highly Important, or Critically Important.

76 Original text: Describe your security staffing at the facility.

Read as: Describe your security plan, including staffing at the facility. (Important)

77 Will your security exceed the minimum requirements established by Rule in regard to parking lots and building exterior, if so how? (Slightly Important)

78 Original text: Will your security exceed the minimum requirements established by Rule in regard to interior public spaces, if so how?

Read as:Will your security exceed the minimum requirements established by Rule in regard to interior public spaces where an agent identification card is not required for access, if so how? (Important)

79 Original text: Will your security exceed the minimum requirements established by Rule in regard to interior nonpublic spaces, if so how?

Read as:Will your security exceed the minimum requirements established by Rule in regard to interior nonpublic spaces where an agent identification card is required for access, if so how? (Important)

80 Will your security exceed the minimum requirements established by Rule in regard to marijuana containment, if so how? (Important)

81 Will your security exceed the minimum requirements established by Rule in regard to surveillance, if so how? (Important)

82 Describe the methods of screening and monitoring employees. (Critically Important)

83 Describe the methods of maintaining chain of custody, including training. (Critically Important)

84 Will the facility utilize security signage to warn of trespassing, searches, and badge requirements? (Slightly Important)

85 Will the facility have a procedure for notification of lost access cards, termination of lost card access and subsequent reissuance? (Slightly Important)

Advisory Committee on Site Security

By Brandon Dunn

Tuesday morning, the Advisory Committee on Experience in a Legal Cannabis Market met to discuss three questions from the Facility License Application Questions Draft.

The committee, comprised of Bart Hawcroft, Hemp Extract Program Manager at Missouri Department of Agriculture and Tom Salow, Arizona Department of Health Services, met via conference call moderated by General Counsel Richard Moore to discuss questions 86-88.

Miren Klein & Tricia Blocher of the California Department of Public Health were listed as members of the committee, but did not attend.

Per public comment questions 87 and 88 were deleted and question 86 was amended to be inclusive of all three questions.

The new question reads as: Describe the experience, including the number of years, each principal officer or manager has in the legal cannabis market. Accepted as read. (Highly Important)

The original text for all three questions follows:

86 Explain the number of years and type of experience in a legal cannabis market each identified officer has. 87 Explain the number of years and type of experience in a legal cannabis market each identified manager has. 88 Does the ownership of the business have an ownership interest in a legal cannabis business in any other state?Original text from draft

The committee unanimously approved the changes.

Advisory Committee on Experience in a Legal Cannabis Market

By Brandon Dunn

Monday afternoon the Advisory Committee on Infused Product Manufacturing Facility Experience consisting of Eric Hueste, Chief of Bureau of Environmental Health Services for Department of Health and Senior Services, Dr. Chris Riley President of Riley and Rabel Consulting Services, Ray McCarty President of Associated Industries of Missouri, and General Counsel Richard Moore acting as moderator, met to discuss questions and weigh importance for questions 134-144.

Questions listed as corrected, amended, and approved below.

134 Describe your experience, including the experience of any retained contractor, consultant, or employee, in food, beverage, and nutraceutical manufacturing, including any relevant experience with medical marijuana. Critically Important

135 Will the facility consult with or hire a qualified chemist, pharmacist (with manufacturing or compounding experience), food scientist, or chemical engineer for consultation to establish their processes?  If yes and the individual(s) are known, provide the education and relevant experience of each individual. Important

136 Will the facility consult with or hire a qualified chemist, pharmacist (with manufacturing or compounding experience), food scientist, or chemical engineer for consultation after the processes are established?    If yes and the individual(s) are known, provide the education and relevant experience of each individual. Important

137 Describe your experience, including the experience of any retained contractor, consultant, or employee, with extraction of chemicals from plant materials. Critically Important

New Question Added Describe in detail the air-handling systems to ensure worker safety. Highly Important

138 In addition to testing, describe the systems you have implemented, or plan to implement, to ensure the consistency of the ingredients in the product, to ensure that a) all the ingredients listed on the label are present, and b) any percentages of ingredients listed on the label are accurate. Critically Important

139 Deleted – Original Text : Describe your experience related to recalls.

140 Describe the system you plan to implement to ensure unacceptable products released into the market are recalled.  Highly Important

141 Describe your plans for waste storage and destruction. Highly Important

142 Describe the system you plan to implement for handling flammable materials, explosive materials, and asphyxiates (such as carbon dioxide) to ensure worker safety and protection of the environment. Critically Important

143 Describe your experience, including the experience of any retained contractor, consultant, or employee, and plans for quality control and quality assurance of products. Critically Important

144 Deleted – Original Text : Has the applicant ever been subject to a civil monetary penalty, criminal prosecution, seizure, or injunction by the FDA for practices in food or beverage manufacturing?  (If yes, please list)

Advisory Committee on Infused Product Manufacturing Facility Experience

By Brandon Dunn

Monday morning, the Advisory Committee on Testing Facilities met at the Truman Building in Jefferson City to review license application questions and assign a degree of importance prior to finalization. The committee reviewed questions 95-116 on the Facility License Application Questions Draft agreeing unanimously on all.

The committee consisted of three members: Brian Lutmer, Program Manager of the Breath Alcohol Program at the Missouri State Public Health Lab; Alan Schaffer, Chemistry Unit Manager at the Missouri State Public Health Lab; Dr. Gary Clapp of Missouri Western State University Organic Chemistry; and, once again, Richard Moore, General Counsel for DHSS, acted as the moderator. Joe Troxell, though listed, was not included.

Moore explained that these questions had received no public feedback and had been kept nearly identical to the originals posted online.

95 Describe your experience testing marijuana, food, or drugs for toxins and/or potency. (Critically Important)

96 Describe your experience testing food or drugs in the healthcare industry (Highly important)

97 Provide your proposed policy and/or documentation as it relates to the standards defined in ISO 17025:2017 relating to impartiality (4.1) (Highly Important)

98 Provide your proposed policy and/or documentation as it relates to the standards defined in ISO 17025:2017 relating to confidentiality (4.2) (Highly Important)

99 Provide your proposed policy and/or documentation as it relates to the standards defined in ISO 17025:2017 relating to structural Requirements (5.0) (Highly Important)

100 Provide your proposed policy and/or documentation as it relates to the standards defined in ISO 17025:2017 relating to resource requirements (6.0) (Critically Important)

101 Provide your proposed policy and/or documentation as it relates to the standards defined in ISO 17025:2017 relating to personnel (6.2) (Critically Important)

102 Provide your proposed policy and/or documentation as it relates to the standards defined in ISO 17025:2017 relating to facilities and environmental conditions (6.3) (Highly Important)

103 Provide your proposed policy and/or documentation as it relates to the standards defined in ISO 17025:2017 relating to equipment (6.4) (Highly Important)

104 Provide your proposed policy and/or documentation as it relates to the standards defined in ISO 17025:2017 relating to metrological traceability (6.5) (Highly Important)

105 Provide your proposed policy and/or documentation as it relates to the standards defined in ISO 17025:2017 relating to externally provided products and services (6.6) (Highly Important)

106 Provide your proposed policy and/or documentation as it relates to the standards defined in ISO 17025:2017 relating to review of requests, tenders and contracts (7.1) (Important)

107 Provide your proposed policy and/or documentation as it relates to the standards defined in ISO 17025:2017 relating to selection, verification and validation of methods (7.2) (Critically Important)

108 Provide your proposed policy and/or documentation as it relates to the standards defined in ISO 17025:2017 relating to sampling (7.3) (Critically Important)

109 Provide your proposed policy and/or documentation as it relates to the standards defined in ISO 17025:2017 relating to handling of test or calibration items (7.4) (Highly Important)

By Brandon Dunn

 

Wednesday afternoon, the Advisory Committee on Background of Principal Officers or Managers  gathered to review questions 1-18 of the Facility License Application Questions Draft and discuss three newly suggested questions to be added. The panel tasked with this review consists of Rev. Tommie Pierson, Sr., Clay Goddard, and Kim Grinston of the Department of Insurance, Financial Institutions & Professional Registration. Rev. Pierson did not attend the committee meeting. The committee was once again asked to evaluate each question, give feedback, and assign a value of importance as slightly important, important, highly important, or critically important.

 

Question 1 – Original text: Submit evidence of the character of Principal Officer or Manager #1 – Letter of Recommendation. Amended to : Submit evidence (including but not limited to, letters of recommendation) of the character and veracity (truthfullness) of all principal officers and managers.  (Maximum of 3 documents per officer or manager.) Accepted as read (Important)

 

Questions 2-6  asking to “Submit evidence of the character of Principal Officer or Manager #2 – Letter of Recommendation” and “Submit evidence of the veracity (truthfulness) of Principal Officer or Manager #1 – Letter of Recommendation” for multiple entities were removed.

 

Question 7 received the same treatment – replacing the existing texts for 7-9 and combining them changing the original text : “Submit evidence of the qualifications and background (including, but not limited to, a resume or curriculum vitae) of Principal Officer or Manager #1”  and amending it  to : “Submit evidence (including, but not limited to, a resume or curriculum vitae) of the qualifications, background, and relevant experience of all principal officers and managers.  (Maximum of 3 documents per officer or manager.)” Accepted as amended. (Highly Important)

 

Question 10 which originally read, “Has any identified principal officer or manager operated and/or managed a business for five or more years? If yes, describe and list the legal business name, business address of each business and period of time at such businesses,” was deleted and replaced.

Describe how your previous business experience will contribute to the success of your medical marijuana business. List the legal business name and address of each business you operated or managed.  The question was accepted as read. (Critically Important)

 

11 Original text, “Describe how the principal officers and managers will reflect the community in which your business will be located,” amended to : “Describe how the background of the principal officers and managers will positively reflect or align with the community in which your business will be located,”  Question accepted as read – (Important)

 

12 Original text, “Does any principal officer or manager have any current outstanding tax liability?”

Question amended to read, “Does any principal officer or manager have any delinquency in the filing or payment of any state income tax, personal property tax, municipal tax, or real property tax, either individually or for a business of which the principal officer or manager has an ownership interest?”  Question accepted as read – (Highly Important)

 

13 Question amended to remove the word identified, original text reads,”Has any identified principal officer or manager been the subject of an action resulting in sanctions, disciplinary actions, civil monetary penalties, or fines being imposed relating to a registration, license, provisional license or any other authorization to cultivate, process, or dispense medical marijuana in any state? If “Yes”,

By Brandon Dunn

Monday afternoon, the Advisory Committee on Maintaining Competitiveness met for the first time in the capitol city. The committee reviewed only two questions approving one and removing one.

The committee, made up of Maggie Kost, Department of Economic Development; Joe Horner, agricultural economist for the University of Missouri Extension; and Kelly Dyer, Missouri Business Development Manager of Entrepreneurship and Business Development at the Missouri Chamber of Commerce and Industry; reviewed questions 93 and 94 from the Facility License Application Questions Draft.

Question 93, “Describe how the facility will contribute to maintaining competitiveness in the marijuana for medical use marketplace,” was approved and graded by the committee as highly important.

Question 94, which originally read as, “What advantages will your business have over potential competitors in the geographic area,” was removed as the committee members contended that there’s definitive evidence that an applicant would not know who else was applying in their area, let alone what their processes or model may be.

DHSS created 10 advisory committees to assist with rulemaking in different areas, the next meeting will be the Advisory Committee on Background of Principal Officers or Managers this Wednesday. All rules must be finalized and posted in forms with instructions by June 4.

Advisory Committee on Maintaining Competitiveness