Understanding CBD in Clinical Practice: Legal and Ethical ... · Clinical Practice: Legal and Ethical Considerations 1 Agenda •8:00-8:30 AM Registration •8:30-10:30AM The Legality

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Dr. Merrill Norton Pharm.D.,D.Ph.,ICCDP-D

Clinical Associate Professor

University of Georgia College of Pharmacy

[email protected]

Understanding CBD in Clinical Practice: Legal and

Ethical Considerations

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Agenda

• 8:00-8:30 AM Registration

• 8:30-10:30AM The Legality of CBD- A Confusing Dilemma

• 10:30-10:45AM Break

• 10:45AM-12 Noon. The Neuroscience of CBD vs THC• 12 Noon-1PM. Lunch

• 1:00- 2:30PM The Ethics of Selling CBD and the Current Market of CBD Products

• 2:30-2:45PM Break

• 2:45-3:45PM Ethical Solutions for Practitioners• 3:45-4:00PM Wrap Up / Questions and Answers

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Learning Objectives

• Participants will:

• 1.) Evaluate medical cannabinoid products and their beneficial potential to include ethical and legal considerations of CBD products in a clinical practice;

• 2.) Contrast the various legalization processes of medical cannabinoids in the US;

• 3.) Formulate the profile of adverse drug effects of CBD oils;

• 4.) Discuss updated prescribing models for medical cannabinoids in the US.

• 5.) Evaluate legal and ethical dilemma around the recommending, prescribing, or selling CBD products.

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Discussion Points

• Is CBD legal??? What are the possible consequences??• What about my malpractice

coverage?• Is CBD safe???• Where do I get my evidence-based

information on CBD?• What the adverse drug effects of

CBD?

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2nd Year Pharmacology Class Quiz

• What are the benefits of marijuana?

• Is marijuana a medicine (by FDA definition)?

• What are the pharmacokinetic and pharmacodynamic differences between THC and CBD?

• What are the appropriate doses for medical THC? CBD Oil? CBD edibles?

• Does marijuana have beneficial components to treat incurable chronic diseases? If so, please identify 3 evidence based articles.

• Should leaf marijuana be legalized? If so, how should marijuana be regulated?

• List 5 adverse drug effects of THC.• List 5 adverse drug effects of CBD.

• Should marijuana be a RX or OTC?

• At what age should some be allowed to purchase marijuana?• What penalties should be in place for illegal use of marijuana?

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NAS Report – released Jan 2017PURPOSE: To provide a comprehensive review of the current evidence regarding the health effects of using cannabis and cannabis-derived productsReport made 4 recommendations.1. Address Research Gaps;2. Improve Research Quality;3. Improve Surveillance Capacity;4. Address Research Barriers.Committee on the Health Effects of Marijuana: An Evidence Review and Research Agenda; Board on Population Health and Public Health Practice; Health and Medicine Division; National Academies of Sciences, Engineering, and Medicine

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The Legality of CBD:A Confusing Dilemma

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Medical Cannabis States 03/2020

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What Is the Legal Status of THC and CBD?• This is the current question among medical practitioners

(Physicians, Pharmacists, Nurses, etc.);

• 46 states have passed some form of legalization for the use of medical cannabinoids( THC and CBD);

• Some states allow THC/CBD only for specific medical conditions while other states allow only use of CBD based products to be used;

• All of these changes have occurred since 2013 and has created a medical dilemma:

• A patient population who are demanding the use of Medical cannabinoids for various chronic disease states vs. what do states do to improve healthcare in the state population.

• Thus the passage of multiple state laws to “legalize” the medical use of THC and CBD products.


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Federal Law Definitions

• Cannabinoid: Cannabinoids are the naturally-occurring, biologically active, chemical constituents in hemp and marijuana, both of which are varieties of cannabis. Examples include CBD, THC, and cannabinol. • CBD: cannabidiol (“CBD”) is a cannabinoid that is

chemically similar to THC, but does not have the same psychoactive effects. One CBD-based medication has federal approval for seizure treatment. Researchers continue to investigate whether CBD may also help individuals manage anxiety, insomnia, and chronic pain. • THC: delta-9-tetrahydrocannabinol (“THC”) is a

cannabinoid that is responsible for producing psychoactive effects.

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Total US Sales of CBD

• Source: Hemp Business Journal, The CBD Report: 2018 Industry Outlook, 2019 (New Frontier Data). All pharmaceutical channel sales are represented by the drug Epidiolex®.

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CBD Market in the United

States

• From an industry perspective, there are three markets for CBD: hemp-derived CBD, marijuana-derived CBD (currently a Schedule I controlled substance), and pharmaceutical CBD (currently only Epidiolex®). In 2018, CBD sales in the United States from all three markets were estimated at $534 million, according to the Hemp Business Journal .

• More than 1,000 companies produced and marketed CBD for the U.S. market. Compared to 2014, when total CBD sales were a reported $108 million, U.S. sales of CBD have risen fivefold.

• The Hemp Business Journal projects U.S. sales of CBD will exceed $1 billion in 2020 and reach nearly $2 billion in 2022, divided about evenly among the three markets.

• At the retail level, CBD is marketed in a range of foods and beverages, dietary supplements, and cosmetic and personal care products, some of which are now being sold by large retailers such as CVS Pharmacy and Walgreens.

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What Is the Legal Status of THC and

CBD?

• This is the current question among medical practitioners (Physicians, Pharmacists, Nurses, etc.);

• 46 states have passed some form of legalization for the use of medical cannabinoids( THC and CBD);

• Some states allow THC/CBD only for specific medical conditions while other states allow only use of CBD based products to be used;

• All of these changes have occurred since 2013 and has created a medical dilemma:

• A patient population who are demanding the use of Medical cannabinoids for various chronic disease states vs. what do states do to improve healthcare in the state population.

• Thus the passage of multiple state laws to “legalize” the medical use of THC and CBD products.

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DEA Schedule 1-5 Drugs • Examples of substances

listed in Schedule I:Marijuana (cannabis)• Heroin• LSD• Peyote (mescaline)• Methaqualone

(Quaalude)• 3,4-

methylenedioxymeth amphetamine (“ecstasy”)

• “bath salts”

• Schedule 2: Vicodin, Cocaine, Meth, OxyContin, Adderall

• Schedule 3: Tylenol with Codeine, Steroids, Ketamine, Testosterone

• Schedule 4: Xanax, Valium, Ativan, Ambien, Tramadol

• Schedule 5: Robitussin AC, Lomotil, Lyrica

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What Does Schedule I Really Mean

• Title 21 Code of Federal Regulations (C.F.R.) §§1308.11 through 1308.15.

• Schedule I Controlled Substances• Substances in this schedule have no currently

accepted medical use in the United States, a lack of accepted safety for use under medical supervision, and a high potential for abuse.

• Latest outcome of request for rescheduling cannabis from schedule I to schedule III, IV, or V

• On June 21, 2011, The DEA concluded that there is NO substantial evidence that cannabis should be removed from Schedule I. This was reiterated again in June 2017.

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But Wait..Read

the Fine Print….

• Under international treaties, cannabis, cannabis resin, and extracts and tinctures of cannabis are listed in Schedule I. The cannabis plant contains more than 100 cannabinoids. Among these are tetrahydrocannabinols (THC) and CBD. Material that contains THC and CBD extracted from the cannabis plant falls within the listing of extracts and tinctures of cannabis for purposes of the Single Convention. Thus, such material, which includes, among other things, a drug product containing CBD extracted from the cannabis plant, is a Schedule I drug under the Single Convention. OTC CBD Oils have not been approved for any medical use according to FDA guidelines, thus are regarded as Schedule I drugs.

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https://www.deadiversion.usdoj.gov/21cfr/cfr/2108cfrt.htm

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But What About CBD???

• Effective September 28, 2018.• With the issuance of this final order, the Acting

Administrator of the Drug Enforcement Administration places certain drug products that have been approved by the Food and Drug Administration (FDA) and which contain cannabidiol (CBD) in schedule V of the Controlled Substances Act (CSA). Specifically, this order places FDA-approved drugs that contain CBD derived from cannabis and no more than 0.1 percent tetrahydrocannabinols in schedule V. This action is required to satisfy the responsibility of the Acting Administrator under the CSA to place a drug in the schedule he deems most appropriate to carry out United States obligations under the Single Convention on Narcotic Drugs, 1961. Also consistent therewith, DEA is adding such drugs to the list of substances that may only be imported or exported pursuant to a permit.


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But Wait..Readthe Fine Print….

• Section 811(d)(1) is relevant here because, on June 25, 2018, the Food and Drug Administration (FDA) announced that it approved a drug that is subject to control under the Single Convention. Specifically, the FDA announced that it approved the drug Epidiolexfor the treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastautsyndrome and Dravet syndrome, in patients two years of age and older.

• Now that Epidiolex has been approved by the FDA, it has a currently accepted medical use in treatment in the United States for purposes of the CSA. Accordingly, Epidiolex no longer meets the criteria for placement in schedule I of the CSA.

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https://www.deadiversion.usdoj.gov/21cfr/21usc/811.htm

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Official DEA Approved Cannabidiol Drug

• Approved cannabidiol drugs. (1) A drug product in finished dosage formulation that has been approved by the U.S. Food and Drug Administration that contains cannabidiol (2-[1R-3-methyl-6R-(1-methylethenyl)-2-cyclohexen-1-yl]-5-pentyl-1,3-benzenediol) derived from cannabis and no more than 0.1 percent (w/w) residual tetrahydrocannabinols• Sec. 1308.15 Schedule V. Department of Justice,

Drug Enforcement Administration Rules; 21 CFR Parts 1308, 1312

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What Does This Legal Stuff Mean?

• In the US are physicians allowed to prescribed illegal (either by state or federal regulations) medications?

• What does the medical liability carriers required to cover malpractice?

• Under the current federal law, the only CDB product approved for use is Epidiolex per federal regulation;

• All other products are not approved and are considered Schedule I;

• More regulation will need to be needed to appropriately correct this misstep of the federal regulators.

• Please seek legal advise prior to prescribing any product other than Epidiolex.

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https://www.deadiversion.usdoj.gov/21cfr/cfr/1308/1308_15.htm

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What are the actual legal risks to physicians if recommending Medical Cannabis Therapy (MCT) as a treatment for their patients?

• Based on federal regulations, if a physician was to prescribe MCT it would constitute aiding and abetting the acquisition of marijuana, which could result in revocation of DEA licensure and even prison time. However, in states where medicinal cannabis is legal, doctors can write a recommendation for the plant, after determining and certifying that the patient suffers from one of the conditions that the state’s law deems to warrant medicinal cannabis. This recommendation “loophole” was upheld by the US Court of Appeals for the Ninth Circuit in Conant v. Walters, which decided that a physician’s discussion of the potential benefits of medicinal cannabis and making such recommendations constitute protected speech under the First Amendment. The court reasoned that doctors should not be held liable for conduct that patients might engage in after leaving the office and that open and unrestricted communication is vital in preserving the patient-doctor relationship and ensuring proper treatment[ii],[iii],[iv].

• [ii]Gregorio, J. Physicians, Medical Marijuana, and the Law. AMA Journal of Ethics. Sept. 2014.

• [iii]Garvey, T., Doyle, C. and Carpenter, D.H., Marijuana: Medical and Retail –Selected Legal Issues. Congressional Research Service. April 8, 2015. 7-5700.

• [iv]Conant v Walter, 309 F3d 629, 636 (9th Cir 2002)


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The FDA Has Provided Approved Medical Cannabinoid Medications for Prescribers

• CBD Products• Epidiolex- CBD Oil• THC Products• Cesamet (Nabilone) Capsules• Marinol (Dronabinol) Tablets, Capsules• Syndros (Dronabinol) Oil Extract• Combination CBD/THC Products• Sativex (Awaiting FDA approval) Buccal Spray

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applewebdata://7181A146-D698-4469-9BE0-925B7A14EF88/





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Agricultural Laws: The Farming of CBD

HEMP REGULATIONS FEDERAL

GOVERNMENT

HEMP REGULATION STATE GOVERNMENT

USDA RULES AND REGULATIONS

APPROVED HEMP VARIETIES (STATE

APPROVAL)

THE FARM BILL 2018 PROCESSION REGULATIONS

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Distribution of CBD Products ?????

• Most of these laws also limit who or what entity may distribute the marijuana product.

• For example, Kentucky 2014 Acts, Ch. 112 (Ky. SB 124) precludes the distribution of cannabidiol except by a physician or hospital or associated clinic affiliated with a public university,

• the Alabama Act prohibits the distribution of CBD oil except by the Department of Neurology at the University of Alabama at Birmingham, and

• the Mississippi law only authorizes the use of CBD oil that is obtained from or tested by the National Center for Natural Products Research at the University of Mississippi and dispensed by the Department of Pharmacy Services at the University of Mississippi Medical Center. Unlike states that couple distribution with state universities,

• the Florida law provides for the creation of one to four regional distributors of low-THC cannabis for medical purposes.

• The Missouri law creates cannabidiol oil care centers and cultivation and production facilities to oversee distribution of the oil.

• The 2013 Wisconsin Act 267 (Wisc. AB 726) allows a pharmacy or physician to dispense cannibidiol in a form without a psychoactive effect as a treatment for a seizure disorder.

• Iowa 2014 Acts, Ch. 1125 (Ia. SF 2360) and North Carolina Session Law 2014-53 (N.C. HB 1220) are silent as to who or what entity is responsible for distribution of the marijuana product.

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CBD Shipping 101: Can You Ship CBD and Who Will Ship It?

The CBD you ship must have THC levels below 0.3%, and you must be able to verify in writing the CBD and THC levels of the products you are shipping.

The CBD you sell should come from (extracted from) hemp plants, not marijuana. Talk to an attorney if your CBD comes from synthetic sources, but the THC level must still be below 0.3%. If you’re working with any partners, like a supplier, you’ll need to keep close tabs to make sure that the products consistently hit this standard.

Whether you use a CBD supplier or grow it yourself, any CBD product must come from a licensed grower. In other words, you can’t just ship your uncle’s experimental cannabis plants he grew in his shed. You may be able to legally import into the U.S. a CBD product, but you should consult an attorney.

Both you and your supplier can face legal challenges and risk getting arrested or shut down for selling illegal products. Being a licensed grower means a state government official has oversight over the production of the hemp crop.

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You are a considered a “compliant” CBD business if you:

Have all required licenses — including a grower, processor, or retail license,

Only sell CBD products containing less than 0.3% THC,

Only source from growers operating a legitimate, licensed business,

Have a third-party testing process, and

Have documented results from this testing.

If you meet all of these requirements, you should be able to ship CBD to locations where it’s legal

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If you can’t 100% prove that you have met all the prerequisite requirements above, you have a good chance of violating the terms and agreements of the approved carriers below.

If you attempt to ship CBD with a THC level greater than 0.3%, you may face consequences, including arrest, for sending illegal substances through the mail. At the very least, your products can be destroyed in transit upon discovery.

Shipping Carriers: UPS

USPS allows you to ship CBD if you have signed a self-certification statement that helps ensure you are selling legal CBD, that your CBD supplier uses only hemp plants and has a license, and that your CBD is derived from industrial hemp with no more than 0.3% THC concentration. You also have to maintain the supporting documentation for at least two years after the date of mailing.

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UPS

To ship CBD with UPS, you must be able to identify where the raw materials grew, how they were processed, and how they were obtained (or who shipped the product to the supplier and how that supplier got it to the customer after the fact).

DHL

DHL can ship CBD products as long as the shipper meets these requirements:

The shipment contains hemp or hemp-based products that contain less than 0.3% of THC on a dry weight basis.

The shipper complies with all applicable federal, state, and local laws.

The shipper retains records establishing compliance with such laws, including laboratory test results, licenses, or compliance reports.

The packaging does not contain any branding or labeling that indicates the content of the item.

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https://cannabusiness.law/usps-issues-guidelines-for-mailing-cbd/

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Checklist for Finding a High Quality CBD and Hemp Oil Product

• 1.) Does it meet the following quality standards?• Current Good Manufacturing Practices Certification(CGMP) from

FDA;• EU, AUS, or CAN organic certification;• National Science Foundation International certification.• 2.) Does the company have an independent review adverse event

reporting program?• 3.) Is the product certified organic or ecofarmed?• 4.) Have the company’s products been lab tested to confirm THC

levels( <0.3% and no pesticides or heavy metals).


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The Neuroscience of CBD vs THC

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What Do Behavioral Health Professionals Need To Know About Medical Cannabinoids

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Varieties of Cannabinoids

Endocannabinoids Phytocannabinoids Syntheticcannabinoids

In your brain and body In plants From the lab

Anandamide, 2-AG, Noladin ether etc.

THC, CBD, CBG, CBDV, THCV, CBC, CBN, THCVA

etc.

Nabilone, HU-210, AB-PINACA, JWH-018,

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Brain regions that express the CB1 cannabinoid receptor

Red = abundant CB1 receptor expression Black = moderately abundant CB1 receptor expression

Adapted from Joy JE et al, eds. Marijuana and Medicine. 1999.7/3/20 33

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CB2 Receptors: immune system modulators

• CB2 receptors found in spleen, tonsils, thymus gland, bones, skin• Localized in monocytes, macrophages, B-cells and T-cells• Limited CB2 in brain, except in inflammatory states (microglia)

• Stimulation of CB2 can reduce inflammation and neuropathic pain

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Endocannabinoid System

Retrieved from marijuana.com Jul 7, 20177/3/20 35

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CBD and Endocannabinoids

• Universal body mechanism for homeostatic regulation

• Largest neurotransmitter system system in the body

• Regulates/Balances:

• ▪ Nerve Function (pain levels, anxiety levels, sleep, • seizure activity, nerve growth/repair, attention)

• ▪ Movement coordination

• ▪ Immune system activity • ▪ Inflammation (injury repair, swelling, pain)

• ▪ Energy Intake and Storage (appetite/metabolism)

• ▪ Cell life-cycles/apoptosis

• ▪ Reproduction (hormone levels, implantation) • ▪ Circulatory System (Blood pressure, pulse rate)

• ▪ Bone Metabolism (osteoclast activity)

• ▪ Mood/Reward signaling (Addiction Implications)

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Hemp vs Marijuana

• Both are considered Cannabis sativa but there is a distinction between hemp and marijuana.• Marijuana contains significant amounts of the

psychoactive phytocannabinoid known as THC. • Industrial Hemp is cultivated very differently and has very

little if any THC after extraction.• Cannabidiol (CBD) - the non-psychoactive component of

marijuana.• Hemp CBD products can technically come from either

cannabis plant – it just really boils down to being below that magic number of 0.1% of THC in the product.

• Hilderbrand R. L. (2018). Hemp & Cannabidiol: What is a Medicine?. Missouri medicine, 115(4), 306–309.

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PhytocannabinoidsMarijuana vs Hemp

• Tetrahydrocannabinol (THC)• Psychoactive • Has medicinal value

• Cannabidiol (CBD) • Not Psychoactive• Has anxiety relieving properties• Antagonizes effects of THC• Has medicinal value

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AVERAGE THC CONCENTRATIONS IN CANNABIS SEIZED BY DEA1980 TO 2014

1.24

3.3

2.363.04 3.08

3.87

4.9

6.11

8.148.76

9.75

12.311.84

0.28 0.41 0.55 0.51 0.46 0.28 0.17 0.150

2

4

6

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PERC

ENT

YEAR80 83 86 89 92 95 98 2001 2004 2007 2010 2013 2014

THC

CBD

ElSohly, et al. Biological Psychiatry 79:613 (2016) ElSohly, et al., Journ of Forensic Sci 45:24 (2000) 397/3/20

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Cannabinoid( Intoxicates?( Possible(Medicinal(Application(THC( √! Nausea!and!Vomiting,!Muscular!Spasms,!PTSD,!Pain,!Cancer,!Inflammation,!!

CBD( x! Epilepsy,!Psychosis,!Anxiety,!PTSD,!Addiction,!Dementia,!Cancer,!Insomnia!

CBDA( x! Epilepsy,!Nausea!and!Vomiting,!Cancer!

CBDV( x! Epilepsy!

THCA( x! Nausea!and!Vomiting,!Epilepsy!

THCV( x! Diabetes,!Obesity,!Pain,!Inflammation,!Epilepsy!

THCVA( x! Under!investigation!

CBG( x! Glaucoma,!Cancer,!Inflammation,!Anxiety,!Huntingdon’s!Disease!

CBGA( x! Under!investigation!

CBN( x! Anxiety,!Insomnia,!Epilepsy,!AntiHbacterial!effects!

CBC( x! Pain,!Inflammation,!Cancer!

!

Preclinical research identifies a range of possible therapeutic effects from phytocannabinoids

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Farming Act

• Hemp Farming Act of 2018 became law December 20, 2018 removing hemp (defined as cannabis with less than 0.1% THC) from Schedule I controlled substances and making it an ordinary agricultural commodity.

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Farm Bill passed but the FDA…

• Hemp (contains no more than 0.1% THC) has been removed from the Government’s Controlled Substance Acts.• However, the Food and Drug Administration

(FDA) has not approved CBD’s use in food or beverages.• The FDA controls the regulation of Cannabidiol

(CBD),NOT the Farm Bill.

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PubMed.gov

THC (Tetrahydrocannabinol)

• Psychoactive• Analgesic• Anti-inflammatory• Antioxidant• Anti-emetic • Euphoric• Anti-neoplastic• Anti-spasmodic• Anti-tremor • Appetite Stimulant

CBD (Cannabidiol)• Non-psychoactive• Analgesic• Anti-inflammatory• Antioxidant• Anti-emetic • Anxiolytic• Anti-psychotic• Anti-convulsant/spasmotic• Anti-epileptic• Immunomodulatory• Neuroprotective• Decrease THC psychoactivity

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CVS in the CBD business

• More than 800 stores in Alabama, California, Colorado, Illinois, Indiana, Kentucky, Maryland, and Tennessee now offer CBD products.

• “These products include topicals such as creams, sprays, roll-ons, lotions and salves. We are not selling any CBD-containing supplements or food additives. We have partnered with CBD product manufacturers that are complying with applicable laws and that meet CVS’s high standards for quality,” CVS statement.

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Psychoactive (Personal) vs Non-Psychoactive( Medical)

Cannabinoids

Delta-9-THC “PSYCHOACTIVE”

CBD “NOT PSYCHO ACTIVE”

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Endocannabinoids are the body’s endogenous cannabinoids.“The Bliss Molecules”

Anandamide (Sanskrit ananda inner bliss) is one endocannabinoid. It is found in chocolate (though there is some controversy over whether the small quantity has any effect on the body). It is about as potent as THC.

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Endocannabinoid System – Endogenous Messengers

• The are two major endogenous messengers that bind to the cannabinoid receptors:

• 2 AG (2-arachidonoylglycerol)

• anandamide (arachidonoylethanolamine or AEA)

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Effects of THC on the Brain

https://www.drugabuse.gov/publications/drugfacts/marijuana7/3/20 49

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Cell Destruction Occurs with both THC and CBD:The Result is Suppressed Immune Function

Rieder, S. A., Chauhan, A., Singh, U., Nagarkatti, M., & Nagarkatti, P. (2010). Cannabinoid-induced apoptosis in immune cells as a pathway to immunosuppression. Immunobiology, 215(8), 598–605. doi:10.1016/j.imbio.2009.04.001

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Impact of Addiction■ MARIJUANA:

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16 y.o.2 year history of daily abuse

underside surface view of prefrontal and temporal lobe activity© 2006 Amen Clinics Inc

Normal

124




Normal

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Normal

124




Normal

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Symptoms of Cannabis WithdrawalWithdrawal symptom % (n) subjects

reportingOnset after quitting (days) (mean [SD])

Peak intensity (mean [median])

Craving for cannabis 59.4% (228) 4.4 (0.9) 4.4 (5.0)Sleep difficulties 50.5% (194) 2.6 (4.9) 3.8 (4.0)

Insomnia 48.7% (187) 2.7 (5.0) 3.8 (4.0)

Feeling angry and/or aggressive and/or irritable 45.6% (175) 3.0 (5.5) 3.9 (4.0)

Feeling anxious, “nervous” 38.5% (148) 3.4 (6.5) 3.6 (3.0)

Change in appetite 36.4% (140) 3.7 (5.9) 3.9 (4.0)

Feeling sad, depressed 34.4% (132) 4.0 (6.7) 3.7 (4.0)

Feeling angry and/or aggressive 33.9% (130) 2.8 (5.4) 3.9 (4.0)Feeling irritable, “jumpy” 29.4% (113) 3.3 (6.1) 3.7 (4.0)

Feeling angry 28.9% (111) 3.1 (5.7) 3.9 (4.0)

Physical symptom 25.3% (97) 3.1 (5.0) 3.6 (4.0)

Feeling restless 21.9% (84) 2.8 (4.4) 3.7 (4.0)

Feeling aggressive 20.1% (77) 3.6 (5.6) 3.8 (4.0)

Weight loss and/or decreased appetite 20.8% (80) 4.9 (8.1) 3.5 (4.0)

Increased appetite 20.8% (80) 3.3 (6.1) 4.0 (4.0)

Decreased appetite 17.4% (67) 4.0 (7.3) 3.6 (4.0)

*Diagnostic criteria for cannabis withdrawal syndrome. Gorelick, D.A., et al (2012). Drug and alcohol dependence 123, 141-147.7/3/20 53

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Cannabis

Withdrawal Time Course

NSW Drug and Alcohol Withdrawal Clinical Practice Guidelines. Mental Health and Drug & Alcohol Office, NSW Department of Health, Australia 2008Time-course of the DSM-5 cannabis withdrawal symptoms in poly-substance abusers Hesse and Thylstrup BMC Psychiatry 2013, 13:258

Total Sum Withdrawal

Day

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Psychoactive (Personal) vs Non-Psychoactive( Medical)

Cannabinoids

Delta-9-THC “PSYCHOACTIVE”

CBD “NOT PSYCHO ACTIVE”

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CBD –Pharmacological Actions

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• Anti-seizure effects

Well Documented:

• Analgesic (acute and chronic pain)• Antipsychotic• Anxiolytic• Anti-cancer• Anti-inflammatory

Suggested:

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CBD Pharmacology

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CBD does act via the endocannabinoid system as usually defined.

It does not activate CB1 or CB2 receptors - or mimic 2AG, anandamide or any known endocannabinoid.

It may interact with the endocannabinoid system indirectly, e.g. antagonizes CBD1 receptors and inhibits FAAH (?).

What receptors does it bind to?

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CBD –Receptors?

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A very confused field. It has been reported to act on:

CBD does NOT act on the CB1 or CB2 rceptors

Instead it acts on the following:

• 5 HT 1A – partial agonist (anxiolytic? antidepressant?)• Adenosine receptors – agonist (anxiolytic?) • TRPV1 - weak agonist, desensitizes (analgesia?)• Mu and delta opiate receptors – allosteric modulator

(analgesic?)• PPAR – agonist (anticancer?)• GPR55 – antagonist (effect?)• ETC, ETC

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The Ethics of Selling CBD and the Current Market of CBD Products

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CBD- Is It Safe to take????

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BUYER BEWARE!!!!!!

BTW a 2OZ bottle of pure CBD oilwill cost more than the $24.95.

It is an expensive extraction process!!!!

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Costs of Production and Extraction of CBD

Cultivation Costs: $5,000 per acre

Following decortication, the extraction is conducted to access the cannabinoids, flavonoids, terpenes, etc. Two of the most popular ways that extraction occurs include CO2 and ethanol. A CO2 extraction machine is estimated to cost between $135,000 and $150,000.

Costs of example products: $59.99-187.99 per 30 ml

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New Products for 2020

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Edibles

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Edibles and The Law

• Can THC or CBD products be sold as dietary supplements?

• A. No. Based on available evidence, FDA has concluded that THC and CBD products are excluded from the dietary supplement definition under section 201(ff)(3)(B) of the FD&C Act [21 U.S.C. § 321(ff)(3)(B)]. Under that provision, if a substance (such as THC or CBD) is an active ingredient in a drug product that has been approved under section 505 of the FD&C Act [21 U.S.C. § 355], or has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, then products containing that substance are excluded from the definition of a dietary supplement.

• There is an exception to section 201(ff)(3)(B) if the substance was "marketed as" a dietary supplement or as a conventional food before the drug was approved or before the new drug investigations were authorized, as applicable. However, based on available evidence, FDA has concluded that this is not the case for THC or CBD.

• Ingredients that are derived from parts of the cannabis plant that do not contain THC or CBD might fall outside the scope of this exclusion, and therefore might be able to be marketed as dietary supplements.

• https://www.fda.gov/news-events/public-health-focus/fda-regulation-cannabis-and-cannabis-derived-products-including-cannabidiol-cbd#dietarysupplements

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Concerns about CBD Safe Products

• High dose side effects:

• Tiredness

• Decreased appetite

• Gastrointestinal problems• Altered liver enzymes (see following section for more on

liver enzymes)

• Other issues include:

• Pesticides and heavy metals from bad farming practices

• High levels of THC (more than desired)• Synthetic cannabinoids

• Any kind of contaminants (mold, bacteria, rancidity, etc)

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Concerns about CBD Safe Products

Drug to Drug Interactions:

HIV medications

Warfarin

Anticonvulsants

Chemotherapy

Liver Disease : elevated liver enzymes

Low Blood Pressure: othostatic hypotension, increased risk of falls

Conception: Lower fertility rates

Pregnancy and Breastfeeding; Passes to the placenta to unborn fetus

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The FDA Safety Warnings• CBD has the potential to harm you, and harm can happen even before you become aware of it.

• CBD can cause liver injury.• CBD can affect the metabolism of other drugs, causing serious side effects.• Use of CBD with alcohol or other Central Nervous System depressants increases the risk of sedation and

drowsiness, which can lead to injuries.• CBD can cause side effects that you might notice. These side effects should improve when CBD is

stopped or when the amount ingested is reduced.• Changes in alertness, most commonly experienced as somnolence (drowsiness or sleepiness).• Gastrointestinal distress, most commonly experienced as diarrhea and/or decreased appetite.• Changes in mood, most commonly experienced as irritability and agitation.

• There are many important aspects about CBD that we just don’t know, such as:• What happens if you take CBD daily for sustained periods of time?• What is the effect of CBD on the developing brain (such as children who take CBD)?• What are the effects of CBD on the developing fetus or breastfed newborn?• How does CBD interact with herbs and botanicals?• Does CBD cause male reproductive toxicity in humans, as has been reported in studies of animals?

• It will take time to discover these answers and others that will arise-so buyer be aware!!!

• https://www.fda.gov/news-events/public-health-focus/fda-regulation-cannabis-and-cannabis-derived-products-including-cannabidiol-cbd7/3/20 68

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Ethical Solutions for Practitioners

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Issues To Be Considered About Client Care and CBD

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1. MALPRACTICE; 2. SCOPE OF PRACTICE; 3. EDUCATION OF PRACTITIONER;

4. FEDERAL REGULATIONS;

5. STATE REGULATIONS;

6. PROFESSIONAL LIMITATIONS OF

CREDENTIALING BODIES;

7. CONFLICTS OF INTEREST: PERSONAL

OWNERSHIP AND USE;

8. LIABILITY OF SALES.

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Malpractice

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Malpractice Considerations

• A counselor’s client brings a CBD product into the office to discuss about if the product is a relapse risk?• What does the counselor need to do?• The counselor makes the determination that the CBD product is safe for

the client to take during their aftercare period.• After six months, the client has a serious reaction to the product that has

physical consequences.• Is the counselor liable and does their malpractice cover the liability?

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Malpractice

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The cannabis industry is evolving and expanding as more states legalize either or both medicinal and recreational cannabis use throughout the U.S. With new entrepreneurs, investors, large corporate businesses, companies going public and executives entering the market, there is a new level of sophistication to the cannabis industry. The state legalized cannabis businesses, like any other businesses, face a variety of risks and would like to have access to insurance to mitigate these risks.

REGULATORY GUIDE UNDERSTANDING THE MARKET FOR CANNABIS INSURANCE NAIC White Paper July 9, 2019 Drafted by the Cannabis Insurance (C) Working Group of the Property and Casualty Insurance (C) Committee.

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Malpractice

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One of the most complex issues facing the cannabis industry is the different treatment of cannabis under federal and state law in states that have legalized cannabis. Despite being legal in many states, at the federal level, cannabis is a Schedule 1 substance that is illegal to manufacture, distribute or sell in the U.S.

New and innovative insurance products for which there is no loss history are difficult, if not impossible, to appropriately price using common actuarial methods. Often, after a new coverage has generated sufficient data, the coverage eventually becomes a standard product in the admitted market.” Despite the risks, state insurance regulators should encourage insurers who choose to enter the cannabis market to do so on the admitted market to drive the costs of policies down and make cannabis insurance more accessible for the cannabis industry.

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Insurance Gaps In Cannabis Industry

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• Automobile, including

Distribution (auto and cargo)

• Commercial General Liability

• Crop (Indoor/Outdoor) • Crime Insurance • Disaster

Coverage• Director and Officer Liability

• Employment Practices Liability

• Equipment Breakdown

• Errors and Omissions • Excess/Umbrella • General Liability • Product Liability

• Premises Liability • Property • Surety Bonds • Workers’

Compensation

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Federal Criminal Laws

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Cannabis’ prohibited status triggers three main federal criminal laws when individuals engage in transactions involving cannabis or proceeds from cannabis:

1.) the Federal Bank Secrecy Act (BSA),26 requires financial institutions to report to the Treasury Department any transactions over $5,000 that the institution knows, or has reason to know, involve assets derived from illegal sources;

2.) Federal statute implicated in transactions involving cannabis is the money laundering statute;

3.) Federal statute implicated by cannabis transactions is the unlicensed money transmitter statute.4.) The Federal has been inconsistent with enforcement of these laws in legalized states due to the Cole Memorandum, which indicates to exercise discretion in its enforcement in legalized jurisdictions.5.) Insurers have no assurance that the Attorney General’s comments extend to financial institutions engaging with cannabis businesses, nor, is there any guarantee that this policy extends beyond the tenure of the Attorney General who made the statement. Insurers must assess a business risk decision, including legal risks and financial implications, about whether they will provide services to the cannabis industry. 6.) The U.S. Supreme Court, in its landmark 2005 Gonzales v. Raich opinion, reaffirmed the supremacy of the CSA over state legalization statutes.Since the Gonzales decision, the judiciary has upheld criminal prosecutions involving cannabis transactions, even where legalized at the state level. To date, the Supreme Court has not expressed a willingness to revisit the Gonzales decision. Similarly, lower federal courts have shown a reluctance to address the issue of state legalized cannabis.

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How Does These Laws Impact Malpractice?

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1.) McCarron-Ferguson Act precludes federal law (CSA) from state law regarding the business of insurance unless the federal law specifically relates to the business of insurance.

2.) Many traditional medical professional liability policies may exclude liability for “recommended” prescription of controlled substances. Accordingly, practitioners who prescribe or recommend medical cannabis to patients may seek special coverage limited to liability losses arising from prescription, recommendation or failure to prescribe or recommend medical cannabis. Coverage limits for such policies resemble those of traditional medical professional liability policies; the base limit is often $1 million peroccurrence/$3 million annual aggregate.

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Scope of Practice

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Who Can Recommend CBD Products Within Their Scope of Practices

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• Physicians• Pharmacists (Limited)• Psychologists?????• Counselors (LPC, LCSW, LMFT)?????• Addiction Counselors( CAC, CDAC,

MAC)?????

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Does Your Scope of Practice Include Counseling on CBD Products: Licensed Alcohol and Drug Abuse

Counselor?

• Nothing in this chapter shall be construed as permitting an individual licensed as a Licensed Alcohol and Drug Abuse Counselor to administer, dispense, or prescribe drugs or in any manner engage in the practice of medicine as defined by Tennessee Law. • RULES GOVERNING LICENSURE OF ALCOHOL AND DRUG ABUSE

COUNSELORS• CHAPTER 1200-30-01, May 2017

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Does Your Scope of Practice Include Counseling on CBD Products: Licensed Professional Counselors, Martial and Family Therapists, and Clinical Pastoral Therapists

• Nothing in these rules shall be construed as permitting individuals registered with the board to administer or prescribe drugs or in any manner engage in the practice of medicine as defined by Tennessee law. • CHAPTER 0450-01 GENERAL RULES GOVERNING

PROFESSIONAL COUNSELORS Revised April 2020• CHAPTER 0450-02 GENERAL RULES GOVERNING

MARITAL AND FAMILY THERAPISTS Revised April 2020

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Education of Practitioner

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2nd Year Pharmacology Class Quiz

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What are the benefits of marijuana?

Is marijuana a medicine (by FDA definition)?

What are the pharmacokinetic and

pharmacodynamic differences between THC

and CBD?

What are the appropriate doses for medical THC? CBD Oil? CBD edibles?

Does marijuana have beneficial components to

treat incurable chronic diseases? If so, please

identify 3 evidence based articles.

Should leaf marijuana be legalized? If so, how should

marijuana be regulated?

List 5 adverse drug effects of THC.

List 5 adverse drug effects of CBD.

Should marijuana be a RX or OTC?

At what age should some be allowed to purchase

marijuana?

What penalties should be in place for illegal use of

marijuana?

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Do Healthcare Practitioners Feel Competent With CBD Information?

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Be Aware That Most CE Courses Are From the Marijuana Industry

• Buyer Beware!!!!

• “It is a kind of a new snake oil in the sense that there are a lot of claims and not so much evidence,” said one expert.

• Product Information Report: “Indeed, a recent study that evaluated dozens of CBD products ordered online found that nearly 70 percent were not labeled accurately and had either higher or lower concentrations of the ingredient than indicated on the label. Some also contained THC.”

• Bonn-Miller,MO,et al.Labeling Accuracy of Cannabidiol Extracts Sold Online, JAMA.2017 Nov 7;318(17): 1708-1709.

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https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5818782/

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But Where Do I Go For Appropriate Info on CBD

• Degree Programs• University of Maryland School of Pharmacy• https://learn.pharmacy.umaryland.edu/masters-plant-medical-

2020/?gclid=Cj0KCQjwpLfzBRCRARIsAHuj6qWBElXCUfPP07fAlp4ojM8sol1z9dHfdz7C4SEnUdNUwt1D1xgK-YAaAmVdEALw_wcB• CE Nursing• https://www.pedagogyeducation.com/Class-Catalog/General/CBD-101-An-

Introductory-Course.aspx• Example of State Education Programs• Georgia • https://www.hempstaff.com/cannabis-training-for-dispensary-jobs/georgia• New York

https://www.health.ny.gov/regulations/medical_marijuana/practitioner/7/3/20 87

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Federal Regulations

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https://learn.pharmacy.umaryland.edu/masters-plant-medical-2020/%3Fgclid=Cj0KCQjwpLfzBRCRARIsAHuj6qWBElXCUfPP07fAlp4ojM8sol1z9dHfdz7C4SEnUdNUwt1D1xgK-YAaAmVdEALw_wcB

https://www.pedagogyeducation.com/Class-Catalog/General/CBD-101-An-Introductory-Course.aspx

https://www.hempstaff.com/cannabis-training-for-dispensary-jobs/georgia

https://www.health.ny.gov/regulations/medical_marijuana/practitioner/

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How Does the 2018 Farm Bill Define Hemp? What Does It Mean for FDA-Regulated Products?

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At the federal level, the Agriculture Improvement Act of 2018, Pub. L. 115-334, (the 2018 Farm Bill) was signed into law on

Dec. 20, 2018. Among other things, this new law changes certain federal authorities

relating to the production and marketing of hemp, defined as "the plant Cannabis sativa L. and any part of that plant, including the seeds thereof and all derivatives, extracts,

cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol concentration

of not more than 0.3 percent on a dry weight basis.”

The 2018 Farm Bill, however, explicitly preserved FDA’s authority to regulate

products containing cannabis or cannabis-derived compounds under the FD&C Act and section 351 of the Public Health Service Act (PHS Act). FDA treats products containing

cannabis or cannabis-derived compounds as it does any other FDA-regulated products —

meaning they’re subject to the same authorities and requirements as FDA-

regulated products containing any other substance. This is true regardless of whether

the cannabis or cannabis-derived compounds are classified as hemp under the

2018 Farm Bill.

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Has FDA Approved Any Medical Products Containing Cannabis Or Cannabis-Derived Compounds Such As CBD?

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To date, the agency has not approved a marketing application for cannabis for the treatment of any disease or condition. FDA has, however, approved one cannabis-derived and three cannabis-related drug products. These approved products are only available with a prescription from a licensed healthcare provider.

FDA has approved Epidiolex, which contains a purified form of the drug substance CBD for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients 2 years of age and older. That means FDA has concluded that this particular drug product is safe and effective for its intended use.

The agency also has approved Marinol and Syndros for therapeutic uses in the United States, including for the treatment of anorexia associated with weight loss in AIDS patients. Marinol and Syndros include the active ingredient dronabinol, a synthetic delta-9- tetrahydrocannabinol (THC) which is considered the psychoactive component of cannabis. Another FDA-approved drug, Cesamet, contains the active ingredient nabilone, which has a chemical structure similar to THC and is synthetically derived.

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https://www.fda.gov/news-events/press-announcements/fda-approves-first-drug-comprised-active-ingredient-derived-marijuana-treat-rare-severe-forms

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Aside from Epidiolex, are there other CBD drug products that are FDA-approved? What about the products I’ve seen in stores or online?

• No. There are no other FDA-approved drug products that contain CBD. We are aware that some firms are marketing CBD products to treat diseases or for other therapeutic uses , and we have issued several warning letters to such firms. Under the FD&C Act, any product intended to have a therapeutic or medical use, and any product (other than a food) that is intended to affect the structure or function of the body of humans or animals, is a drug. Drugs must generally either receive premarket approval by FDA through the New Drug Application (NDA) process or conform to a "monograph" for a particular drug category, as established by FDA's Over-the-Counter (OTC) Drug Review. CBD was not an ingredient considered under the OTC drug review. An unapproved new drug cannot be distributed or sold in interstate commerce.

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Why hasn’t FDA approved more products containing cannabis or cannabis-derived compounds for medical uses?

• FDA is aware that unapproved cannabis or cannabis-derived products are being used for the treatment of a number of medical conditions including, for example, AIDS wasting, epilepsy, neuropathic pain, spasticity associated with multiple sclerosis, and cancer and chemotherapy-induced nausea.

• To date, FDA has not approved a marketing application for cannabis for the treatment of any disease or condition and thus has not determined that cannabis is safe and effective for any particular disease or condition. The agency has, however, approved one cannabis-derived and three cannabis-related drug products.

• The study of cannabis and cannabis-derived compounds in clinical trial settings is needed to assess the safety and effectiveness of these substances for the treatment of any disease or condition. FDA’s December 2016 Guidance for Industry: Botanical Drug Development provides specific recommendations on submitting INDs for botanical drug products, such as those derived from cannabis, in support of future marketing applications for these products.

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https://www.fda.gov/news-events/public-health-focus/warning-letters-and-test-results-cannabidiol-related-products

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/botanical-drug-development-guidance-industry

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Has the agency received any adverse event reports associated with cannabis use for medical conditions?

• The agency has received reports of adverse events in patients using cannabis or cannabis-derived products to treat medical conditions. The FDA reviews such reports and will continue to monitor adverse event reports for any safety signals, with a focus on serious adverse effects.• Information from adverse event reports regarding cannabis use is extremely

limited; FDA primarily receives adverse event reports for approved products. General information on the potential adverse effects of using cannabis and its constituents can come from clinical trials that have been published, as well as from spontaneously reported adverse events sent to the FDA. Additional information about the safety and effectiveness of cannabis and its constituents is needed. Clinical trials of cannabis conducted under an IND application could collect this important information as a part of the drug development process.

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Is it legal for me to sell CBD products?

• It depends, among other things, on the intended use of the product and how it is labeled and marketed. Even if a CBD product meets the definition of "hemp" under the 2018 Farm Bill, it still must comply with all other applicable laws, including the FD&C Act. The below questions and answers explain some of the ways that specific parts of the FD&C Act can affect the legality of CBD products.• We are aware that state and local authorities are fielding numerous

questions about the legality of CBD. There is ongoing communication with state and local officials to answer questions about requirements under the FD&C Act, to better understand the landscape at the state level, and to otherwise engage with state/local regulatory partners.

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Can THC or CBD products be sold as dietary supplements?

• No. Based on available evidence, FDA has concluded that THC and CBD products are excluded from the dietary supplement definition under section 201(ff)(3)(B) of the FD&C Act [21 U.S.C. § 321(ff)(3)(B)]. Under that provision, if a substance (such as THC or CBD) is an active ingredient in a drug product that has been approved under section 505 of the FD&C Act [21 U.S.C. § 355], or has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, then products containing that substance are excluded from the definition of a dietary supplement. FDA considers a substance to be "authorized for investigation as a new drug" if it is the subject of an Investigational New Drug application (IND) that has gone into effect. Under FDA’s regulations (21 CFR 312.2), unless a clinical investigation meets the limited criteria in that regulation, an IND is required for all clinical investigations of products that are subject to section 505 of the FD&C Act.

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Many Other Questions Concerning Federal Laws and CBD

• Answers are located at:• https://www.fda.gov/news-

events/public-health-focus/fda-regulation-cannabis-and-cannabis-derived-products-including-cannabidiol-cbd#farmbill

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https://www.fda.gov/news-events/public-health-focus/fda-regulation-cannabis-and-cannabis-derived-products-including-cannabidiol-cbd

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State Regulations

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Tennessee CBD Regulations

• All Tennessee hemp is required to meet the state standard of containing .3% or less of THC.

• All purchases of hemp-derived CBD products must have a lab report or verification that the product they are purchasing contains less than .3% of THC. Hemp flower products must be sold in a sealed container.

• Under the law, licensed physicians can recommend cannabis oil that contains less than 0.9% THC, but only to treat severe seizure disorders. In Tennessee, cannabis must be produced and manufactured by a university in as part of an approved clinical trial

• In Tennessee, CBD products are only legal with a prescription from a regulated pharmacy.

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• The medical criteria to qualify for medical cannabis are as follows:

• Must be a resident of the state

• Must be diagnosed with an intractable form of epilepsy• Must be enrolled in an state-approved research study

• Must be under the care of a licensed medical marijuana doctor or a hospital affiliated with a school of medicine

• Must not possess any form of CBD product with THC content higher than 0.9%

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• In 2016, Senate Bill 2125 was signed into law. This bill amended the marijuana laws in Tennessee to exclude any cannabis oil, including cannabis flower and seeds, containing less than .6% of THC from the legal definition of marijuana.

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https://publications.tnsosfiles.com/acts/109/pub/pc1083.pdf

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• Later in 2016, House Bill 1044 was signed into law, allowing cannabis with .9% of THC or lower to be manufactured, processed, dispensed, and possessed by patients referred to by a four-year public institution within the state as part of a clinical research study on antiseizure, anticancer, or other immunomodulatory properties of the plant. This bill is the closest Tennessee has to a legal medical marijuana system,and may be used as an affirmative defense in the event that a patient is arrested with cannabis containing .9% THC or less.

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• Tennessee's Department of Agriculture has laid out rules for hemp cultivators in light of the Hemp Farming Act, creating a system of licensing for hemp farmers, producers, and transporters. As of late 2019, there were more than 3,400 licensed hemp growers in Tennessee, ;]'[and the Tennessee Department of Agriculture is still accepting applications to become a licensed hemp grower. In order to transport hemp plants or products, a permit is required to be submitted by licensed growers at least three days in advance of making any movement.

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http://www.capitol.tn.gov/Bills/109/Bill/SB2125.pdf

https://www.tn.gov/agriculture/farms/hemp-industry.html

https://www.tn.gov/content/dam/tn/agriculture/documents/industrial-hemp/updated_hemp_application.pdf

https://agriculture.tn.gov/HempPermit/

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• CBD products containing less than .6% THC are legal for possession, and patients enrolled in a clinical study by a four-year college or university may possess CBD oil containing up to .9% THC, but there are no legal avenues to purchase any medical cannabis products, so certain products containing this amount of THC must be procured in another state. Possession of CBD oil without evidence that it was procured in another state is considered a Class C misdemeanor offense, punishable by a fine of up to $50, up to 30 days in jail, or both.

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• The possession of marijuana containing a higher amount of THC is considered illegal. However, both Nashville and Memphis have succeeded in decriminalizing the possession of small amounts of marijuana, treating it like a traffic ticket with a fine of $50, which may be waived by the court if the individual completes community service.

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• The possession of half an ounce of marijuana or less elsewhere in the state of Tennessee is considered a misdemeanor, with a fine of up to $250, and up to one year in jail. The possession of more than half an ounce of marijuana is still considered a misdemeanor offense, but the fine increases to $500, with up to one year in jail.

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• For those seeking hemp-derived CBD products containing less than .3% THC, there are plenty of options inside the state of Tennessee. In some larger cities such as Memphis and Nashville, there are shops that sell CBD products, including oils, tinctures, infused products, and topicals. Ordering CBD products online is always an option, as well, as there are many CBD companies that offer online ordering and shipping. However, it is important to do research to find a reputable company that sells high-quality products that have been tested for pesticides and potency, and that offer a lab report for all of the products available.

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Tennessee CBD Purchasing

• When purchasing hemp CBD products, one of the most important first steps to determine if this is a reputable source for high quality CBD is to examine the lab report and certificate of analysis, which is usually available on the label and packaging of the product. Most reputable hemp CBD companies will include the following information on the label:

• Amount of active CBD per serving

• Supplement Fact panel, including other ingredients

• Net weight

• Manufacturer or distributor name• Suggested use

• Whether the product is full-spectrum, broad-spectrum, or isolate

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• To qualify for the state’s medical marijuana laws and purchase CBD oil with up to 0.9 percent THC, patients must be diagnosed with an intractable seizure disorder such as epilepsy. They must also show that traditional treatments have been tried without success.

• According to Tennessee Dispensaries website over 50 medical disorders are being treated with CBD products.

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• Yes, Tennesseans are permitted to purchase CBD products online.

• If you’re a medical marijuana patient and you’re looking for CBD products containing more than the 0.3 percent THC limit, you’ll have to purchase your medicine from a state-licensed dispensary.

• No a person cannot grow hemp in their backyard in Tennessee. A license from the Department of Agriculture is required.

• Other than the usual business licenses, no specific license is required to sell CBD oil in Tennessee.

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Tennessee Regulations (Synopsis)• What conditions or diseases are covered by the law?• The law lists the following conditions and diseases which qualify for the Low THC Oil Registry:• Cancer, when such diagnosis is end stage or the treatment produces related wasting illness or recalcitrant nausea and vomiting• Amyotrophic lateral sclerosis, when such diagnosis is severe or end stage• Seizure disorders related to diagnosis of epilepsy or trauma related head injuries• Multiple sclerosis, when such diagnosis is severe or end stage• Crohn’s disease• Mitochondrial disease• Parkinson’s disease, when such diagnosis is sever or end stage• Sickle cell disease, when such diagnosis is severe or end stage• Tourette’s syndrome, when such syndrome is diagnosed as severe• Autism spectrum disorder, when (a) patient is 18 years of age or more, or (b) patient is less than 18 years of age and diagnosed with severe autism• Epidermolysis bullosa• Alzheimer’s disease, when such disease is severe or end stage• AIDS when such syndrome is severe or end stage• Peripheral neuropathy, when symptoms are severe or end stage• Patient is in hospice program, either as inpatient or outpatient• Intractable pain• Post-traumatic stress disorder resulting from direct exposure to or witnessing of a trauma for a patient who is at least 18 years of age

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Professional Limitations of Credentialing

Bodies

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CBD Production and Sales Remain a

Federal Crime Without FDA

Approval and a Doctor's

Prescription

• The law on CBD products is confusing, due to conflicts among local, state, federal, and international laws. Under the Supremacy Clause to the US Constitution, federal law controls to the extent it conflicts with state or local law. State law also controls to the extent it conflicts with city or county laws. Federal law in this area is moving, but it is not clear in what direction. Some predict the federal government will relinquish all regulation of CBDs and cannabis generally to the states, and keep a hands-off approach. Others expect the federal government to strictly regulate CBDs and cannabis as they do with prescription drugs through the FDA, leaving the states with little control.

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Bodies- CSA Violations

• Because of resource limitations, DOJ typically has not prosecuted individuals who possess marijuana for personal use on private property, but instead has “left such lower-level or localized marijuana activity to state and local authorities through enforcement of their own drug laws.” Moreover, in each budget cycle since FY2014 Congress has passed an appropriations rider preventing DOJ from using taxpayer funds to prevent the states from “implementing their own laws that authorize the use, distribution, possession, or cultivation of medical marijuana.” The current appropriations rider is in effect through November 21, 2019. Several courts have interpreted the appropriations rider to bar DOJ from expending any appropriated funds to prosecute activities involving marijuana that are conducted in “strict compliance” with state law. However, activities that fall outside the scope of state medical marijuana laws remain subject to prosecution. For example, in United States v. Evans, the Ninth Circuit upheld the prosecution of medical marijuana growers who smoked some of the marijuana they grew because the defendants failed to show they were “qualifying patients” who acted in strict compliance with state medical marijuana law.

• The Controlled Substances Act (CSA): A Legal Overview for the 116th Congress

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• Notwithstanding the appropriations rider, marijuana-related activity may still give rise to serious legal consequences under federal law. DOJ issued guidance in 2018 reaffirming the authority of federal prosecutors to exercise prosecutorial discretion to target federal marijuana offenses “in accordance with all applicable laws, regulations, and appropriations.” Furthermore, regardless whether they are subject to criminal prosecution, participants in the cannabis industry may face numerous collateral consequences arising from the federal prohibition of marijuana because other federal laws impose noncriminal consequences based on criminal activity, including violations for the CSA. For example, cannabis businesses that are legal under state law may be unable to access banking services due to federal anti-money laundering laws, and those businesses may be ineligible for certain federal tax deductions.


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• Removing marijuana from the coverage of the CSA could, however, raise new legal issues. For instance, by default, the repeal of federal criminal prohibitions rarely applies retroactively. As a result, if Congress were to remove marijuana from the CSA, it might want to consider how to address past criminal convictions related to marijuana and whether to take any action to mitigate the effects of past convictions. In addition, Congress would not be precluded from regulating marijuana in other ways if it were to remove the drug from the ambit of the CSA. For instance, legislation has been introduced that would impose new federal regulations on marijuana akin to those applicable to alcohol and cigarettes. • The Controlled Substances Act (CSA): A

Legal Overview for the 116th Congress

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• In addition, descheduling marijuana would not, standing alone, alter the status of the substance under the FD&C Act and, thus, would not bring the existing cannabis industry into compliance with federal law. FDA has explained that it “treat[s] products containing cannabis or cannabis- derived compounds as [it does] any other FDA-regulated products,” and that it is “unlawful under the FD&C Act to introduce food containing added CBD or THC into interstate commerce, or to market CBD or THC products as, or in, dietary supplements, regardless of whether the substances are hemp-derived.” FDA is currently engaged in “consideration of a framework for the lawful marketing of appropriate cannabis and cannabis-derived products under our existing authorities.” Congress could also pass legislation to alter FDA regulation of cannabis-based products. For example, the Legitimate Use of Medicinal Marihuana Act would provide that neither the CSA nor the FD&C Act “shall prohibit or otherwise restrict” certain activities related to medical marijuana that are legal under state law.


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• TITLE 16. CRIMES AND OFFENSES CHAPTER 13. CONTROLLED SUBSTANCES ARTICLE 1. GENERAL PROVISIONS

• Georgia CSA Law Concerning Marijuana:• The controlled substances listed in this Code

section are included in Schedule I: • Tetrahydrocannabinols which shall include, but are

not limited to: • (i) All synthetic or naturally produced samples

containing more than 15 percent by weight of tetrahydrocannabinols; and

• (ii) All synthetic or naturally produced tetrahydrocannabinol samples which do not contain plant material exhibiting the external morphological features of the plant cannabis.

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• Penalties of violation of Georgia CSA:• Any person who violates subsection (a) of this Code section with

respect to a controlled substance in Schedule II, other than a narcotic drug, shall be guilty of a felony and, upon conviction thereof, shall be punished as follows: (1) If the aggregate weight, including any mixture, is less than two grams of a solid substance, less than two milliliters of a liquid substance, or if the substance is placed onto a secondary medium with a combined weight of less than two grams, by imprisonment for not less than one nor more than three years; 2) If the aggregate weight, including any mixture, is at least two grams but less than four grams of a solid substance, at least two milliliters but less than four milliliters of a liquid substance, or if the substance is placed onto a secondary medium with a combined weight of at least two grams but less than four grams, by imprisonment for not less than one nor more than eight years; and 20,000 fine for each violations.

• TITLE 16. CRIMES AND OFFENSES CHAPTER 13. CONTROLLED SUBSTANCES ARTICLE 1. GENERAL PROVISIONS

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• 2018 Georgia CodeTitle 26 - Food, Drugs, and Cosmetics• Chapter 4 - Pharmacists and Pharmacies Article 2 - State

Board of Pharmacy§ 26-4-29. Georgia Drugs and Narcotics Agency

• The agency created in 1908 as the Office of the Chief Drug Inspector and known as the Georgia Drugs and Narcotics Agency since 1976 is continued in existence as the Georgia Drugs and Narcotics Agency. This agency shall be a budget unit as defined under Code Section 45-12-71; provided, however, that the agency shall be assigned for administrative purposes only, as defined in Code Section 50-4-3, to the Department of Community Health, except that such department shall prepare and submit the budget for the Georgia Drugs and Narcotics Agency. The Georgia Drugs and Narcotics Agency is authorized by this Code section to enforce the drug laws of this state.

• Law enforcement arm of state licensing boards.

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• In Georgia, those who have “been convicted of any felony or of any crime involving moral turpitude in the courts of this state or any other state, territory, or country” are subject to having their application denied on account of their conviction.

• This restriction severely curtails the number of professions available to people coming out of prison, many of which offer considerable promise for returning citizens given the vocational training they received in prison.

• As it stands now, nearly 80 professions are off-limits to those with a felony conviction, including becoming a barber, cosmetologist, electrical contractor, plumber, conditioned air contractor, auctioneer, utility contractor, registered trade sanitarian, and scrap metal processor, among others.

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http://law.justia.com/codes/georgia/2010/title-43/chapter-1/43-1-19

http://statutes.laws.com/georgia/title-43

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Conflicts of Interest: Personal

Ownership and Use

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Conflicts of Interest: Personal Ownership and Use

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Conflicts of Interest: Personal Ownership and Use

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• Research that was published nearly one year ago demonstrated that the CBD Industry is not free from undue influence from industry and vested interests.

• First, any mechanism to address conflicts of interest should be focused on preventing private, financial and vested interests which conflict with the public interest. These types of interests are measurable and it has been shown for example that the source of funding has an impact on the conclusions of published studies.

• Second, conflicts of interest should be assessed against the objectives, purposes and principles of the Convention and its Protocols. In addition we suggest there should a definition of conflicts of interests in the context of the CBD included.

• Does a healthcare practitioner need to disclose ownership (stock) in a CBD company to a client that they are recommending a CBD product from such company?

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The Liability of CBD Sales

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“When you talk about opportunities in product liability insurance, the biggest emerging trend we see today is CBD products,” says Donnacha Smyth, president, global excess casualty, AXA XL. “You’ve just got to walk down the street to see shops selling CBD products everywhere.”

For starters, it’s not closely regulated—“there is no substantive regulatory framework in place,” Smyth says. “We’re likely to see some regulation from the U.S. Food and Drug Administration as it develops, but the areas of concern for insurers include the supply chain of the products, contractual management and pure quality control.”

That’s because, due to the emerging nature of CBD, “companies that are actually harvesting and producing the products tend to be more unsophisticated type of businesses that might not understand the broader product risks,” Smyth explains.

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• Despite the aforementioned state-by-statelegalizations, cannabis is still illegal under federal law. “You’ve got a whole bunch of carriers that are still waiting on the sidelines because they don’t want to get into the dispute of state versus federal and insuring something that technically could be deemed illegal,” Alder explains. “There’s a long way to go on that.”

• “It’s changing, and it’ll continue to change the more education and knowledge there is around it,” adds Alder, who notes that one of the carriers he works with recently announced it would write cannabis-derivative products like CBD—just not cannabis itself. “But until there’s legal continuity, you’re going to continue to see a lot of players sitting on the sidelines. Any real, significant change is going to be tied to how the legal climate changes.”

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https://www.iamagazine.com/markets/market/product-liability

https://www.iamagazine.com/markets/read/2017/10/23/high-and-dry-how-will-legal-marijuana-impact-workers-comp

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As insurers continue to respond to the growing CBD market, then, “underwriters might be asking questions like, ‘Where are the products placed in shops? Are they in the pain medication area?’ There’s a lot going on here, but I think it’s a tremendously growing industry and a great opportunity,” Smyth says. “We just have to approach it in a thoughtful, balanced way.”

Beyond CBD derivatives, cannabis as a whole is an emerging opportunity for the product liability space. But so far, “there are very few insurers willing to dive in and write direct marijuana-related facilities,” points out Marc Alder, managing director, Burns & Wilcox Brokerage.

“It’s changing, and it’ll continue to change the more education and knowledge there is around it,” adds Alder, who notes that one of the carriers he works with recently announced it would write cannabis-derivative products like CBD—just not cannabis itself. “But until there’s legal continuity, you’re going to continue to see a lot of players sitting on the sidelines.Any real, significant change is going to be tied to how the legal climate changes.”

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• What this means is there are few liability onsurance carriers available to cover for the various liability issues that could arise from the emerging CBD industry.• The practitioner that is providing CBD products

to their clients maybe running a tremendous financial risk if a liability issue arises.• A long list of businesses fall into the high-risk

category, including:• online gaming services,• vaping/e-cigarette companies,• and the adult toy industry, to name a few.

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In December of last year, President Donald Trump’s

signature effectuated the law, which removed hemp from the definition of marijuana under the Controlled Substances Act

of 1970 and officially recognized the non-

psychoactive plant as an agricultural crop.

This meant that instead of putting the Drug Enforcement

Agency (DEA) in charge of overseeing crop regulation, the

duty was instead bestowed upon the U.S. Department of Agriculture (USDA). The Farm Bill however preserved FDA’s

authority.

Ultimately, this led some lawyers to make claims about CBD’s legal status, with many falsely claiming that products

containing the non-psychotropic cannabinoid

could be shipped to any state without legal repercussions. According to the FDA, those

attorneys stand to be corrected. A recent statement published by the FDA clarified this by informing the people of

America that the agency maintains the right to regulate all CBD products, even those

derived from hemp.

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• FDA Statement:

• Cannabis is a plant of the Cannabaceae family and contains more than eighty biologically active chemical compounds. The most commonly known compounds are delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). THC is the component that produces the “high” associated with marijuana use. Much interest has been seen around CBD and its potential related to health benefits.

• Marijuana is different from CBD. CBD is a single compound in the cannabis plant, and marijuana is a type of cannabis plant or plant material that contains many naturally occurring compounds, including CBD and THC.

• The FDA has approved only one CBD product, a prescription drug product to treat two rare, severe forms of epilepsy.

• It is currently illegal to market CBD by adding it to a food or labeling it as a dietary supplement.

• The FDA has seen only limited data about CBD safety and these data point to real risks that need to be considered before taking CBD for any reason.

• Some CBD products are being marketed with unproven medical claims and are of unknown quality.

• The FDA will continue to update the public as it learns more about CBD.

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Until the FDA adopts new rules, it will continue to

enforce current restrictions around

cannabis products. But in signaling it’s willing to

relax its stance, the FDA could spur even more interest in cannabis-

derived products. Industry analysts have

already expected a major boom in CBD — short for cannabidiol — oils, drinks

and more.

In the meantime, the FDA will continue to go after

companies that make egregious unproven

claims. It has already issued warning letters to

companies selling CBD products, including those that claim to fight cancer.

The FDA’s recent approval of Epidiolex — a

cannabis-derived CBD drug — shows that the regulatory body may be

open to a gradual, controlled introduction of

other products going forward, Horn said.

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• Rapid expansion of the CBD and hemp industries is prompting an elevated need for product liability insurance.

• Without the assistance of an agent who is well-versed on the ins and outs of the industry, you may fall victim to a claim that could seriously damage your reputation as an industry seller, not to mention cause you financial implications.

• Just because CBD product liability insurance was created specifically for companies operating in the marijuana and hemp space, it is no different than regular product liability insurance. In basic terms, CBD product liability insurance comes in handy when a consumer feels as though he or she has been harmed by a faulty product. The insurance coverage can be used to shield suppliers, producers and/or manufacturers when a claim of this kind is made.

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• Four Product Claims That Companies and Practitioners Should Be Prepared For• Ingestible products.• Topical products.• Medical claims.• Legal disputes.• Two Types of CBD Insurance• Product Liability• General Liability

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• Staying out of trouble in regards to advertising, marketing and selling ingestible or topical CBD products online is possible. CBD product liability insurance will be a valuable tool, but it does not prevent enforcement. Further, FDA warning letters are made public. Getting on the wrong side of the FDA can land you in serious trouble and tarnish all of your hard work. With some jurisdictions having outlawed CBD in its entirety, it really doesn’t hurt to be prepared.

• Product liability insurance coverage could safeguard your finances and the livelihood of a business in this avenue, should a claim be filed regarding faulty design, manufacturing, instructions and warnings.

• So, why not do something today that your future self will thank you for? We’ve provided the knowledge and tools you need to conduct safe ecommerce practices; now you just need to execute a CBD insurance strategy that begins with picking a provider.

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References

• Gabay M. The federal controlled substances act: schedules and pharmacy registration. Hosp Pharm. 2013 Jun;48(6):473-4. [PMC free article: PMC3839489] [PubMed: 24421507]

• Larrat EP, Marcoux RM, Vogenberg FR. Implications of recent controlled substance policy initiatives. P T. 2014 Feb;39(2):126-8. [PMC free article: PMC3956388] [PubMed: 24669180]

• Gabay M. Federal controlled substances act: controlled substances prescriptions. Hosp Pharm. 2013 Sep;48(8):644-5. [PMC free article: PMC3847977] [PubMed: 24421533]

• Drug Enforcement Administration, Department of Justice. Controlled Substances Quotas. Final rule. Fed Regist. 2018 Jul 16;83(136):32784-90. [PubMed: 30020581]

• Coleman JJ. The supply chain of medicinal controlled substances: addressing the Achilles heel of drug diversion. J Pain Palliat Care Pharmacother. 2012 Sep;26(3):233-50. [PubMed: 22973912]

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135

References

• NCBI. PubChem Compound Database; CID=26346 August 1 2017]; Available from: • https://pubchem.ncbi.nlm.nih.gov/compound/26346 • Cayman Chemical. Cannabidiol (DEA Schedule I Regulated Compound). Safety

Data Sheet 2015; Available from: https://www.caymanchem.com/msdss/90080m.pdf. • WHO Expert Committee on Drug Dependence : thirty-eighth report. Geneva:

World Health Organization; 2017 (WHO technical report series ; no. 1005). Licence: CC BY-NC-SA 3.0 IGO. • Shah, V.J., Synthesis of cannabidiol stereoisomers and analogs as potential

anticonvulsant agents. The University of Arizona. • Bisogno, T., et al., Molecular targets for cannabidiol and its synthetic analogues:

effect on vanilloid VR1 receptors and on the cellular uptake and enzymatic hydrolysis of anandamide. British Journal of Pharmacology, 2001. 134(4): p. 845-852.

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https://www.ncbi.nlm.nih.gov/pubmed/24421507







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References

• Pacher, P., Bátkai, S., and Kunos, G. The endocannabinoid system as an emerging target of pharmacotherapy. PharmacolRev. 2006; 58: 389–462• | Agricultural Act of 2014, HR 2642, 113th Cong, 2nd Sess

(2014). (US Government Publishing Office website) (Accessed June 1, 2018)https://www.gpo.gov/fdsys/pkg/BILLS-113hr2642enr/pdf/BILLS-113hr2642enr.pdfDate accessed: January 3, 2014• Mead, A. The legal status of cannabis (marijuana) and cannabidiol

(CBD) under U.S. law. Epilepsy Behav. 2017; 70: 288–291

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References

• Woods, S.C. The endocannabinoid system: mechanisms behind metabolic homeostasis and imbalance. Am J Med. 2007; 120: S9–S17• Witkamp, R. and Meijerink, J. The endocannabinoid system: an emerging

key player in inflammation. Curr Opin Clin Nutr MetabCare. 2014; 17: 130–138• Acharya, N., Penukonda, S., Shcheglova, T., Hagymasi, A.T., Basu, S., and

Srivastava, P.K. Endocannabinoid system acts as a regulator of immune homeostasis in the gut. Proc Natl Acad Sci U S A. 2017; 114: 5005–5010• Bluett, R.J., Gamble-George, J.C., Hermanson, D.J., Hartley, N.D., Marnett,

L.J., and Patel, S. Central anandamide deficiency predicts stress-induced anxiety: behavioral reversal through endocannabinoid augmentation. Transl Psychiatry. 2014; 4: e408

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https://www.gpo.gov/fdsys/pkg/BILLS-113hr2642enr/pdf/BILLS-113hr2642enr.pdf

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References

• Peachman, R.R. Clinicians support medical marijuana use in children with cancer, but lack knowledge. JAMA. 2018; 319: 852–853• Rubin, R. Medical marijuana is legal in most states, but physicians

have little evidence to guide them. JAMA. 2017; 317: 1611–1613• Friedman, D. and Sirven, J.I. Historical perspective on the medical

use of cannabis for epilepsy: ancient times to the 1980s. Epilepsy Behav. 2017; 70: 298–301

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References

• Epidiolex [package insert]. Carlsbad, CA: Greenwich Biosciences, Inc; 2018. (US Food and Drug Administration website) (Published June 2018. Accessed November 16, 2018)https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdfDate: 2018• State medical marijuana laws. National Conference of State

Legislatures. NCSL website. http://www.ncsl.org/research/health/state-medical-marijuana-laws.aspxDate accessed: June 1, 2018• Cherney, J.H. and Small, E. Industrial hemp in North America:

production, politics, and potential. Agronomy. 2016; 6: 58

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https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210365lbl.pdf

http://www.ncsl.org/research/health/state-medical-marijuana-laws.aspx

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Questions

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Understanding CBD in Clinical Practice: Legal and Ethical ... · Clinical Practice: Legal and Ethical Considerations 1 Agenda •8:00-8:30 AM Registration •8:30-10:30AM The Legality