What if Marijuana Were NOT a Schedule I Drug: Legal...
Transcript of What if Marijuana Were NOT a Schedule I Drug: Legal...
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What if Marijuana Were NOT a Schedule I Drug:Legal & Policy Implications
Kerry Cork, J.D., MA, Senior Staff Attorney, Public Health Law Center Hudson Kingston, J.D., LL.M, LL.M, Staff Attorney, Public Health Law Center
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Public Health Law Center
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Legal Technical Assistancewww.publichealthlawcenter.org
Legal Research
Policy Development, Implementation, Defense
Publications
Trainings
Direct Representation
Lobby
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Legal Technical Assistance
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Guiding Principles
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Use the power of law to improve health for all‒ Reduce health disparities‒ Protect vulnerable populations, such as minors, those with behavioral
health/mental illness, other priority groups
Rely on evidence-based policymaking, including safeguards from corporate interests
Preserve local control
Support regulatory environments that protect public health and safety
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Agenda
Cannabis Conundrum & Catch-22
Our Government at Work
A Menu of Options‒ Maintain Status Quo – “Let It Be!”‒ Cooperative Federalism – “Let’s Get Real!”‒ Deschedule – “Let’s Get Radical!”‒ Reschedule – “Let’s Get Creative!”
Where Does This Leave Us?
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Cannabis Conundrum
Marijuana is illegal under federal law.
Federal law PREEMPTS local law. . . .
YET . . . .33 states, DC, Guam, & Puerto Rico have passed laws broadly legalizing medical marijuana in some forms &
10 states & DC permit recreational marijuana use.
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Cannabis Catch-22
“Difficult situation or problem whose seemingly alternative solutions are logically invalid.”
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Cannabis Catch-22
To become a legal substance under federal law, clinical trials need to show marijuana has a medical use.
This would move it from Schedule 1.
But because marijuana is illegal under federal law, doing clinical trials to show it has a medical use is nearly impossible.
Thus, there’s no evidence to move it from Schedule 1.
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Controlled Substances Act (1970)
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Factors in Drug Classification
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1. Drug’s actual or relative potential for abuse2. Scientific evidence of its pharmacological effect, if known3. The state of current scientific knowledge regarding the drug or other substance4. Its history and current pattern of abuse5. The scope, duration, and significance of abuse6. What, if any, risk there is to public health7. Its psychic or physiological dependence liability8. Whether the substance is an immediate precursor of a substance already controlled
under the CSA
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Type of Drug Schedules
Schedule 1: Heroin, LSD, “Ecstasy,” peyote, cannabis Schedule II: Methadone, OxyContin, Percocet
Schedule III: Cocaine, morphine, hydrocodone (Vicodin)
Schedule IV: Ativan, Ambien, Lunesta, Valium, Xanax
Schedule V: Cough preparations w/ <200 mg codeine per 100 grams (Robitussin AC)
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The Most Dangerous – Schedule 1
1. A “high potential for abuse”2. No “currently accepted medical use” in the
U.S.3. Lack “accepted safety for use ... under
medical supervision.”
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Scheduling Controlled Substances
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Congress created original listing
DEA and FDA determine which substances are added to or removed from the various schedules
Scheduling can be changed via:‒ Congressional action (either new marijuana legislation or CSA
amendments)‒ Administrative action
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Food & Drug Administration
• Protects public health by assuring safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.
• Also responsible for safety and security of U.S. food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
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Cannabis Catch Up
The FDA has recently approved a few cannabinoids as drugs:‒ Epidiolex (CBD) oral solution for treatment of seizures associated with
rare, severe forms of epilepsy (2018)• First FDA-approved drug derived from an extract of the cannabis plant• Accepted medical use
‒ Synthetic cannabinoids dronabinol and nabilone to treat nausea and vomiting associated with chemotherapy & loss of appetite in people with AIDS
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A Few Federal Agencies Regulating Alcohol
U.S. Department of Treasury‒ Alcohol and Tobacco Tax and Trade Bureau (TTB)
U.S. Department of Justice (DOJ)‒ Bureau of Alcohol, Tobacco, Firearms and Explosives
(ATF)
U.S. Department of Labor‒ Occupational Safety and Health Administration (OSHA)
U.S. Environmental Protection Agency (EPA) U.S. Department of Transportation (DOT) U.S. Postal Service
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A Few Federal Agencies Regulating Opiates
• U.S. Department of Health and Human Services (HHS)
• Food and Drug Administration (FDA)• Centers for Disease Control and Prevention
(CDC)• Substance Abuse and Mental Health Services
Admin. (SAMHSA)• Centers for Medicare and Medicaid (CMS)
• U.S. Department of Justice• Drug Enforcement Administration (DEA)
• U.S. Department of Labor• Occupational Safety and Health Administration
(OSHA)
• U.S. Environmental Protection Agency (EPA)
• U.S. Department of Transportation (DOT)
• U.S. Postal Service
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A Few Federal Agencies Regulating Tobacco
• U.S. Department of Health and Human Services (HHS)
• Food and Drug Administration (FDA)• Centers for Disease Control and Prevention (CDC)• Substance Abuse and Mental Health Services
Administration (SAMHSA)
• U.S. Department of Treasury• Alcohol and Tobacco Tax and Trade Bureau (TTB)
• U.S. Department of Justice (DOJ) /Federal Communications Commission (FCC) /Federal Trade Commission (FTC)
• DOJ, Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF)
• U.S. Environmental Protection Agency (EPA)
• U.S. Department of Labor• Occupational Safety and Health Administration (OSHA)
• U.S. Postal Service
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Marijuana Policy Taxonomy
Product control‒ Agency w/authority to regulate‒ Cultivation and distribution‒ Product testing, specification and
certification‒ Packing, warning labels, methods of
distribution‒ Licensing of retail sales outlets‒ Retail sales transactions,‒ Local authority
Taxation, fees, and pricing
Advertising, marketing, and mass media
Transportation, crime, and public safety
Health care services and financing
Education
Public services, functions, and programs
Employment and workplace issues
Other marijuana policy areas (not otherwise categorized)
Klitzner et al, The New Cannabis Policy Taxonomy on APIS, 38 J. PRIMARY PREVENTION 295 (2017)
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International Drug Treaties
U.N. Single Convention on Narcotic Drugs, 1961 Aims to combat drug abuse by coordinated international
action ‒ Limits the possession, use, trade in, distribution, import, export,
manufacture and production of drugs exclusively to medical and scientific purposes.
‒ Combats drug trafficking through international cooperation to deter and discourage drug traffickers.
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A Menu of Options
“Government is at best but an expedient; but most governments are usually, and all governments are sometimes, inexpedient.”
Thoreau, Civil Disobedience (1849)
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A Menu of Options
Maintain Status Quo (“Let It Be!”)
Collaborative Federalism (or “Let’s Get Real!”)
Deregulate (“Let’s Get Radical!”)
Reschedule (“Let’s Get Creative!”)
Menu adapted in part from Carnevale Associates, Regulating Cannabis: Recommendation on How to Regulate the New Cannabis Industry (2017)
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1. Status Quo
As Schedule 1 drug under CSA:‒ Federal offense to –
• Cultivate, manufacture, distribute• Sell, purchase, possess, or use
marijuana
‒ Harsh penalties: $1,000s+ in fines & substantial prison time
Current “prosecutorial forbearance” (per DOJ’s Cole & Ogden memos) could change at any time
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Cannabis Catch Up
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2 Out of 3 U.S. Adults Favor Marijuana Legalization
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Benefits of Status Quo
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Depends on who you ask & where you live‒ Recreational marijuana industry & related businesses‒ Some pro-marijuana advocates‒ Some in law enforcement?
Tobacco industry staying out for now
Ensures compliance with U.S. obligations under international drug treaties/conventions
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Drawbacks of Status Quo
Inconsistent state and federal lawsUnpredictable & unfair legal
enforcement
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Drawbacks of Status Quo
Insufficient research on health effect & therapeutic potential of marijuana
Significantly impedes:‒ Scientific understanding of
cannabis‒ Advancement of public policy
& overall public health
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Drawbacks of Status Quo
• Lack of federal regulatory oversight over ̶
• Agriculture & production• Manufacture• Advertising• Sales• Dissemination
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Drawbacks of Status Quo• Development of Big Weed
industry
• Limited collaboration among federal agencies –
• In understanding and preventing current harms & forecasting industrialization effects
• FDA, National Institutes of Health, SAMHSA, the National Highway Traffic Safety Administration & others
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Drawbacks of Status Quo• Significant impact on –
• Criminal justice system / health equity
• Social normalization• Black market
• Lack of funding to invest in –• Proactive regulatory planning &
research• Balanced thorough assessments of
local/state regulatory systems
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Implications of Status Quo• Lack of commercial banking services
• Many marijuana businesses operate solely in cash
• Public safety concern from law enforcement perspective
• Disadvantageous federal income tax terms
• Limited access to legal services
• Possible loss of employment for off-site marijuana users
• Role of marijuana use in family law proceedings
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How’s That Working Out for Ya?
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2. Cooperative Federalism
Respect states’ rights by codifying current approach in Cole Memorandum
Amend CSA to exempt marijuana activities that are lawful in jurisdictions where they occur
More permanent than Attorney General guidance or agreements between states and the AG regarding enforcement
“STATES Act of 2018” – ensures each state has right to determine best approach to marijuana w/in its borders
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Canada, O Canada!
Canada’s Cannabis Act took effect Oct. 17, 2018 Legalizes the sale, cultivation, and use
of marijuana throughout Canada.
Sets limit for marijuana possession at 30 grams and 4 marijuana plants.
Leaves everything else to the provinces—age restrictions, who can sell and distribute marijuana, where you can sell or smoke, police protocol, etc.
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Benefits of Cooperative Federalism
Respects state sovereignty & local control
Provides consistent legal norms
Would solve critical conflict-of-law concerns (e.g., unpredictable criminal enforcement)
Would result in more comprehensive federal regime than current approach (perhaps stepping stone?)
Would promote stability for medical users and suppliers
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Drawbacks of Cooperative Federalism
Still would NOT –‒ Ease research into marijuana harms and benefits‒ Bring products into FDA purview to ensure safety, quality control, &
efficacy‒ Reduce likelihood of Big Marijuana Industry‒ Prevent tobacco industry appropriation / involvement‒ Address potential conflicts with international treaty obligations‒ Solve other problems resulting from status quo approach, including
impact on social justice, etc.
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Status Quo & Cooperative Federalism: Regulatory Gaps & Concerns
Lack of scientific and safety data, controlled studies, epidemiologic research, evidence-based findings from states that have legalized cannabis
Limited experience of state and local governments in developing and implementing effective regulatory policies –
scatter-shot state-by-state regulation
Trend to pass marijuana laws via ballot initiatives
Tendency of some states to “borrow” regulatory language from other states
Bandwagon effect & focus on “pay-off” (tax revenue)
Ongoing challenges posed by federal prohibition and need to align dual regulatory systems for medical & recreational marijuana
State of uncertainty re. federal position on marijuana; sense that “something’s coming”; likelihood of major marijuana industry in future (similar to Big Tobacco, Big Pharma, Big Alcohol)
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3. Deregulation
Deregulation?
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Deregulation
Deregulation?
Remember: You can’t spell “deregulation” without “regulation”
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Deregulation
DeregulationRemoving marijuana from CSA entirely would have
significant repercussions, including existing federal regulatory authorities.
Research on marijuana would be significantly easier to do, a prerequisite for reasoned regulation.
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Deregulation
Deregulation For example: pesticides. EPA has duty:
‒ Under FIFRA to regulate pesticides on crops. ‒ Under FFDCA to set pesticide residue limits on foods.
Currently, because of CSA, marijuana is not a legal crop, medicine, or food. But the moment that it is removed from CSA…
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Deregulation
If marijuana was out of CSA and not a “drug”… EPA has duty under FIFRA to regulate pesticides on crops:
‒ Instead of long approval process, EPA has already begun allowing some special uses of pesticides on hemp, and could probably temporarily extend similar pesticide regulation to marijuana as a crop.
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Deregulation
If marijuana was out of CSA and not a “drug”… FDA definition of food is met: edibles.
EPA has duty under FFDCA to limit pesticide residues on food.
No existing EPA-recognized studies of pesticides on marijuana as a food.
Normal process: pesticide makers submit detailed applications, including rigorous studies; and pesticide limits are set through formal rulemaking with publication in the Federal Register. This takes months or years but should improve product safety.
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Deregulation
If marijuana was out of CSA and not a “drug”…No pesticide regulation corollary in tobacco control.
FDA regulates tobacco under a different/independent authority, and tobacco excepted from many federal laws.
EPA has no duty under FFDCA to regulate pesticide residues on tobacco. No EPA pesticide residue limits on tobacco leaf.
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Deregulation
If marijuana was out of CSA and not a “drug”… Tobacco industry excepted from many federal laws.
Alcohol/tobacco highly regulated within industry-specific taxes, but lobbying keeps tax low.
Will the marijuana industry benefit from similar exceptions or experience robust regulatory scrutiny under deregulation?
‒ Depends on political power of the industry.
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Deregulation
If marijuana was out of CSA, what would likely happen to industry?Ready access to investment and banking.
Potential change to federal tax projected to make marijuana businesses pay an extra $5 billion/decade.
Increased certainty in market invites larger investors who are happy to take higher returns at reduced risk.
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Deregulation
If marijuana was out of CSA, what would likely happen to industry?Ready access to investment and banking.
Potential change to federal tax projected to make marijuana businesses pay an extra $5 billion/decade.
Increased certainty in market invites larger investors who are happy to take higher returns at reduced risk.
… so, the industry is likely to GROW (and consolidate).2019 North American Cannabis Summit 50
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Deregulation
Industry structure and power
Two current issues under status quo:‒ Diversion to other states.‒ Diversion to black market (e.g. to minors or outside of tracking and
taxation).
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Deregulation
Industry structure and power
If CSA drops marijuana:‒ Diversion to other states.‒ Diversion to black market (e.g. to minors or outside of tracking and
taxation).
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Deregulation
Industry structure and power
If CSA drops marijuana:‒ Diversion to other states:
• In immediate aftermath still illegal under state laws, but this could be changed to benefit industry (CA and OR overproduction)
• U.S. Constitution Commerce Clause argument• NAFTA argument
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Deregulation
Status quo:‒ Diversion to/from other states
currently not allowed byfederal policy becausestates must stop interstate diversion toavoid DOJ enforcement.
‒ Authority: Cole memo, (revoked but still apparently status quo)
MapSource: https://www.businessinsider.com/legal-marijuana-states-2018-1
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Deregulation
If CSA drops marijuana:‒ Diversion to/from other states
no longer opposed by federal law
‒ Industry is overproducing and needs new markets to stay afloat/expand profit
‒ States cannot ban interstate trade under the U.S. Constitution Commerce Clause (with caveats)
MapSource: https://www.businessinsider.com/legal-marijuana-states-2018-1
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Deregulation
If CSA drops marijuana:‒ Diversion to/from other
countries (where marijuana is legal)‒ NAFTA doesn’t allow
discrimination against foreign avocados, corn syrup, or Coca-Cola… marijuana could be treated the same.
‒ NAFTA’s Investor-State Dispute Settlement gives companies a way to undo trade obstruction.
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Deregulation
If CSA drops marijuana:‒ All these arrows suggest a
growing market that can now consolidate into (or getpurchased by) large corporate businesses:
• Race to the bottom concern• Concentration of power
concern• Big industry will be ahead of
regulation at the outset
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Deregulation
Addressing black-market diversion post-CSA
Under status quo:‒ Diversion to other states.‒ Diversion to black market (e.g. to minors or outside of tracking
and taxation).
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Deregulation
Addressing black-market diversion post-CSA
If CSA drops marijuana:‒ Diversion to black market is not new.
This is the plot of notable cautionary tale…
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Deregulation
Addressing black-market diversion
If CSA drops marijuana:‒ Diversion to black market is not new.
This is the plot of notable cautionary tale:
Half Baked (1998)
photo credit: http://eclecticboredom.blogspot.com/2014/01/delayed-movie-reaction-half-baked.html
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Deregulation
Addressing black-market diversion post-CSA
If CSA drops marijuana:‒ Diversion to black market:
• This could grow significantly if chosen method of enforcement/community education fails to control it.
• Federal role unclear.• Corollary to tobacco and alcohol black-market sales. • Culture of forbearance by those with access (adults/workers) might not be
there yet.
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Deregulation
Addressing black-market diversion post-CSA
If CSA drops marijuana:‒ States could adopt different market structures to avoid diversion to
illegal uses, including ownership and direct control of industry.‒ RAND Corporation’s analysis suggested twelve different structures,
where “standard commercial model” was one of many and likely not the best option for public health.
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Deregulation
Addressing black-market diversion post-CSA
RAND take on “standard commercial model”:‒ Exists to maximize efficient market within some constraints.‒ This is why CO and WA allowed regulation by Revenue/Liquor
Board instead of Health Department.‒ But is an efficient market really an optimal goal, or good for public
health?
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Deregulation
Addressing black-market diversion post-CSA
RAND take on “standard commercial model”:‒ Public health agency would likely focus on (1) killing the black
market (2) without generally increasing use.‒ But Health Departments aren’t usually in the business of: collecting
taxes, issuing licenses, monitoring compliance, and enforcement.‒ So there is a disconnect between abilities and needs if you want to
do a public-health-first commercial model.
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Deregulation
RAND position:From: Considering Marijuana Legalization: Insights for Vermont and Other Jurisdictions
Available at: https://www.rand.org/pubs/research_reports/RR864.html
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Deregulation
Addressing black-market diversion post-CSA
RAND position:‒ “A state monopoly option is—arguably—the most attractive supply
model of legalization for protecting public health while reducing or even eliminating the black market.”
‒ Options include: no legal sales but allow individual/group grow; limited licenses; non-profit/for-benefit/government sales only; strong local control.
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Deregulation
Addressing black-market diversion post-CSA
My take on RAND position:‒ Tobacco lessons: limiting licenses and strong local control.‒ Alcohol lessons: government control of sales, or even more of
supply chain.‒ Public utility lesson: states can allow legal monopolies and
regulate/control every aspect of their business (e.g. prices, safety, standards) without having to own/run the monopoly.
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Deregulation
Free speech
Under the status quo:‒ Marijuana is illegal, advertising to sell it is illegal.‒ Commercial speech is protected only if speech is not misleading
and legal.‒ It follows that states may restrict advertising however they want.‒ The (limited so far) court cases seem to support this.
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Deregulation
Free speech post-CSA
If marijuana is removed from CSA:‒ Marijuana is not illegal at the federal level.‒ Commercial speech is protected if truthful.‒ States can only control speech that is misleading, or burden truthful
speech in ways that are:• Based on a substantial government interest.• Directly advanced by the control on speech.• Without the control being more extensive than necessary.
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Deregulation
Free speech post-CSA If marijuana is removed from CSA:
‒ Tobacco lesson: companies have sued to stop point-of-sale controls to eliminate tobacco advertising.
‒ Junk food lesson: companies have sued to stop warning labels on sugar-sweetened beverages.
States can still protect youth from exposure to advertising, but will need to carefully calibrate prohibitions. Current broad power will be circumscribed. Incidentally: There will be a gold rush of trademark registrations
at federal level.2019 North American Cannabis Summit 70
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Deregulation Scorecard
Benefits
Research now much easier.
States have new options for structuring legal marijuana that might improve health.
Existing federal health standards (e.g. pesticide regulation) should apply.
Drawbacks
Industry likely to grow quickly and lobby at federal level.
Unclear if federal policy will be hands-off or will support state efforts and health.
Industry could sue over existing controls.
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4. Rescheduling
What automatically happens if marijuana stays in the CSA but is rescheduled?
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Rescheduling
What automatically happens if marijuana stays in the CSA but is rescheduled?Nothing, but…
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Rescheduling
If marijuana were rescheduled:NIH could begin funding research, and researchers might not need to use DEA source.The justification for existing federal prosecutorial discretion (Cole memo) would get stronger.More marijuana-derived medicines could be submitted to FDA for approval, especially since research on effectiveness would be easier to do.
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Rescheduling
One medicine already approved and rescheduled: In June FDA approved Epidolex, a drug using CBD to treat rare forms of epilepsy. DEA scheduled Epidolex as Schedule V.Note: Epidolex is made abroad, avoiding the current CSA issues around sourcing, and allowing sufficient clinical trials to meet FDA standards.
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Rescheduling
If marijuana were rescheduled:Smoked marijuana may never be approved by FDA as a drug.But closing all recreational facilities is likely beyond the power/interest of the federal government.Marijuana sold as “medical” could be better tested and proven, but likely to continue as distinct FDA/state tracks.
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Rescheduling Scorecard
Benefits
Research now easier.
FDA could start vetting more drugs for formal approval.
State’s efforts likely to be treated similar to now, state medical marijuana on a different track from FDA.
Drawbacks
Does not resolve most issues in Status Quo.
Similar to opioid crisis: making something Schedule II or lower is not a panacea for health.
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Where Does This Leave Us?
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Precautionary Principle
“When an activity raises threats of harm to human health or the environment, precautionary measures should be taken even if some cause and effect relationships are not fully established scientifically. In this context the proponent of an activity, rather than the public, should bear the burden of proof. The process of applying the precautionary principle must be open, informed and democratic and must include potentially affected parties. It must also involve an examination of the full range of alternatives, including no action.”
– Wingspread Statement on the Precautionary Principle, Jan. 1998
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Guiding Principles
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Use the power of law to improve health for all‒ Reduce health disparities‒ Protect vulnerable populations, such as minors, those with behavioral
health/mental illness, other priority groups
Rely on evidence-based policymaking, including safeguards from corporate interests
Preserve local control
Support regulatory environments that protect public health and safety
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www.publichealthlawcenter.org
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Questions
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Place your company logo here.
Kerry Cork, J.D., MA – Senior Staff AttorneyHudson Kingston, J.D., LL.M, LL.M – Staff AttorneyPublic Health Law CenterSt. Paul, MN [email protected]
www.publichealthlawcenter.org