Public comment we submitted the CA Bureau of Medical Cannabis Regulation: Rule too lax to protect public health

Comment on Proposed Regulation
 
CALIFORNIA CODE OF REGULATIONS TITLE 16, DIVISION 42
BUREAU OF MEDICAL CANNABIS REGULATION

April 18, 2017
 
Candice Bowling, JD, MPA[*]
Postdoctoral Fellow
 
                                                     Daniel G. Orenstein, JD, MPH[†]
Postdoctoral Fellow
 
Stanton A. Glantz, PhD[‡]
Professor of Medicine
Truth Initiative Distinguished Professor in Tobacco Control
Director, Center for Tobacco Control Research and Education
 
Center for Tobacco Control Research and Education
University of California San Francisco
530 Parnassus Ave., Suite 366
San Francisco, CA 94143-1390
[email protected]
 
June 12, 2017
 
BMCR’S PROPOSED DAILY LIMIT AND LOCAL LAW ENFORCEMENT CARVE-OUT ARE TOO PERMISSIVE AND WILL IMPOSE UNNECESSARY
RISKS ON THE HEALTH OF CALIFORNIANS

 
Legalization of cannabis for medical and, more recently, recreational use in California and other states represents a sea change in the regulatory approach to the substance, despite its continued illegality under federal law.  The creation and government endorsement of a legal cannabis industry that will span both medical and recreational use presents risks that the new industry will use modern product design, advertising and promotion seek to drive up demand, exploit abusive use to increase profit, and exert powerful influence over the regulatory environment.
 
            Protecting the public health requires that both medical and recreational cannabis markets be well controlled and designed to prevent the emergence of a powerful industry that resembles the tobacco or alcohol industries.  Indeed, in the 1970s the tobacco industry actively considered entering the anticipated legal marijuana market.[1]  The tobacco and alcohol industries have a long well-documented history of using their economic and political power to engage in predatory marketing practices (such as marketing to youth and encouraging high consumption of their products) with the attendant damage to the health of Californians.  These activities include marketing to adolescents (although the industries strenuously deny doing so) and encouraging high consumption of their products, particularly among vulnerable populations, as well as actions to limit advertising restrictions, to limit on public use, to limit locations of sales outlets, and to keep taxes low.  Recognizing that heavy alcohol users represent a major market strata, the alcohol industry has targeted heavy consumers as a reliable source of profits.  It is important that the Bureau be cognizant of these risks and develop its regulations to minimize the chance that the burgeoning legal cannabis industry revisits upon the public the same pernicious tactics historically used by the tobacco and alcohol industries that continue to be so damaging to public health. 
 
Unless the State of California clearly adopts a public health framework  for regulating this new legal market,[2] normal profit-maximizing behavior by business is likely to impose health costs on the people of California similar to those imposed by the tobacco and alcohol industries, including using their political power to oppose effective regulatory, tax, and public education policies that would reduce consumption and profits.    
 
Research into potential harms and benefits of medical cannabis use is still developing, but existing evidence of harm is sufficient to support a precautionary approach to regulation.  Among other risks, marijuana and tobacco smoke share similar toxicity profiles,[3] and the State of California has listed cannabis smoke on the Proposition 65 list of substances known to cause cancer.[4],[5] The 2016 National Academies of Sciences, Engineering and Medicine report The Health Effects of Cannabis and Cannabinoids concluded that cannabis smoking was associated with worse respiratory symptoms and more frequent chronic bronchitis episodes, as well as moderate evidence of other respiratory effects.[6]  Even secondhand exposure to marijuana smoke has negative cardiovascular effects; a recent study in rats found that one minute of exposure impaired normal functioning of arteries (endothelial function) for at least ninety minutes.[7]  Changes in endothelial function are associated with development of heart disease and triggering heart attacks.[8],[9] 
 
Vaporized forms of cannabis may reduce some cancer risks associated specifically with combustion, but likely still present risks like those of e-cigarettes and similar products, including inhalation of ultrafine particles and various chemical additives (e.g., diacetyl, propylene glycol, flavoring compounds).[10],[11],[12] Inhalation of ultrafine particles causes cardiovascular and pulmonary disease, including triggering heart attacks and asthma attacks.[13],[14] Use of high-potency cannabis concentrates such as butane hash oil may increase risks for dependence, tolerance, and withdrawal among users.[15] Cannabis consumption has also been associated with altered or decreased brain function among adolescents,[16] cyclic vomiting syndrome,[17] and manifestation of psychotic disorders.[18]
 
Two aspects of the proposed regulations protect the public health and should be maintained as proposed:
 

  • The ability for applicants with past cannabis-related criminal history to present evidence of rehabilitation of character 
  • The requirement for child-proof packaging of marijuana products

 
There are, however, four problematic areas in the proposed regulations that need to be revised or strengthened:
 

  • The eight ounce daily limit, as proposed in § 5172 is too high  
  • The carve-out found in § 5008(c) that excepts local law enforcement from conflicts of interest provisions applicable to other state employees involved in enforcement of the MCRSA
  • The absence of a robust unannounced inspection routine or procedure
  • The absence of an explicit requirement for delivery drivers to verify age and identity of a medical cannabis delivery patient
  • The lack of concrete guidance regarding the calculation of an average display amount found in § 5163

 
The ability of licensee applicants should be mainatined (§§ 5006 & 5033)
 
            The criminal justice reform-driven rehabilitative application provisions in draft § 5006 and § 5033, allow a licensee with a previous cannabis-related criminal charge the opportunity to enter into the trade by demonstrating rehabilitation of their character is appropriate.  While these provisions cannot undo the inequities visited upon minority communities and individuals imprisoned for non-violent cannabis possession crimes unrelated to drug trafficking and racketeering, these proposed sections serve notions of social equity. 
 
The exit- and child-resistant packaging provisions are appropriate (§ 5184)
 
            The Bureau’s proposed regulations regarding exit packing that is child-resistant embodied in § 5184 are on par with other states’ requirements with regard to opacity, ability to be resealed, and the degree to which the package is difficult for a child to open support the dovetailing public health aims of ensuring that a patient is not in danger of violating open container laws upon egress from the situ of dispensation and that children are not able to access medical cannabis goods.
 
The  8 ounce daily sale limit is too permissive and might contribute to diversion (§ 5172)
 
We agree with the Bureau in the need to impose a limit on the amount of cannabis that may be dispensed or sold to a patient to deter over-use, dependency, and dispensation leading to diversion of the product.  However, the eight (8) ounce daily limit proposed in § 5172(a) of the draft regulations is excessive, may contribute to diversion of the product to illegal markets, and may attract crime to patients possessing that amount of product. 
 
In addition, as contemplated in the MCRSA, “‘Medical cannabis,’ ‘medical cannabis product,’ or ‘cannabis product’ means a product containing cannabis, including, but not limited to, concentrates and extractions, intended to be sold for use by medical cannabis patients in California. . . .”  Cal. Bus. & Prof. Code § 19300.5(af) (West).  The proposed regulation does not account for the fact that the concentration of THC and other active ingredients varies widely in these different forms of cannabis products; it should.
 
At 2 grams per joint, eight ounces of dried flower is equivalent to about 113 joints.[19]  To demonstrate the absurdity of this daily sale limit, a patient would have to smoke 4.7 joints per hour for twenty-four hours in order to consume eight ounces in a day.  At this rate, and given the negative health effects of consuming that much cannabis smoke, a patient requiring higher dosages of medical cannabis for treatment would be better off consuming a concentrated form of cannabis, such as an infused chocolate bar or a tincture.  
 
The Bureau’s draft regulation § 5172 mandates a daily sale limit of eight (8) ounces to a qualifying patient.  In relevant part, “(a)  A licensee shall not sell more than eight ounces of medical cannabis in a single day to a single medical cannabis patient. . .  . (b) A licensee shall not sell more than eight ounces of medical cannabis in a single day to a primary caregiver for each medical cannabis patient that the primary caregiver is authorized to purchase for.”  Draft Regulations, § 5172(a)-(b) (pending 2017).
 
Draft regulation § 5172(a) establishes an eight (8) ounce daily sale limit for the dispensing of medical cannabis to patients.  The Initial Statement of Reasons states that the dispensing limit is tied to the eight (8) ounce medical cannabis possession limit referenced in Cal. Health & Safety Code § 11362.77(a) (Initial Statement of Reasons, p.65).  The Initial Statement of Reasons justifies imposing the eight (8) ounce to: (1) prevent patients and caregivers from running afoul of the possession limit in Cal. Health & Safety Code § 11362.77(a); (2) stem the urge for a patient to purchase more than she can use and divert the excess to the grey or black markets; and (3) reduce the risk that a patient becomes a target of crime after they exit the dispensary (pg. 65).  It is neither necessary nor appropriate to rely on this provision to inform the daily sale limit in proposed § 5172 because the possession limit specified in § 11362.77 was declared unconstitutional.  People v. Kelly, 47 Cal. 4th 1008, 222 P.3d 186 (2010).
           
The eight ounce sale limit does not differentiate between the type of cannabis goods that may be dispensed
 
While the definition of medical cannabis and medical cannabis products contained in MCRSA Cal. Bus. & Prof. Code § 19300.5(af) includes all types of cannabis products and the proposed definition of medical cannabis goods in §5000(m) of the draft regulations is inclusive of dry flower and manufactured cannabis products, § 5172 is vague as to which type of product the daily sale limit is referring to.  Even assuming that a patient is withdrawing enough for a monthly supply, eight (8) ounces of dry flower per day is an excessive limit that encourages over-use driving dependency and diversion to the illicit market or to youth. 
 
The proposed eight Ounce limit dramatically exceeds the limits in place in other states and should be substantially lowered
 
Our survey of 21 states and Washington, D.C. that have legalized medical cannabis (Appendix and Table of Statutes)  indicates that California’s eight (8) ounce daily sale limit of medical cannabis is the highest in the nation.  In sum,
 

  • Two states impose daily sale limits of 1-2 ounces of medical cannabis
  • Sale Limit Outliers
    • One state imposes a two ounce sale limit for a ten-day period  
    • New Mexico imposes an eight ounce sale limit for a three-month period
    • Massachusetts imposes a 10 ounce sale limit for a two-month period
  • Eight states impose a biweekly sale limit between 2.5-4 ounces of medical cannabis
  • Three states and Washington, D.C. imposed a monthly sale limit of 2.5 ounces of medical cannabis
  • The regulatory election to tie the sale limit to the discretion of a physician is sound practice and bears resemblance to accepted practice in the medical and pharmacological fields
  • Two states impose comparable eight ounce limits with dispensing terms of one month and three months 

 
To harmonize the eight ounce possession limit and the potential needs of patients while inhibiting diversion, the Bureau should extend the daily limit term within which a patient may purchase eight ounces of medical cannabis to an extended temporal term to a standard per three months.  At this point, it is difficult to recommend any term as we lack scientific evidence of dose responses to the myriad types of cannabis.  The Bureau should conduct the needed research and submit an updated evidence-based standard for further public comment before finalizing the time period for the sales limit.
 
The regulation should be revised to define the sales limit based on total THC delivered
 
The draft regulation and the accompanying Initial Statement of Reasons do not make clear whether the sale limit was set at an eight ounce outer limit to account for a patient electing to purchase a plurality of medical cannabis goods (e.g., 2 ounces of dry flower, a cookie weighing 2 ounces, a bottle of tincture or topical totaling 4 ounces).  All these products have different amounts of THC per ounce of finished product.  Given that the eight ounce limit as contemplated in the Compassionate Use Act refers only to dry flower, the need for the Bureau to more clearly define a limit per category of medical cannabis goods is apparent. 
 
In traditional medical settings, a physician would have dose response information to rely upon when prescribing a medicine to patient, and could, subsequently titrate the dosage based upon feedback from the patient during future consultation.  Barring adoption of the preceding recommendations, the Bureau should benchmark the sale limit against a physician’s recommendation issued in response to patient feedback. 
 
Washington state’s statute provides an example that delineates between sale limits for particular categories of medical cannabis goods:
 
the qualifying patient or designated provider may purchase or obtain at a retail outlet holding a medical marijuana endorsement a combination of the following: Forty-eight ounces of marijuana-infused product in solid form; three ounces of useable marijuana; two hundred sixteen ounces of marijuana-infused product in liquid form; or twenty-one grams of marijuana concentrates.”  Wash. Rev. Code Ann. § 69.51A.210(1) (West), [emphasis added].  
 
The Washington state model language demonstrates that other state policymakers have recognized the need to clearly define limits for each category of cannabis good, which is an implicit recognition of the fact that different cannabis products deliver different amounts of THC and other active components. 
 
The Bureau should hold issuance of a sales limit regulation in abeyance until it has had the opportunity to inform its rulemaking process with research into the dose response of medical cannabis goods.  The Bureau should re-issue the sale limit recommendation based upon reasoned dose response research, and resubmit the proposed recommendation for Public Comment at a later date.
 
The Bureau should develop a system to red flag suspicious purchasing behavior to avoid diversion of medical cannabis
 
As noted above, an eight ounce daily limit on dry flower allows a patient to exit a dispensary having bought enough cannabis flower to produce 113 large joints at two grams a per joint.  There is nothing in the regulation to prevent a patient from returning the next day to purchase another eight ounces.  Diversion to the illicit market could present itself in myriad forms.  Product could be diverted to the grey market, to the black market the legal regulation is designed to undercut, or to youth and adolescents intent upon abusing the drug for non-medical purposes. 
 
The Bureau needs to implement regulations to ensure that patients are not buying more medical cannabis than they may use personally with the aim of diverting the goods to the illicit market.  Without a mechanism to monitor or red flag the amount of cannabis product a medical cannabis patient is dispensed, a bad faith patient could exploit this loophole, purchasing eight ounces of dry flower per day and divert much of it to the illicit market, stymying the Bureau’s espoused rationale in imposing a daily limit.
 
A patient withdrawing eight ounces multiple times a week could easily violate the eight ounce possession limit as specified in Cal. Health & Safety Code § 11362.77.  Likewise, a bad faith patient could make multiple eight ounce purchases of dry flower per week, divert much of it, and still remain under the eight ounce possession limit established in Cal. Health & Safety Code § 11362.77, providing additional support for the argument that tying the dispensing limit directly to the possession limit is unworkable in California.  It is reasonable to retain a possession limit that exceeds the daily sale limit given that a patient might want to withdraw enough cannabis for a month while remaining under the possession limit.  A patient may also retain excess unused medical cannabis between months and may accumulate more than is needed for a particular month with the carryover cannabis product. 
 
While fully recognizing the privacy concerns inherent in maintaining a database of cannabis patients under the current state of Federal prohibition, the Bureau should enact a measure that will prevent against over-dispensation of cannabis to patients in light of the economic incentive to divert the product to an unintended illegal use.  Absent a system designed to red flag suspicious behavior the daily sale limit should be lowered to 2 ounces or lower and equivalent amounts of THC delivery from other products. 
 
The Excessive Eight Ounce  Sale Limit May Attract Robberies of Patients, Not Deter Them
 
Finally, as the Initial Statement of Reasons recognizes, a patient possessing an excessive amount of medical cannabis  may attract robberies.  However, the proposal of an eight ounce sale limit is inconsistent with this stated objective, as a criminal has greater incentive to rob a patient carrying such an excessive amount of cannabis. 
 
For the foregoing reasons, the eight ounce medical cannabis possession limit is excessive, and furthermore, should not be pinned to the possession limit found in the constitutionally preempted Cal. Health & Safety Code § 11362.77.  Instead, the Bureau should defer final rulemaking procedures on the sale limit until they have developed a sale limit based upon research into proper dosage recommendations to be resubmitted for public comment at a later date.   
 
The exemption to the prohibition on local law enforcement personnel not holding licenses should be dropped (§5008(c))
 
In relevant part, proposed BMCR § 5008(a)-(c) states:
 
 (a) No license authorized by the Act and issued by the bureau shall be held by, or issued to, any person holding office in, or employed by, any agency of the State of California or any of its political subdivisions when the duties of such person have to do with the enforcement of the Act or any other penal provisions of law of this State prohibiting or regulating the sale, use, possession, transportation, distribution, testing, manufacturing, or cultivation of medical cannabis goods.
(b) This section applies to, but is not limited to, any persons employed in the State of California Department of Justice, in any district attorney's office, in any city attorney’s office, in any sheriff's office, in any local police department, or in the State Department of Consumer Affairs.
(c) This section shall not prohibit the ownership of any licensed commercial cannabis business by any local law enforcement officer or local reserve law enforcement officer when the licensed premises are located in a county other than that in which he or she is employed as a law enforcement officer.
 
The general prohibitions against California state employees involved in enforcement of the MCRSA holding medical cannabis licenses during the term of their employment in § 5008(a)-(b) are appropriate because they will deter regulatory capture, avoid conflicts of interest, and deter corruption. However, the carve-out for local law enforcement in § 5008(c) is inappropriate because it ignores the conflict of interest inherent in allowing local law enforcement to exert market influence both as a licensee and as a law enforcement officer imbued with the discretion to enforce drug interdiction laws.  The Initial Statement of Reasons appropriately justifies the general prohibition as it applies to state-level employees, but conspicuously omits any reasoning to justify the local law enforcement carve-out (Initial Statement of Reasons, pg. 19).   
 
Indeed, the Bureau, in its Initial Statement of Reasons, recognizes the value of avoiding conflicts of interest and the appearance of impropriety as justification for the general prohibition against entering into licensure by state-level employees involved in enforcement of the MCRSA (Initial Statement of Reasons, pg. 19).  The proposed regulation’s allowance for local law enforcement to enter into medical cannabis licensure in a county other than that of their employment is inconsistent with the (appropriate) reasoning in the rule as applied to state officials, and, at worst, gives the appearance of lobbying or special interest influence.   
 
The extra-county caveat does not diffuse the inherent conflict of interest.  The § 5008(c) exception would allow a local police officer licensee to engage in noncompetitive behaviors by over-policing competitors in their county of employment to drive business to their county of licensure.  Moreover, other law enforcement officers and other government agents familiar with the police officer licensee may be incentivized to privilege the license holder to the detriment of other license holders.  Local law enforcement licensees may be the inadvertent or intended beneficiaries of privilege by government officials’ subconscious of conscious bias due to the status of respectability American culture confers upon police officers.
 
Faith in the regulatory system is necessary to move the cannabis trade from the illicit market to the licit market.  The Bureau’s § 5008(c) exception could erode public faith and damage the agency’s credibility, thereby subverting these regulations and undermining protection of public health.  The Bureau should strike the local law enforcement carve-out found in § 5008(c) from the proposed regulations because it creates a glaring conflict of interest and opens the door to corruption and serves no public good.
 
The regulation should explicitly establish a program of unannounced compliance inspections on a routine and frequent basis
 
The Bureau has outlined its general authority to inspect dispensaries under the proposed regulations.[20] In addition, public health best practices from alcohol and tobacco control indicate that a system of unannounced compliance checks is needed to promote effective adherence to sales restrictions.[21],[22],[23],[24],[25]  (California has been particularly successful in reducing youth sales using unannounced compliance checks through the STAKE Act.[26])  While there is no minimum age limit set for access to medical cannabis, restrictions on sales to individuals without a valid Medical Marijuana Recommendation presents an analogous concern and justifies a similar enforcement approach to prevent unauthorized access and product diversion.
 
California recently advanced its efforts to eliminate youth tobacco use by raising the minimum age to purchase or consume tobacco to 21.[27]  Recreational cannabis under the recently passed Adult Use of Marijuana Act will similarly be restricted to those over 21.[28]  While there is no minimum age for medical cannabis use under current California law, robust enforcement of proper identification verification procedures is essential to reduce or eliminate efforts to misuse or abuse the medical cannabis program by those under the lawful age for non-medical cannabis consumption and those under the lawful age for tobacco consumption who may seek to substitute cannabis for tobacco. A properly regulated system for medical cannabis sales must not undo hard-fought gains in tobacco control through lack of enforcement.  Best practices from alcohol and tobacco control indicate that unannounced compliance checks are a critical component of ensuring that retailers conform to sales regulations that protect public health.
 
The regulations for delivery (§ 5187) should include requirement for the driver to verify the identity of the cannabis consumer
 
Section 19334(b) of the MCRSA enables the Bureau to establish minimum requirements for the delivery of medical cannabis to patients.  While the MCRSA does not contain a specific requirement for delivery drivers to verify the age and identity of medical cannabis patients, the Initial Statement of Reasons pertaining to §5187 recognizes the need for delivery drivers to perform this threshold duty to ensure that medical cannabis is delivered to the intended patient  (Initial Statement of Reasons, pg. 68).  Given that the Bureau recognizes the obligation for delivery persons to verify age and identity in its Initial Statement of Reasons, the Bureau should include an additional provision explicitly requiring delivery persons to check the identification and age of the medical cannabis recipient to ensure compliance and dissuade diversion to youth or illicit markets.
 
There should be explicit rules for calculating the average medical cannabis display amount (§ 5163)
 
While we appreciate that the Bureau has sought to constrain display amounts, §5163(d) is vague as to what term the daily average clause is predicated upon calculating.  The Initial Statement of Reasons is also silent as to the term which licensees should use to calculate the daily average.  For instance, does the Bureau intend for the daily average to be calculated based upon an average for a weekday versus a weekend day when sales might surge; upon a weekly average; upon a monthly average; or upon an average of 365 days of sales?  Recognizing that the Bureau may have drafted the section to account for the fact that nascent businesses might not have robust sales data and/or the fact that established businesses will have to adapt their previous practices to fit the new rule, the Bureau should explicitly flesh out the temporal term upon which the daily average display limit should be calculated and submit this calculation for additional public comment before finalizing it
 
Conclusion
 
The BMCR’s proposed regulations are a first step in the important process of bringing the medical cannabis industry into the light and away from its status as an under-regulated industry.  The Bureau’s proposed regulations that provide ex-convict applicants the ability to rehabilitate their character will lower barriers to entry for minority communities and victims of the inequitable war on drugs.  The provision establishing standards for exit packaging will ensure that patients do not violate open container laws, especially while operating vehicles, while child-resistant packaging will protect children from access to medical cannabis.  However, the proposed daily eight ounce sale limit is excessive and damaging to public health in that it encourages robbery crime against patients, promotes diversion, and may drive over-consumption.  To bring the regulations into parity with the sale limits in other states, the Bureau should either decrease the sale limit to two (2) ounces per day or retain the eight (8) ounces limit but increase the dispensation term from per day to per three months.  Finally, the Bureau should completely drop the carve-out for local law enforcement found in § 5008(c), as its codification of a glaring exception from the general prohibition against state employees holding licenses during the term of their employment is damaging to the public trust.   
 

 
APPENDIX
 
Results of State Survey on Medical Cannabis Sale Limits
 
Study Population
 
The study population includes all states having legalized medical cannabis.  Florida and Maryland were excluded from the study population for not having implemented a solidified medical cannabis regulatory scheme.  Oregon was excluded for being in the midst of aligning medical and recreational cannabis regulation under a unitary regulatory scheme.  West Virginia was excluded for not having assigned a 30-day possession or sale limit.  Michigan and Montana were excluded for not specifying either a dispensing limit nor term.  Vermont was excluded for only specifying a 2.5 ounce possession limit to be shared jointly between a patient and caregiver.  We then analyzed the possession and dispensing limits of the remaining 21 states and Washington DC, including: Alaska, Arizona, Arkansas, Colorado, Connecticut, Delaware, Hawai’i, Illinois, Maine, Massachusetts, Minnesota, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Dakota, Ohio, Pennsylvania, Rhode Island, and Washington, D.C.  California was excluded from the Excel workbook tabulation for being the subject of this Public Comment.       
 
Daily Limit
 
Two states in the study sample impose daily limits.  Alaska mandates that one ounce may be dispensed per transaction, while Colorado mandates that two ounces may be dispensed per transaction (which, in practice, is taken to be a daily limit).  The Bureau’s proposed daily sale limit of eight ounces far exceeds the daily sale limits set by Alaska and Colorado.

Two Week Sale Limit
 
Eight states in the sample impose a dispensation schedule mandating maximum purchase limits during a 14 or 15 day term. Arizona, Arkansas, Illinois, Maine, Nevada and Rhode Island mandate that a patient may only be dispensed 2.5 ounces in a 14 or 15 day period.  Delaware specifies a dispensing limit of 3 ounces in a 14-day period.  Hawai'i specifies a dispensing limit of no more than 4 ounces in a 14-day period or 8 ounces in a 30-day period.  The eight ounce daily sale limit proposed by the Bureau is especially high in comparison to other states imposing more restrictive sale limits over a greater two-week dispensation term.
 
30-day or Monthly Sale Limit
 
Three states and Washington, D.C. impose 30-day or monthly sale limits on the sale and dispensation of medical cannabis.  Connecticut and North Dakota mandate a dispensing limit of 2.5 ounces per month, while New Jersey and Washington, D.C. mandate a dispensing limit of 2 ounces per 30-day monthInterestingly, these monthly limits are more restrictive in the sale limit than Colorado or Alaska’s daily sale limit amounts.  The Bureau’s proposed daily sale limit of eight ounces exceeds the monthly sale limits imposed by Connecticut, North Dakota, New Jersey, and Washington, D.C. by three and four fold.

Outliers
 
Three states were defined as outliers in that their sale limits and dispensing terms were unique from other states, and therefore, incapable of grouping by code.  Of the states with outlier dispensing limits, New Mexico allows a patient to be dispensed no more than eight ounces over a three-month period, Massachusetts allows 10 ounces over a 60-day period, and New Hampshire allows 2 ounces over a ten-day period.  California's proposed eight ounce daily sale limit far exceeds all of these states’ limits and appears arbitrary and excessively permissive.
 
Imposition of Sale Term Without Specified Sale Limit
 
Five states in the study sample impose dispensing terms, without specifying the amount of medical cannabis that may be provided.  Minnesota and New York prescribe 30-day and 90-day terms, respectively, and benchmark the amount to be dispensed to the physician's recommendation.  Of states specifying a dispensing term without an accompanying dispensing or sale limit, Minnesota, New York, Pennsylvania, and West Virginia allow only a 30-day supply to be dispensed, while only Ohio specifies a dispensing term without an accompanying limit.  While analysis of these states is of limited utility to the present issue due to the indefinite sale limits, we argue that tying the dispensing limit to the discretion of a physician is sounder policy and more closely tracks accepted medical and pharmacy practices.  However, there exists little scholarly research on the absorption rates, pharmacokinetics, or patients’ idiosyncratic dose responses to the myriad types of medical cannabis products the draft regulations contemplate, making accurate titration by physicians a difficult task.  Further, without standardized dosing for each strain or product type, the justification for leaving the dosage determination to the discretion of the physician may be attenuated.  In light of the foregoing, and barring adoption of our previous recommendations, we suggest that the Bureau impose a sale limit benchmarked against a physician’s recommendation for that particular patient and ailment, not to exceed the recommended amount for a standardized term.
 
Eight (8) Ounce Limit
 
When examining the eight ounce sale limit variable in isolation, Hawai’i and New Mexico provide a foil for the proposed eight ounce daily limit.  Hawa’i allows for the dispensation of eight ounces in a 30-day period, while New Mexico mandates an eight ounce sale limit during a three-month time period, terms which anticipate a more reasonable rate of consumption than the Bureau’s proposed eight ounce daily sale limit.   
 
See Table of Statutes for specific statutory language and citations, attached.  
 
 

[1] Barry RA, Hiilamo H, Glantz SA. Waiting for the Opportune Moment: The Tobacco Industry and Marijuana Legalization. Milbank Q 2014;92(2): 207-242. doi:  10.1111/1468-0009.12055

[2] Barry RA, Glantz SA. A Public Health Framework for legalized Retail marijuana Based on the US Experience: Avoiding a New Tobacco Industry. PLoS Med 2016;13(9): e1002131. doi:  10.1371/journal.pmed.1002131

[3] Moir D, Rickerrt WS, Levasseur G, Larose Y, Maertens R, White P, et al. (2008). A Comparison of Mainstream and Sidestream Marijuana and Tobacco Cigarette Smoke Produced under Two Machine Smoking Conditions. Chem Res Toxicol 21: 494–502. pmid:18062674

[4] 27 CCR § 25603.3. 

[5] Reproductive and Cancer Hazard Assessment Branch Office of Environmental Health Hazard Assessment, California Environmental Protection Agency. Evidence on the Carcinogenicity of Marijuana Smoke (2009).

[6] National Academies of Sciences, Engineering, and Medicine. 2017. The health effects of cannabis and cannabinoids: The current state of evidence and recommendations for research. Washington, DC: The National Academies Press. doi: 10.17226/24625.

[7] Wang X, Derakhshandeh MS, Liu J, et al. One Minute of Marijuana Secondhand Smoke Exposure Substantially Impairs Vascular Endothelial Function. J Am Heart Assoc 2016;5:e003858. https://doi.org/10.1161/JAHA.116.003858.

[8] Widlandky ME, Gokce N, Keaney JF Jr, Via JA. The clinical implications of endothelial dysfunction. J Am Coll Cardiol 2003; 42(7): 1149-60.

[9] Yeboah J, Folsom AR, Burke GL, et al. Predictive Value of Brachial Flow-Mediated Dilation for Incident Cardiovascular Events in a Population-Based Study: The Multi-Ethnic Study of Atherosclerosis. Circulation 2009; 120(6): 502-509. doi:  10.1161/CIRCULATIONAHA.109.864801.

[10] Grana R, Benowitz, N, Glantz SA. E-Cigarettes: A Scientific Review. Circulation 2014; 129(19): 1972-1986. doi:  10.1161/CIRCULATIONAHA.114.007667.

[11] Chun LF, Moazed F, Calfee CS, Matthay MA, Gotts JE. Pulmonary Toxicity of E-cigarettes. Am J Physiol Lung Cel Mol Physiol 2017 May 18:ajplung.00071.2017. doi: 10.1152/ajplung.00071.2017. [Epub ahead of print].

[12] Canistro D, Vivarelli F, Cirillo S, et al. E-cigarettes induce toxicological effects that can raise the cancer risk. Sci Rep 2017; 7: 2028. doi:  10.1038/s41598-017-02317-8.

[13] Pope CA 3rd, Burnett RT, Krewski D, et al. Cardiovascular mortality and exposure to airborne fine particulate matter and cigarette smoke: Shape of the exposure-response relationship. Circulation 2009; 120(11): 941-8 doi: 10.1161/CIRCULATIONAHA.109.857888. 

[14] Talal A, Pena I, Temesgen N, Glantz SA. 2017. Electronic cigarette use and myocardial infarction: A national cross-sectional study in the United States. (Submitted for publication)

[15] Loflin M, Earleywine M. A new method of cannabis ingestion: The dangers of dabs? Addictive Behav 2014; 39(10): 1430-1433. https://doi.org/10.1016/j.addbeh.2014.05.013.

[16] Lorenzetti V, Alonso-Lana S, Youssef GJ, Verdejo-Garcia A, Suo C, Cousijn J, Takagi M, Yücel M, Solowij N.  Adolescent Cannabis Use: What is the Evidence for Functional Brain Alteration?  Curr Pharm Des. 2016; 22(42): 6353-6365.

[17] Blumentrath CG, Dohrmann B, Ewald N.  Cannabinoid hyperemesis and the cyclic vomiting syndrome in adults: recognition, diagnosis, acute and long-term treatment.  Ger Med Sci. 2017; 15:Doc06

[18] National Academies of Sciences, Engineering, and Medicine. 2017. The health effects of cannabis and cannabinoids: The current state of evidence and recommendations for research. Washington, DC: The National Academies Press. doi: 10.17226/24625.

[19] Assumption: Average large joint contains 2 grams of dry flower; 8 ounce daily limit X 28.3 grams/ounce  = 227 grams;  227 grams/ average 2 gram joint = 113 average large joints 

[20] Bureau of Marijuana Control Proposed Text of Regulations §§5017(a)(3), 5054(b).

[21] Interagency Coordinating Committee for the Prevention of Underage Drinking (ICCPUD) (2015) Annual Report to Congress on the Prevention and Reduction of Underage Drinking. Rockville, MD: Substance Abuse and Mental Health Services Administration (SAMHSA).

[22] U.S. Surgeon General (2007) The Surgeon General’s Call to Action to Prevent and Reduce Underage Drinking. Rockville, MD: Office of the Surgeon General.

[23] Office of the Surgeon General (2016) Facing Addiction in America: The Surgeon General's Report on Alcohol, Drugs, and Health. Washington, DC: US Dept of Health and Human Services.

[24] U.S. Department of Health and Human Services (2012) Preventing Tobacco Use among Youth and Young Adults: A Report of the Surgeon General. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health.

[25] U.S. Department of Health and Human Services (2014) The Health Consequences of Smoking—50 Years of Progress: A Report of the Surgeon General. Atlanta, GA: U.S. Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion, Office on Smoking and Health.

[26] Landrine H, Klonoff EA, Reina-Patton A. Minors' access to tobacco before and after the California STAKE Act.  Tobacco Control 2000;9:ii15-i17.

[27] S.B.x2-7, 2015-2016 Leg. (Ca. 2016).

[28] Cal. Health & Safety Code § 11362.1 et seq.

[*] Candice Bowling, JD, MPA brings forth her expertise in the interplay between public health, local control, and cannabis regulation gained through her tenure at Colorado Department of Public Health, Prevention Services Division; coursework and thesis component at the University of Colorado—Denver; and her time at a Postdoctoral Fellow researching cannabis regulatory policy at UCSF in the Center for Tobacco Control Research and Education.

[†] Daniel G. Orenstein, JD, MPH is currently a Postdoctoral Fellow in the UCSF Center for Tobacco Control Research and Education where his focus is marijuana policy and its intersection with tobacco control. Mr. Orenstein has researched, taught, and published on numerous aspects of health and public health law and policy, including interpretation of medical marijuana laws in Arizona.

[‡] Dr. Glantz, the Truth Initiative Distinguished Professor of Tobacco Control, conducts research on a wide range of topics ranging from the health effects of secondhand smoke (with particular emphasis on the cardiovascular system) to the efficacy of different tobacco control policies.