Cannabis Regulation: Law, Society, and Health

Thomas Parker Redick. Agricultural Management Committee Newsletter. July 30, 2019.

This article will discuss the rapidly evolving legal landscape and liability risks of cannabis in the United States. Although marijuana and cannabis remain illegal on a federal level, that hasn’t stopped various states from continuing their efforts to increase tolerance for this product in many U.S. states. Indeed, as the chart appended to this article shows, only four states have no laws allowing cannabis or cannabidiol (CBD) to be sold while both remain on the federal list of illegal drugs.

Founding Fathers Hailed Hemp

Historical research has revealed that Washington, Jefferson, and Madison grew hemp for commercial gain; Thomas Jefferson smoked it as medicine for migraines; and James Madison suggested that “sweet hemp” sent him the “insight to create a new and democratic nation.” Some Jefferson experts admit Jefferson wanted to grow stronger cannabis, so he is supposed to have illegally smuggled potent hemp seeds from China into France. Like Washington, Jefferson improved hemp landraces, inventing a tool for crushing the plant’s stems during fiber processing. Washington’s diary records him immersing his hemp in water to drink, indicating he may have been seeking the benefits of its psychoactive component THC (tetrahydrocannabinol).

The Legalization Bandwagon Rolls On

While both cannabis and CBD remain federally illegal, perhaps the biggest and most effective lobby for national legalization of those two compounds are veterans suffering from pain, PTSD, addiction, or other ailments that these compounds are believed to be effective in treating. Under federal law, veterans are denied access to these treatment options.

The issue of national legislation may not need to wait for a democrat to take the presidency, if enough republicans shift their support to cannabis, former House Speaker John Boehner has reversed his unalterable opposition to cannabis, stating on Twitter that: “I’m convinced de-scheduling the drug is needed so we can do research, help our veterans, and reverse the opioid epidemic ravaging our communities.” Calling on the federal government to reclassify marijuana, Boehner and William F. Weld, the former Massachusetts governor, who both sit on the board of Acreage Holdings (a cannabis production company), jointly stated, “the time has come for serious consideration of a shift in federal marijuana policy.”

President Trump, however, remains opposed to any loosening of federal restrictions to help veterans. As of May 2019, his administration has opposed three proposed bills that would: (1) allow cannabis prescriptions for veterans; (2) conduct a study on health effects of cannabis; and (3) stop stripping veterans of VA benefits when they consume state-legal cannabis.

The Rohrabacher-Farr amendment) prevents the U.S. Department of Justice (DOJ) from spending money to prevent states where medical marijuana is legal from “implementing their own State laws that authorize the use, distribution, possession, or cultivation of medical marijuana.”

The DOJ rescinded the Cole guidelines that encouraged federal prosecutors to take a hands-off approach in legal states, and some U.S. attorneys have diversion, violence, or illegal sales to minors could prompt them to take action. He’s presumably not too pleased with reports like one issued this week by Oregon cannabis regulators that found a number of stores around the state that reportedly sold cannabis to minors.

In 2018, a lawsuit alleging that the federal ban is illegal was filed, with interesting constitutional claims. First, a former professional football player who sells cannabis pills asserted the right to conduct interstate commerce. Second, an epileptic young girl with a serious seizure disorder sued under her right to unimpeded travel to obtain treatment. Third, a nonprofit alleged that these policies illegally discriminated against minorities. Fourth, plaintiffs alleged federal policy and law lack any scientific justification, citing Obama’s Surgeon General support for medical use.

Medical Marijuana Now in Majority of U.S. States

Currently, 33 states plus Washington, D.C., allow medical marijuana consumption, with that number only expected to increase in the coming years. The first state to effectively legalize medical cannabis was California in 1996, when voters approved Proposition 215 by a 56-44 margin. Several states followed with successful ballot initiatives in 1998, and in 2000 Hawaii became the first to legalize by state legislature.

States have imposed an array of different requirements for getting a medical marijuana card, which is a hurdle that seems to be getting lower with passing time. Acceptance of cards across states seems to be the norm.

Legalization in Minority of U.S. States and Some Nations

Colorado led the way in legalizing cannabis for recreational use. To date, Vermont has legalized recreational marijuana along with Oregon, Maine, Alaska, California, Nevada, and Michigan. Many other medical marijuana states will soon follow suit, according to industry observers.

A majority of Americans (61 percent) want recreational marijuana legalized and 94 percent favor medical marijuana use. In 2016, cannabis sales totaled $6.7 billion Katch, supra.

America’s polite neighbor to the North, Canada, issued a nationwide legalization law in 2018, following the first nation, Uruguay, in legalizing cannabis nationwide.

Following in the footsteps of the United States, cannabis was banned in Canada in 1923. In the 1960s, again parallel to the United States, Canadians used pot in counterculture settings. In contrast to the U.S. ban on research, however, Canada’s Le Dain Commission studied adverse effects of cannabis and recommended the decriminalization of possession of cannabis in 1972. This was largely ignored (except in nearby Ann Arbor, Michigan, which decriminalized pot in 1972), and cannabis remained widely used throughout North America, but against the law. Statistics in Canada report that in 2017, Canadians spent about $5.7 billion Canadian on cannabis, mostly for illegal nonmedical purposes. The United States spent about $10 billion in 2017, but with half of that coming from legal sources in states with medical or legalization laws.

Federal Policy and Health Risks of Cannabis

After years of legally imposed barriers to research on the health effects of cannabis, the federal Food and Drug Administration (FDA) is finally taking on the health issues, as researchers begin unearthing potential long-term health effects of cannabis.

FDA Notices Hearing on Health Effects of CBD

The FDA finally appears to be ready to address how to handle products containing CBD, which are being widely marketed in the United States. On Wednesday, April 3, 2019, the FDA announced plans to hold a meeting to discuss its regulatory approach to products that contain cannabis and cannabis-derived compounds, including CBD. The public hearing held on May 31, 2019, sought to obtain scientific data and information regarding the safety, manufacturing, product quality, marketing, labeling, and sale of products containing cannabis and cannabis-derived compounds.

FDA also announced the opening of a docket for public comments on three general topics:

  1. health and safety risks;
  2. manufacturing and product quality; and
  3. marketing, labeling, and sales.

In June 2018, FDA approved the prescription drug Epidiolex, with a purified form of CBD as its active ingredient. FDA will allow the marketing of food and dietary supplement products containing CBD if it can resolve questions over the health and safety of CBD. FDA is particularly interested in methods by which the maximal acceptable daily intake of cannabis and cannabis-derived compounds maybe determined. FDA also drilled down into detailed information on health effects among different populations (e.g., children, adolescents, pregnant and lactating women, specific species, and breeds of animals) as well as the influence that the mode of delivery (e.g., ingestion, absorption, inhalation) affects safety and exposure.

Avoiding Liability for Causing Schizophrenia

The strongest evidence that cannabis use is a contributory cause of schizophrenia comes from longitudinal studies of large representative samples of the population that have been followed over time to see if cannabis users are at higher risk of developing schizophrenia. The observed relationship between cannabis consumption and psychosis has long been recognized.

The lack of federal research into the health effects of cannabis may mean that companies may ignore their duty to warn of such health effects.

Pfizer has incurred liability for allegedly causing suicides with Prozac and other antidepressants like Zoloft, and cannabis may face similar lawsuits for alleging causing schizophrenia in cannabis users. For example, Zoloft’s side effects include depersonalization blunting of emotion and a condition called “akathisia,” a neurological phenomenon with characteristics of intense internal restlessness, agitation, and dysphoria, alone or in combination with other side effects, such as emotional blunting, are associated with acts of self-harm. In addition, Zoloft can cause manic, hypomanic, or even psychotic symptoms. Zoloft “pushes” the serotonin system, which can result in reciprocal switching off of the dopamine system. In the striatum of the brain, this can result in tremor and occasional dystonia and in the frontal lobes it can result in symptoms similar to the negative symptoms of schizophrenia. These symptoms can include patients feeling as if they were outside of their body. In short, the drug may drive some people to take their own life without delivering significant benefit.

The success in these cases sets the stage for litigation against providers of cannabis who fail to warn of the potential for cannabis to induce schizophrenia. Providing paperwork similar to the drug side effect warning inserts may be required to ensure that consumers are well-informed about these risks,

Does THC Appear in the Milk or Meat of Animals Fed THC-Containing Food?

Yes, milk and dairy products from animals fed with products containing hemp and hemp products may contain traces of THC. THC in Feeds Made from Hemp and Hemp Products with Regard to Animal Health and the Carry-Over to Foods of Animal Origin, BfR Opinion No. 044/2012 of September 18, 2012.

In a European study, the the German Federal Institute for Risk Assessment (Bundesinstitut für Risikobewertung, or BfR) calculated the intake of THC from feed by livestock by means of a model. THC is lipophilic and will accumulate in the fatty tissue of animals, so the THC concentration in meat and other foods of animal origin depends on the fat content. As a result, livestock with high fat levels accumulate more THC than animals with low fat deposits. Id.

Would Animals Incur Adverse Health Effect from Hemp or THC in Feed?

As with human health, there are few studies of health effects from cannabis and its psychoactive component THC in animals. In one study, mice, rats, dogs, and monkeys were measured for effects of low doses of THC on animal health. This data shows how individual animal species react differently to THC. For livestock, however, it appears that feeding of hemp and hemp products with THC concentrations as low as 0.2 percent (the maximum permitted concentration in the hemp varieties in European cultivation) will not impair animal health.

At the request of the European Commission, the European Food Safety Authority (EFSA) delivered a scientific opinion on the safety of hemp (cannabis) for use as animal feed. EFSA suggested to put whole hemp plant-derived feed materials on the list of materials whose placing on the market or use for animal nutritional purposes is restricted or prohibited and to introduce a maximum THC content of 10 mg/kg to hemp seed derived feed materials.

Conclusion

Regulatory bodies will continue to wrestle with cannabis issues, and states will continue to expand legalization if past trends are accurate indicators. While it remains illegal under federal law, cannabis has taken root legally in states across America.

Under the U.S. federal system, states are “laboratories of law” where policies can be tested and perfected. It would appear to be only a matter of time before the United States follows its neighbor to the north, Canada, in legalizing cannabis, given the steady expansion of legalization across the United States.

Only two states in the United States continue to ban all three–medical, legal, and CBD cannabis use–with no decriminalization or normalization: Idaho and South Dakota (although there is some confusion on the latter state’s position regarding CBD).