For most people with epilepsy, diagnosis sets off a gauntlet of trial-and-error attempts to find the right medication. The process is tortuous, with seizures alternately dying down and flaring up while side effects— fatigue, nausea, liver damage, and more—develop without warning. This is partly due to the fact that “epilepsy” is actually a broad category that includes a number of distinct seizure disorders. About 30 medications approved by the U.S. Food and Drug Administration are currently used to treat these conditions, and when a person first begins having seizures, there is often much tinkering with combinations and dosages. I spent years battling side effects like vomiting, dizziness, drowsiness, and severe headaches, which were alleviated only by yet another prescription medication. Parents who endure enough sleepless nights caring for a sick child can become desperate for a cure.
Cooper recently got funding from the National Institutes of Health for a study looking at cannabinoids — including CBD in isolation — as a substitute for opioids, and numerous other clinical trials of CBD are underway. It will be several years before results are available, but these studies should help clarify both what benefits the substance may provide and any side effects it may come with. Most of the adverse effects so far associated with cannabis, such as impairments in short-term memory, coordination and judgment,2 come from products that contain THC as well as CBD, Cooper said, but we need to do more studies to find out for sure whether CBD has fewer risks. Studies are also needed to identify the best way to administer and dose CBD. “I get emails from people asking me what dose of CBD to use, and the truth is, we really don’t know,” Cooper said.
Cannabis , also known as marijuana, originated in Central Asia but is grown worldwide today. In the United States, it is a controlled substance and is classified as a Schedule I agent (a drug with a high potential for abuse, and no currently accepted medical use). The Cannabis plant produces a resin containing psychoactive compounds called cannabinoids, in addition to other compounds found in plants, such as terpenes and flavonoids. The highest concentration of cannabinoids is found in the female flowers of the plant. Clinical trials conducted on medicinal Cannabis are limited. The U.S. Food and Drug Administration (FDA) has not approved the use of Cannabis as a treatment for any medical condition. To conduct clinical drug research with Cannabis in the United States, researchers must file an Investigational New Drug (IND) application with the FDA, obtain a Schedule I license from the U.S. Drug Enforcement Administration, and obtain approval from the National Institute on Drug Abuse.
For many, the medical and therapeutic potential of cannabis is what makes legalizing the marijuana plant such an important political and social task. Federal prohibition has established barriers to comprehensive cannabis research in the United States. However, researchers in other countries continue to make significant contributions to our knowledge of the cannabis plant and how it affects the human body.
Yet when one looks at the industry more broadly, there is cause for concern. In February, as part of an investigation into the marketing claims of six hemp oil companies, the FDA analyzed 18 CBD products. What it found was disturbing: Many of these supposed CBD products were entirely lacking in CBD. Of the products tested, six contained no cannabinoids whatsoever. Another 11 contained less than 1 percent CBD. The product that tested highest in CBD, at 2.6 percent, was a capsule for dogs. In states that have legalized CBD, regulations can require CBD products to contain at least 5 percent CBD, more often 10 or 15 percent.
An alternative to the gateway hypothesis is the common liability to addiction (CLA) theory. It states that some individuals are, for various reasons, willing to try multiple recreational substances. The "gateway" drugs are merely those that are (usually) available at an earlier age than the harder drugs. Researchers have noted in an extensive review that it is dangerous to present the sequence of events described in gateway "theory" in causative terms as this hinders both research and intervention.
Those warning letters aside, there’s not a lot of federal oversight right now over the claims being made or the products that are being sold. Cohen warned against buying CBD products online, because “there’s a lot of scams out there.” Yet his clinic sells CBD, and he admits, “I say ‘Don’t buy online,’ but ours is worth doing, because we know what we’re doing. We ship all over.”
The CBD utilized in our tinctures is extracted from industrial hemp cultivated in the United States. To further ensure quality and purity, our industrial hemp goes through a supercritical CO2 extraction process to obtain the best possible CBD solution. This solution is then formulated by our board-certified pharmacists into finished products and sent out for third-party testing. Our CBD oil is made with high-quality CBD extracted from organic hemp that is abundant in naturally produced terpenes, oils, vitamins, omega fatty acids, and other components.
Both in Canada and the US, the most critical problem to be addressed for commercial exploitation of C. sativa is the possible unauthorized drug use of the plant. Indeed, the reason hemp cultivation was made illegal in North America was concern that the hemp crop was a drug menace. The drug potential is, for practical purposes, measured by the presence of THC. THC is the world’s most popular illicit chemical, and indeed the fourth most popular recreational drug, after caffeine, alcohol, and nicotine. “Industrial hemp” is a phrase that has become common to designate hemp used for commercial non-intoxicant purposes. Small and Cronquist (1976) split C. sativa into two subspecies: C. sativa subsp. sativa, with less than 0.3% (dry weight) of THC in the upper (reproductive) part of the plant, and C. sativa subsp. indica (Lam.) E. Small & Cronq. with more than 0.3% THC. This classification has since been adopted in the European Community, Canada, and parts of Australia as a dividing line between cultivars that can be legally cultivated under license and forms that are considered to have too high a drug potential. For a period, 0.3% was also the allowable THC content limit for cultivation of hemp in the Soviet Union. In the US, Drug Enforcement Agency guidelines issued Dec. 7, 1999 expressly allowed products with a THC content of less than 0.3% to enter the US without a license; but subsequently permissible levels have been a source of continuing contention. Marijuana in the illicit market typically has a THC content of 5% to 10% (levels as high as 25% have been reported), and as a point of interest, a current Canadian government experimental medicinal marijuana production contract calls for the production of 6% marijuana. As noted above, a level of about 1% THC is considered the threshold for marijuana to have intoxicating potential, so the 0.3% level is conservative, and some countries (e.g. parts of Australia, Switzerland) have permitted the cultivation of cultivars with higher levels. It should be appreciated that there is considerable variation in THC content in different parts of the plant. THC content increases in the following order: achenes (excluding bracts), roots, large stems, smaller stems, older and larger leaves, younger and smaller leaves, flowers, perigonal bracts covering both the female flowers and fruits. It is well known in the illicit trade how to screen off the more potent fractions of the plant in order to increase THC levels in resultant drug products. Nevertheless, a level of 0.3% THC in the flowering parts of the plant is reflective of material that is too low in intoxicant potential to actually be used practically for illicit production of marijuana or other types of cannabis drugs. Below, the problem of permissible levels of THC in food products made from hempseed is discussed.
A randomized, placebo-controlled, crossover pilot study of nabiximols in 16 patients with chemotherapy-induced neuropathic pain showed no significant difference between the treatment and placebo groups. A responder analysis, however, demonstrated that five patients reported a reduction in their pain of at least 2 points on an 11-point scale, suggesting that a larger follow-up study may be warranted.
The 2014 US Farm Bill allows states that have passed their own industrial hemp legislation to grow industrial hemp for purposes of research and development. Several states — including Kentucky, Colorado, and Oregon — are already conducting hemp pilot projects. Many other states are currently pursuing similar legislation and programs. After many years of prohibition, American farmers are finally reacquainting themselves with industrial hemp.
Most human studies of CBD have been done on people who have seizures, and the FDA recently approved the first CBD-based drug, Epidiolex, for rare forms of epilepsy. Clinical trials for other conditions are promising, but tiny. In one Brazilian study published in 2011 of people with generalized social anxiety disorder, for example, taking a 600-mg dose of CBD (higher than a typical dose from a tincture) lessened discomfort more than a placebo, but only a dozen people were given the pill.
The reason so many people are interested in cannabis products that don’t make them high, proponents say, is that CBD helps with everything from pain and nausea to rheumatoid arthritis, cancer, Crohn’s disease, and dementia. CBD is anti-inflammatory, anti-anxiety, antibacterial, immunosuppressive, and more, says Joseph Cohen, D.O., a cannabis doctor in Boulder, CO.
In the UK, the Department for Environment, Food and Rural Affairs treats hemp as a purely non-food crop, but with proper licensing and proof of less than 0.2% THC concentration, hemp seeds can be imported for sowing or for sale as a food or food ingredient. In the U.S., imported hemp can be used legally in food products and, as of 2000, was typically sold in health food stores or through mail order.