The federal medical marijuana bill introduced this week would specifically legalize CBD, a chemical component of cannabis.
It is a move that could have broad implications.
Plants rich in CBD have been found to be of particular use by children suffering from rare and severe forms of epilepsy and other seizure disorders. CBD is regarded as a powerful anti-inflammatory and anti-oxidant. Many families from Pennsylvania and New Jersey have moved to Colorado specifically to access CBD oils and CBD-rich cannabis.
The U.S. Senate bill would reclassify CBD, and separate it from marijuana in general. This could allow CBD to be shipped between states with laws that allow its production or use.
Eleven states have passed laws that deny broad access to medical marijuana, but do allow for some forms of CBD oils. Yet not a single child or patient has actually received any CBD under those extremely limited laws. Only states with robust medical marijuana programs currently offer any hope for patients. The Senate bill could change this landscape.
Meanwhile three hospitals in Pennsylvania, including Children's Hospital of Philadelphia, are conducting clinical trials with a CBD drug developed by GW Pharmaceuticals called Epidiolex. The Epidiolex oil uses CBD extracted from specially-cultivated marijuana plants. The experimental treatment has gained coveted orphan drug status by the FDA but the trials are very limited. Perhaps 10 patients, children with seizure disorders, are getting Epidiolex in Pennsylvania.
Proponents of CBD often describe it as being non-psychoactive. But if that were true it wouldn't work. Psychoactive means a substance that affects the mind or behavior. CBD-rich strains of cannabis are often described as being "calming" or even "sedative." This is in contrast to THC rich strains that are described as being "uplifting" or "creative." It is true however that CBD does not cause intoxication like THC.
The language of the new Senate bill -- the Compassionate Access, Research Expansion and Respect States (CARERS) Act, makes it painfully clear that the federal government currently considers CBD contraband.
Still, right now, outside of the medical marijuana community there is already a booming business in CBD that is extracted from plant material shipped from overseas and then sold across the United States.
Several large companies have found local outlets in Pennsylvania and New Jersey for products marketed as containing cannabidiol. The products also can be purchased readily online. But what are they?
The sellers of these products claim that they are legal in every state. But that claim may be premature. Serious questions remain as to their status under the law. Last week, the FDA issued warning letters to 26 companies selling CBD products saying that CBD is an "unapproved new drug." FDA testing actually found some of the products failed to contain any CBD at all.
The new wave of CBD products are marketed as "dietary supplements." Unlike the companies targeted by the FDA letters, others are more careful not to make specific claims about treating any disease or condition. Instead they are promoting general "wellness."
The manufacturers and sellers claim that their powders, oils and vaporizer cartridges are legal because they say their CBD is derived from industrial hemp. That hemp is farmed in Canada, China or Europe.
Such sourcing, if true, may still be an issue. Foreign farmers are growing the hemp primarily for fiber used to make everything from t shirts to building materials or producing non-germinated hemp seeds for human consumption.
The most famous cannabinoid is THC because it causes the main euphoric effect or "high" with marijuana. Hemp does contain every low levels of cannabinoids. All industrial hemp products imported to the U.S., whether it is cloth for backpacks or seeds to mix into yogurt, must have less than 0.3% THC.
Federal regulators have focused on THC levels when it comes to testing these hemp products, ostensibly so that no one is smoking their hemp shower curtain to get high.
Hemp is in the Cannabis family, which is why it remains federally illegal to grow in the U.S. Some states have allowed limited, research crops but only for fiber uses.
The sellers of the new CBD "dietary supplements" claim that their "hemp-derived" products have very low levels of THC. Compared to marijuana plants, hemp plants will yield only small amounts of cannabinoids.
In September 2014, a lawsuit was filed in New Jersey Superior Court on behalf of a Elevate Smart Shop in Voorhees who stock a product called "Cibdex" that contains very low levels of CBD. They are seeking a judge to decide on the legality of CBD products. No ruling has yet been issued.
Last fall a group called ProjectCBD launched an investigation into the trend.
ProjectCBD was founded by two veteran journalists. Fred Gardener has published a medical marijuana journal called O'Shaughnessy's since 2003. Martin Lee founded the well-known media watchdog group FAIR and published a book called Smoke Signals: A Social History of Marijuana.
In October, the group published their report Hemp Oil Hustlers: A ProjectCBD Special Report On Medical Marijuana Inc., HempMeds And Kannaway.
They focused on some of main wholesalers of the "hemp derived" CBD products. According to their report, a product from HempMeds, a black paste said to be rich in CBD called "RSHO Hemp Oil," was being aggressively offered to parents with severely ill children. It was seen as an alternative to CBD-rich medical marijuana being grown domestically under state law.
ProjectCBD went further by testing some of the products in a laboratory. Some of the products tested clean but with THC levels greater than 1%, well above the federal limits for industrial hemp. Disturbingly, some of the tests showed the presence of heavy metals and solvents that might be dangerous if ingested by humans-- especially already ill children.
There were two other companies mentioned in the report: CannaVest (the makers of Cibdex) and KannLife Sciences. One has a local connection. KannaLife operates a laboratory in Doylestown where they say they are developing cannabinoid drugs to treat brain conditions.
After ProjectCBD issued its report the CBD companies sued for $100 million saying the lab tests were "false claims." CannaVest and ProjectCBD later issued a joint press release that seemed to quell the lawsuit. ProjectCBD agreed to conduct further tests on more samples submitted directly by CannaVest. Those tests showed no contaminants.
Last year, I attended an event in New York City where many of these companies made presentations. They showed slides of lab test reports and set up booths where products were given away. At the CannaVest booth there were banners proudly proclaiming that their products had won awards at the High Times Magazine Cannabis Cup events. They readily offered samples of their sprays, powders and pills. All were labeled as containing CBD.
The displays at the event played on the biggest claim by the CBD "dietary supplement" hemp crowd: That CBD is already legal everywhere.
ProjectCBD posted a blog recently that fact-checked that assertion:
Purveyors of imported, CBD-infused hemp oil claim it's legal to market their wares anywhere in the United States as long as the oil contains less than 0.3 percent THC. Actually, it's not so simple. Federal law prohibits U.S. farmers from growing hemp as a commercial crop, but the sale of imported, low-THC, industrial hemp products is permitted in the United States as long as these products are derived from the seed or stalk of the plant, not from the leaves and flowers. Here's the catch: Cannabidiol can't be pressed or extracted from hempseed. CBD can be extracted from the flower, leaves, and, only to a very minor extent, from the stalk of the hemp plant. Hemp oil start-ups lack credibility when they say their CBD comes from hempseed and stalk. Congress may soon vote to exempt industrial hemp and CBD from the definition of marijuana under the Controlled Substances Act. Such legislation would not be necessary if CBD derived from foreign-grown hemp was already legal throughout the United States.
ProjectCBD went further:
"CBD is CBD – It doesn't matter where it comes from."
Yes it does matter. The flower-tops and leaves of some industrial hemp strains may be a viable source of CBD (legal issues notwithstanding), but hemp is by no means an optimal source of cannabidiol. Industrial hemp typically contains far less cannabidiol than CBD-rich cannabis. Huge amounts of industrial hemp are required to extract a small amount of CBD, thereby raising the risk of toxic contaminants because hemp is a "bio-accumulator" that draws heavy metals from the soil. Single-molecule CBD synthesized in a lab or extracted and refined from industrial hemp lacks critical medicinal terpenes and secondary cannabinoids found in cannabis strains. These compounds interact with CBD and THC to enhance their therapeutic benefits.
Two weeks ago, I posted the ProjectCBD "misconceptions" blog to the Keystone Cannabis Coalition group on Facebook. This generated an intense debate with a Pennsylvania resident who is importing these products and selling them. We'll call him "Pa CBD Guy."
Pa CBD Guy was, at first, conversational. He dismissed the ProjectCBD reports and insisted that he was operating acceptably under the law. When I pressed further about the source farm for his material he named a company called Hempflax.
Pa CBD Guy said that Hempflax sold CBD oils, fiber containing CBD and "hemp hurd" (the leftover stalks) which could be used for extraction.
Hempflax is a well-known company based in the Netherlands and Germany where they farm hundreds of acres of industrial hemp. The company website touts the many uses of their products; horse bedding, planting pots and raw fiber. There was nothing about CBD.
I emailed the company and asked a few questions. Mark Reinders, the Hempflax director of wholesale business, was happy to answer.
"We are supplying raw materials for extraction for CBD and extracts with high CBD levels," said Reinders, "We are not making end products and we do not market end users directly."
So it seems Hempflax is fully aware that their industrial hemp was being used to make some CBD products down the line. Pa CBD Guy was telling the truth about the source farm. But it seems he also got his facts mixed up a bit.
"We are an industrial hemp company producing hemp fibers for automotive, construction, textiles etc. During the harvest of our industrial hemp we are able to cut the leaves separate from the stalks," Reinders explained, "Those leaves are dried and pelletized so they can be extracted any moment in time. Industrial hemp hardly has any THC so the extract doesn't have any THC in it, max 0.3%. CBD levels are above 10%."
So it was leaves and not stalks being used. Reinders detailed the process: "We cut the upper 20-30 cm of the stem and chop it directly. It is transported to a drying facility immediately so it is dried and pelletized. This is the biomass of the industrial hemp, all with >0.2% THC. This product is legal to harvest and trade."
Cutting the tops of hemp plants would also gather the flowering portion.
Mark from Hempflax also made this careful statement about how third-party companies were using their industrial hemp: "I would like to stress very clearly that we are not exporting to the U.S. We sell to customers who organize the import and transport themselves and are responsible about the legality."
I went back into the Facebook group to point out the discrepancies to Pa CBD Guy; mainly that Hempflax was not shipping already extracted CBD oil. The local seller then said Hempflax was just one source for his products. The others were in California. He mentioned CannaVest.
I asked if Pa CBD Guy would be willing to have his name or his company name in this article. At first he was amenable, but then retracted. He then threatened lawsuits if I wrote about the exchange made some veiled personal threats as well. Pa CBD Guy concluded by deleting all of his comments from the thread. He also sent me several emails asking that the post and my own comments be deleted. I kept screenshots for my notes and left the post up.
Unlike Pa CBD Guy, companies such as CannaVest, the maker of the Cibdex being sold in New Jersey, have not disclosed the exact source farms for their hemp. On their website they proudly proclaim their model:
"CannaVest is in the business of developing, producing, marketing and selling end-consumer products containing industrial hemp-based compounds with a focus on cannabidiol (CBD). We seek to take advantage of an emerging worldwide trend to re-energize the production of industrial hemp and to foster its many uses for consumers. Our health and wellness raw industrial and consumer products are produced with cannabidiol (CBD), which is derived from hemp seed and stalk."
Notice there is nothing about flowers or leaves. That's because the entire CBD "dietary supplement" industry hangs their legal hats on a 2004 federal appeals court ruling in a case of the Hemp Industries Association (HIA) v. The Drug Enforcement Administration. The ruling talked about "non-psychoactive" hemp and specifically allowed the import of hemp derived from the seed or stalk of the plant, not from the leaves and flowers and, again, with THC content measures below 0.3 percent.
The case was seen as landmark for companies looking to use hemp food products and fibers in the United States. But those issues have since been clouded by the "hemp derived" CBD market.
Last year, the HIA issued a statement seeking to clarify the issue and separate themselves from the "dietary supplement" manufactures.
"Our Hemp Industries Association position regarding this distinction calls on makers of CBD products to brand and market their products truthfully and clearly, so as to not further the confusion surrounding CBD products in the marketplace," said Eric Steenstra the HIA executive director.
The warning letters from the FDA last week were the first time any federal agency took notice of the CBD sellers. Nothing was mentioned by the FDA regarding the legal status of CBD but that should not be taken as a blessing. In fact the FDA warning may be the first salvo of federal attention.
Still there has not been any crackdown, seizure, arrest or law enforcement action brought to the CBD sellers or their local outlets. The wholesale companies continue to be publicly traded on the stock market. This lack of action is something the retailers are quick to point out. If it is illegal how come it is shipped into the U.S. through Customs, extracted in one state then shipped by the case around the country?
There are more than 80 cannabinoids in marijuana. Our bodies even make similar chemicals called endocannabinoids. The internal or external chemicals bind with special receptors; not just in our brain but throughout our body.
Since the 1980's there has been a synthetic drug available called Marinol. It is 100% pure THC, but it does not come from plants. Prescribed for nausea it has annual sales of more than $10 million. Marinol has been offered to patients in studies comparing it to marijuana. Patients prefer the plants.
Cannabinoids don't work as well when they are isolated. Stand alone synthetics are even less effective. Doctors and scientists have found that natural CBD works best when there is also some THC. They have dubbed this the "entourage effect." That is why whole plant cannabis is so important for consumers.
The debate over CBD-rich marijuana and now CBD "dietary supplements" is not helping the overall issue of legalization. States passing extremely limited laws are failing to deliver on promises to the very ill. Politicians get to appear compassionate, the press excitedly proclaims another "medical marijuana" state but in fact it is only a paper garden.
The sources of domestic marijuana are carefully regulated or grown by patients themselves. This is in stark contrast to the sources of the CBD "dietary supplements" whose origins remain largely unknown.
The CARERS Act seeks to help those suffering from serious conditions access medical marijuana. But it may also give an unintended boost to businesses whose model may be more profit than altruism.