Welcome to our weekly roundup of CBD and hemp-related legal and regulatory news:
CBD
Validcare finds no evidence of liver toxicity in participants in CBD clinical trials
After seven months of clinical investigation, Validcare’s investigators met with members of the FDA’s Cannabis Product Council to share findings from the industry-sponsored, decentralized human safety study of hemp-derived CBD products. This study was commissioned and designed in response to the FDA’s requests, including the Agency’s Mar. 5, 2020 report to Congress for science-based data, so the FDA can determine the appropriate regulatory path(s) for hemp-derived CBD products. Preliminary findings show no evidence of liver disease in the 839 participants and no increase in the prevalence of elevated liver function tests when compared to a population with a similar incidence of medical conditions. The investigators were surprised to find almost 70% of study participants reported having a medical condition and taking medications for those conditions, without an increase in reporting of adverse events. Studies of similar populations demonstrate an 11% elevation in liver function tests, while this research demonstrated ~9% elevation. Principal investigators met with FDA on Mar. 15 and reviewed preliminary liver safety study results in the form of an abstract. The parties also discussed establishing a direct communication feed to FDA so it can receive raw, blinded, aggregate data for its analysis. Validcare
Rejuvenol Laboratories seeks judgement in its favor in CBD lotion IP suit
A cosmetics company asked a Fla. federal judge to grant its exit out of a trade secrets suit, saying discovery showed no evidence that its recipe for cannabinoid-infused lotion was stolen. N.Y.-based manufacturer Rejuvenol Laboratories, one of a host of companies that Fla.’s Healthcare Resources Management Group has accused of misappropriating a secret CBD formula, asked the court to grant summary judgment in its favor, claiming its own CBD lotion wasn’t only created before Healthcare Resources’ but was made with different ingredients and manufacturing processes. Rejuvenol said Healthcare Resources wasn’t specific enough with the details of the allegedly stolen trade secrets, and the company never received any details or information about the purported secrets from Healthcare Resources or its principals. Law360 (sub. req.)
Brooklyn CBD business sues NYC, FedEx over wrongly seized hemp
A Brooklyn CBD business is suing the city of N.Y. and FedEx after a nine-box shipment of hemp ended up in police custody instead of getting properly delivered, according to a suit in federal court in Brooklyn. In the action, plaintiffs RDK NY, which does business as Green Angel CBD, and Oren and Ronen Levy claim the hemp they ordered from a farm in Vt. never arrived at Ronen Levy’s home on the day they were expecting it in Nov. 2019. The Levys claim that before the packages left Vt., a FedEx agent mistook them for marijuana and had them confiscated by the police. The Green Mountain State authorities realized the tip-off was an error and sent the packages to Brooklyn. The hemp never made it, because a FedEx driver brought the packages to a Brooklyn police precinct, where they were confiscated by the cops. The Levys claim that although the police officers “had knowledge and learned that the packages were of hemp products and not marijuana as assumed, nevertheless they refused to release” them. The suit names the city of N.Y., two New York City police officers allegedly working in Brooklyn’s easternmost precinct, FedEx and FedEx Ground as well as several as-yet-unidentified police officers and an unnamed FedEx truck driver who are included in the suit as John Doe defendants. Law360 (sub. req.)
CBG, THCV, CBN, Delta-8-THC among other cannabinoids that may benefit people
Cannabis consists of about 600 different molecules, some 140 of which are called cannabinoids because they work on our body’s endocannabinoid system. It was only a matter of time until new cannabinoids were discovered and commercialized. Some of the newer cannabinoids are:
- CBG, or cannabigerol, is a nonintoxicating cannabinoid being marketed for the alleviation of anxiety, pain, infection, inflammation, nausea and even the treatment of cancer. Experiments in mice have shown it can decrease inflammation associated with inflammatory bowel disease, and that it can slow the growth of colorectal cancer. In cells, it inhibits glioblastoma multiforme cells. CBG has also been shown to act as an antimicrobial against many different agents. Additionally, CBG is an appetite stimulant, and it may help treat bladder contractions;
- THCV, or tetrahydrocannabivarin, is potentially exciting because it may support efforts to treat the obesity and diabetes epidemics. There is robust animal data that it lowers fasting insulin levels, facilitates weight loss and improves glycemic control. In a 2016 study, THCV was shown to improve fasting glucose, pancreatic beta cell function, as well as several other hormones associated with diabetes. In both animals and humans, it has been well-tolerated without significant side effects;
- CBN, or cannabinol, is present in trace amounts in the cannabis plant but is mainly a byproduct of the degradation of THC. CBN is widely marketed for its sedative and sleep-inducing qualities, but there is no scientific evidence that CBN makes people sleepy, except for one study of rats that were already on barbiturates, and who slept longer when CBN was added. CBN does, however, have the potential to act as an appetite stimulant and an anti-inflammatory agent. One study from Israel in humans demonstrated that strains of cannabis higher in CBN were associated with better symptom control of ADHD; and
- Delta-8-THC is found in trace quantities in cannabis but can be distilled and synthesized from hemp. Unlike the other compounds discussed here, Delta-8-THC is an intoxicating cannabinoid, but it has only a fraction of the high that THC causes – and much less of the accompanying anxiety and paranoia. It can alleviate many of the same symptoms cannabis can, making it a potentially attractive medicine for people who want little to do with the high of cannabis. It is thought to be helpful for nausea and appetite stimulation. There is some evidence that suggests Delta-8-THC may be an effective option to prevent vomiting during chemotherapy treatments for cancer. Harvard Health Publishing
Hemp
Ore. hemp processor files suit regarding shipment it says CBP seized illegally
An Ore.-based hemp processor filed suit against U.S. Customs and Border Protection in N.C. federal court, accusing the agency of seizing thousands of pounds of legal hemp and determining it was contraband. In its complaint, We CBD said CBP seized the hemp shipment as it passed through Charlotte Douglas International Airport in N.C. on its way to a buyer in Switzerland, in early Nov. According to We CBD, it was told the test results indicated there was THC in the hemp but those results weren’t shared with the company. The federal agency told the company it found nearly 2,800 pounds of the export contained more than 0.3% of THC, which federal law specifies is the threshold for differentiating between hemp and cannabis plants that would be considered marijuana as defined by the Controlled Substance Act. The company said it never got a proper notice of detention or notice of seizure in connection with the shipment. In early Mar., CBP informed the company it planned to destroy the 2,800 pounds, the company said. The company’s suit lists all of the information it shared with the government to substantiate its contention that its shipment should be returned. The company said CBP violated its constitutional right to due process and stole its export. We CBD is seeking a court declaration that its shipment should be returned, as well as a temporary restraining order and preliminary injunction to keep CBP from destroying the seized goods. Law360 (sub. req.)
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