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Source: @norml @WeedConnection
Posted By: norml@weedconnection.com
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- Thu, 12 Dec 2019 04:20:21 PST

FDA Sends Warning Letters to Multiple Companies for Illegally Marketing CBD Products

Washington, DC: Representatives of the US Food and Drug Administration recently issued warning letters to multiple companies for marketing CBD-specific products in ways that violate federal law.

The agency issued warning letters last week to 15 commercial entities. Seven additional companies received similar letters earlier this year.

The FDA alleges that the companies marketed CBD as either a dietary supplement or as a food additive, or in a manner that implied it could prevent or cure serious diseases -- all of which violate the federal Food, Drug & Cosmetics Act.

Following the passage of the 2018 Farm Bill, which removed low-THC hemp and extracts from the plant from the Controlled Substances Act, the agency advised: "Cannabis and cannabis-derived products claiming in their marketing and promotional materials that they're intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases are considered new drugs or new animal drugs and must go through the FDA drug approval process for human or animal use before they are marketed in the U.S. ... Additionally, it's unlawful under the FD&C Act to introduce food containing added CBD or THC into interstate commerce, or to market CBD or THC products as, or in, dietary supplements, regardless of whether the substances are hemp-derived."

Two weeks prior to the FDA's action, a review of 300 leading online CBD retailers by the group LegitScript.com reported that 92 percent of sellers marketed products in a manner that was non-compliant with current FDA policies.

The FDA also issued a separate advisory acknowledging that many commercially available CBD products lack appropriate regulatory controls and may be of variable quality and purity. NORML has previously highlighted several independent investigations identifying product mislabeling and/or the presence of adulterants and/or heavy metals in some commercially available CBD products, such as those here, here, and here.

Currently, commercially available CBD products are not regulated by the FDA, despite the fact that some three in four Americans presume otherwise. By contrast, CBD-infused products sold at state-licensed dispensaries are typically subject to state-specific regulations and lab testing protocols. However, such facilities are typically only open to either state-qualified patients or to adults in states that legally regulate whole-plant cannabis sales.

In May, NORML provided written testimony to the FDA urging the agency to move expeditiously to provide regulatory guidelines governing CBD-infused products, including best practices for their manufacturing, standardization, and purity. In Monday's announcement, the agency acknowledged that it "plans to provide an update on its progress regarding the agency's approach to these products in the coming weeks."

Study: Daily Cannabis Use Among Pain Patients Associated with Less Non-Prescription Opioid Use

Vancouver, Canada: Patients suffering from persistent pain conditions who frequently use cannabis are far less likely to use non-prescription opioids, according to longitudinal data published in the journal PLOS One.

A team of investigators from Canada and the United States assessed drug use trends in chronic pain patients over a multi-year period (June 1, 2014 to December 1, 2017).

Authors reported "an independent negative association between frequent cannabis use and frequent illicit opioid use." Specifically, subjects who consumed cannabis daily "had about 50 percent lower odds of using illicit opioids every day [as] compared to cannabis non-users."

Investigators did not identify a similarly significant association between occasional cannabis use and daily non-prescription opioid use.

They concluded, "These findings provide longitudinal observational evidence that cannabis may serve as an adjunct to or substitute for illicit opioid use among PWUD (people who use drugs) with chronic pain."

The findings are consistent with those of prior studies – such as those here, here, and here – reporting that pain patients reduce their use of opioids following the initiation of medical cannabis therapy.

In late November, federal officials affirmed that no funding from the Substance Abuse and Mental Health Services Administration could be directed toward programs that propose the use of medical cannabis for those suffering from opioid dependence issues.

Full text of the study, "Frequency of cannabis and illicit opioid use among people who use drugs and report chronic pain: A longitudinal analysis," appears in PLOS One.

Study: Daily Use of CBD Extracts Mitigates Symptoms in Patients with Autism Spectrum Disorder

Brasilia, Brazil: The twice-daily administration of plant-derived CBD-dominant extracts is associated with symptom improvement in adolescents with autism spectrum disorder (ASD), according to observational data published in the journal Frontiers in Neurology.

Brazilian investigators assessed the use of CBD-enriched cannabis extracts (75 to 1 ratio CBD to THC) in 15 ASD patients over at least six months. Study participants were between the ages of six and 17 years and subjects consumed between 50 to 100mg of oral CBD capsules daily.

Authors reported, "Fourteen out of these 15 patients (93 percent) showed improvements equal to or above 30 percent in at least one symptom category. Most patients that adhered to the treatment had improvements in more than one symptom category: seven patients (47 percent) had improvements equal to or above 30 percent in four or more symptom categories; two patients (13 percent) presented improvements equal to or above 30 percent in two symptom categories, and five patients (33 percent) presented improvements equal to or above 30 percent in one symptom category."

They concluded, "The findings presented here, taken together ... indicate that CBD-enriched CE [cannabis extracts] yields positive effects in multiple autistic symptoms, without causing the typical side effects found in medicated ASD patients. Most patients in this study had improved symptoms even after supervised weaning of other neuropsychiatric drugs."

The findings are similar to those of other recent trials -- including those here, here, here, and here -- reporting that the use of CBD-dominant extracts reduces symptoms of ASD and is well-tolerated by most patients.

Full text of the study, "Effects of CBD-enriched cannabis sativa extract on autism spectrum disorder symptoms: An observational study of 18 participants undergoing compassionate use," appears in Frontiers in Neurology.

Federal Agencies Provide Guidance for Banks Working with Hemp Providers

Washington, DC: Federal banking agencies released a joint statement on Tuesday acknowledging that banks and other financial institutions may work with those in the commercial hemp industry.

The new guidance memo states, "[B]anks are no longer required to file suspicious activity reports (SAR) for customers solely because they are engaged in the growth or cultivation of hemp in accordance with applicable laws and regulations." The statement was issued by the Federal Reserve Board, the Federal Deposit Insurance Corporation, FinCEN, the Office of the Comptroller of the Currency and the Conference of State Bank Supervisors.

Banks have historically been reluctant to work with any businesses involved with the production or sale of cannabis-related products.

Legislation signed into federal law in 2018 descheduled low-THC hemp and products derived from industrial hemp plants from the Controlled Substances Act. In October, the USDA issued interim rules governing the commercial hemp cultivation.

Another Study Links Vitamin E Additive to Lung Illness

St. Paul, MN: Data published on November 27 in the weekly publication of the US Centers for Disease Control and Prevention provides further evidence that the presence of vitamin E acetate (oil) in illicit market, e-liquid vape products is likely associated with EVALI (e-cigarette or vaping product use-associated lung injury).

Minnesota investigators identified the presence of the oil additive in 24 of the products used by 11 patients with lung disease. Virtually all of the patients interviewed in the study acknowledged obtaining THC vape products on the underground market.

A previous analysis in 2018 of illicit vape products seized by police in Minnesota failed to identify the presence of vitamin E. "Whereas vitamin E acetate was not detected in the limited number of tested products seized in 2018, it was detected in products seized in 2019, suggesting that vitamin E acetate might have been introduced recently as a diluent or filler," investigators reported.

They concluded, "According to these and other published data, using THC-containing products with vitamin E acetate appears to be associated with EVALI; however, it is possible that more than one compound or ingredient could be a cause of lung injury, and evidence is not yet sufficient to rule out contribution of other toxicants."

In November, CDC representatives for the first time identified vitamin E acetate as a "very strong culprit of concern" in EVALI.

The online publication Leafly.com has issued several extensive reports regarding the use of vitamin E among illicit market vendors of e-liquid products. Their reporting indicates that beginning in late 2018, some vendors began to use the oil as an additive to thicken the consistency of their e-liquids and to mask dilution.

Full text of the study, "Characteristics of e-cigarette, or vaping, products used by patients with associated lung injury and products seized by law enforcement – Minnesota, 2018 and 2019, " appears online in the journal Morbidity and Mortality Weekly Report.

Case Report: Cannabis Treatment Provides Symptom Relief in Patient with Treatment-Resistant Stiff Person Syndrome

Tampa, FL: The use of plant-derived cannabis extracts is associated with symptom improvements in a patient with refractory paraneoplastic stiff person syndrome (PSPS), according to a case report published in the Journal of Pain and Symptom Management. Paraneoplastic stiff person syndrome is a rare, but debilitating manifestation of cancer, characterized by painful extremities, truncal and facial spasms.

Researchers affiliated with the Moffitt Cancer Center in Florida reported on the successful treatment of PSPS in a 60-year-old woman who began using an oral tincture of a one-to-one ratio of plant-derived THC and CBD.

They reported, "[U]se of the cannabinoids markedly minimized [the subject's] stiffness and the intensity and frequency of spasm episodes." The patient also reduced her use of prescription medications.

Authors concluded, "Our case suggests that state medical marijuana program THC/CBD products may provide relief for patients with refractory PSPS symptoms."

Full text of the study, "Medical cannabis as an effective treatment for refractory symptoms of paraneoplastic stiff person syndrome," appears in the Journal of Pain and Symptom Management.

Massachusetts: Vitamin E Additive Identified in Some Unregulated THC Vape Products

Framingham, MA: The presence of vitamin E has been identified in several unregulated THC vapor products obtained in the state of Massachusetts, according to testing results provided by MCR laboratories. By contrast, the lab has not yet identified the additive in any legally regulated cannabis vape products.

Recently, the US Centers for Disease Control identified vitamin E acetate as a "very strong culprit of concern" in EVALI (e-cigarette or vaping product use-associated lung injury). Illicit market manufacturers sometimes use the oil as an additive in an effort to thicken the consistency of their e-liquids and to mask dilution.

Of the 109 product samples submitted to the lab for analysis, nine tested positive for the presence of vitamin E acetate. By contrast, investigators said, "Every vaping product supplied to us by a regulated producer has been shown to be free of this particular additive."

State regulators recently took steps to prohibit the sale of all cannabis e-liquid vapor products. Vaporizer products that are manufactured to vape herbal cannabis flower are not included in the ban. Massachusetts is the first legal cannabis state to institute such a blanket ban on e-liquid vapor products. However, that restriction is anticipated to be lifted on December 11, when new statewide regulations are expected to be finalized.

Colorado: Supreme Court Ruling Upholds Medical Cannabis Use While on Probation

Denver, CO: Persons on probation may legally consume medical cannabis unless such use explicitly conflicts with "the goals of sentencing," according to a decision rendered by the Colorado Supreme Court.

Justices unanimously opined that a defendant possesses a presumed right to consume cannabis therapeutically unless there exists material evidence to show that prohibiting such use "is necessary and appropriate" to accomplish explicit sentencing goals.

Lawmakers approved legislation in 2015 permitting medical cannabis use by certain defendants while on probation.

The case is Walton v. People (Case No. 18SC84).

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