December 13, 2019 at 9:29 am EST | by Staff reports
Cannabis Culture

Fed’l agencies offer guidance for banks, hemp providers

Federal banking agencies released a joint statement last week 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 de-scheduled low-THC hemp and products derived from industrial hemp plants from the Controlled Substances Act. In October, the USDA issued interim rules governing commercial hemp cultivation.

CBD extracts aid patients with autism: study

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 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.

FDA warns companies against illegally marketing CBD

Representatives of the U.S. 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.”

Cannabis Culture news in the Blade is provided in partnership with NORML. For more information, visit norml.org.

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