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Source: @norml @WeedConnection
Posted By: norml@weedconnection.com
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- Thu, 09 Apr 2020 04:20:21 PST

FDA Provides Updated Report to Congress Regarding Regulatory Pathways for CBD-Infused Products

Washington, DC: Representatives from the US Food and Drug Administration (FDA) have recently provided a report to members of Congress with respect to the safety and marketing of commercially available CBD products.

The report reiterates the agency's longstanding position that the majority of commercially available CBD-infused products are marketed in a manner that is inconsistent with the Food, Drug & Cosmetics Act. Specifically, the agency states, "It is not currently lawful to add CBD to human or animal food, ... [and] CBD products cannot be lawfully sold as dietary supplements." The agency additionally states that CBD-infused vape products "cannot be marketed without FDA-approved drug applications." It issued similar guidance for CBD-branded cosmetic and topical products that are "intended to affect the structure or function of the body, or [that are] intended for therapeutic use."

The FDA acknowledged that many commercially available products are of variable quality and potency, and may contain contaminants or elevated levels of heavy metals. It stated, "FDA intends to continue monitoring the marketplace, and to initiate and expand appropriate compliance and enforcement actions against unlawful CBD products that pose the greatest risk harm to the public."

The agency said that it is continuing to evaluate safety information regarding CBD consumption. Specifically, it "is actively evaluating what and how much data would be sufficient to support a conclusion that CBD can be safely allowed in dietary supplements under certain conditions." The FDA acknowledged that CBD products could ultimately be permitted to be marketed in such a manner, but that allowing such activities would require explicit changes to the agency's current rules.

It concluded, "We recognize the high level of interest in dietary supplements as potential pathways for products containing CBD, and we are actively evaluating potential rulemaking to allow CBD in dietary supplements." The agency added, however, that doing so would present "certain challenges," including potentially discouraging clinical investigations of the cannabinoid by drug development companies.

In 2018, Congress enacted explicit language amending the US Controlled Substances Act so that hemp plants containing no more than 0.3 percent THC and/or cannabinoids extracted from said plants, are no longer federally prohibited by the CSA.

Full text of the FDA report is available online.

Coalition of Senators Urge SBA to Provide Economic Assistance to State-Licensed Cannabis Business

Washington, DC: A coalition of US Senators are urging leadership to permit licensed cannabis operators to qualify for loans and other forms economic assistance available from the Small Business Administration (SBA).

Under current law, licensed cannabis businesses are ineligible for financial aid opportunities because marijuana remains classified as a schedule I controlled substance. In a March 26 letter addressed to the Chairman and Vice-Chair of the Senate Committee on Appropriations, senators urge "the Subcommittee on Financial Services and General Government to include language in ... forthcoming legislation to help extend SBA loan programs to legal cannabis businesses."

Senators Michael Bennett (), Cory Booker (D-NJ), Tammy Duckworth (D-IL), Kirsten Gillibrand (D-NY), Kamala Harris (D-CA), Edward Markey (D-MA), Robert Menendez (D-NJ), Jeffrey Merkley (D-OR), Jacky Rosen (D-NV), Bernie Sanders (D-VT) and Ron Wyden (D-OR) signed on to the letter.

Commenting on the letter, NORML Political Director Justin Strekal said: "In this time of crisis and unprecedented federal support for the economy, Congress should not allow all of the small and midsize cannabis businesses to be excluded by the SBA. Be it in the appropriations package or the next round of stimulus, this is a common-sense solution will help protect jobs in 33 states and provide much needed support to Main Street small businesses."

In recent months, NORML has been working with its Congressional allies to move forward several pieces of legislation, such as HR 3540: The Ensuring Safe Capital Access for All Small Businesses Act, and HR 3884/S 2227: The Marijuana Opportunity, Reinvestment, and Expungement Act – which "prohibit the Small Business Administration from declining to provide certain small business loans to an eligible entity solely because it is a cannabis-related legitimate business or service provider."

The state-licensed cannabis industry employs more than 240,000 American workers, over four times the number of American workers as does the coal industry. The majority of these businesses are small-to-medium in size.

Review: Clinical Evidence Lacking in Support of CBD as an Anti-Viral Agent

Varese, Italy: There is an absence of clinical data supporting the efficacy of CBD as an antiviral agent, according to a systematic literature review published in the journal Cannabis and Cannabinoid Research.

A team of researchers from Italy and the United Kingdom performed a systematic review of peer-reviewed papers specific to the application of CBD in viral diseases. They reported "circumstantial evidence" suggesting that CBD may possess antiviral activity in a limited number of conditions, specifically in the treatment of hepatitis C and Karposi sarcoma. However, this preliminary finding was based solely upon the interpretation of preclinical data. By contrast, authors reported that there exists "no evidence from properly designed clinical trials to support the use of CBD for the treatment" of these or other conditions, such as the flu, West Nile virus, Ebola, or common cold viruses.

Yet, despite this lack of clinical data, authors identified numerous commercial websites touting CBD as a clinically beneficial antiviral agent. They reported, "Claims about the benefits of using CBD on viral infections were largely supported by CBD online retailers and most often appear to be a biased interpretation of the scientific literature or a dishonest manipulation of the information for commercial purposes."

They concluded: "CBD sellers should stop promoting claims that are not backed by scientific evidence. Misleading claims represent both a threat to public health and a violation of consumer access to accurate information."

In recent days, NORML has issued multiple warnings cautioning people to beware of online misinformation surrounding the use of either whole-plant cannabis or CBD as a potential remedy for the COVID-19 virus. Specifically, NORML Executive Director Erik Altieri has stated: "If something sounds too good to be true, it likely is. During these difficult times, we encourage people to be skeptical of any unsubstantiated claims, particularly those circulating online, surrounding the use of cannabis or any other uncorroborated treatment for COVID-19."

Full text of the study, "Cannabidiol for viral diseases: Hype or hope?" appears in Cannabis and Cannabinoid Research.

Polls: Americans Favor Designating Dispensaries as "Essential Services"

Washington, DC: Americans mostly agree with states' decisions to classify licensed medical cannabis facilities as "essential services" to the community – a designation that permits them to maintain uninterrupted retail operations during regional 'stay-at-home' orders.

Nationwide polling data compiled by YouGov.com reported that 53 percent of respondents believe that medical marijuana dispensaries "should be considered essential services." Support was strongest among self-identified Democrats (62 percent), but was significantly lower among Republicans (43 percent).

Separate polling data compiled by CivicScience.com reported that a plurality of Americans consider medical cannabis dispensaries to be "essential" during the COVID-19 outbreak.

To date, nearly two-dozen states have explicitly designated certain licensed cannabis providers as "essential services." In several other jurisdictions, regulators have either relaxed protocols or moved forward with new, emergency rules to facilitate expanded access – such as permitting patients to seek telemedicine appointments and allowing dispensaries to permit curbside pick-up and home delivery.

NORML's State Policies Coordinator Carly Wolf said, "The reality that a growing number of jurisdictions have taken these important steps is further evidence of the degree to which above-ground cannabis access is now widely recognized to be an essential part of the fabric of our society, and is regarded as being crucial to patients' health and welfare."

NORML has summarized regional policies governing retail cannabis access during the COVID-19 outbreak here. NORML will continue to update these policies accordingly in the coming days and weeks.

Utah: Law Signed Expediting Patients' Access to Medical Cannabis Products, Capping THC Potency

Salt Lake City, UT: Republican Gov. Gary Herbert has signed legislation into law, House Bill 425, expediting medical cannabis access to certain patients with a doctor's authorization.

Under the new law, which took immediate effect, patients who possess a written authorization from their physician may legally access medical cannabis products from a licensed provider without further delay. The rule change permits patients who possess a valid recommendation, but are still in the process of waiting for a state-issued registration card, to have immediate access to cannabis.

To date, state regulators have issued just over 1,000 identification cards to qualifying patients.

Separate provisions in the bill establish a "legal dosage limit" for medical cannabis products that shall not exceed 20 grams of THC per single dose. The language further mandates that a patients' 30-day supply of "unprocessed cannabis" should not exceed 113 grams by weight.

The state's first medical cannabis provider began operations in early March. The law allows for a total of 14 retail providers in the state.

West Virginia: Law Signed Permitting Patients Access to Herbal Cannabis Preparations

Charleston, WV: Republican Gov. Jim Justice has signed legislation into law expanding the types of cannabis preparations that will soon be available to qualified medical cannabis patients.

Senate Bill 339, which took effect upon its passage, expands the state's definition of acceptable "forms of medical cannabis" to include "dry leaf or plant form."

As initially enacted, the state's medical cannabis access law limited marijuana formulations to include only infused pills, oils, creams, liquids, dermal patches, or preparations in "a form medically appropriate for administration by vaporization or nebulization."

Though initially enacted by lawmakers in 2017, the state's cannabis access program is not yet fully operational.

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