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Tilray Brands Inc TLRY

Alternate Symbol(s):  T.TLRY

Tilray Brands, Inc. is a global lifestyle and consumer packaged goods company. The Company operates through four segments: Cannabis operations, Distribution business, Beverage alcohol business and Wellness business. The Cannabis operations, which encompasses the production, distribution, sale, co-manufacturing and advisory services of both medical and adult-use cannabis. The Beverage alcohol operations, which encompasses the production, marketing and sale of beverage alcohol products. The Distribution operations, which encompasses the purchase and resale of pharmaceuticals products to customers. The Wellness products, which encompasses hemp foods and cannabidiol (CBD) products. The Company offers a portfolio of adult-use brands and products and expands its portfolio to include new cannabis products and formats. Its brands include Good Supply, RIFF, Broken Coast, Solei, Canaca, HEXO, Redecan, Original Stash, Hop Valley, Revolver, Bake Sale, XMG, Mollo, and others.


NDAQ:TLRY - Post by User

Post by DaveInCalgaryon Jan 17, 2024 11:13am
87 Views
Post# 35831256

Tilray Brands - American Cannabis Update

Tilray Brands - American Cannabis Update

US federal health officials acknowledge ‘accepted
medical use’ of cannabis

The HHS has released documents confirming its
recommendation that cannabis be rescheduled as a
lower risk drug.


Published 

 on

 

Federal health officials in the US have acknowledged the ‘accepted medical use’ of cannabis for the first time, in documents confirming a recommendation that it be reclassified as a lower risk drug. 

The US Department of Health and Human Services (HHS) has released documents which confirm its recommendation that cannabis be rescheduled under the Controlled Substances Act (CSA). 

In August, Bloomberg News reported on a leaked letter in which the HHS recommended that the Drug Enforcement Administration (DEA) reclassify cannabis as a lower risk drug, moving it from Schedule I to a Schedule III, following a review instructed by President Joe Biden.

The rescheduling would mean cannabis would no longer be classed as a ‘high risk’ drug alongside other Schedule I drugs such as heroin, LSD and ecstasy, defined as substances, or chemicals with ‘no currently accepted medical use and a high potential for abuse’. 

Now a litigation over an Freedom of Information Act request (FOIA) brought by US lawyer Matthew Zorn, has led to the release of over 250 documents explaining the rationale behind this recommendation. Zorn first shared the documents in his On Drugs newsletter on Friday 12 January, which is co-authored by fellow lawyer Shane Pennington.

These confirm for the first time that federal health officials acknowledge that cannabis has ‘accepted medical use in treatment in the United States’ and its potential for abuse is ‘less than the drugs or other substances in Schedules I and II’.

The documents also highlight the fact that thousands of doctors are currently recommending medical cannabis to six million registered patients in 43 US states and that there exists ‘considerable evidence in favour of [its] effectiveness’ in the treatment of various health conditions.

The decision was based on the HHS considering the following eight factors:

  1. Cannabis’s actual or relative potential for abuse;
  2. Scientific evidence of its pharmacological effect, if known;
  3. The state of current scientific knowledge regarding the drug or other substance;
  4. Its history and current pattern of abuse;
  5. The scope, duration, and significance of abuse;
  6. What, if any, risk there is to the public health;
  7. Its psychic or physiological dependence liability; and
  8. Whether the substance is an immediate precursor of a substance already controlled.

According to the documents, both the US Food and Drug Administration (FDA) and the US National Institute on Drug Abuse (NIDA) are in agreement with the HHS recommendation. 

In further analysis of the contents, published on Sunday 14 January, Pennington writes: “After gathering and reviewing a broad swath data and several studies, expert opinions, and the ‘position statements of professional organisations relevant to the indications discussed’ FDA concluded that ‘the totality of the available data’, supports a finding ‘that, for purposes of the drug scheduling criteria in 21 U.S.C. 812(b), marijuana has a currently accepted medical use in the United States for: anorexia related to a medical condition; nausea and vomiting (e.g., chemotherapy-induced); and pain’.”

Although, this does not mean that the FDA ‘has approved cannabis as safe and effective for marketing as a drug in interstate commerce under the Federal Food, Drug, and Cosmetic Act’.

He added: “Finally, HHS concluded that “abuse of marijuana may lead to moderate or low physical dependence, depending on frequency and degree of marijuana exposure.” While cannabis “can produce psychic dependence in some individuals,” HHS emphasized that “the likelihood of serious outcomes is low, suggesting that high psychological dependence does not occur in most individuals who use marijuana.”

Now the decision is in the hands of the DEA which will make a recommendation based on its own five-factor analysis. Earlier this month, DEA officials confirmed it is in the process of conducting its review, telling congress that it has the ‘final authority’ on any scheduling decision. 

Commenting on the documents’ release, deputy director of US NORML, Paul Armentano, said: “It is significant for these health agencies to acknowledge publicly, for the first time, what many patients and advocates have known for decades: that cannabis is a safe and effective therapeutic agent for tens of millions of Americans.”

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