DarthYoda
2 months ago
"Fourth Circuit Court Rules Hemp-Derived Products Legal Nationwide, Contradicting DEA":
Sep19, 2024
The Fourth Circuit Court of Appeals has ruled that all hemp-derived products, including those created through chemical synthesis, are legal under federal law.
This ruling aligns with a 2022 decision from the Ninth Circuit but goes against more recent guidance from the DEA. In a letter from February 2023, the DEA stated that the 2018 Farm Bill was not intended to legalize synthetic cannabinoids, such as THC-O, even if their THC content is below the legal limit.
Despite acknowledging the disagreement, the Fourth Circuit sided with the Ninth Circuit’s interpretation, which held that the Farm Bill’s definition of hemp includes all cannabis plant derivatives as long as they contain less than 0.3 percent delta-9 THC. The court stated that this interpretation is clear and that they did not need to defer to the DEA’s position.
“The Ninth Circuit held that it didn’t need to consider the DEA’s position on synthetically derived substances because the definition of ‘hemp’ under the 2018 Farm Act was unambiguous in its application to all products derived from the cannabis plant, ‘so long as they do not cross the 0.3 percent delta-9 THC threshold,’” states the court. “Between the DEA’s February 2023 letter and [the Ninth Circuit decision], we think the Ninth Circuit’s interpretation of the 2018 Farm Act is the better of the two. And we’re free to make that determination ourselves, despite a contrary interpretation from the DEA, because we agree with the Ninth Circuit that § 1639o is unambiguous.”
The case arose from a dispute over whether an employer could fire an employee for using hemp products. The court ultimately upheld the firing because the employee failed to prove the products used were compliant with the THC limits outlined in the 2018 Farm Bill.
https://themarijuanaherald.com/2024/09/fourth-circuit-court-rules-hemp-derived-products-legal-nationwide-contradicting-dea/
"New Study Reveals CBD’s Surprising Ability To Combat Deadly Mosquitoes":
September 20, 2024
CBD results in 100% mortality of pesticide-resistant mosquito larvae.
New research in the effort to address global insecticide resistance has found that CBD, commonly used to manage various health conditions, is also highly effective in eliminating mosquito larvae.
The study, published in the journal Insects, found that hemp leaf extract – which contains the active ingredient cannabidiol, or CBD – kills mosquito larvae from two different strains of the yellow fever mosquito within 48 hours, one that was resistant to typical insecticides and another that was not.
“Mosquitoes are one of the deadliest animals in the world, mainly because as adults they serve as vectors of disease,” said Erick Martinez Rodriguez, lead author of the study and a graduate student in entomology at The Ohio State University. “It’s very important to be able to control these pests at an early stage, when they are at the most vulnerable.”
Unlike adult mosquitoes that can fly across great distances and transmit disease by biting, mosquito larvae are aquatic organisms often found in standing water. Conventional synthetic insecticides are critical chemical tools for killing mosquito larvae populations, but their rampant overuse has led to both insecticide resistance and other detrimental effects on the environment.
Challenges of Conventional Insecticides
Inspired by previous Ohio State research that discovered that the bark properties of a plant native to Madagascar worked as a natural mosquito insecticide and repellent, Martinez Rodriguez sought to determine if hemp could act as a viable and safe alternative to current biopesticides.
The hemp plant is related to marijuana, but does not contain its levels of the ingredient that makes people feel “high.” CBD from hemp is used in a variety of products from gummies and oils to treat anxiety, pain, insomnia, and other conditions.
To test hemp’s toxic effects against mosquito larvae, the team took air-dried hemp leaves, pulverized them into a fine powder, and soaked the material in methanol for a few weeks to reach the desired CBD concentrations.
The methanol was later removed from the solution to make it easier to chemically analyze, resulting in an extract that was eventually given to the larvae with their food.
Depending on the concentration of hemp extract used, the team discovered that the hemp leaf was potent enough to be equally toxic to both strains of mosquito larvae. What was surprising, though, said Martinez Rodriguez, was the small amount needed to be so deadly.
“If you compare the amount of hemp extract needed to kill 50% of the population to other synthetic conventional insecticides, it is on the high side, but when you compare it side-by-side to other natural extracts we have tested in our lab, only a relatively low amount is required to produce high mortality values in larvae,” said Martinez Rodriguez. While CBD eventually led to 100% mortality for the larvae, different concentrations of the hemp extract caused different mortality rates in the hours leading up to that time.
Hemp’s Advantages and Future Research Directions
The mosquito larvae were considered dead if no movement was recorded after scientists gently touched their abdomen with a needle or pipette tip. Although it’s still unclear how the extract affects them biologically, the team’s findings showed that CBD was the primary active ingredient in the extract and that it can successfully bypass the larvae’s metabolic resistance to other insecticides, which aligns with past work that found CBD has notable growth-inhibiting properties against other insects.
Since hemp is also a more sustainable crop than many other plant alternatives, insecticide products that use it could potentially be produced relatively cheaply, said Martinez Rodriguez.
While this discovery bodes well for developing future natural-based mosquito control products, said Peter Piermarini, co-author of the study and a professor of entomology at Ohio State, further research would have to be done to investigate how safe hemp and CBD would be for non-target organisms, like honey bees or other pollinating insects that scientists don’t want to kill or disrupt by introducing potentially harmful additives to the environment.
“CBD is a compound that appears to be safe for people and our companion animals to ingest,” said Piermarini. “It’ll be interesting to learn more about how CBD interacts with various proteins in mammals and insects to understand why it’s safe for people but not insects.”
Reference: “Larvicidal Activity of Hemp Extracts and Cannabidiol against the Yellow Fever Mosquito Aedes aegypti” by Erick J. Martínez Rodríguez, P. Larry Phelan, Luis Canas, Nuris Acosta, Harinantenaina L. Rakotondraibe and Peter M. Piermarini, 9 July 2024, Insects.
DOI: 10.3390/insects15070517
This work was supported by the Infectious Diseases Institute and the College of Food, Agricultural, and Environmental Sciences at Ohio State. Other Ohio State co-authors include Larry Phelan, Luis Canas, Nuris Acosta and Harinantenaina L. Rakotondraibe.
https://scitechdaily.com/new-study-reveals-cbds-surprising-ability-to-combat-deadly-mosquitoes/
Wolf-man jack
3 months ago
“ Charlotte's Web Holdings, Inc. (TSE:CWEB) just released its latest quarterly report and things are not looking great. It definitely looks like a negative result overall with revenues falling 14% short of analyst estimates at US$12m. Statutory losses were US$0.07 per share, 40% bigger than what the analysts expected. Following the result, the analysts have updated their earnings model, and it would be good to know whether they think there's been a strong change in the company's prospects, or if it's business as usual. Readers will be glad to know we've aggregated the latest statutory forecasts to see whether the analysts have changed their mind on Charlotte's Web Holdings after the latest results.
Following the recent earnings report, the consensus from three analysts covering Charlotte's Web Holdings is for revenues of US$50.8m in 2024. This implies a measurable 6.9% decline in revenue compared to the last 12 months. The loss per share is expected to greatly reduce in the near future, narrowing 33% to US$0.19. Before this earnings announcement, the analysts had been modelling revenues of US$57.5m and losses of US$0.22 per share in 2024. We can see there's definitely been a change in sentiment in this update, with the analysts administering a meaningful downgrade to next year's revenue estimates, while at the same time reducing their loss estimates.
The consensus price target fell 14% to CA$0.65, with the dip in revenue estimates clearly souring sentiment, despite the forecast reduction in losses.”
https://finance.yahoo.com/news/earnings-release-heres-why-analysts-122818344.html
DarthYoda
3 months ago
"Citing failures to protect public health, lawmaker looks to remove FDA's food authority":
August 2nd 2024
Rep. Rosa DeLauro (D-CT), who's been in Congress for more than three decades, has had enough.
She's introduced legislation to remove the FDA's food authority and start fresh with a new agency: The Federal Food Administration.
https://wjla.com/resources/pdf/1425c052-a30c-4578-90ea-6744f83ac635-TAM24855.pdf
The agency sent us the below statement:
"As you may be aware, in May the FDA reached a significant milestone with approval of its reorganization involving the creation of a unified Human Foods Program (HFP), adoption of a new model for its field operations and other significant modernization efforts. The reorganization implementation is currently targeted for Oct. 1, 2024, notably enhancing the agency’s ability to oversee and protect the human food supply and other products the FDA regulates. The reorganization will enable the FDA to be more efficient, nimble and prepared for the ever-changing and complex industries we regulate, new food and medical product technologies, as well as the impacts of globalization, climate change and other factors that require the agency to quickly adapt.
Additional information can be found here:
https://www.fda.gov/about-fda/fda-organization/fda-modernization-efforts-establishing-unified-human-foods-program-new-model-field-operations-and
https://wjla.com/news/spotlight-on-america/toxic-baby-food-fda-citing-failures-protect-public-health-formula-bacteria-heavy-metals-tainted-applesauce-rosa-delauro-connecticut-test-contaminants-safe-products
DarthYoda
4 months ago
I found a recently published research paper that was funded by Charlotte's Web, and I threw in a couple more papers below it as well. The one funded by Charlotte's Web is focused on a new cannabinoid called Cannabielsoin or CBE, (there is S-CBE and R-CBE, this paper focused on S-CBE), which is an oxidation product of CBD. You guys know I love seeing stuff like this...Enjoy!
"Cannabielsoin (CBE), a CBD Oxidation Product, Is a Biased CB1 Agonist":
Published: 12 July 2024
Funding
Funding for this study was provided by Charlotte’s Web.
https://www.mdpi.com/2227-9059/12/7/1551
"Cannabidiol ameliorates lipopolysaccharide-induced cardiovascular toxicity by its antioxidant and anti-inflammatory activity via regulating IL-6, Hif1a, STAT3, eNOS pathway":
18 July 2024
Results
Histopathological analysis of the LPS group showed moderate hyperemia, hemorrhages, edema, inflammation, and myocardial cell damage. There was a slight to moderate increase in Cox-1, G-CSF, and IL-3 immunoexpressions, along with enhanced expressions of IL-6, Hif1a, and STAT3 genes, and decreased expressions of eNOS genes. Additionally, there were increased levels of TOS and decreased TAS levels observed biochemically. CBD treatment effectively reversed and improved all of these observed changes.
Conclusions
CBD protects the heart and aorta against systemic inflammation through its antioxidant and anti-inflammatory activity via regulating IL-6, Hif1a, STAT3, and eNOS intracellular pathways.
https://link.springer.com/article/10.1007/s11033-024-09772-3
"Cannabinoid Content and Label Accuracy of Various Hemp-Derived Haircare, Cosmetic, and Edible Products Available at Retail Stores and Online in the United States":
19 July 2024
Results: Ninety-seven products were purchased (35 in-store, 62 online). Of the 71 products with a specific total CBD amount on the label, 35 (49%) were underlabeled (>10% more CBD than advertised), 27 (38%) were overlabeled (>10% less CBD than advertised), and 9 (12.7%) were accurately labeled (within ±10% of labeled CBD). The median (range) percentage deviations were -53% (-100%–76%) for haircare products, +18% (-100%-1076%) for cosmetics, and -1% (-100%-4468%) for food/drinks. CBD label accuracy did not differ significantly between products with external testing claims versus those without (t40 = 0.23, p = 0.82). Overall, 24% of the 97 (total) products made a cosmetic or beauty claim (e.g., “skin looks more youthful”), 40% made a therapeutic claim (e.g., “pain relief”), and 86% made a health halo effect claim (e.g., “paraben-free,” “dye-free,” etc.). Most products (63%) did not include a disclaimer that claims had not been evaluated by the FDA.
Conclusions: Most of the products included in this sample were inaccurately labeled for CBD content, including those claiming to have been tested by third party laboratories. A notable finding was that 10 products did not contain any CBD. Many products made therapeutic claims or used marketing tactics to seemingly convey they were safe/healthy, but only about one-third included disclaimers that these statements had not been evaluated by the FDA. These findings highlight the need for proper regulatory oversight of cannabinoid-containing products to ensure quality assurance and deter misleading or unfounded health claims in product marketing.
https://www.liebertpub.com/doi/abs/10.1089/can.2024.0039
DarthYoda
4 months ago
"Case Report: Cannabis Oil Treats Common Skin Disease in Dog":
JUL 11, 2024
Veterinary students and scientists in Brazil used cannabis oil to successfully treat a dog with a common skin disease that did not respond to previous treatment. The corresponding study was published in Frontiers in Veterinary Science.
Discoid lupus erythematosus (DLE) is a common autoimmune disease that typically affects the skin on the nose and ears of dogs. It is characterized by inflammation, loss of hair pigment, and redness, which can lead to crusting and ulceration. The condition's underlying cause remains unknown; however, it is thought to arise from a mix of genetics, infections, hormones, and sun exposure. Current treatments include corticosteroids to reduce inflammation; however, these carry a risk of unwanted side effects.
Previous research suggests that cannabinoids cannabidiol (CBD) and tetrahydrocnnabidiol (THC) reduce inflammation in both dogs and humans without any detrimental side effects.
In the current case report, a two-year-old female mixed-breed dog with DLE was not responding to corticosteroids and other medications. The researchers thus decided to treat the dog with cannabis oil.
After some experimentation, they found that cannabis oil containing CBD and THC on a ratio of 3:1 worked best. To begin, the dog was given a single drop orally once daily for three days to test for negative reactions. The treatment continued after no negative reactions were reported, and the dosage was slowly adjusted until the minimum effective dose was found. After several weeks, some signs of DLE started to disappear, and after a year, all symptoms were relieved.
"After 1year, the dog remains clinically stable on a low dose of full-spectrum CBD-rich oil. No evidence of DLE recurrence was observed," wrote the researchers in their paper.
“This case suggests that cannabinoid therapy (CT) may be a viable alternative or complementary therapy for DLE in dogs, particularly for those experiencing adverse effects from conventional treatments. Further research is warranted to confirm the efficacy and safety of CT for DLE management in dogs,” continued the researchers.
https://www.labroots.com/trending/cannabis-sciences/27420/report-cannabis-oil-treats-common-skin-disease-dog-2
Here is the actual paper...
"Case report: Cannabinoid therapy for discoid lupus erythematosus in a dog":
https://www.frontiersin.org/journals/veterinary-science/articles/10.3389/fvets.2024.1309167/full
DarthYoda
4 months ago
"Supreme Court’s Chevron Doctrine Ruling Could Limit FDA’s Regulatory Authority":
Jul 01, 2024
In overruling Chevron on Friday, the Supreme Court ushered in a new framework, dubbed Loper Bright. Courts are now required to “exercise their independent judgement in deciding whether an agency has acted within its statutory authority” and “may not defer to an agency interpretation of the law simply because a statute is ambiguous.”
This new framework could have significant consequences for the FDA and its regulatory authority, according to an analysis by global law firm Sidley.
The firm contends that Loper Bright could potentially open the regulator’s drug approvals to legal challenges. Companies need to provide “substantial evidence” that their drug candidates are safe and effective before securing approval, but courts in the past have found this ambiguous and have allowed the FDA to ask for additional requirements, such as data showing that the candidate’s effects are clinically meaningful, according to Sidley.
Under Loper Bright, more companies could try and challenge this approach, Sidley warned.
The overturning of Chevron could also pose some jurisdictional questions for the FDA, which is typically given the leeway to decide what constitutes a dietary supplement or a device product. These kinds of determinations affect how products are regulated, produced, or imported—and companies can now mount stronger challenges to this function by the FDA.
https://www.biospace.com/article/supreme-court-s-chevron-doctrine-ruling-could-limit-fda-s-regulatory-authority/
Here are two opposing opinions on how the chevron decision could affect rescheduling...
https://www.marijuanamoment.net/the-supreme-court-nuked-cannabis-rescheduling-with-its-chevron-ruling-op-ed/
https://www.marijuanamoment.net/reports-of-marijuana-reschedulings-chevron-related-death-are-greatly-exaggerated-op-ed/
Wolf-man jack
5 months ago
In my opinion, It doesn’t appear that BAT is investing in OGI and CWBHF for any other reason, but to make sure their investments are protected. Most likely there would be no mergers planned for the two entities along with BAT. Poison pills 💊 in both agreements. But agreements can be negotiated for any and all reasons as long as both parties agree. The recent tranche of funds for the Jupiter program of acquiring other cannabis companies could prove me wrong. With the limited amount of funds available, they are considering smaller companies. Unless, they offer equity and stock for any possible acquisition of CWBHF by OGI.
“ BAT will subscribe for 12,893,175 million shares on the closing of the first tranche (currently expected to be on or around January 16, 2024) for gross proceeds of C$41.5 million with the remaining 25,786,350 shares to be subscribed for in two further equal tranches on or around August 30, 2024 and February 28, 2025.
To the extent BAT exceeds 30.0% holding of outstanding Common Shares, it will be issued non-voting Class A convertible preferred shares ("Preferred Shares"). Accordingly, in aggregate, based on Organigram’s current 81,161,630 Common Shares outstanding, 12,999,231 Common Shares will be issued, and the remaining 25,680,294 shares will be initially issued as Preferred Shares. The Preferred Shares will be eligible for conversion into voting Common Shares at BAT’s option, provided that such conversion would not result in BAT’s voting interest in the Company exceeding 30%.
In connection with the closing of the first tranche of the Investment and subject to approval by Organigram’s shareholders, the Company will file articles of amendment to create the new class of Preferred Shares to be issued to BAT in the Investment.
Class A Preferred Shares
Each Preferred Share shall be economically equivalent to a Common Share and will be convertible into Common Shares at the option of BAT without payment of any additional consideration. The conversion ratio shall initially be one-for-one, and post-issuance shall increase at a rate of 7.5% per annum, compounded annually, until such time as the Preferred Shares are converted into Common Shares or the aggregate equity interest of BAT in Organigram (inclusive of both the Common Shares and Preferred Shares as if converted into Common Shares) reaches 49%. BAT shall be periodically required to convert Preferred Shares to the extent that it holds less than 30% of the Common Shares outstanding”
Wolf-man jack
5 months ago
“Investor Rights Agreement, dated November 14, 2022, by and between Charlottes Web Holdings, Inc. and BT DE Investments, Inc. a wholly-owned subsidiary of BAT Group“
https://contracts.justia.com/companies/charlottes-web-holdings-inc-14559/contract/261689/
“ Since March 2021, Organigram’s partnership with BAT has gone from strength-to-strength, most significantly the progress achieved as part of the PDC agreement.”
https://finance.yahoo.com/news/organigram-announces-c-124-6-110000751.html
“BT DE INVESTMENTS INC. ACQUIRES STAKE IN CHARLOTTE'S WEB HOLDINGS, INC.
NEWS PROVIDED BY
BT DE Investments Inc.
Nov 15, 2022, 08:19 ET
WILMINGTON, Del., Nov. 15, 2022 /CNW/ - BT DE Investments Inc. (the "Purchaser") announced today that it has acquired (the "Transaction") C$75,341,080 aggregate principal amount of a 5.00% senior unsecured convertible debenture due 2029 (the "Convertible Debenture"), which is convertible, in whole or in part, at any time and from time to time, into 37,670,540 common shares (the "Common Shares") of Charlotte's Web Holdings, Inc. (the "Issuer") at a price of C$2.00 per Common Share (the "Conversion Price"). The Convertible Debenture provides for the adjustment of the Conversion Price in certain customary events. The Purchaser is a wholly owned indirect subsidiary of British American Tobacco p.l.c.
Immediately prior to the Transaction, the Purchaser did not have beneficial ownership of any securities of the Issuer. Immediately after the Transaction, and assuming the conversion of the Convertible Debenture in full, the Purchaser acquired beneficial ownership of 37,670,540 Common Shares, representing approximately 19.9% of the issued and outstanding Common Shares (calculated on a non-diluted basis).”
“ The Purchaser entered into the Transaction as part of an investment in the Issuer and intends to review its investment in the Issuer on a continuing basis. The Purchaser may, subject to the terms of the investor rights agreement entered into between the Purchaser and the Issuer dated November 14, 2022, depending upon a number of factors including market and other conditions, increase or decrease its beneficial ownership, control, direction or economic exposure over securities of the Issuer.”
https://www.newswire.ca/news-releases/bt-de-investments-inc-acquires-stake-in-charlotte-s-web-holdings-inc--851723097.html
This statement would allow BAT to bring OGI and CWBHF together as a merger opportunity. Depending on the BAT and OGI agreement, which I haven’t researched, then BAT may be able to bring both entities under the BAT Umbrella.
“ The Purchaser may not convert the Convertible Debenture, in whole or in part, if and to the extent that, as a result of such conversion, the Purchaser would beneficially own or exercise control or direction over in excess of 19.9% of the number of Common Shares outstanding immediately after giving effect to such conversion.”
oystersnbeer
7 months ago
US drug control agency will move to reclassify marijuana in a historic shift
The U.S. Drug Enforcement Administration will move to reclassify marijuana as a less dangerous drug, The Associated Press has learned, a historic shift to generations of American drug policy that could have wide ripple-effects across the country.
The DEA’s proposal, which still must be reviewed by the White House Office of Management and Budget, would recognize the medical uses of cannabis and acknowledge it has less potential for abuse than some of the nation’s most dangerous drugs. However, it would not legalize marijuana outright for recreational use.
The agency’s move, confirmed to the AP on Tuesday by five people familiar with the matter who spoke on the condition of anonymity to discuss the sensitive regulatory review, clears the last significant regulatory hurdle before the agency’s biggest policy change in over 50 years can take effect.
Once OMB signs off, the DEA will take public comment on the plan to move marijuana from its current classification as a Schedule I drug, alongside heroin and LSD. It moves pot to Schedule III, alongside ketamine and some anabolic steroids, following a recommendation from the federal Health and Human Services Department. After the public-comment period the agency would publish the final rule.
Read more: https://apnews.com/article/marijuana-biden-dea-criminal-justice-pot-f833a8dae6ceb31a8658a5d65832a3b8
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