Cannabis
FDA warns company marketing unapproved cannabidiol products with unsubstantiated claims to treat cancer, Alzheimer’s disease, opioid withdrawal, pain and pet anxiety
Today, the U.S. Food and Drug Administration announced that it has issued a warning letter to Curaleaf Inc., of Wakefield, Massachusetts, for illegally selling unapproved products containing cannabidiol (CBD) online with unsubstantiated claims that the products treat cancer, Alzheimer’s disease, opioid withdrawal, pain and pet anxiety, among other conditions or diseases.
“As we examine potential regulatory pathways for the lawful marketing of products containing cannabis and cannabis-derived compounds like CBD, protecting and promoting public health remains our top priority. Selling unapproved products with unsubstantiated therapeutic claims — such as claims that CBD products can treat serious diseases and conditions — can put patients and consumers at risk by leading them to put off important medical care. Additionally, there are many unanswered questions about the science, safety, effectiveness and quality of unapproved products containing CBD,” said Acting FDA Commissioner Ned Sharpless, M.D. “Today’s action demonstrates that the agency stands firm in its commitment to continue monitoring the marketplace and protecting the public health by taking action as needed against companies that deceive consumers and put them at risk by illegally selling products marketed for therapeutic uses for which they are not approved, such as those claiming to treat cancer or Alzheimer’s disease. Consumers should beware of purchasing or using any such products.”
Given the interest in products containing cannabis or cannabis-derived compounds, and CBD in particular, the FDA has and continues to take an agency-wide, integrated, and collaborative approach to addressing the regulation of products made from CBD that fall under its jurisdiction. The agency has established a high-level internal working group to explore potential pathways for various types of CBD products to be lawfully marketed. An important component of this work is obtaining and evaluating information to address outstanding questions related to the safety of CBD products that will inform the agency’s consideration of potential regulatory frameworks for CBD while maintaining the FDA’s rigorous public health standards. As part of that work, the FDA held a public hearing in May, and opened a docket for written comments, to obtain scientific data and information about the safety, manufacturing, product quality, marketing, labeling and sale of products containing cannabis or cannabis-derived compounds.
“We will continue to work to protect the health and safety of American consumers from products that are being marketed in violation of the law through actions like those the FDA is taking today. At the same time, we also recognize the potential opportunities and significant interest in drug and other consumer products containing CBD,” said FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D. “We understand this is an important national issue with public health impact and of interest to American hemp farmers and many other stakeholders. The agency has a well-established pathway for drug development and drug approvals, and we remain committed to evaluating the agency’s regulatory policies related to other types of CBD products. We plan to report our progress by early this fall as we expedite our work to address the many questions about CBD. The step-wise, science-based approach we’re taking protects patients and the public health, fosters innovation for safe and appropriate products, and promotes consumer confidence.”
As described in the warning letter issued to Curaleaf, the company used product webpages, its online store and social media websites to make unfounded claims about more than a dozen different CBD products. Examples of the unsupported and unapproved claims made by the company include:
- “CBD has been demonstrated to have properties that counteract the growth of [and/or] spread of cancer.”
- “CBD was effective in killing human breast cancer cells.”
- “CBD has also been shown to be effective in treating Parkinson’s disease.”
- “CBD has been linked to the effective treatment of Alzheimer’s disease ….”
- “CBD is being adopted more and more as a natural alternative to pharmaceutical-grade treatments for depression and anxiety.”
- “CBD can also be used in conjunction with opioid medications, and a number of studies have demonstrated that CBD can in fact reduce the severity of opioid-related withdrawal and lessen the buildup of tolerance.”
- “CBD oil is becoming a popular, all-natural source of relief used to address the symptoms of many common conditions, such as chronic pain, anxiety … ADHD.”
- “What are the benefits of CBD oil? …. Some of the most researched and well-supported hemp oil uses include …. Anxiety, depression, post-traumatic stress disorders, and even schizophrenia …. Chronic pain from fibromyalgia, slipped spinal discs . . . Eating disorders and addiction . . ..”
- “[V]ets will prescribe puppy Xanax to pet owners which can help in certain instances but is not necessarily a desirable medication to give your dog continually. Whereas CBD oil is natural and offers similar results without the use of chemicals.”
- “For dogs experiencing pain, spasms, anxiety, nausea or inflammation often associated with cancer treatments, CBD (aka cannabidiol) may be a source of much-needed relief.”
The FDA has requested responses from Curaleaf within 15 working days stating how the violations will be corrected. Failure to correct the violations promptly may result in legal action, including product seizure and injunction.
The agency continues to be concerned at the proliferation of products asserting to contain CBD that are marketed for therapeutic or medical uses that have not been approved by the FDA. The FDA approval process ensures that drugs on the market are safe and effective for their intended therapeutic uses. CBD is marketed in a variety of product types, such as oil drops, capsules, syrups, teas and topical lotions and creams. Often such products are sold online and are therefore available throughout the country. Other than one prescription human drug product to treat rare, severe forms of epilepsy, the FDA has not approved any other CBD products, and there is very limited information for other marketed CBD products, which likely differ in composition from the FDA-approved product and have not been evaluated for potential adverse effects on the body.
Unlike drugs approved by the FDA, the manufacturing process of these products has not been subject to FDA review as part of the drug approval process, and there has been no FDA evaluation of whether these products are effective for their intended use, what the proper dosage is, how they could interact with FDA-approved drugs, or whether they have dangerous side effects or other safety concerns. Unsubstantiated claims associated with CBD products may lead consumers to put off getting important medical care, such as proper diagnosis, treatment and supportive care. For that reason, it’s important that consumers talk to a health care professional about the best way to treat diseases or conditions with existing, approved treatment options. The FDA also cautions pet owners against the use of such products and recommends talking with a veterinarian about appropriate treatment options for pets. The agency also has not approved cannabis or cannabis-derived compounds like CBD for any use in animals and cannot ensure the safety or effectiveness of these products.
The FDA has previously sent warning letters to other companies illegally selling CBD products that claimed to prevent, diagnose, treat, or cure serious diseases, such as cancer. Some of these products were in further violation of the Federal Food, Drug and Cosmetic Act because they were marketed as dietary supplements or because they involved the addition of CBD to food.
SOURCE U.S. Food and Drug Administration
TORONTO and GLIL YAM, Israel, Sept. 11, 2024 /PRNewswire/ — IM Cannabis Corp. (“IMC” or the “Company“) (NASDAQ: IMCC) (CSE: IMCC), a leading medical cannabis company with operations in Israel and Germany, is pleased to announce that Mr. Shmulik Arbel has been appointed to the Company’s board of directors (the “Board“) effective September 9, 2024. Mr. Arbel brings a wealth of experience in strategic plans that drive profitability, as well as, finance and corporate governance, further strengthening the company’s commitment to driving growth while focusing on sustainable profitability.
“We are thrilled to welcome Shmulik to our Board of Directors,” said Oren Shuster, Chief Executive Officer of IM Cannabis. “Shmulik’s extensive international experience at Leumi, coupled with his proven track record in banking and finance will be invaluable as we continue to deliver on our strategic initiatives.”
Mr. Arbel retired as Deputy CEO from Leumi, Israel’s largest banking group, in April 2023, where he was instrumental in business growth and leading the service revolution. With over 25 years of experience at Leumi, Arbel has held senior roles throughout the organization, such as head of retail banking, head of the corporate division, and as chairman of Leumi UK. With key roles in Israel, New York and London, Mr. Arbel has a wide view on international business.
“I am honored to join the Board of Directors at IMCC,” said Mr. Arbel. “I look forward to leveraging my experience in banking and finance, providing guidance as IMCC continues to establish itself as the go-to brand in the cannabis world. I look forward to contributing to the company’s growth.”
Arbel holds a BA and MBA from Tel Aviv University.
About IM Cannabis Corp.
IMC (Nasdaq: IMCC) (CSE: IMCC) is an international cannabis company that provides premium cannabis products to medical patients in Israel and Germany, two of the largest medical cannabis markets. The Company has focused its resources to achieve sustainable and profitable growth in its highest value markets, Israel and Germany. The Company leverages a transnational ecosystem powered by a unique data-driven approach and a globally sourced product supply chain. With an unwavering commitment to responsible growth and compliance with the strictest regulatory environments, the Company strives to amplify its commercial and brand power to become a global high-quality cannabis player.
The IMC ecosystem operates in Israel through its commercial relationship with Focus Medical Herbs Ltd., which imports and distributes cannabis to medical patients, leveraging years of proprietary data and patient insights. The Company also operates medical cannabis retail pharmacies, online platforms, distribution centers, and logistical hubs in Israel that enable the safe delivery and quality control of IMC products throughout the entire value chain. In Germany, the IMC ecosystem operates through Adjupharm GmbH, where it distributes cannabis to pharmacies for medical cannabis patients.
Disclaimer for Forward-Looking Statements
This press release contains forward-looking information or forward-looking statements under applicable Canadian and United States securities laws (collectively, “forward-looking statements“). All information that addresses activities or developments that we expect to occur in the future are forward-looking statements. Forward-looking statements are often, but not always, identified by the use of words such as “seek”, “anticipate”, “believe”, “plan”, “estimate”, “expect”, “likely” and “intend” and statements that an event or result “may”, “will”, “should”, “could” or “might” occur or be achieved and other similar expressions. Forward-looking statements are based on the estimates and opinions of management on the date the statements are made. In the press release, such forward-looking statements include, but are not limited to, statements relating to: the stated benefits Mr. Arbel’s appointment, including the further strengthening the Company’s commitment to driving growth in the German market while focusing on sustainable profitability; and Mr. Arbel’s international experience and track record in banking and finance will be invaluable to the Company.
Forward-looking statements are based on assumptions that may prove to be incorrect, including but not limited to: the Company’s ability to realize upon the stated benefits Mr. Arbel’s appointment; and Mr. Arbel’s international experience and track record in banking and finance becoming invaluable to the Company.
The above lists of forward-looking statements and assumptions are not exhaustive. Since forward-looking statements address future events and conditions, by their very nature they involve inherent risks and uncertainties. Actual results may differ materially from those currently anticipated or implied by such forward-looking statements due to a number of factors and risks. These include: the failure of the Company to comply with applicable regulatory requirements in a highly regulated industry; unexpected changes in governmental policies and regulations in the jurisdictions in which the Company operates; the Company’s ability to continue to meet the listing requirements of the Canadian Securities Exchange and the NASDAQ Capital Market; any unexpected failure to maintain in good standing or renew its licenses; the ability of the Company and its subsidiaries (collectively, the “Group“) to deliver on their sales commitments or growth objectives; the reliance of the Group on third-party supply agreements to provide sufficient quantities of medical cannabis to fulfil the Group’s obligations; the Group’s possible exposure to liability, the perceived level of risk related thereto, and the anticipated results of any litigation or other similar disputes or legal proceedings involving the Group; the impact of increasing competition; any lack of merger and acquisition opportunities; adverse market conditions; the inherent uncertainty of production quantities, qualities and cost estimates and the potential for unexpected costs and expenses; risks of product liability and other safety-related liability from the usage of the Group’s cannabis products; supply chain constraints; reliance on key personnel; the risk of defaulting on existing debt; risks surrounding war, conflict and civil unrest in Eastern Europe and the Middle East, including the impact of the Israel-Hamas war on the Company, its operations and the medical cannabis industry in Israel; risks associated with the Company focusing on the Israel and Germany markets; the inability of the Company to achieve sustainable profitability and/or increase shareholder value; the inability of the Company to actively manage costs and/or improve margins; the inability of the company to grow and/or maintain sales; the inability of the Company to meet its goals and/or strategic plans; the inability of the Company to reduce costs and/or maintain revenues; the Company’s inability to take advantage of the legalization of medicinal cannabis in Germany; and the Company’s inability to realize upon the stated benefits Mr. Arbel’s appointment; and Mr. Arbel’s international experience and track record in banking and finance not becoming valuable to the Company.
Please see the other risks, uncertainties and factors set out under the heading “Risk Factors” in the Company’s annual report dated March 28, 2024, which is available on the Company’s issuer profile on SEDAR+ at www.sedarplus.ca and Edgar at www.sec.gov/edgar. Any forward-looking statement included in this press release is made as of the date of this press release and is based on the beliefs, estimates, expectations and opinions of management on the date such forward looking information is made. The Company does not undertake any obligation to update forward-looking statements except as required by applicable securities laws. Investors should not place undue reliance on forward-looking statements. Forward-looking statements contained in this press release are expressly qualified by this cautionary statement.
Company Contact:
Anna Taranko, Director Investor & Public Relations
IM Cannabis Corp.
+49 157 80554338
[email protected]
Oren Shuster, CEO
IM Cannabis Corp.
[email protected]
Logo: https://mma.prnewswire.com/media/1742228/IM_Cannabis_Logo.jpg
View original content:https://www.prnewswire.co.uk/news-releases/im-cannabis-announces-appointment-of-shmulik-arbel-to-board-of-directors-302244961.html
Cannabis
Europe Medical Cannabis Market Forecast 2024-2032: Tilray, Aurora Cannabis, and GW Pharmaceuticals Dominate the Market Landscape
Dublin, Aug. 29, 2024 (GLOBE NEWSWIRE) — The “Europe Medical Cannabis Oil Market Size, Industry Dynamics, Opportunity Analysis and Forecast 2024-2032.” report has been added to ResearchAndMarkets.com’s offering.
The Europe Medical Cannabis Oil market is poised for significant growth, projected to escalate from US$ 0.91 billion in 2023 to US$ 2.40 billion by 2032, advancing at a CAGR of 12.08%. In this comprehensive research report, the market is analyzed by:
- Derivatives;
- Source;
- Application;
- Route of Administration;
- End-user;
- Distribution Channel; and
- Country.
Market Highlights Identified in the Report
- Progressive legalization across Europe is creating a favorable regulatory environment, enhancing market expansion for medical cannabis oil products.
- Germany leads the market with a robust infrastructure and supportive regulations, while other countries like the UK, Italy, and Spain show significant growth potential based on evolving regulatory landscapes and market dynamics.
- Key players such as Tilray, Aurora Cannabis Inc., and GW Pharmaceuticals dominate the market, emphasizing research, strategic partnerships, and innovation to maintain competitive edge amidst evolving industry dynamics.
The medical cannabis oil market has experienced substantial growth as legalization and acceptance of cannabis-based treatments expand globally. Cannabis oil, derived from the cannabis plant through extraction methods, contains cannabinoids such as THC and CBD, known for their therapeutic properties. Increasing recognition of cannabis oil’s potential in alleviating symptoms of various medical conditions, including chronic pain, epilepsy, and anxiety disorders, has driven its adoption in medical settings.
Governments in several countries are progressively legalizing medical cannabis, creating a conducive regulatory environment for market expansion. Additionally, growing consumer awareness about alternative and natural therapies has fueled the demand for cannabis oil products. The market is characterized by diverse product offerings, including full-spectrum and CBD-isolate oils, catering to different therapeutic needs and preferences.
Despite regulatory challenges and stigma associated with cannabis, the medical cannabis oil market continues to evolve, driven by ongoing research, favorable legislative changes, and shifting attitudes toward cannabis-based therapies in healthcare.
Regional Insights
Germany is likely to maintain its leadership position in the European medical cannabis oil market due to its established infrastructure, supportive regulations, and strong healthcare system. Germany legalized medical cannabis in 2017, giving the market a head start compared to many other European countries. This established infrastructure and experience position Germany as a leader in the field. As awareness and acceptance of medical cannabis increase, the number of patients seeking treatment in Germany is steadily rising. This fuels market growth and incentivizes further investment in research and development.
Germany’s regulatory framework for medical cannabis is considered relatively patient-friendly compared to some other European countries. This facilitates access for patients with qualifying conditions. The UK legalized medical cannabis in 2018 and is experiencing an increase in patient access programs. This, coupled with ongoing research, could lead to significant market growth. Italy legalized medical cannabis in 2006 but has faced challenges with availability. As regulations become more streamlined and patient access expands, the Italian market holds significant growth potential. Spain has a well-established medical cannabis industry with a focus on domestic production. As regulations evolve and export opportunities increase, the Spanish market could see a boost.
Competitive Landscape
The Medical Cannabis Oil market is characterized by a vigorous competitive landscape, with prominent entities like Tilray, Aurora Cannabis Inc., GW Pharmaceuticals, Almiral, Bedrocan, and others at the forefront, collectively accounting for approximately 41 % of the overall market share. This competitive milieu is fueled by their intensive efforts in research and development as well as strategic partnerships and collaborations, underscoring their commitment to solidifying market presence and diversifying their offerings.
The primary competitive factors include pricing, product caliber, and technological innovation. As the Medical Cannabis Oil industry continues to expand, the competitive fervor among these key players is anticipated to intensify. The impetus for ongoing innovation and alignment with evolving customer preferences and stringent regulations is high. The industry’s fluidity anticipates an uptick in novel innovations and strategic growth tactics from these leading corporations, which in turn propels the sector’s comprehensive growth and transformation.
Key Topics Covered
Chapter 1. Research Framework
Chapter 2. Research Methodology
Chapter 3. Executive Summary: Europe Medical Cannabis Oil Market
Chapter 4. Europe Medical Cannabis Oil Market Overview
Chapter 5. Europe Medical Cannabis Oil Market Analysis, by Derivatives
Chapter 6. Europe Medical Cannabis Oil Market Analysis, by Source
Chapter 7. Europe Medical Cannabis Oil Market Analysis, by Application
Chapter 8. Europe Medical Cannabis Oil Market Analysis, by Route of Administration
Chapter 9. Europe Medical Cannabis Oil Market Analysis, by End-user
Chapter 10. Europe Medical Cannabis Oil Market Analysis, by Distribution Channel
Chapter 11. Europe Medical Cannabis Oil Market Analysis, by Country
Chapter 12. The UK Medical Cannabis Oil Market Analysis
Chapter 13. Germany Medical Cannabis Oil Market Analysis
Chapter 14. The Netherlands Medical Cannabis Oil Market Analysis
Chapter 15. Italy Medical Cannabis Oil Market Analysis
Chapter 16. Spain Medical Cannabis Oil Market Analysis
Chapter 17. Poland Medical Cannabis Oil Market Analysis
Chapter 18. Rest of Europe Medical Cannabis Oil Market Analysis
Chapter 19. Company Profiles (Company Overview, Financial Matrix, Key Product Landscape, Key Personnel, Key Competitors, Contact Address, and Business Strategy Outlook)
A selection of companies mentioned in this report includes, but is not limited to:
- Aurora Cannabis Inc.
- Bedrocan
- Biocann
- BIOTA Biosciences LLC
- Cannamedical
- Mary Jane CBD
- Sanity Group GmbH
- Tilray
- Valcon Medical
For more information about this report visit https://www.researchandmarkets.com/r/dh7q46
About ResearchAndMarkets.com
ResearchAndMarkets.com is the world’s leading source for international market research reports and market data. We provide you with the latest data on international and regional markets, key industries, the top companies, new products and the latest trends.
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