#Curaleaf Holdings (MA) | Explore Tumblr Posts and Blogs

itswallstreetpr · 4 years

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The Pot Stock Rebirth (GWPH, NUGS, CURLF, GRWG)

Remember a few years ago, when cannabis stocks were all the rage? It’s been a brutal bear for the pot stock crowd for the past couple years, but the signs and signals are piling up that the space is once again catching fire. To help size up the landscape and formulate a plan, we offer up the following survey of some of the most interesting and talked about names in the space: GW Pharmaceuticals PLC- ADR (NASDAQ:GWPH), Cannabis Strategic Ventures (OTCMKTS:NUGS), Curaleaf Holdings Inc (OTCMKTS:CURLF), and GrowGeneration Corp (NASDAQ:GRWG). GW Pharmaceuticals PLC- ADR (NASDAQ:GWPH) recently reported Q1 results, with sales at $120.6 million, more than triple the numbers dropped in the year-ago quarter, blowing out analyst estimates (consensus $109.4 million). The big driver, as one may have expected, was Epidiolex, an FDA approved CBD treatment for refractory childhood epilepsies, as well as for the treatment of Dravet syndrome, Lennox-Gastaut syndrome, tuberous sclerosis complex, and infantile spasms. Net product sales for the drug totaled $116.1 million in Q1, with $106.1 million of this amount generated in the U.S. GW Pharmaceuticals PLC- ADR (NASDAQ:GWPH) bills itself as a biopharmaceutical company that engages in discovering, developing, and commercializing cannabinoid prescription medicines using botanical extracts derived from the Cannabis plant. The company operates through three segments: Commercial, Sativex Research and Development, and Pipeline Research and Development. Its lead product is Epidiolex, an FDA approved treatment of refractory childhood epilepsies, as well as for the treatment of Dravet syndrome, Lennox-Gastaut syndrome, tuberous sclerosis complex, and infantile spasms. The company also develops and markets Sativex, an oromucosal spray for the treatment of spasticity due to multiple sclerosis. In addition, it develops various product candidates, which are in Phase I and II clinical development for the treatment of glioma, neonatal hypoxic-ischemic encephalopathy, adult epilepsy, and schizophrenia. The context for this announcement is a bit of a bid, with shares acting well over the past five days, up about 4% in that timeframe. Shares of the stock have powered higher over the past month, rallying roughly 21% in that time on strong overall action. GW Pharmaceuticals PLC- ADR (NASDAQ:GWPH) generated sequential quarter-over-quarter growth rate of 22.3% on the top line. In addition, the company has a strong balance sheet, with cash levels far exceeding current liabilities ($536.9M against $117.6M). Cannabis Strategic Ventures (OTCMKTS:NUGS) is nailing things right now, in terms of execution. Cometh the moment, cometh the company. That’s what seems to be the case. We are seeing dramatic sales growth, advances in product quality (as evidenced by increased pricing out the door), and expanding production capacity. The stock is up nearly 100% since its March lows – when the whole market panicked into a major bottom and turned back higher. At this point, we are seeing bids show up around the 50-day MA, which is a positive sign. Cannabis Strategic Ventures (OTCMKTS:NUGS) also recently announced that it is about to launch a full line of branded products. We like to see the increased pricing power. It shows strong execution from the ground up. And a robust relationship with key distribution partners. But a branded product line can push that aspect considerably further. The difference between a white label cannabis supplier and a branded products name with a popular brand is night and day. And if the branded products name first learned how to be effective as a generic producer, a real edge is born. That may well be where NUGS is right now: working with a macro tailwind and the good side of the execution narrative, but still ahead of the powerful news of a branded products launch. Either way, the company’s most recent release suggests NUGS may be set to do more than twice the sales it was targeting for 2020 when it entered the year. Curaleaf Holdings Inc (OTCMKTS:CURLF) just announced that retail locations in Massachusetts re-opened for adult-use purchases starting on May 25th, 2020. "We are pleased that our three adult use dispensaries in Ware, Oxford and Provincetown are among the first of Commonwealth businesses allowed to re-open on May 25, and we appreciate the Governor and Lt. Governor's decision," said Patrik Jonsson, president of Curaleaf Massachusetts. "We're very much looking forward to resuming serving our customers with the quality products they have come to rely on, and also getting our people back to work. We expect sales to be brisk as a result of pent up demand, and we are working closely with the Cannabis Control Commission and the Massachusetts Department of Health to comply with all guidelines surrounding our reopening." Curaleaf Holdings Inc (OTCMKTS:CURLF) promulgates itself as a company that operates as an integrated medical and wellness cannabis operator in the United States. Curaleaf Inc.'s Florida operations were the first in the cannabis industry to receive the Safe Quality Food certification under the Global Food Safety Initiative, setting a new standard of excellence. And the stock has been acting well over recent days, up something like 2% in that time. Shares of the stock have powered higher over the past month, rallying roughly 20% in that time on strong overall action. Curaleaf Holdings Inc (OTCMKTS:CURLF) generated sales of $129.8M, according to information released in the company's most recent quarterly financial report. That adds up to a sequential quarter-over-quarter growth rate of 30.3% on the top line. In addition, the company has a strong balance sheet, with cash levels far exceeding current liabilities ($251M against $177.1M). GrowGeneration Corp (NASDAQ:GRWG) managed to rope in revenues totaling $33M in overall sales during the company's most recently reported quarterly financial data -- a figure that represents a rate of top line growth of 152%, as compared to year-ago data in comparable terms. If there’s any concerns here from a fundamental metric perspective, the company is battling some balance sheet hurdles, with cash levels struggling to keep up with current liabilities ($11.4M against $17.3M, respectively). GrowGeneration Corp (OTCMKTS:GRWG) trumpets itself as a company that, through its subsidiaries, owns and operates retail hydroponic and organic gardening stores in the United States. Currently, GrowGen has 27 stores, and carries and sells thousands of products, including organic nutrients and soils, advanced lighting technology and state of the art hydroponic equipment to be used indoors and outdoors by commercial and home growers. According to company materials, “Our mission is to own and operate GrowGeneration branded stores in all the major states in the US and Canada. Management estimates that roughly 1,000 hydroponic stores are in operation in the US. By 2025 the market is estimated to reach over $30 billion with a compound annual growth.” If you're long this stock, then you're liking how it has responded in recent days as well. GRWG shares have pushed about 27% to the upside on above average trading volume in the past week since releasing Q1 financials. Read the full article

#CBDstocks #canabisstocks #NASDAQ #NYSE #Stocks

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bestmarijuanaboutiques · 5 years

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Curaleaf shares down 8% after FDA sends warning letter over CBD health claims

New Post has been published on https://bestmarijuanaboutiques.com/?post_type=wprss_feed_item&p=23532

Curaleaf shares down 8% after FDA sends warning letter over CBD health claims

Marketwatch report….

Shares of cannabis company Curaleaf Holdings Inc. tumbled more than 7% Tuesday and dragged the broader sector lower, after the U.S. Food and Drug Administration sent a warning letter to the company for selling CBD-based products that claim to treat serious diseases.

Curaleaf CURLF, -7.27% is “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,” the FDA wrote.

Full report at

https://www.marketwatch.com/story/curaleaf-shares-tumble-8-after-fda-warning-letter-over-cbd-health-claims-2019-07-23?mod=personal-finance

Full Letter

Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/curaleaf-inc-579289-07222019

Delivery Method:Via Overnight Delivery

Product:Animal & Veterinary Drugs

Recipient: Joseph Lusardi President Curaleaf, Inc

301 Edgewater Place Suite 405Wakefield, MA 01880United States

Issuing Office: Center for Drug Evaluation and Research

10903 New Hampshire Avenue,Silver Spring, MD 20993United States

WARNING LETTER

VIA OVERNIGHT DELIVERY RETURN RECEIPT REQUESTED

July 22, 2019

Joseph Lusardi, President Curaleaf, Inc. 301 Edgewater Place Suite 405 Wakefield, MA 01880 RE: 579289

Dear Joseph Lusardi:

This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address https://curaleafhemp.comExternal Link Disclaimer in April and June 2019 and has determined that you take orders there for the products “CBD Lotion,” “CBD Pain-Relief Patch,” “CBD Tincture” (5 versions), “CBD Disposable Vape Pen” (5 versions) and “Bido CBD for Pets” (3 versions), all of which you promote as products containing cannabidiol (CBD).1 We have also reviewed your social media websites at www.facebook.com/CuraleafHempExternal Link Disclaimer and https://twitter.com/curaleafhempExternal Link Disclaimer; these websites direct consumers to your website, https://curaleafhemp.comExternal Link Disclaimer, to purchase your products. FDA has determined that your “CBD Lotion,” “CBD Pain-Relief Patch,” “CBD Tincture,” and “CBD Disposable Vape Pen” products are unapproved new drugs sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. 355(a) and 331(d). Furthermore, these products are misbranded drugs under section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1). FDA has also determined that your “Bido CBD for Pets” products are unapproved new animal drugs that are unsafe under section 512(a) of the FD&C Act, 21 U.S.C. 360b(a), and adulterated under section 501(a)(5) of the FD&C Act, 21 U.S.C. 351(a)(5). As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the FD&C Act. You can find the FD&C Act and FDA regulations through links on FDA’s home page at www.fda.gov.

Unapproved New and Misbranded Human Drug Products

Based on our review of your website, your “CBD Lotion,” “CBD Pain-Relief Patch,” “CBD Tincture,” and “CBD Disposable Vape Pen” products are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or any function of the body.

Examples of claims observed on your website and social media accounts in April 2019 that establish the intended use of your products as drugs include, but may not be limited to, the following:

On your product webpage for CBD Disposable Vape Pen (Relieve): • “[F]or chronic pain.”

On your product webpage for CBD Tincture (Relieve): • “[S]oothing tincture for chronic pain.”

Additional claims observed on your website in June 2019 include, but are not limited to, the following:

On your webpage titled “Can CBD Oil be Used for ADHD?” • “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.” • “The Benefits of CBD Oil for ADHD . . . It’s not unusual for people with ADHD to feel anxious and on the edge. CBD is known for its anti-anxiety properties that can promote relaxation and stress relief. It can also help to restore focus and ability to concentrate on specific tasks, as well as reduce impulsivity.”

On your webpage titled “How to Use CBD Oil for Anxiety” • “CBD can successfully reduce anxiety symptoms, both alone and in conjunction with other treatments.” • “CBD oil can be used in a variety of ways to help with chronic anxiety.”

On your webpage titled “CBD Benefits: Top 5 Research-Backed Benefits of CBD” • “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 has been demonstrated to have properties that counteract the growth of spread of cancer.” • “CBD was effective in killing human breast cancer cells.” • “Heart disease is one of the leading causes of death in the United States each year, and CBD does a number of things to deter it. The two most important of these are the ability to lower blood pressure, and the ability to promote good cholesterol and lower bad cholesterol.”

On your webpage titled “Hemp Oil vs. CBD Oil: Everything You Need to Know” • “CBD . . . can be used to help manage a wide range of health conditions, such as . . . Anxiety and depression . . . Chronic or arthritic pain . . ..”

On your webpage titled “How to Choose the Best CBD Oil for You” • “Some of the most common reasons to use CBD oil include . . . Chronic pain . . . Mental conditions like anxiety, depression, and PTSD . . ..”

On your webpage titled “Is CBD Oil Good for Depression?” • “A 2014 study showed that participants who received CBD oil experienced anti-anxiety and anti-depression effects from the oil.” • “A 2018 study showed that CBD offers quick relief of depression and anxiety symptoms and that the residual effects can last up to seven days.”

On your webpage titled “What are the Benefits of Hemp-Derived CBD Oil?” • “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 . . ..”

On your Facebook Social Media Account: • April 8, 2019 posting – “CBD Can be a powerful ally if you’re suffering from chronic inflammation and pain.” • March 14, 2019 posting – “The top five research backed benefits of CBD include: 1) neuro[de]generative disease 2) depression and anxiety treatment 3) pain treatment 4) aids in the treatment of cancer and related symptoms to cancer . . ..”

On your Twitter Social Media Account: • March 27, 2019 posting – “#ICBD to help lower anxiety . . ..” March 25, 2019 posting – “CBD is being adopted more and more as a natural alternative to pharmaceutical-grade treatments for depression and anxiety.”

Your “CBD Lotion,” “CBD Pain-Relief Patch,” “CBD Tincture,” and “CBD Disposable Vape Pen” products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p). New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from the FDA, as described in sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.

Your “CBD Lotion,” “CBD Pain-Relief Patch,” “CBD Tincture,” and “CBD Disposable Vape Pen” products are also misbranded within the meaning of section 502(f)(1) of the FD&C Act, 21 U.S.C. 352(f)(1), in that their labeling fails to bear adequate directions for use. “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended, 21 CFR 201.5. Your “CBD Lotion,” “CBD Pain-Relief Patch,” “CBD Tincture,” and “CBD Disposable Vape Pen” products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes. FDA-approved prescription drugs which bear their FDA-approved labeling are exempt from the requirements that they bear adequate directions for use by a layperson. However, your products are not exempt from the requirement that their labeling bear adequate directions for use, 21 CFR 201.100(c)(2) and 201.115, because no FDA-approved applications are in effect for them. It is prohibited to introduce or deliver for introduction into interstate commerce a misbranded drug under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).

Dietary Supplement Labeling

Information on your website and social media accounts suggests that you may intend to market your CBD products as dietary supplements. For example, a disclaimer on your website includes the statement “Cannabidiol (CBD) is a natural constituent of industrial hemp and is a dietary supplement.” You also display a photo of a CBD product with a supplement facts panel that appears to be your “CBD Tincture” (Relax version) on your social media accounts. Furthermore, you state under the disclaimer section on your “CBD Lotion,” “CBD Pain-Relief Patch,” “CBD Tincture,” and “CBD Disposable Vape Pen” products’ webpages that “Cannabidiol (CBD) . . . is a dietary supplement.” Based on these observations, it appears you intend to market your CBD products as dietary supplements. However, they cannot be dietary supplements because they do not meet the definition of a dietary supplement under sections 201(ff)(3)(B) and 201(ff)(2)(A)(i) of the FD&C Act, 21 U.S.C. 321(ff)(3)(B) and 321(ff)(2)(A)(i).

FDA has concluded based on available evidence that CBD products are excluded from the dietary supplement definition under sections 201(ff)(3)(B)(i) and (ii) of the FD&C Act, 21 U.S.C. 321(ff)(3)(B)(i) and (ii). Under those provisions, if an article (such as CBD) is an active ingredient in a drug product that has been approved under section 505 of the FD&C Act, 21 U.S.C. 355, or has been authorized for investigation as a new drug for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public, then products containing that substance are outside the definition of a dietary supplement. There is an exception if the substance was “marketed as” a dietary supplement or as a conventional food before the new drug investigations were authorized; however, based on available evidence, FDA has concluded that this is not the case for CBD.2 FDA is not aware of any evidence that would call into question its current conclusion that CBD products are excluded from the dietary supplement definition under sections 201(ff)(3)(B)(i) and (ii) of the FD&C Act, but you may present FDA with any evidence that has bearing on this issue.

Furthermore, your “CBD Lotion” product’s labeling states that it is intended to be applied directly to the skin; your “CBD Pain-Relief Patch” product’s labeling states that it is intended to be applied to the body for transdermal use; and your “CBD Disposable Vape Pen” products’ labeling states that they are intended for inhalation. The FD&C Act defines the term “dietary supplement” in section 201(ff)(2)(A)(i) as a product that is “intended for ingestion.” Because these products are not intended for ingestion, this is an additional reason why your “CBD Lotion,” “CBD Pain-Relief Patch,” and “CBD Disposable Vape Pen” products do not meet the definition of a dietary supplement under the FD&C Act. Furthermore, with respect to your “CBD Tincture” products, the “Suggested Use” section of these products’ labeling includes both “edible” uses and topical uses. To the extent that your “CBD Tincture” products are intended for a delivery method other than ingestion, as evidenced by the labeling describing topical uses, this is an additional reason why these products also do not meet the definition of a dietary supplement under the FD&C Act.

Unapproved New Animal Drugs

During a recent review of your firm’s website (https://curaleafhemp.com/collections/pet-dropsExternal Link Disclaimer), FDA determined that your firm is marketing “Bido CBD for Pets” (Pure, Bacon and Salmon Flavor), which are unapproved new animal drugs. Based on our review of the information provided, we determined that these products are intended for use in the mitigation, treatment, or prevention of diseases in animals, which makes them drugs under section 201(g)(1)(B) of the Federal Food, Drug and Cosmetic Act (the FD&C Act), 21 U.S.C. 321(g)(1)(B). Further, as discussed below, these products are unapproved new animal drugs and marketing them violates the FD&C Act.

Examples of claims observed on your firm’s website (https://curaleafhemp.com/blogs/cbdExternal Link Disclaimer) that show the intended uses of these products include, but are not limited to, the following:

Found at: https://curaleafhemp.com/blogs/cbd/reasons-to-use-cbd-oil-for-dogsExternal Link Disclaimer • “Decrease compulsive behavior like biting, scratching, chewing, whining, eliminating, and other symptoms of dog separation anxiety” • “Decrease autonomic arousal symptoms like fast/irregular heartbeat, panting, and general distressed feelings” • “Alleviate fear feelings” • “Prevent the longer-term health effects of anxiety” • “CBD may help with cat anxiety” (https://curaleafhemp.com/blogs/cbd/cbd-oil-for-catsExternal Link Disclaimer ) • “It’s natural, safe and will allow your dog to play, eat, and do other things dogs enjoy without the symptoms of anxiety.” (https://curaleafhemp.com/blogs/cbd/cbd-for-dog-separation-anxietyExternal Link Disclaimer) • “vets 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.” (https://curaleafhemp.com/blogs/cbd/how-much-cbd-oil-should-i-give-my-dogExternal Link Disclaimer ) • “Relief of seizures and neurological problems” (https://curaleafhemp.com/blogs/cbd?page=2External Link Disclaimer ) • “Soothing of trauma and anxiety” (https://curaleafhemp.com/blogs/cbd?page=2External Link Disclaimer )

Found at: https://curaleafhemp.com/blogs/cbd/reasons-to-use-cbd-oil-for-dogsExternal Link Disclaimer

“For dogs with arthritis and other joint issues, the American Kennel Club reports that CBD treats inflammation in the muscle tissue and joints—which works to improve the overall musculoskeletal system.” • “…this helps take pressure away from the surrounding nerve endings and directly reduces pain.”

Found at: https://curaleafhemp.com/blogs/cbd?page=3External Link Disclaimer

“Pain relief from cancer or after surgery” • “Relief of muscle spasms” • “Recently published research confirms that CBD helps dogs with osteoarthritis. All dogs in the trial showed marked improvement in their overall activity levels and apparent pain levels. So it’s believed that CBD would provide the same results for cats with arthritis or inflammation.”

Found at: https://curaleafhemp.com/blogs/cbd/cbd-oil-for-catsExternal Link Disclaimer “•Diabetes”

Found at: https://curaleafhemp.com/blogs/cbd/is-cbd-oil-safe-for-dogsExternal Link Disclaimer “What are the benefits of using CBD oil for your pets?….. •Pain relief from arthritis and aging”

Found at: https://curaleafhemp.com/blogs/cbd/cannabis-oil-dog-cancerExternal Link Disclaimer • “CBD oil can help relieve cancer pain and spasms” • “CBD oil may slow the growth of cancer”

Found at: https://curaleafhemp.com/blogs/cbd?page=9External Link Disclaimer • “…it has been found to assist in the reduction of tumor size while stunting the potential spreading of cancer through the body.” • “Chemotherapy, radiation treatments, and surgery can quickly push into the tens of thousands of dollars. While you may not be able to afford such cancer treatments for your dog, CBD oil is a viable and inexpensive alternative.” • “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.” (https://curaleafhemp.com/blogs/cbd?page=3External Link Disclaimer ) • “…CBD oil has been clinically shown to help manage the symptoms of cancer treatment, which can improve a patient’s quality of life.” (https://curaleafhemp.com/blogs/cbd?page=3External Link Disclaimer )

Found at: https://curaleafhemp.com/blogs/cbd/how-much-cbd-oil-should-i-give-my-dogExternal Link Disclaimer • “Many dogs, especially those with thinner, shorter coats, suffer from skin conditions. Whether due to allergies or the weather, CBD oil can help improve the overall quality of your dog’s skin.”

Because the products are intended to mitigate, treat, or prevent disease in animals, they are drugs within the meaning of section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B). Further, these products are “new animal drugs” under section 201(v) of the FD&C Act, 21 U.S.C. 321(v), because they are not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling.

To be legally marketed, a new animal drug must have an approved new animal drug application, conditionally approved new animal drug application, or index listing under sections 512, 571, and 572 of the FD&C Act, 21 U.S.C. 360b, 360ccc, and 360ccc-l. These products are not approved or index listed by the FDA, and therefore these products are considered unsafe under section 512(a) of the FD&C Act, 21 U.S.C. 360b(a), and adulterated under section 501(a)(5) of the FD&C Act, 21 U.S.C. 351(a)(5). Introduction of an adulterated drug into interstate commerce is prohibited under section 301(a) of the FD&C Act, 21 U.S.C. 331(a).

The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your marketed products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law and FDA regulations.

You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.

Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction.

Your response should be sent to U.S. Food and Drug Administration, CDER/OC/Office of Unapproved Drugs and Labeling Compliance, 10903 New Hampshire Avenue, WO51, Silver Spring, MD 20993-0002 or by email to [email protected].

Sincerely, /s/ Donald D. Ashley Director Office of Compliance Center for Drug Evaluation and Research Food and Drug Administration /s/ Eric Nelson Director Office of Compliance Center for Veterinary Medicine Food and Drug Administration

[1] Full product list: CBD Tincture Digest, CBD Tincture Uplift, CBD Tincture Relieve, CBD Tincture Revive, and CBD Tincture Relax; CBD Disposable Vape Pen Digest, CBD Disposable Vape Pen Uplift, CBD Disposable Vape Pen Relieve, CBD Disposable Vape Pen Revive, and CBD Disposable Vape Pen Relax; and Bido CBD for Pets Bacon, Bido CBD for Pets Pure, and Bido CBD for Pets Salmon.

[2] CBD is the active ingredient in the approved drug product Epidiolex. Furthermore, the existence of substantial clinical investigations regarding CBD has been made public. For example, two such substantial clinical investigations include GW Pharmaceuticals’ investigations regarding Sativex and Epidiolex. (See Sativex Commences US Phase II/III Clinical Trial in Cancer PainExternal Link Disclaimer and GW Pharmaceuticals Receives Investigational New Drug (IND) from FDA for Phase 2/3 Clinical Trial of Epidiolex in the Treatment of Dravet SyndromeExternal Link Disclaimer). FDA considers a substance to be “authorized for investigation as a new drug” if it is the subject of an Investigational New Drug application (IND) that has gone into effect. Under FDA’s regulations [21 CFR 312.2], unless a clinical investigation meets the limited criteria in that regulation, an IND is required for all clinical investigations of products that are subject to section 505 of the FD&C Act.

Content current as of:

07/23/2019

Regulated Product(s)

Animal & Veterinary

Drugs

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weedconsortium2 · 5 years

Link

Marketwatch report….

Full report at

https://www.marketwatch.com/story/curaleaf-shares-tumble-8-after-fda-warning-letter-over-cbd-health-claims-2019-07-23?mod=personal-finance

Full Letter

Source: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/curaleaf-inc-579289-07222019

Delivery Method:Via Overnight Delivery

Product:Animal & Veterinary Drugs

Recipient: Joseph Lusardi President Curaleaf, Inc

301 Edgewater Place Suite 405Wakefield, MA 01880United States

Issuing Office: Center for Drug Evaluation and Research

10903 New Hampshire Avenue,Silver Spring, MD 20993United States

WARNING LETTER

VIA OVERNIGHT DELIVERY RETURN RECEIPT REQUESTED

July 22, 2019

Joseph Lusardi, President Curaleaf, Inc. 301 Edgewater Place Suite 405 Wakefield, MA 01880 RE: 579289

Dear Joseph Lusardi:

Unapproved New and Misbranded Human Drug Products

Examples of claims observed on your website and social media accounts in April 2019 that establish the intended use of your products as drugs include, but may not be limited to, the following:

On your product webpage for CBD Disposable Vape Pen (Relieve): • “[F]or chronic pain.”

On your product webpage for CBD Tincture (Relieve): • “[S]oothing tincture for chronic pain.”

Additional claims observed on your website in June 2019 include, but are not limited to, the following:

Dietary Supplement Labeling

Unapproved New Animal Drugs

Found at: https://curaleafhemp.com/blogs/cbd/reasons-to-use-cbd-oil-for-dogsExternal Link Disclaimer

Found at: https://curaleafhemp.com/blogs/cbd?page=3External Link Disclaimer

Found at: https://curaleafhemp.com/blogs/cbd/cbd-oil-for-catsExternal Link Disclaimer “•Diabetes”

Found at: https://curaleafhemp.com/blogs/cbd/is-cbd-oil-safe-for-dogsExternal Link Disclaimer “What are the benefits of using CBD oil for your pets?….. •Pain relief from arthritis and aging”

Found at: https://curaleafhemp.com/blogs/cbd/cannabis-oil-dog-cancerExternal Link Disclaimer • “CBD oil can help relieve cancer pain and spasms” • “CBD oil may slow the growth of cancer”

Content current as of:

07/23/2019

Regulated Product(s)

Animal & Veterinary

Drugs

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Warning Letters

About Warning and Close-Out Letters

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gigglesndimples · 6 years

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The Cannabis Industry’s 20 Hottest Pot Stocks of 2019

With mergers and acquisitions moving at a fast pace, it’s hard to know which cannabis companies are the best values. Last year, we provided a list of the Top 12 Canadian Pot Stocks. Here’s an expanded 2019 list that includes U.S. companies investors are high on.

Acreage Holdings

OTC: ACRGF

Based: New York, NY

Cap: $1.65 billion

Stock price: $19.10

About: Holds dispensary and cultivation licenses in 10 states; former Speaker of the House John Boehner And Canadian Prime Minister Brian Mulroney are on their board.

Related Article: They Say It’s an Evolution: On John Boehner’s Cannabis Switcheroo

Aphria Inc.

NYSE: APHA

Based: Leamington, ON

Cap: $2.55 billion

Stock price: $10.31

About: The Canadian licensed producer faced a short seller in 2018. Note: Licensed producers are legally allowed to cultivate in Canada.

Related Article: Quintessential Capital Challenges Aphria

Aurora Cannabis Inc.

NYSE: ACB

Based: Cremona, AB

Cap: $7.33 billion

Stock Price: $7.30

About: The Canadian licensed producer met with Coca-Cola in 2018

Canopy Growth Corp.

NYSE: CGC

Based: Smiths Falls, ON

Cap: $16.10 billion

Stock price: $47.10

About: The Canadian licensed producer sold 38% of the company to alcohol maker Constellation Brands in 2018

Charlotte’s Web Holdings Inc.

OTC: CWBHF

Based: Boulder, CO

Cap: $259.43 million

Stock price: $14.16

About: Produces hemp and CBD products under the CW Hemp brand

Cronos Group Inc.

NASDAQ: CRON

Based: Toronto, ON

Cap: $3.91 billion

Stock Price: $21.75

About: The Canadian licensed producer sold 45% of company to tobacco giant Altria Group in 2018

Related Article: Big Tobacco Makes Major Move into Canadian Cannabis Market

Curaleaf Holdings Inc.

OTC: CURLF

Based: Wakefield, MA

Cap: $3.48 billion

Stock Price: $7.60

About: Holds dispensary and cultivation licenses in 10 states

Freedom Leaf Health

OTC: FRLF

Based: Las Vegas, NV

Cap: $49.70 million

Stock Price: $0.22

About: Publishes Freedom Leaf magazine and manufactures hemp-CBD products

Related Article: Freedom Dives into the Hemp/CBD Market

Green Organic Dutchman Holdings Ltd.

OTC: TGODF

Based: Mississauga, ON

Cap: $893.06 million

Stock Price: $3.29

About: Canadian licensed producer

GW Pharmaceuticals

NASDAQ: GWPH

Based: Cambridge, UK

Cap: $5.4 billion

Stock Price: $177.49

About: Maker of Sativex and Epidiolex, both approved by the FDA

Related Article: The Epidiolex Effect: Will Other CBD Drugs Receive FDA and DEA Approvals?

Hexo Corp.

OTC: HEXO

Based: Gatineau, QB

Cap: $1.17 billion

Stock Price: $5.67

About: The Canadian licensed producer partnered with Molson Coors Canada in 2018

iAnthus Capital Holdings Inc.

OTC: ITHUF

Based: New York, NY

Cap: $407.62 million

Stock Price: $5.47

About: Holds dispensary and cultivation licenses in seven states

KushCo Holdings Inc.

OTC: KSHB

Based: Garden Grove, CA

Cap: $521.81 million

Stock Price: $5.94

About: Manufactures packaging products for the cannabis industry

Liberty Health Sciences

OTC: LHSIF

Based: Toronto, ON

Cap: $233.81 million

Stock Price: $0.82

About: Holds dispensary and cultivation licenses in Florida

MedMen Enterprises

OTC: MMNFF

Based: Culver City, CA

Cap: $351.07 million

Stock Price: $2.96

About: Holds dispensary and cultivation licenses in five states

Related Article: MedMen Defend Itself Over Parker Suit

MPX Bioceutical Corp.

Other OTC: MPXEF

Based: Toronto, ON

Cap: $3.4 million

Stock Price: $0.92

About: Holds dispensary and cultivation licenses in three states and owns Melting Point Extracts

Scotts Miracle-Gro Company

NYSE: SMG

Based: Dayton, OH

Cap: $4.53 billion

Stock Price: $81.80

About: Manufactures soil, fertilizer and hydroponic gardening equipment

Terra Tech Corp.

OTC: TRTC

Based: Irvine, CA

Cap: $69.69 million

Stock Price: $0.88

About: Holds dispensary and cultivation licenses in two states

Therapix Biosciences Ltd.

NASDAQ: TRPX

Based: Givatayim, Israel

Cap: $12.71 million

Stock Price: $4.61

About: Pharma company moving into cannabis formulations for specific conditions

Tilray Inc.

NASDAQ: TLRY

Based: Nanaimo, BC

Cap: $7.41 billion

Stock Price: $79.50

About: The Canadian licensed producer partnered with pharma and alcohol companies in 2018

Related Article: Tilray Makes Deals with Novartis and Anheiser-Busch

The post The Cannabis Industry’s 20 Hottest Pot Stocks of 2019 appeared first on Freedom Leaf.

Source: https://www.freedomleaf.com/top-20-pot-stocks-2019/

The Cannabis Industry’s 20 Hottest Pot Stocks of 2019 was first published to GigglesNDimples.com

from Giggles N Dimples - Feed https://gigglesndimples.com/2019/03/04/the-cannabis-industrys-20-hottest-pot-stocks-of-2019/

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itswallstreetpr · 4 years

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Gearing Up for the Pot Stock Election Run (MJNA, CRLBF, MCTC, CURLF)

The 2016 general election November vote was one of the biggest catalysts for the cannabis space. 2020 is shaping as potentially another similar situation, with 4 states already on the ballot for legalization (2 for recreational) and another 6 states pushing to get on the ballot (5 for recreational), making it potentially even more explosive for the overall legalization movement than we saw in the historic 2016 process. The rationalization for this last claim is about percentage change: the ultimate shift would be to get cannabis legalized on a recreational basis in the majority of the US, thereby putting pressure on the federal government to accept the verdict by states and start removing federal statutes around cannabis, which would likely accelerate the dominoes as a “tipping point” phenomenon. In percentage terms, if all states seeking to get on the ballot for recreational “adult use” legalization are successful in doing so, then 2020 will be a bigger shift (provided they all pass) than the movement in 2016. In other words, start getting your pot stock portfolio picks together ASAP. Below you will find our thoughts and analysis on some of the more widely discussed names in the space, including: Medical Marijuana Inc (OTCMKTS:MJNA), CRLBF, MCTC Holdings Inc (OTCMKTS:MCTC) aka Cannabis Global Inc. (OTCMKTS:MCTC), and CURLF Medical Marijuana Inc (OTCMKTS:MJNA) isn’t what we would consider a “prime investment pick” in this space. The company has remained on the pink sheets, offering up unaudited financials only for all of its tenure as a publicly traded stock (and we’re talking about years here), despite claiming tens of millions in revenues. In case you’re wondering, this is not remotely typical. As far as we can tell, MJNA is the only stock in the history of the world that fits this description. And it’s certainly not a reassuring idea. Why would you hide on the pink sheets and avoid producing audited financial reports if you are seeing such success? To underscore this, the stock has done nothing but slide lower despite the company’s proclamations of ever-growing revenues. Smoke equals fire. We would simply be careful with any company that seems to overpromise and overhype, and then claim the opaque lack of transparency afforded to companies trading on the pink sheets. While we have seen a recent spike following news that Aurora bought out a CBD name (CBD is the main focus of MJNA), we would remain skeptical that the long history here of underperformance in MJNA is likely to change on a sustained basis anytime soon. Medical Marijuana Inc (OTCMKTS:MJNA) bills itself as an investment holding company that operates in the medical marijuana and industrial hemp markets. Its products range from patented and proprietary based cannabinoid products to seed and stalk or isolated high value extracts manufactured and formulated for the pharmaceutical, nutraceutical, and cosmeceutical industries. The company licenses its proprietary testing, genetics, labeling and packaging, tracking, production, and standardization methods for the medicinal cannabinoid industry. It engages in the research and development of cannabinoid-based pharmaceuticals; and marketing and distribution of cannabidiol hemp oil-based products. In addition, the company provides management support and services to cooperatives, collectives, health and wellness facilities, and medical clinics; and consulting and securities services to businesses and individuals in the legal cannabis industry. It’s subsidiary, Kannaway, is a network sales and marketing company specializing in the sales and marketing of hemp-based botanical products. Kannaway currently hosts weekly online sales meetings and conferences across the United States, offering unique insight and opportunity to sales professionals who are desirous of becoming successful leaders in the sale and marketing of hemp-based botanical products. MJNA has been acting well over recent days, up something like 30% in that time. Shares of the stock have powered higher over the past month, rallying roughly 75% in that time on strong overall action. Medical Marijuana Inc (OTCMKTS:MJNA) managed to rope in revenues totaling $16.9M in overall sales during the company's most recently reported quarterly financial data -- a figure that represents a rate of top line growth of -4.2%, as compared to year-ago data in comparable terms. In addition, the company is battling some balance sheet hurdles, with cash levels struggling to keep up with current liabilities ($6.2M against $11M, respectively). Cresco Labs Inc (OTCMKTS:CRLBF) continues to act like a new leader in the making, with an expanding footprint in terms of market density and geographic range. Moreover, this is a company very much tied to the process of gradual legalization in the US marketplace, with a widely known brand and a growing scale in terms of distribution relationships. Cresco Labs Inc (OTCMKTS:CRLBF) trumpets itself as a company that manufactures and sells medical cannabis products in the United States. It offers cannabis dry flower; vaporizer forms of cannabis; cannabis oil in capsule, oral and sublingual solutions; cannabis in topical; and other cannabis products. The company also provides cannabis infused edibles, including chocolate and toffee confections, fruit-forward gummies, and hard sweet and chews. Cresco Labs Inc. sells its products under the Cresco brand. In addition, it operators a Hope Heal Health dispensary in Fall River, Bristol County, Massachusetts. If you're long this stock, then you're liking how the stock has responded to the announcement. CRLBF shares have been moving higher over the past week overall, pushing about 8% to the upside on above average trading volume. Shares of the stock have powered higher over the past month, rallying roughly 24% in that time on strong overall action. Cresco Labs Inc (OTCMKTS:CRLBF) generated sales of $54.6M, according to information released in the company's most recent quarterly financial report. That adds up to a sequential quarter-over-quarter growth rate of 14.2% on the top line. In addition, the company is battling some balance sheet hurdles, with cash levels struggling to keep up with current liabilities ($70.2M against $194.7M, respectively). MCTC Holdings Inc (OTCMKTS:MCTC), now doing business as Cannabis Global, Inc. (MCTC), has started to emerge as a new focus point for cannabis stock traders in the past few weeks. The company has been an IP leader, with a number of major patents related primarily to infusion technology for CBD, THC, CBG, and THC-V in the works. It’s rare to see substantive IP as a factor in the pot stock space – most of these names are basically commodity plays – but MCTC appears to be the genuine item on that note. To help reinforce that idea, the company just announced it has completed product development and has begun distribution of its unique tetrahydrocannabivarin (THC-V) coffee and tea products to product beta testers. This comes on the heels of news that the company has been approved as an Amazon.com platform seller for its Hemp You Can Feel branded line of CBD products. According to the release, “Cannabis Global has integrated three internally developed technologies into the unique manufacturing process for the industry's first THC-V beverages. The first of these is the process developed by the Company to produce 70%+ loaded THC-V, controlled release, nanoparticles utilizing laboratory-based, pharmaceutical-grade production equipment. The Company is also utilizing both its internally developed powerization and one step dosing system, ensuring precise dosing and significantly faster production. The Company has filed provisional patents on all three technologies.” As noted, Cannabis Global (OTCMKTS:MCTC) has recently filed six patents on cannabinoid extraction technologies and delivery systems. Management is currently working with patent counsel to protect various other technologies it has developed or is currently developing, including its programs pertaining to cannabinoid glycosides, polymeric cannabinoid nanoparticles and nanofibers, and its hemp extract-based alcohol replacement technologies. "Our unique infusion and production technologies provide Cannabis Global with a product purity advantage as well as a clear path to low cost leadership," commented CEO Arman Tabatabaei. "The THC-V cannabinoids are synthesized and entirely free of impurities. While there were some upfront technology development and intellectual property protection costs, we expect our ongoing variable production costs to be less than half of any potential competitor. Via our technologies, we turn one of the cannabis industry's most expensive items – pure THC-V cannabinoids – into a cost-effective solution that sets a new standard for product purity in the cannabinoid-based products marketplace." MCTC Holdings Inc (OTCMKTS:MCTC) had no reported sales in its last quarterly financial data. In addition, the company is battling some balance sheet hurdles, with cash levels struggling to keep up with current liabilities ($157K against $1.5M, respectively). Curaleaf Holdings Inc (OTCMKTS:CURLF) shares have been moving steadily higher as the company continues to expand and solidify itself as one of the primary leaders in the space, particularly in the US market. CURLF shares pushed above their key 200-day simple moving average line two weeks ago, and have held up above that key technical marker on a closing basis since, with two critical tests, both passed nicely thus far. At this point, all of the stock’s major MA’s are curving into a bullish posture on a long-term basis. Curaleaf Holdings Inc (OTCMKTS:CURLF) promulgates itself as a company that operates as an integrated medical and wellness cannabis operator in the United States. The Company is the parent of Curaleaf, Inc., a leading vertically integrated cannabis operator in the United States. Headquartered in Wakefield, Massachusetts, Curaleaf, Inc. has a presence in 12 states. Curaleaf, Inc. operates 30 dispensaries, 12 cultivation sites and 9 processing sites with a focus on highly populated, limited license states, including Florida, Massachusetts, New Jersey and New York. Curaleaf, Inc. leverages its extensive research and development capabilities to distribute cannabis products in multiple formats with the highest standard for safety, effectiveness, consistent quality and customer care. Curaleaf is committed to being the industry's leading resource in education and advancement through research and advocacy. Curaleaf Inc.'s Florida operations were the first in the cannabis industry to receive the Safe Quality Food certification under the Global Food Safety Initiative, setting a new standard of excellence. It cultivates, processes, markets, and/or dispenses a range of cannabis products in various operating markets, including flower, pre-rolls and flower pods, dry-herb vaporizer cartridges, concentrates for vaporizing, concentrates for dabbing, tinctures, lozenges, capsules, and edibles. Shares of the stock have powered higher over the past month, rallying roughly 26% in that time on strong overall action. Curaleaf Holdings Inc (OTCMKTS:CURLF) generated sales of $129.8M, according to information released in the company's most recent quarterly financial report. That adds up to a sequential quarter-over-quarter growth rate of 30.3% on the top line. In addition, the company has a strong balance sheet, with cash levels far exceeding current liabilities ($251M against $177.1M). Read the full article

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