FDA Archives - Green Market Report

Debra BorchardtDebra BorchardtOctober 22, 2019
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4min5610
The U.S. Food and Drug Administration and the Federal Trade Commission posted a joint warning letter dated October 10, 2019 to Rooted Apothecary LLC, of Naples, Florida, for illegally selling unapproved products containing cannabidiol (CBD) online with unsubstantiated claims that the products treat teething pain and earaches in infants, autism, attention-deficit/hyperactivity disorder (ADHD), as well as Parkinson’s and Alzheimer’s disease, among other conditions or diseases.
The company used product webpages to make unfounded medical claims about its CBD products, and some of the products were also unlawfully marketed as dietary supplements. The agency has determined that CBD products cannot be marketed as dietary supplements.
The letter read, “The FDA has determined that your “Teeth/TMJ – Essential Oil + CBD Infusion,” “Ears – Essential Oil + CBD Infusion,” “Hemp Capsules, 750 mg,” “Hemp Infused Body Butter,” and “Hemp Oil” 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). “
The letter noted that “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended. “Your 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.”
It went on to say “It is unlawful under the FTC Act, 15 U.S.C. § 41 et seq., to advertise that a product can prevent, treat, or cure human disease unless you possess competent and reliable scientific evidence, including, when appropriate, well-controlled human clinical studies, substantiating that the claims are true at the time they are made.” The letter cited the product POM Wonderful, a pomegranate beverage that is suggested to be healthy.
The company has 15 days to correct its violations.

Debra BorchardtDebra BorchardtSeptember 17, 2019
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4min3550
According to the U.S. Hemp Roundtable,  Majority Leader Mitch McConnell (R-KY) introduced language on the Agriculture Appropriations bill that would require the FDA to issue formal “enforcement discretion” on the sale of hemp CBD products.  The FDA had suggested it would take them 3-5 years to decide on rules and regulations for CBD.

The group’s website posted that the US Senate Appropriations Subcommittee on Agriculture will “mark up” language submitted by Senator McConnell that would require the FDA to formally stand down on any enforcement of its troublesome anti-CBD guidance. The notes are as follows:

  • Within 90 days, provide Congress a report outlining its efforts to develop an enforcement discretion policy on hemp CBD;

  • Within 120 days, issue its formal enforcement discretion policy on hemp CBD;

  • Keep the enforcement discretion policy in effect until the agency has implemented its final regulatory process; and

  • Ensure that going forward, CBD manufacturers would be able share safety data through existing FDA notification procedures to be fully compliant with federal law and policy.

The group also added that the bill will be marked up by the full Senate Appropriations Committee on Thursday, and could go to the full Senate soon. The Hemp Roundtable said that last week, Reps. Chellie Pingree (D-ME) and James Comer (R-KY) sent all members of the US House of Representatives a “Dear Colleague” letter, asking them to co-sign a letter that urges the FDA to issue formal “enforcement discretion” on the sale of hemp CBD products.

One of the biggest complaints following the passage of the 2018 Farm Bill that legalized hemp was that the product remained in a legal quagmire. Some states have outlawed hemp-derived CBD products, while others have no problems. Banks aren’t sure how to address CBD customers and even e-commerce has struggled with the issue. Shopify only just announced on Tuesday that it began working with CBD merchants, while Google refuses to allow CBD advertising.

The letter said, “However, FDA’s current regulatory approach on CBD has created significant regulatory
and legal uncertainty for participants in this quickly evolving industry. FDA maintains that food products
containing CBD remain illegal under the FDCA because it is the active ingredient in an epilepsy drug,
Epidiolex, that is undergoing clinical trials. Although the agency is exploring alternative regulatory
pathways, the FDA claims that a rulemaking process could take the agency anywhere between 3-5 years
to complete.”

 

 


William SumnerWilliam SumnerJune 4, 2019
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4min3330

It’s time for your Daily Hit of cannabis financial news for June 4, 2019.

On the Site

FDA Holds Public Hearing on Regulating CBD

Last week, the U.S. Food and Drug Administration (FDA) held its first public hearing on regulating cannabidiol (CBD). Over the last several years, CBD has been growing in popularity as a health and wellness product. That popularity has only been amplified by the passage of the 2018 Farm Bill, which removed hemp and hemp-derived products (CBD included) from the federal government’s list of controlled substances. At stake in these hearings is a potentially billion-dollar market. According to Brightfield Group, the CBD market could grow to as high as $22 billion by 2022.

Green Growth Brands

Green Growth Brands, Inc. (GGB.CN) (GGBXF) has announced that it has executed an arm’s length definitive agreement to acquire all issued and outstanding shares of Spring Oaks Greenhouses (Spring Oaks) for approximately $54.6 million. Spring Oaks is a licensed medical cannabis provider in the state of Florida.

In Other News

DionyMed Brands

DionyMed Brands Inc. (CSE: DYME) (OTCQB: DYMEF) has announced its financial results for the quarter ending on March 31, 2019. Quarter-over-quarter, revenue rose from $5.5 million to $14.4 million. Adjusted EBITDA was a loss of $6 million, which the company attributes to increasing platform costs to support its continued growth activities. The net loss for the period was $1.03 million. “Our continued growth, both financial and operational, is a direct result of our ability to deliver today’s leading cannabis brands to consumers through the industry’s most efficient cannabis brands platform. Our first quarter financial results demonstrate the success of our efforts to scale our Direct-to-Consumer and retail distribution businesses through organic growth initiatives,” said DionyMed CEO Edward Fields.

Fire & Flower

Fire & Flower Holdings Corp. (TSXV:FAF) announced that it has entered into a letter of engagement with Eight Capital, pursuant to which Eight Capital and GMP Securities L.P. will purchase, as co-lead underwriters and joint bookrunners, 15 million convertible debenture units of the company for $15 million. A single unit consists of one $1,000 principal amount unsecured convertible debenture and 278 common share purchase warrants. Each warrant entitles the holder to purchase one common share of the company, for up to 24 months following the closing period, at a price of $1.45 per share. The company will use the proceeds from the offering for working capital and general corporate purposes.


William SumnerWilliam SumnerJune 4, 2019
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4min9830

Last week, the U.S. Food and Drug Administration (FDA) held its first public hearing on regulating cannabidiol (CBD). Over the last several years, CBD has been growing in popularity as a health and wellness product. That popularity has only been amplified by the passage of the 2018 Farm Bill, which removed hemp and hemp-derived products (CBD included) from the federal government’s list of controlled substances.

At stake in these hearings is a potentially billion-dollar market. According to Brightfield Group, the CBD market could grow to as high as $22 billion by 2022. How the FDA decides to regulate the substance will play a significant role in how high that figure grows. Currently, there are several competing ideas about how CBD should be regulated.

Some individuals want CBD to be treated as a pharmaceutical ingredient, which means that any product containing CBD would have to go through the lengthy and arduous FDA approval process. Others would rather see CBD classified as a nutritional supplement, which carries fewer regulatory requirements before hitting the market.

Many operators in both the hemp and cannabis industry would rather see the FDA create separate categories for CBD products, depending on their intended use. Products meant to treat, diagnose or cure an illness, like GW Pharmaceuticals’ epilepsy drug Epidiolex, would be treated as a pharmaceutical while food products or extracts containing CBD would be classified as a nutritional supplement.

During the hearing, FDA officials were looking for answers to three primary issue: how safe is CBD; what kind of rules should be in place to ensure product safety, quality, and consistency; and what sort of labeling requirements should govern CBD products? Listening to testimony from over 120 industry stakeholders, advocates, and medical professionals; officials heard varying responses.

While cannabis and hemp industry advocates argued for different classifications for different types of CBD products, individuals representing large biopharmaceutical companies argued tighter controls. One woman representing GW Pharmaceuticals argued that the FDA approval process was the only way to know for sure what the health effects of CBD are, arguing that her company did not know that CBD may negatively affect the liver until they conducted clinical trials.

It is also important to note that GW Pharmaceuticals is the only company with an FDA-approved CBD-based drug on the market at the moment.

While it appears that the FDA is committed to hashing out the details of how to regulate CBD, it is unlikely that the issue will be resolved soon. In a message on social media, acting FDA CIO and Principal Deputy, Dr. Amy Abernathy, emphasized that critical issues needed to be addressed before regulatory action is taken.

“Given the rapid expansion of the market, timely clarification of the path forward is critical,” Abernathy wrote, “but it’s our responsibility to ensure that the regulatory path is scientifically sound and in the interest of public health.”

An FDA appointed working group, chaired by Abernathy, is currently exploring potential regulatory pathways for CBD. Interested parties and industry stakeholders are also encouraged to provide written commentary, which can be submitted online. The deadline for written comments is July 2, 2019.


StaffStaffFebruary 20, 2019
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6min4430

It’s time for your Daily Hit of cannabis financial news for February 20, 2019

On The Site

FDA

A letter to the (Food & Drug Administration) FDA Commissioner Scott Gottlieb was penned by a group of politicians requesting guidance with regards to CBD (cannabidiol). The letter referred to New York City’s ban on food products containing CBD and enforcement actions happening in the states of Maine and Ohio.

Representative Chellie Pingree posted the letter on her Twitter feed. It acknowledged that the FDA had posted a response with regards to CBD following the passage of the2018 Farm Bill. The letter also noted that there is a “tremendous amount of confusion among product manufacturers, hemp farmers, and consumers.”

The letter said, “We are calling on the FDA to swiftly provide guidance on lawful pathways for food products with CBD.” The group asked that answers to the following questions be provided by Friday, February 22.

In Other News

Tilray

Tilray, Inc. (NASDAQ: TLRY) entered into a definitive agreement pursuant to acquire all of the issued and outstanding securities of FHF Holdings Ltd. from Compass Group Diversified Holdings, LLC (NYSE: CODI) and other shareholders of Manitoba Harvest.  Tilray will acquire Manitoba Harvest on a cash and debt-free basis, for an aggregate purchase price, including cash and class 2 Common Stock in the capital of Tilray of up to C$419 million pending the achievement of certain milestones after the closing of the Transaction.

Tilray said it now expects to launch CBD-derived products in the U.S. as early as this summer. Manitoba Harvest Chief Executive Bill Chiasson said the company has been in business for more than 20 years and is the world’s largest hemp food maker. It generated C$94 million in 2018 sales. Manitoba Harvest makes products such as granola, protein powder, and hemp oil, and has 30,000 acres of cultivation contracted for this year.

Ascend

Ascend Wellness Holdings (AWH) secured $37 million in a bridge round of preferred equity and $18 million in a senior secured cultivation note. The $55 million in raised funds will be used to build out market-leading operations in Massachusetts, as well as the continued expansion in limited market-leading markets.

AWH is entering Ohio through an agreement to purchase a tier II cultivation license. It is also in advanced discussions for dispensary licenses. Ohio allowed medical cannabis use in January and marks AWH’s fourth market. AWH will provide care to Ohio residents for different approved medical conditions, solidifying its commitments to limited license markets.

Cannabis Strategic Ventures

Los Angeles-based Cannabis Strategic Ventures, Inc. (OTC: NUGS) today announced it has secured up to a $3 million investment from TRITON FUNDS subsequent to an upcoming S1 registration statement. TRITON FUNDS is a San Diego-based investment fund focused on creating a greater sense of community through investments in local companies, entrepreneurs and philanthropy. The new partnership is led by TRITON FUNDS Advisor, Mr. Robert Hymers III CPA and alumni of California State University Northridge where TRITON FUNDS was founded.

The new financing will allow Cannabis Strategic Ventures to accelerate its business priorities related to cannabis cultivation operations in California and the expansion of existing portfolio brands such as The Asher House Wellness, Fitamins, and LYXR.

GW Pharmaceutical

GW Pharmaceuticals (GWPH -2.8%) slips on below-average volume in apparent response to social media comments about an epileptic patient’s father who has been unable to procure Epidiolex for about a week and the frequency of his daughter’s seizures have increased.

Kona

Kona Gold Solutions, Inc. (OTC: KGKG)  has entered into distribution agreements with three Missouri based Anheuser Busch distributors: River Eagle Distributing, Inc., Bradley Distributing, Inc. and Bob Ralph Dist. Co., Inc.  The partnership between Kona Gold and River Eagle, Bradley, and Bob Ralph Dist., will cover the southeast of the state of Missouri.  All three distributors will distribute the Company’s popular Kona Gold Hemp Energy Drinks and HighDrate CBD Energy Waters.

CannTrust

CannTrust Holdings Inc. (TSX: TRST) has satisfied all the regulatory requirements to list its common shares on the New York Stock Exchange. Trading of the Company’s common shares on the NYSE will begin on Monday, February 25, 2019, under the ticker symbol “CTST”. The Company’s common shares will continue to be listed on the Toronto Stock Exchange under the ticker symbol “TRST”.

 

 

 


Debra BorchardtDebra BorchardtFebruary 20, 2019
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3min11040

A letter to the (Food & Drug Administration) FDA Commissioner Scott Gottlieb was penned by a group of politicians requesting guidance with regards to CBD (cannabidiol). The letter referred to New York City’s ban on food products containing CBD and enforcement actions happening in the states of Maine and Ohio.

Representative Chellie Pingree posted the letter on her Twitter feed. It acknowledged that the FDA had posted a response with regards to CBD following the passage of the 2018 Farm Bill. The letter also noted that there is a “tremendous amount of confusion among product manufacturers, hemp farmers and consumers.”

The letter said, “We are calling on the FDA to swiftly provide guidance on lawful pathways for food products with CBD.” The group asked that answers to the following questions be provided by Friday, February 22.

When will FDA provide guidance on lawful pathways for food products containing hemp-derived CBDin interstate commerce? For example, the GRAS Notification program seems as though it is one such pathway.

When will FDA hold a public meeting on the regulation of food products containing hemp-derived CBD in interstate commerce?

New York City’s Health Department has confused food producers and restaurants as well. The group initially banned all CBD food products, but then reversed course last week and delayed the ban until July 1. The information was sent out in an email to restaurant owners.

The NYC Hospitality Alliance said it has requested the DOH to provide guidance but has received no answers to its requests. “This aggressive enforcement is another example of New York City’s regulatory approach: issue fines first, and educate last. Issuing a violation for using CBD in food and drink is especially ironic to happen when New York is seriously considering legalizing marijuana.  Enough is enough.  The city must stop finding ways to fine our city’s small businesses.”

One manufacturer of CBD edible products said he was operating “business as usual” apparently unconcerned about the confusion created by the FDA.


Debra BorchardtDebra BorchardtFebruary 4, 2019
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4min10521

LB Equity has raised $50 million for a portfolio titled LB Equity Emerging Growth Fund, which will be concentrating its investments in cannabis companies that are involved in beauty, health, and wellness. The company’s first investment is with the platform Standard Dose, which is dedicated to selling hemp-based CBD products as well as educating consumers on these new products. The company did not announce how much of an investment it made into Standard Dose.

The retail platform will provide content to educate consumers on the emerging CBD market, plus current industry research and information about CBD products. This information will include dosage and regulatory updates.

The market has been exploding with CBD products since the 2018 Farm Bill was passed legalizing hemp and products made from hemp-derived CBD. The problem is that not all hemp CBD is created equally and there is quite a bit of inferior product on the market. Standard Dose is starting with 37 distinct beauty and lifestyle products that it has vetted and tested.

The company’s ingestible products include vape pens, tinctures, olive oil, honey, and beverages. Consumers should be aware though that the FDA must approve of any foods containing hemp-derived CBD. In a statement issued in December, the FDA said, “Congress explicitly preserved the agency’s current authority to regulate products containing cannabis or cannabis-derived compounds under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and section 351 of the Public Health Service Act.” The FDA went on to add, “The FDA requires a cannabis product (hemp-derived or otherwise) that is marketed with a claim of therapeutic benefit, or with any other disease claim, to be approved by the FDA for its intended use before it may be introduced into interstate commerce.”

“Our goal at Standard Dose is to facilitate an honest conversation about CBD and to help consumers gain clarity of an industry that, until now, has been confusing and unregulated,” said Anthony Saniger, Founder and CEO of Standard Dose. “We take the time to vet all of our products and share information so that consumers can choose CBD products with confidence. With the very recent legalization of CBD, we know that interest in the industry and its products will skyrocket.”

LB Equity is led by Jay Lucas, a former partner at Bain & Company, Karen Ballou, a highly experienced beauty industry professional (Redken and Elizabeth Arden) and Jim Morrison, who served as President of L’Oreal U.S. for nearly 10 years. The extended team consists of strategy and investment professionals along with an advisory group of veteran industry executives across core value creation disciplines.  Prior to Standard Dose and the latest Fund, LBE has completed investments in ten additional beauty and personal care brands, including MD Complete, Marula Pure Oil, Immunocologie and Blamtastic among others.

“LBE is targeting the massive opportunity available at the intersection of the rapidly growing cannabis industry and the many emerging brands within the skincare, beauty and related personal care sectors,” said Jay Lucas, Managing Partner of LB Equity. “With experienced executives from both the finance and beauty industries, LBE is perfectly positioned to leverage the transformational impact that these newly legalized cannabis-based products will have on the beauty industry.”


Debra BorchardtDebra BorchardtSeptember 27, 2018
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5min9440

The Acting Administrator of the Drug Enforcement Administration has placed FDA-approved drugs that contain CBD derived from cannabis and no more than 0.1 percent tetrahydrocannabinols  (THC) in schedule V. GW Pharmaceutical’s (GWPH) Epidiolex had been a schedule I controlled substance, with this new directive Epidiolex (and any generic versions of the same formulation that might be approved by the FDA in the future) will be a schedule V controlled substance.

Schedule five drugs are considered to have a low level of abuse and include substances like Robitussin cough syrup or Lomotil diarrhea medicine.

The order made it clear that other cannabis products would remain in the schedule 1 category. The statement said, “As further indicated, any material, compound, mixture, or preparation other than Epidiolex that falls within the CSA definition of marijuana set forth in 21 U.S.C. 802(16), including any non-FDA-approved CBD extract that falls within such definition, remains a schedule I controlled substance under the CSA.” The document is scheduled to be published on September 28, 2018.

The order also said, “Now that Epiodiolex has been approved by the FDA, it has a currently accepted medical use in
treatment in the United States for purposes of the CSA. Accordingly, Epidiolex no longer meets the criteria for placement in schedule I of the CSA.”

The order went on to stress that CBD material, “which includes, among other things, a drug product containing CBD extracted from the cannabis plant, is a Schedule I drug under the Single Convention.”

Dr. George E. Anastassov, Chief Executive Officer of AXIM Biotechnologies remarked, “Today’s news is an important step for the pharmaceutical cannabinoid industry. It signifies an understanding on behalf of the regulatory agencies in the United States, such as the FDA and DEA, that cannabidiol (CBD) has therapeutic potential and a very low potential for abuse and misuse. However, this applies ONLY to Epidiolex, i.e. to the molecule contained within this particular formulation. Otherwise, CBD still remains as a Schedule I controlled substance and the current classification is non-applicable to the rest of the products available on the market.”

Thoma Kikis, Chief Communications Officer of Kannalife Sciences said, “The DEA’s rescheduling of Epidiolex from a Schedule I to a Schedule V controlled substance gives cannabidiol (CBD) more credibility and recognition as a treatment in the U.S. that does, in fact, have medical value. This is a watershed moment for the cannabinoid industry, and very encouraging for Kannalife Sciences and the work we have done to research and develop our own CBD-derived molecule (KLS-13019) for the treatment of diseases with unmet medical needs, such as Chemotherapy-Induced Neuropathic Pain (CINP), Hepatic Encephalopathy (HE), and Chronic Traumatic Encephalopathy (CTE). However, there is still more work to be done.”

GW Pharmaceutical stock jumped over 8% on the news to lately trade at $176.


Debra BorchardtDebra BorchardtJune 25, 2018
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8min26141

The U.S. Food and Drug Administration (FDA) approved GW Pharmaceuticals’ (GWPH) cannabidiol (CBD) drug Epidiolex as an oral solution for the treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome, and Dravet syndrome, in patients two years of age and older. According to the press release, this is the first FDA-approved drug that contains a purified drug substance derived from marijuana and it is also the first FDA approval of a drug for the treatment of patients with the Dravet syndrome.

“Today, the FDA approved a purified form of the drug cannabidiol (CBD). This is one of more than 80 active chemicals in marijuana. The new product was approved to treat seizures associated with two rare, severe forms of epilepsy in patients two years of age and older,” said FDA Commission Scott Gottlieb, M.D.

He went on to add, “But it’s also important to note that this is not an approval of marijuana or all of its components. This is the approval of one specific CBD medication for a specific use. And it was based on well-controlled clinical trials evaluating the use of this compound in the treatment of a specific condition. Moreover, this is a purified form of CBD. It’s being delivered to patients in a reliable dosage form and through a reproducible route of delivery to ensure that patients derive the anticipated benefits. This is how sound medical science is advanced.”

Gottlieb cautioned though that he remains concerned about the proliferation and illegal marketing of unapproved CBD-containing products with unproven medical claims. The FDA has taken action against companies making unsupported CBD claims in the past couple of years and the agency said it would continue to do so.

GW Says Rescheduling Within 90 Days

Even though the FDA has now approved the use of Epidiolex as a real treatment for these diseases, it doesn’t immediately change the status of cannabis as a controlled substance. The two defining factors of the schedule one designation include not having a medicinal purpose and being a highly addictive drug.

The FDA release stated, “Under the Controlled Substances Act (CSA), CBD is currently a Schedule I substance because it is a chemical component of the cannabis plant. In support of this application, the company conducted nonclinical and clinical studies to assess the abuse potential of CBD. The FDA prepares and transmits, through the U.S. Department of Health and Human Services, a medical and scientific analysis of substances subject to scheduling, like CBD, and provides recommendations to the Drug Enforcement Administration (DEA) regarding controls under the CSA. DEA is required to make a scheduling determination.”

The FDA did not say in its release whether it had delivered a recommendation to the DEA regarding Epidiolex and its schedule status.

However, in GW Pharmaceutical’s statement, the company said it would have to be rescheduled before it could be made available to patients. “Rescheduling is expected to occur within 90 days. Access is expected to be similar to other branded AEDs and EPIDIOLEX is expected to be available to appropriate patients by Fall 2018.”

“While we applaud the FDA for confirming what many of us have long known–that the benefits of cannabis are immense–we do find it a bit comical that the federal government now contradicts itself once again,” said Chris Driessen, President of Organa Brands U.S. “While the FDA touts the benefits of this new drug, the DEA maintains a Schedule One classification for cannabis, stating that it has no medical application and a high potential for abuse. We have to ask–does the left hand know what the right hand is doing?

Management Comments

“Today’s approval of EPIDIOLEX is a historic milestone, offering patients and their families the first and only FDA-approved CBD medicine to treat two severe, childhood-onset epilepsies,” said Justin Gover, GW’s Chief Executive Officer. “This approval is the culmination of GW’s many years of partnership with patients, their families, and physicians in the epilepsy community to develop a much needed, novel medicine. These patients deserve and will soon have access to a cannabinoid medicine that has been thoroughly studied in clinical trials, manufactured to assure quality and consistency, and available by prescription under a physician’s care.”

“In my practice, I often see patients with these highly treatment-resistant epilepsies who have tried and failed existing therapies and are asking about CBD,” said Orrin Devinsky, M.D., of NYU Langone Health’s Comprehensive Epilepsy Center and a lead investigator in the EPIDIOLEX clinical program. “I am delighted that my physician colleagues and I will now have the option of a prescription cannabidiol that has undergone the rigor of controlled trials and been approved by the FDA to treat both children and adults.”

“For those living with intractable seizures caused by LGS and Dravet syndrome, EPIDIOLEX represents a true medical advancement,” said Philip Gattone, president and CEO of the Epilepsy Foundation.  “Clinical development for these rare and severe conditions is essential, and today’s news brings hope for these patients and their families that a new treatment option may have the potential to help better control their seizures.”

Epidiolex

Epidiolex’s effectiveness was studied in three randomized, double-blind, placebo-controlled clinical trials involving 516 patients with either Lennox-Gastaut syndrome or Dravet syndrome. Epidiolex, taken along with other medications, was shown to be effective in reducing the frequency of seizures when compared with placebo. It uses CBD, which is a chemical component of the Cannabis sativa plant. CBD does not give patients a psychotropic effect like getting “high” that comes from the other part of the cannabis plant –  tetrahydrocannabinol (THC).

 


Debra BorchardtDebra BorchardtNovember 1, 2017
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5min16900

The Food and Drug Administration has issued warnings letters to four CBD (cannabidiol)  companies for touting unsubstantiated therapeutic claims. The companies named in today’s press release were Greenroads Health, Natural Alchemist, That’s Natural Marketing and Consulting and Stanley Brothers Social Enterprises.

CBD products have become a huge part of the cannabis industry. Matt Karnes of Greenwave Advisors estimated that the growth of the CBD market recently saying, “In terms of the CBD market size, I estimate an almost $3 billion market by 2021.”

The FDA cited 25 products spanning multiple websites that make unfounded claims about the products ability to treat or cure cancer and other serious diseases. The FDA noted that these were some of the claims:

“Combats tumor and cancer cells;”

“CBD makes cancer cells commit ‘suicide’ without killing other cells;”

“CBD … [has] anti-proliferative properties that inhibit cell division and growth in certain types of cancer, not allowing the tumor to grow;” and

“Non-psychoactive cannabinoids like CBD (cannabidiol) may be effective in treating tumors from cancer – including breast cancer.”

“Substances that contain components of marijuana will be treated like any other products that make unproven claims to shrink cancer tumors. We don’t let companies market products that deliberately prey on sick people with baseless claims that their substance can shrink or cure cancer and we’re not going to look the other way on enforcing these principles when it comes to marijuana-containing products,” said FDA Commissioner Scott Gottlieb, M.D. “There are a growing number of effective therapies for many cancers. When people are allowed to illegally market agents that deliver no established benefit they may steer patients away from products that have proven, anti-tumor effects that could extend lives.”

The CBD products have not been approved by the FDA and the manufacture of them also also not been subjected to FDA review. The FDA has asked for responses from the companies on how they plan to correct the violations saying, “Failure to correct the violations promptly may result in legal action, including product seizure and injunction.”

The statement today said, “This latest action builds on the more than 90 warning letters issued in the past 10 years, including more than a dozen this year, to companies marketing hundreds of fraudulent products making cancer claims on websites, social media and in stores. Additionally, the FDA recently took decisive action to prevent the use of a potentially dangerous and unproven treatment used in ‘stem cell’ centers targeting vulnerable cancer patients. The FDA encourages healthcare professionals and consumers to report adverse reactions associated with these or similar products to the agency’s MedWatch program.”

“We have an obligation to provide caregivers and patients with the confidence that drugs making cancer treatment claims have been carefully evaluated for safety, efficacy, and quality, and are monitored by the FDA once they’re on the market,” Commissioner Gottlieb added. “We recognize that there’s interest in developing therapies from marijuana and its components, but the safest way for this to occur is through the drug approval process – not through unsubstantiated claims made on a website. We support sound, scientifically-based research using components derived from marijuana, and we’ll continue to work with product developers who are interested in bringing safe, effective, and quality products to market.”



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