CBD Archives - Green Market Report

StaffStaffJune 22, 2020
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8min1380

Full birth name: 

Barbara Goodstein

 Title: 

Founder and CEO

 Company: 

B GREAT

 Years at current company

2 years

 

Education profile: 

earned a Bachelor’s degree from Brown University and an M.B.A. from Columbia University School of Business

 Most successful professional accomplishment before cannabis: 

I’ve spent my career as the chief marketing officer and chief executive officer for major global brands—delivering new products/services and hundreds of millions of dollars in revenue in the financial and technology segments. Often times I’ve been the only woman decision-maker in the room. This experience has taught me to be attentive to all consumers and consider issues from a 360-degree view. I was named one of the Top 25 Women in Finance (US Banker’s Most Powerful Women Annual Ranking) two years in a row, and I am a member of C200. I also know that the road to success is not a straight line and not always smooth. Over the course of my career, I’ve seen pretty much every crisis and problem, and know that setbacks are also opportunities. The best brands have obstacles to overcome, and it’s the way you overcome them that sets you apart.

Company Mission: 

Before I started B GREAT, I looked around at the CBD space and noticed that it was like The Wild West—there were a lot of CBD brands making wildly exaggerated claims about their products and making promises that couldn’t possibly be true. I was interested in the therapeutic benefits of CBD and knew that consumers deserved more transparency and a line of CBD products that they could trust. That’s our company mission—to provide the highest quality CBD products that consumers can believe in and depend on to help them feel and look their best. In terms of transparency, on our website you can click a tab to see the exact elements in every B GREAT product you purchase. We also have a five-star standard, which guarantees that every one of our products is made from the highest quality full-spectrum hemp, is non-GMO, third-party tested to ensure quality, is made in immaculate FDA-registered facilities, and is all made in the USA.  

Company’s most successful achievement: 

Frankly, just surviving in this economic climate is a huge achievement for any brand, particularly a start-up company. The economic landscape is shifting for everyone, and brands need to figure out how to thrive in that new landscape. B GREAT has actually done well during this global pandemic. We’ve been getting incredible press, from being included in Rolling Stone’s “Best Products for Anxiety,” to being featured in NewsweekUSA TODAYYahoo! Finance and many other publications. I’d say our other big achievement is the formulation of our Relax and Focus shots. When I started B GREAT, I tasted all the shots out there, and all of them tasted awful—they were basically undrinkable. I spent a lot of time working with formulation experts to make sure our shots are effective for focus and rest, but also taste amazing. Shots are meant to be used often, so you want to drink something that tastes good. Our shots are berry flavor and people love them.  

Has the company raised any capital (yes or no)?

if so, how much:

We raised $1.5MM from a group of amazing investors who have deep experience in the cannabis industry, venture capital and large retail corporations.   

Any plans on raising capital in the future? 

Today we are raising $1MM in a convertible note. 

Most important company 5-year goal: 

Our 5-year goal is to be an industry leader both in terms of our products but also in terms of our core values as a company. I’m proud that B GREAT is women-owned and women-led and would love to be an example for other CBD companies. In terms of our products, I’d love to see B GREAT in several retailers and be considered the pinnacle of transparency and quality. I also hope to expand our product line to include unique products that other brands do not offer. Right now, for example, we are working on a nasal spray and throat spray, which we think consumers would love. 

Other information about Barbara:

Barbara has served on the Board of Directors at KushCo Holdings, Inc. for three years and previously held many senior leadership roles in operations, business and marketing development – most recently as CEO of Tiger 21, a peer membership network for high net worth entrepreneurs. 

Barbara participates in Fortune’s Most Powerful Women Summits, is a member of the Women’s Forum, and Fortune’s Global Mentor Program.

The core set of B GREAT products include:

  • Hemp Lotion and Balm
  • Hemp Oil
  • Beverage Shots – Relax and Focus
  • Lip Balm
  • Soft Gel Capsules
  • Antioxidant Cream
  • Relief and Recovery Cream
  • Hemp After Shave

 

 

 

 


Debra BorchardtDebra BorchardtJune 17, 2020
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4min2500

Perrigo Company plc (NYSE: PRGO), a global provider of affordable over-the-counter health products is entering the cannabidiol (CBD) market through a strategic investment in and long-term supply agreement with Colorado-based Kazmira LLC. Perrigo is also a leading producer of generic prescription pharmaceutical topical products like creams, lotions, and gels. The company’s second-largest category for sales is pain and sleep aids. Perrigo reported $1.3 billion in sales in the company’s last quarter.

Perrigo’s minority equity investment kicks off the first phase of the partnership where the two companies will collaborate to scale-up Kazmira’s facilities and laboratories, in accordance with current Good Manufacturing Practices (“cGMP”), to produce THC-free CBD from industrial hemp that meets Perrigo’s high standards for reliability and consistency. In the second phase of the partnership, Perrigo will work to launch THC-free hemp-based CBD products in a number of global markets, while leveraging its supply agreement with Kazmira, which is exclusive for the U.S. store brand market.

Perrigo CEO and President Murray S. Kessler said, “Science-based natural products are one of Perrigo’s 5 core growth pillars and THC-free CBD products fit perfectly into our self-care strategy. Until now, this emerging industry has lacked the regulatory expertise necessary to bring a trusted supply of CBD to market. Some have even described it as the wild, wild west. We believe that Kazmira’s deep understanding of CBD science, combined with Perrigo’s regulatory expertise and investment, allows us to lead the industry through the next phase of development of rigorous quality standards and proactive engagement with regulators.”

Kessler continued, “Consumers and retail customers want CBD products and we believe they deserve a reliable source of broad-spectrum, THC-free CBD they can depend on. Whether it is the specific concentration of CBD or a THC-free claim, consumers must be able to trust statements made on the label of a product and we believe Perrigo can provide this to the marketplace. We are excited to partner with the team at Kazmira, who share our passion for developing a science-based, regulatory approach to unlock the full potential of this emerging industry. This collaboration offers a great opportunity to enhance profitable growth for our shareholders over the long-term.”

Kazmira Co-CEOs Dr. Priyanka Sharma and Pulak Sharma said,  “We are proud to launch a strategic relationship with Perrigo, the industry leader in delivering safe and effective OTC self-care products.   As we continue to grow our business, we look forward to leveraging Perrigo’s regulatory and manufacturing expertise in concert with Kazmira’s proprietary technology for large-scale biomass processing and our established reputation for producing and marketing the highest quality THC-free CBD products.”

In addition to the supply agreement, Perrigo will acquire an approximate 20% equity stake in Kazmira for $50 million with $15 million paid upon close of the transaction and the balance within 18 months.


Sean HockingSean HockingMay 20, 2020
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20min4990

This is a guest post from Cannabis Law Review and Tom Brown of honahlee.

CBD: Schedule 4 to Schedule 3 Drug

Recently, the Australian Department of Health announced a proposal to down schedule low-dose CBD to a Schedule 3 drug. This change would mean low-dose CBD would be available for sale in pharmacies.

In order to understand what this possible change means for the Australian consumer, we interviewed Rhys Cohen, a cannabis expert, and the Principal Consultant at FreshLeaf Analytics. The following article has been adapted from our interview with Rhys.

In the interview, Rhys answered the following questions:

Rhys Cohen’s cannabis industry experience:

Rhys’ involvement in the cannabis industry dates back to 2015.. He wrote his honours thesis on cannabis legalization in the US. Since writing his thesis, Rhy spent time as the Lambert Initiative for Cannabinoid Therapeutics at the University of Sydney; he’s become the Director of Cannabis Consulting Australia, he participates in medical cannabis education and is now the Principal Consultant at FreshLeaf Analytics.

FreshLeaf Analytics:

FreshLeaf Analytics is a strategic consulting and market intelligence company that services the medical cannabis industry. The company operates in Australia and works with both local and international clients.

FreshLeaf helps companies figure out what’s going on in medical cannabis. They help identify advantages or potential risks and help companies to make better strategic decisions about launching products or building on the success of their existing product ranges.

FreshLeaf also publishes a quarterly cannabis industry reports which help give insights into the cannabis landscape for patients and the general public.

What triggered the review on CBD re-scheduling?

The Australian CBD market is drastically different from those overseas, particularly the USA and Canada. Part of the reason rescheduling CBD is being explored is because of increasing interest and demand, globally, for access to these sorts of products without a prescription.

Also, community demands for better access to cannabis products in general is increasing.

The news about rescheduling came from a submission by the Department of Health to start an inquiry into barriers to patient access. This inquiry may be a political choice made to demonstrate that the government is taking action to improve access to medical cannabis in Australia.

Australia has made a lot of progress since 2016 when our legal framework came into effect. This is an extension of that framework.

What types of CBD would the rescheduling cover?

The proposed Schedule III entry has the same definition as the current Schedule IV entry of CBD.

The current Schedule IV entry says, “CBD for human therapeutic use,” so not for animals, not for recreation, but for human therapeutic use.

To be considered a Schedule IV or a Schedule III CBD product, 98% of the cannabinoid content needs to be CBD alone. That tends to rule out a lot of the less refined or more crude extracts or products.

So, the rescheduling would likely cover products under the isolate or distillate category.

What does rescheduling CBD actually mean?

At the moment, CBD is a Schedule IV drug. The proposal is not to remove or change that definition, but to create a new supplementary definition. The change means that low dose CBD will be available behind the counter through a pharmacist, for minor ailments.

For more serious medical conditions, epilepsy for example, you will still need to see a doctor or specialist to get a prescription for a higher dose CBD.

The proposal is to create an additional entry at Schedule III, which is a pharmacist only medication. These are products that you can access from a pharmacy, but only by speaking with the pharmacist. They’re not available on the shelves. Some examples of Schedule III drugs are sleeping pills and certain cold and flu medications.

What doses would be available?

The proposal would allow specific low doses of CBD to be made available behind the counter for minor medical conditions. The government has recommended a maximum of  60 milligrams per day for this low-dose CBD category.

They would recommend that only 30-days worth of supply be included in a packet of medication, so about 1,800 milligrams per pack, 60 milligrams per daily dose.

Will individuals or any company be able to sell CBD?

If the new scheduling comes into effect, it will work as follows:

February 1st, next year, the changes are implemented and there would be a Schedule III entry for low-dose CBD.

Before companies will be able to sell those products to consumers through pharmacies, they’ll need to get their specific drug registered on the Australia Register of Therapeutic Goods (ARTG). Companies will need to have a well-designed, well characterised product that’s stable and meets all the quality requirements.

They’ll also need to prove, using clinical data, that their product is effective in treating a specific medical indication or symptom. The company will need to submit all of that information to the TGA to get its product assessed and hopefully registered on the ARTG.

Registration on the ARTG can be quite a challenge even for big companies to pursue.

Challenges of ARTG Listing

There are quite a few unanswered questions about the ability to register.

Is it commercially viable for a company to pursue that strategy? Is pure CBD, at 60 milligrams a day, going to show efficacy in treating a specific condition or symptom?

Then we have questions around evidence. What level of evidence might be required? Will companies need full-blown, costly and time-consuming randomised, placebo-control trials to demonstrate that CBD is effective? Or, would observational data be acceptable? Could people make literature-based submissions, based on information that’s already in the public domain?

These are some of the questionsFreshLeaf is going to be working through with clients over the coming months.

It’s still unclear if this rescheduling is actually going to result in genuine access to these products, or if it will just be one step closer but with much more work needed to be done.

Could the draft proposal be different from the final outcome?

Yes, the current draft is not the only outcome that is possible.

There’s a long consultation process that needs to be followed. This proposal has been sent to the Advisory Committee on Medicines Scheduling (ACMS), which is a group of people within the Department of Health who make these decisions.

Currently, the rescheduling is now open for public consultation. The advisory committee is inviting members of the public to make submissions to them about whether or not they support this change or what they would rather it look like.

After receiving the public recommendations, the AMCS will review and produce an interim decision, and then there will be a second round of public consultations on that interim decision.

Because it’s quite a long process with multiple review points, it’s possible the outcome could change. Some possible changes are daily dose limit changes or fewer or additional restrictions imposed. We’ll have to wait and see what the final outcome is.

When would the new regulations officially begin?

If the changes are implemented:

Effective as of the 1st of February 2021.

At schedule III, what conditions could you buy CBD to treat?

Pharmacist only medicines are not intended to treat serious medical conditions. If you have severe pediatric epilepsy, for example, a very serious medical condition for which CBD is occasionally prescribed, you wouldn’t be accessing those products via your pharmacist. You would still need to access higher dose CBD from your GP or specialist via prescription.

Over-the-counter or behind-the-counter medications are available for minor conditions, for example:

  • mild anxiety
  • mild insomnia
  • mild pain

Again, not for the treatment of chronic and severe conditions.

Are there reasons the proposal would not be passed?

The advisory committee needs to consider several issues around public safety. They’ll ask questions like:

  • Will this be safe?
  • Will this meet a clinical requirement of some kind?
  • Is this going to be good for people?
  • Also, will this have any unintended impact on the community?
  • Is there a potential for people to become dependent on products?
  • Is there a potential for side effects or any other kinds of adverse events?

These are the considerations the committee is taking into account when making these decisions. Rhys went on to say:

“The Department of Health reviewed the safety literature on CBD. They came to the conclusion that based on all of the available data, low dose CBD seems pretty safe for pharmacists to dispense. So, I don’t see the advisory committee having additional concerns around safety or side effects.”

How can I help? How do I make a submission?

We are encouraging anyone who feels strongly about safe access to CBD to make a submission. The TGA website (link in step 1 below) has information about how to make a submission. The same page also lists the current regulations, the proposed changes, reasons for the regulations and more.

In order to make it easier for you, we have submission information right here:

  1. Read the proposed amendment thoroughly
  2. Download the TGA Consultation Submission Coversheet.
  3. Write up your submission which must:
    1. Be relevant to the proposed amendment;
    2. Address matters mentioned in section 52E of the Therapeutic Goods Act 1989;
    3. Be submitted by the closing date of 22 May 2020
  4. Send your submission to the Dept of Health:
    1. Send your submission, including cover sheet to medicines.scheduling@health.gov.au
    2. Please include ‘Proposed Amendments to the Poisons Standard (Medicines/Chemicals)‘ in the subject line of the email

In the next section of this article, we give you some ideas of what a strong submission may include.

What information can I put into my submission

Submissions can include:

  • Discussions around how this might impact you personally, both with regards to your health and/or your business and your business interests.
  • You can also provide an informed opinion about whether you think this is safe or not, whether you think that the daily dose limits are appropriate or not.
  • You can discuss your thoughts around the safety of these products or the risks that you might perceive.

It’s important that you are clear about:

  • Do you support the amendment – yes or no?
  • Suggestions or improvements that you may have.
  • If explaining the impact of the proposed changes on you or your business, please attempt to quantify those costs or benefits.

Tips for making a strong submission

Rhys Cohen is well versed in drug policy in Australia. When asked for tips on making a strong submission he said this:

I know that there’s widespread use of CBD products in Australia and around the world already, not done legally. People are frequently using products that are not regulated, that meet no quality standard requirements, and there are some serious concerns around that.

Surveys in the UK have shown that many of the products available for retail sale in supermarkets in the UK don’t contain what’s on the label. Some contain no CBD, some contain twice as much or half as much as they say on the label. Some contain THC and some have unsafe levels of alcohol. This is an unregulated health product market, and it is concerning.

I would assume that a lot of Australians are already purchasing CBD products, probably online, from these websites, and maybe they don’t even realize that they’re breaking the law. Maybe they think they’re buying something that’s legal and safe and well-regulated, but they’re really not.

If you are taking a CBD product at the moment that isn’t prescribed by a doctor, you’re taking an unregulated and illegal product. If you feel like you should have better access to a legal and regulated product instead, then I would encourage you to voice that to the Department of Health.

Source: https://honahlee.com.au/articles/cannabidiol-schedule-4-to-3/


StaffStaffApril 24, 2020
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7min6970

The U.S. Food and Drug Administration (FDA) has issued warning letters to two companies for illegally selling unapproved products containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FDA said that BIOTA Biosciences and Natures CBD Oil Distribution were claiming their CBD products could be used to treat opioid addiction.

The FDA has requested responses from the companies within 15 working days stating how they will correct the violations. Failure to correct the violations promptly may result in legal action, including product seizure and/or injunction.

“The opioid crisis continues to be a serious problem in the United States, and we will continue to crack down on companies that attempt to benefit from selling products with unfounded treatment claims,” said FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D. “CBD has not been shown to treat opioid addiction. Opioid addiction is a real problem in our country and those who are addicted need to seek out proper treatment from a health care provider. There are many unanswered questions about the science, safety, effectiveness and quality of unapproved products containing CBD, and 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.”

The two warning letters were issued to:

  • BIOTA Biosciences, LLC of Washington state for marketing and distributing injectable CBD products as well as an injectable curcumin product. These products are marketed for serious diseases and as an alternative to opioids. BIOTA Biosciences markets private label CBD and wholesale CBD extracts, and their products include beverages, bulk CBD extracts, and water soluble CBD, as well as injectable curcumin.
  • Homero Corp DBA Natures CBD Oil Distribution of New Hampshire for marketing and distributing CBD products as a treatment to opioid addiction as well as other serious diseases. The firm is an own-label distributor for CBD products as well as a retailer for Green Roads CBD products.

The FDA noted that Natures CBD website claimed that its product “Has had success in alleviating severe withdrawal symptoms associated with opiate dependency. Natures Pure CBD also has taken off the ball and chain around the opiate addicts’ neck and has relieved the addiction totally by using Natures Pure CBD restoring the person back to a quality of life worth living.”  “The Opiate addiction rate of recovery is low and Natures Pure CBD oil offers promise for those suffering from chronic opiate use.”  “Natures Pure CBD oil works for these medications which all have addictive properties to them: opium, fentanyl, heroin, hydrocodone, oxycodone, methadone, morphine and hydromorphone. Natures Pure CBD Oil has been effective in the treatment and eradication of opiate use.”

For BIOTA, the FDA pointed out claims on the website like “CBD . . . and its ability to suppress pain and aid in the detoxification processes has highlighted it as a promising therapeutic for a wide array of disorders such as epilepsy, including many challenging neuropathy conditions. When patients consider trying a new therapeutic like CBD, there are many options for delivery that can be more efficacious to the patient. One delivery option is BIOTA CBD Sterile Vial Therapy.”  “Instant relief for patients that are symptomatic of inflammatory auto-immune diseases”

While there has been anecdotal talk of cannabis with THC as a potential solution to weaning opioid addicts to a less dangerous level of drug use, it has never been proven to be a fail-safe alternative. There have been no FDA evaluation of whether these products are effective for their intended use, what the proper dosage might be, how they could interact with FDA-approved drugs, or whether they have dangerous side effects or other safety concerns.

In addition, the manufacturing process of unapproved CBD drug products has not been subject to FDA review as part of the human or animal drug approval processes. In March, the FDA provided updates on its work related to CBD products with a focus on protecting public health and providing market clarity. The FDA continues to be concerned that some people wrongly think that the myriad of CBD products on the market have been evaluated by the FDA and determined to be safe, or that using CBD “can’t hurt.”

Under the FD&C Act, any product intended to treat a disease or otherwise have a therapeutic or medical use, and any product (other than a food) that is intended to affect the structure or function of the body of humans or animals, is a drug. The FDA has not approved any CBD products other than one prescription human drug product to treat rare, severe forms of epilepsy.


Debra BorchardtDebra BorchardtApril 22, 2020
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5min4110

 Tetra Bio-Pharma Inc. (OTCQB:TBPMF) announced its Orphan Drug development strategy and provided a management update. The company said it is focusing on generating intellectual property including use, manufacturing, and innovative molecule protection. Tetra said it received a U.S. Food and Drug Administration (FDA) Orphan Drug Designation for secondary cannabidiol (CBD) formulation of its cannabinoid topical drug PPP004 in the treatment of epidermolysis bullosa.

“Each ODD application is driven by scientific data generated by Tetra’s research and development department and in line with a commercialization strategy. Tetra is positioning itself as a world leader in cannabinoid drug development and increasing its ODD portfolio provides opportunities that will allow us to generate value for shareholders. Over the coming weeks, Tetra shall expand on its commercial ophthalmic and topical drug programs,” said Dr. Chamberland CEO & CRO, Tetra Bio-Pharma Inc.

Management said it views Tetra’s Orphan Drug program similar to securing a pipeline of innovative molecules that target cannabinoid receptors. Chamberland said, “Many drugs fail during preclinical development and only a few make it to marketing approval for use in humans. A pipeline is critical to any pharmaceutical company’s survival and Tetra is delivering this security for its long-term growth. The ODD strategy has been expanded during COVID-19 and is part of Tetra’s strategy to secure first drug approvals and work with commercial partners to launch potential products sooner. As Tetra’s portfolio of Orphan Drug candidates expands, management is assessing which drug development will remain exclusively developed by Tetra and which drugs development programs will be advanced through strategic partnerships.”

The Orphan Drug Act was created to provide the industry with incentives to develop drugs that are designed to treat or prevent, diseases affecting fewer than 200,000 people in the United States. An application for Orphan Drug Designation (ODD) includes critical aspects such as the scientific mechanism of action for the drug’s role in the target disease, the prevalence of the rare disease in the USA. Typically, the mechanistic rationale involves the company providing experimental data supporting the claim that its drug may be effective.

If granted, an ODD provides the drug with a status that gives exclusive marketing and development rights as well as financial benefits to help recover part of the costs of clinical development. More specifically a 50% tax credit on the cost of clinical trials performed in the USA, a 7-year marketing exclusivity following drug approval, a fast-track type approach to file and review submissions, waiver of the new drug approval fees (estimated at $3 million US), as well as other financial benefits.

The Orphan Drug development strategy does not bring on additional new expenses to the corporation as these products were already advancing through the various drug development stages. The ODDs provide Tetra with the ability to optimize its commercialization strategy for its ophthalmic drug PPP003 and topical formulations referred to as PPP004.

COVID-19 Update

During the COVID-19 crisis, Tetra said it has not suspended or slowed down any of its regulatory and clinical activities and continues to find ways to advance its clinical trials. SERENITY remained Tetra’s top priority and the company is increasing the number of clinical sites while clearing schedule 1-type and export licenses (USA & Mexico) for each site. On April 14, 2020, Tetra has announced that Dr. Sue Sisley’s Scottsdale Research Institute received the renewal of its Schedule 1 license from the US Drug Enforcement Agency (DEA). Tetra is continuing to expand its clinical sites to be ready to accelerate patient enrollment in the USA for its PLENITUDE© and SERENITY© trials.

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Kaitlin DomangueKaitlin DomangueApril 20, 2020
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3min7800

As the world is seemingly closed for business, many business owners find themselves in hot water. According to Liesl Bernard, CEO, and founder of cannabis staffing agency CannabizTeam, the cannabis industry is not one of those businesses. Being coined as “corona stress disorder”, people are turning to cannabis products to ease their anxiety over the current state of the world. And since everyone is at home, people are running through their products at a much faster rate than usual. 

Bernard tells Green Market Report, “There has been a rise in hiring temporary employees in the cannabis industry, even with COVID-19 looming over the economy. Across the board, our clients are looking for extra support. Last month, we saw a 100% increase in temporary staffing, and we’re still getting plenty of clients who need temps. Our top temp positions are warehouse technicians, budtenders, extraction technicians, and dispatch managers.” 

Bernard explains that the drastic changes to our everyday lives coupled with the uncertainty of the future is leading to high stress and increased need for cannabis. “Naturally, people are turning to cannabis to relieve their anxiety. Cannabis users are stockpiling and purchasing even more cannabis than ever before to cope with their worry and fear, so cannabis companies have to rise to the occasion.” Bernard tells us that he believes users are purchasing a mix of different products, “but flowers and edibles are at the top of the list.” He said, “Out of the main sectors of the industry, I would say that manufacturing and retail have the most need for staff right now.” 

Bernard and the CannabizTeam are confident the cannabis industry will grow to become stronger than ever before when we come out on the other side of this global crisis. “It’s an industry that’s used to making adjustments and pivoting, so I see it prospering even more once we get past the coronavirus pandemic,” said Bernard. “I also remember reading a recent report from New Frontier Data, stating that 72% of leading industry stakeholders expect the cannabis industry to grow in 2020. Staffing needs will still be there once this is all over, and we’re going to be here to make the right connections.” 

Bernard says that while temporary staffing is taking the lead, the company is still continuing to recruit executives for cannabis companies. “We have businesses that are making offers to executives, and they’re still moving forward with video interviews.”


Debra BorchardtDebra BorchardtMarch 9, 2020
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4min9080

The FDA provided an update on its efforts at evaluating CBD products over the past year. The agency said that it is taking several new steps in areas of education, research and enforcement with the ultimate goal of continuing to protect the public health and working to provide market clarity.

“We’re seeing CBD being marketed in a number of different products, such as oil drops, capsules, syrups, food products, such as chocolate bars and teas, cosmetics and other topical lotions and creams, as well as products marketed for pets and other animals – and we understand consumers are seeking out these novel products for a variety of perceived health-related or other reasons,” said the FDA’s statement.

“We are concerned that some people wrongly think that the myriad of CBD products on the market have been evaluated by the FDA and determined to be safe, or that using CBD ‘can’t hurt.’ Aside from one prescription drug approved to treat two rare, severe pediatric epilepsy disorders, no other CBD products have been evaluated or approved by the FDA.”

The FDA said it was wanting to get more data on the following conditions:

  • The sedative effects of CBD
  • The impacts of long-term sustained or cumulative exposure to CBD
  • Transdermal penetration and pharmacokinetics of CBD
  • The effect of different routes of CBD administration (e.g., oral, topical, inhaled) on its safety profile
  • The safety of CBD for use in pets and food-producing animals
  • The processes by which “full spectrum” and “broad spectrum” hemp extracts are derived, what the content of such extracts is, and how these products may compare to CBD isolate products

Reopening Public Comments

The FDA said it was re-opening the public docket that was created for the May 2019 public hearing. “We have decided to extend the comment period indefinitely to allow the public to comment and to share relevant data with the agency. This docket also includes a mechanism for a stakeholder to submit data or information that the stakeholder believes to be confidential.”

The FDA’s Office of the Chief Scientist was also recently awarded a grant to the FDA’s National Center for Toxicological Research to conduct a study to better understand the effects of CBD exposure during pregnancy. “Additionally, we’ve initiated a research study in partnership with the University of Mississippi to evaluate the levels of CBD and THC in a sample of cosmetic products to assess sensitization of THC and CBD topically, and dermal penetration.”

No New Guidance on Products

While the FDA did decide to reopen the docket and has begun to dip its toes into research, the agency gave very little new guidance with regard to products. It only stated, “We also have serious concerns about products that put the public at risk in other ways. For example, we are aware of the risks posed by product contaminants such as heavy metals, THC or other potentially harmful substances. We also have significant concerns about products marketed with false claims or statements such as omitted ingredients, incorrect statements about the amount of CBD, products marketed for use by vulnerable populations like children or infants, and products that otherwise put the public health at risk.”

The agency merely stated It was evaluating the issuance of a risk-based enforcement policy.


Kaitlin DomangueKaitlin DomangueFebruary 24, 2020
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4min9820

The Trump Administration has proposed the removal of a rider provision protecting state-legal cannabis businesses from the federal government’s interference. 

This comes with the release of his fiscal year 2021 budget plan.

The rider in question specifically states the Justice Department can’t use federal funding to prohibit states or territories “from implementing their own laws that authorize the use, distribution, possession, or cultivation of medical marijuana.”

Removing this provision would leave a lot of room for government interference, potentially destroying many state-legal businesses.

This action comes contrary to many things President Trump has said and expressed in the past. Most famously, declaring that cannabis legalization should be a state issue. What he is pushing now directly negates that previously spoken belief.

“I think it certainly has to be a state—I have not smoked it—it’s got to be a state decision … I do like it, you know, from a medical standpoint … it does do pretty good things,” Trump said on the 2016 campaign trail. “But from the other standpoint, I think that it should be up to the states.”

Donald Trump also previously spoke in favor of the STATES Act, a bipartisan bill that protects legal cannabis states from federal interference.

When asked if he supported the legislation filed by Democratic senator Elizabeth Warren and Republican Senator Cory Gardner, he said “I really do. I support Senator Gardner.” Trump said in 2018. “I know exactly what he’s doing. We’re looking at it. But I probably will end up supporting that, yes.”

To add fuel to the already ablaze fire, President Trump was heard in a leaked audio clip say that he believes smoking cannabis makes you lose IQ points, though experts seem to disagree.

This rider has been renewed every year since 2014, however, it has faced scrutiny in the past, with President Obama asking for it to be removed during his time in office.

Trump is choosing to take it a step further than Obama by stating he could ignore any medical marijuana protections provided by Congress. This was revealed in his large-scale spending legislation released in December.

The President wrote in a signing statement “Division B, section 531 of the Act provides that the Department of Justice may not use any funds made available under this Act to prevent implementation of medical marijuana laws by various States and territories.” Trump continues by saying “My Administration will treat this provision consistent with the President’s constitutional responsibility to faithfully execute the laws of the United States.”

By calling out this rider specifically, Trump is vaguely saying he believes his administration can enforce federal drug laws that interfere with the state’s laws, even though there is a provision saying he can’t.

Trump’s fiscal year 2021 budget also includes a rider that prohibits Washington D.C. from using local tax dollars to regulate the legal sale of cannabis.

Donald Trump has given the cannabis community good reason to believe that he supports them and their cause. These recent actions and statements may prove otherwise.


Julie AitchesonJulie AitchesonFebruary 21, 2020
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5min11790

Editor’s Note: This story was originally published on our sister site Hemp Market Report.

Amidst concerns on the federal and state levels about violations of FDA regulations regarding CBD products, efforts are being made to allocate more money in the upcoming fiscal year to further define and more stringently enforce CBD laws. President Trump’s proposed budget for the fiscal year 2021, should he gain re-election and have the opportunity to present it to Congress, allocates an additional $5 million to the Food and Drug Administration specifically for further regulation and law enforcement pertaining to cannabis and cannabis-derived products. This is the first time that CBD has been mentioned in a federal budget proposal, which suggests that hemp and CBD may be buzzwords cropping up in Presidential debate topics alongside marijuana leading up to the election.

So where would it leave the future of CBD regulation if Trump is ousted from the White House? Democratic Presidential frontrunners Bernie Sanders and Elizabeth Warren both support the legalization of cannabis, with Sanders proposing to legalize within 100 days of his election to office. A historically outspoken proponent of the war on drugs, Joe Biden is sticking to a half-measure platform with a focus on decriminalization, allowing states to regulate hemp for themselves. Michael Bloomberg supports putting legalization in the hands of individual states, though he is personally opposed to legalization. Pete Buttigieg takes the side of veterans with PTSD who often use cannabis and its derivatives to deal with the aftermath of military service, advocating for the decriminalization of all controlled substances. 

As hemp has yet to be a talking point for presidential candidates, overshadowed as it is by the larger topic of marijuana as a flashpoint for racial justice issues (as criminalization disproportionately affects people of color), what Americans can expect from future budgetary support should a Democrat win office is unclear. What is clear is that the time for comprehensive, consistent regulations and enforcement of cannabis laws on the part of the FDA is long overdue.

  During his January 2020 testimony before the Subcommittee on Health, Committee on Energy and Commerce, and the U.S. House of Representatives, Douglas C. Throckmorton, Deputy Director for Regulatory Programs at the FDA, highlighted the current illegality (per the Food, Drug, & Cosmetic Act)  of interstate commerce of food with CBD additives. He also described in some detail concerns with current CBD marketing tactics that put consumers at risk, such as those products that claim to treat cancer or Alzheimer’s. Throckmorton also identified some particular concerns related to the potential negative health impacts of CBD use, such as liver damage, problematic drug interactions, male reproductive toxicity, and various ill side effects. 

While studies of these impacts are still ongoing and inconclusive, the FDA is clearly intent on taking them, and the future of CBD in the U.S. market, seriously. Whether the President-elect of the United States, whoever he or she may be, manages to pass a budget that supports the FDA in its mission to ensure public safety in regards to CBD is, in many respects, for voters to decide.


Kaitlin DomangueKaitlin DomangueFebruary 19, 2020
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4min6470

It’s time for your Daily Hit of cannabis financial news for February 19th, 2020. 

On the Site

Cannabis Sustainability: Minimize Wastewater

Drought and water shortages are an expensive reality in some of the best cannabis-growing regions. As a result, water conservation practices help reduce water waste and overall operations costs, particularly for commercial grows.

Use Cannabis? Spotlight on Driving Unimpaired

The article went in-depth on what those who are pulled over with medical cannabis in Florida should do. Drivers must be able to produce a valid medical cannabis card. In other words, don’t leave your card at home. Drivers should also not drive with hemp/CBD without a certificate of analysis in the vehicle as well.

Zenabis to Produce Sparkling Beverages

Zenabis Global Inc. (TSX: ZENA)  announced details of its cannabis derivative product strategy and execution, including entering into an agreement with a Canadian beverage manufacturer to produce a range of cannabis-infused beverages.

The initial launch of cannabis-infused sparkling water beverages under the HYTN brand is listed with all Zenabis’ Provincial counterparties, with strong indicative demand. The first shipment of the initial four flavors of the cannabis-infused sparkling water beverages expected in Q2 2020.

Australis Kills Folium Deal

Australis Capital Inc. (CSE: AUSA) (OTC: AUSAF) terminated a proposed merger with Folium Equity Holding LLC and Folium Merger Sub, LLC.

Australis had sent warning signs that the company may not move forward with the deal in corporate meeting notes that surfaced on Google. In those notes, Dowty said, “It was concerning with the multiple lawsuits and all of the stuff on social media. After due diligence and getting to know the team at folium, we felt comfortable you know, with where they are going.”

Move Over Impossible Burger, The CBD Burger Is Next On The Menu

Even though the FDA has expressed its displeasure at adding CBD to food, that hasn’t stopped hamburger chains from tossing in some cannabidiol to enhance their burgers.

Carl’s Jr. became the first fast-food chain to sell a CBD burger for one day at one of its franchises in Denver, Colorado. That has sparked Colorado-based Illegal Burger to offer what it calls its biggest differentiator, “its exclusive line of CBD products.”

In Other News

TILT Holdings Revamps C-Suite

TILT Holdings has appointed interim CEO Mark Scatterday as the permanent CEO of the company. Tim Condor has been appointed as Chief Operating Officer, adding the title of President, effective immediately.

Tilray Stocks at a Low

Tilray (TLRY) has been one of the worst-performing stocks in the cannabis market in the last year. After their IPO price rising to $300 from $17, their luck ran dry and shares recently hit a low around $15. Estimates from analysts predict Tilray’s stock to fall.



About Us

The Green Market Report focuses on the financial news of the rapidly growing cannabis industry. Our target approach filters out the daily noise and does a deep dive into the financial, business and economic side of the cannabis industry. Our team is cultivating the industry’s critical news into one source and providing open source insights and data analysis


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