FDA Archives - Green Market Report

StaffMarch 22, 2021
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7min11060

The U.S. Food and Drug Administration has issued warning letters to two companies for selling products labeled as containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act). Specifically, the warning letters address the illegal marketing of unapproved drugs labeled as containing CBD. The companies are Honest Globe and Biolyte Laboratories.

The letter sent to Honest Globe referenced the products “ELIXICURE ORIGINAL PAIN RELIEF with CBD” (roll-on and pump versions) and “ELIXICURE LAVENDER PAIN RELIEF with CBD” (roll-on and pump versions) (hereinafter referred to as “ELIXICURE PAIN RELIEF with CBD” products). The “ELIXICURE PAIN RELIEF with CBD” products were labeled as containing cannabidiol (CBD) and require no prescription.

The letter read, “Your “ELIXICURE PAIN RELIEF with CBD” products are unapproved new drugs introduced or delivered for introduction into interstate commerce in violation of sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d). Furthermore, your “ELIXICURE PAIN RELIEF” products are misbranded drugs introduced or delivered for introduction into interstate commerce in violation of sections 502(a), 502(ee), and 301(a) of the FD&C Act, 21 U.S.C. 352(a), 352(ee), and 331(a).” The FDA also said that although CBD was listed as an inactive ingredient in the labels of the “ELIXICURE PAIN RELIEF with CBD” products, the product labeling clearly represented CBD as an active ingredient, which is a component of a drug intended to furnish pharmacological activity or other direct effects in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or function of the body. Ultimately an inactive ingredient should not exert pharmacological effects.

In addition to the marketing, Honest Globe was cited for production issues. The letter stated, “Your Quality Unit (QU) lacked control over your topical over-the-counter drug manufacturing operations and failed to ensure that you had adequate procedures. In your response, you committed to working with your contract laboratory to investigate the cited OOS results and future OOS results. Your response is inadequate because you did not address your responsibilities to investigate potential manufacturing deficiencies that may have led to the OOS results. Your response also failed to evaluate batches with OOS test results that had been distributed and were still within expiry.”

Honest Globe also got itself in trouble with claiming its products to be registered with the FDA . “To state that any drug product is “FDA registered” is inaccurate; drugs are subject to listing with FDA, not registration. Moreover, registration of an establishment or listing of a drug does not denote approval of the establishment, the drug, or any other drugs of the establishment, nor does it mean that a product may be legally marketed.”

Biolyte Laboratories LLC was the other company that received a letter. The company made medical claims about its products. Examples given were  “Silver Gel,” – used as an antimicrobial to help treat minor skin wounds, burns, infections . . .” “Silver Gel” – “USEFUL FOR WOUNDS, BURNS, BANDAGES, AND MORE . . . TOPICALLY USED AGAINST INFECTIONS . . . TOPICALLY USED AGAINST SEVERAL SKIN CONDITIONS (Hives, Rashes, eczema, diaper rash).”

“Based on the above labeling claims, your products “(b)(4) Therapeutic Pain Gel,” “(b)(4) Pain Relief Cream,” and “(b)(4) Magnesium Oil Spray” are drugs intended for use as external analgesics. We are not aware of any adequate and well-controlled clinical studies in the published literature that support a determination that “(b)(4) Therapeutic Pain Gel,” “(b)(4) Pain Relief Cream”, or “(b)(4) Magnesium Oil Spray” are generally recognized as safe and effective (GRASE) for use under the conditions suggested, recommended, or prescribed in their labeling.”

The FDA has not approved any over-the-counter (OTC) drugs containing CBD, and none of these products meet the requirements to be legally marketed without an approved new drug application. The letters explain that, as CBD has known pharmacological effects on humans, with demonstrated risks, it cannot be legally marketed as an inactive ingredient in OTC drug products that are not reviewed and approved by the FDA. Additionally, the letters cite substandard manufacturing practices, including failure to comply with current good manufacturing practices.

The FDA said in a statement that the products that are the subject of the warning letters issued today have not gone through the FDA drug approval process and are considered unapproved new drugs. There have been no FDA evaluation of whether these unapproved drug products are effective for the uses manufacturers to claim, what an appropriate dose might be, how they could interact with FDA-approved drugs or other products, or whether they have dangerous side effects or other safety concerns.


Debra BorchardtJuly 21, 2020
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3min10590

The FDA issued draft guidance for clinical research related to the development of drugs containing cannabis or cannabis-derived compounds. The FDA is taking comments and suggestions for the next 60 days. The guidance does not address the development of fully synthetic versions of substances that occur in cannabis.

As part of drug development, sponsors may conduct clinical trials under an investigational new drug (IND) application to determine if a drug is safe and effective for a particular intended use. The IND application provides a mechanism for those developing a new drug to conduct studies and ship their proposed drug to clinical trial sites. The data obtained from these studies may later become part of a new drug application (NDA), which is then used to formally propose that FDA approve a new drug for sale in The United States.

  • The following additional principles and recommendations are particularly relevant for
    developing drugs that contain cannabis and cannabis-derived compounds:

    Cannabis is held to the same regulatory standards as any other botanical raw material,
    botanical drug substance, or botanical drug product. The general considerations and
    recommendations for botanical drugs contained in the guidance for industry Botanical
    Drug Development (December 2016) provides core principles for conducting clinical research on botanical drugs, including drugs that contain cannabis and cannabis-derived compounds.

  • In addition, FDA recommends that those pursuing drug development using cannabis or cannabis-derived compounds consider the following principles and documents:  — Adequate characterization of cannabis and cannabis-derived compounds, for example via a chemical fingerprint, is critical to ensure batch-to-batch consistency.  — USP General Chapter <561> Articles of Botanical Origin, particularly regarding tests for residual pesticides, including any pesticides routinely used in the countries of origin of botanical raw materials.
  • There may be drug scheduling considerations under the CSA for applicants pursuing FDA approval of an NDA for a drug that contains cannabis or cannabis-derived compounds. FDA’s review of the NDA may include an abuse potential assessment to inform labeling and to provide DEA with a scientific and medical evaluation of the drug’s abuse potential.
  • The human major metabolite of cannabidiol, 7-COOH-CBD, is expressed disproportionately in humans compared to animals. While disproportionate metabolism is not limited to botanical products, FDA would like to make stakeholders aware that this is a known issue with certain cannabinoids.
  • Activities related to growing and manufacturing cannabis for use as an investigational drug for research must comply with CSA and DEA requirements

StaffApril 24, 2020
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7min15680

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 BorchardtMarch 9, 2020
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4min15640

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.


Julie AitchesonFebruary 21, 2020
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5min18720

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.


StaffNovember 25, 2019
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10min26170

On Monday, the U.S. Food and Drug Administration has issued warning letters to 15 companies for illegally selling products containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FDA also published a revised Consumer Update detailing safety concerns about CBD products more broadly. The FDA also indicated in the press release that it cannot conclude that CBD is generally recognized as safe among qualified experts for its use in human or animal food.

The warning letters sent to these companies were accused of using product webpages, online stores and social media to market CBD products in ways that violate the FD&C Act, including marketing CBD products to treat diseases or for other therapeutic uses for humans and/or animals. The FDA also noted that some of the products were marketed towards infants and children, which could have adverse reactions. Other violations include marketing CBD products as dietary supplements and adding CBD to human and animal foods.

“As we work quickly to further clarify our regulatory approach for products containing cannabis and cannabis-derived compounds like CBD, we’ll continue to monitor the marketplace and take action as needed against companies that violate the law in ways that raise a variety of public health concerns. In line with our mission to protect the public, foster innovation, and promote consumer confidence, this overarching approach regarding CBD is the same as the FDA would take for any other substance that we regulate,” said FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D. “We remain concerned that some people wrongly think that the myriad of CBD products on the market, many of which are illegal, have been evaluated by the FDA and determined to be safe, or that trying CBD ‘can’t hurt.’ Aside from one prescription drug approved to treat two pediatric epilepsy disorders, these products have not been approved by the FDA and we want to be clear that a number of questions remain regarding CBD’s safety – including reports of products containing contaminants, such as pesticides and heavy metals – and there are real risks that need to be considered. We recognize the significant public interest in CBD and we must work together with stakeholders and industry to fill in the knowledge gaps about the science, safety and quality of many of these products.”

The companies receiving warning letters are:

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.

The FDA also does not approve of companies selling CBD products with the suggestion that the product should be added to either human or animal food.


Debra BorchardtOctober 22, 2019
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4min18640
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 BorchardtSeptember 17, 2019
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4min11740
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 SumnerJune 4, 2019
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4min10510

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 SumnerJune 4, 2019
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4min20420

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.


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