FDA Archives - Green Market Report

Debra BorchardtMay 9, 2022
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7min8470

Last week, the Food & Drug Administration (FDA) sent out warning letters to five cannabidiol (CBD) companies for Unapproved New Drugs/Misbranded/Cannabidiol (CBD) Products.

“The FDA is very concerned about the growing popularity of delta-8 THC products being sold online and in stores nationwide. These products often include claims that they treat or alleviate the side effects related to a wide variety of diseases or medical disorders, such as cancer, multiple sclerosis, chronic pain, nausea and anxiety,” said FDA Principal Deputy Commissioner Janet Woodcock, M.D. “It is extremely troubling that some of the food products are packaged and labeled in ways that may appeal to children. We will continue to safeguard Americans’ health and safety by monitoring the marketplace and taking action when companies illegally sell products that pose a risk to public health.”

The companies receiving the letters were  Kingdom Harvest, Delta 8 Hemp, ATLRx Inc., BioMD Plus and M Six Labs Inc. The FDA reviewed all of the company’s websites and said the following:

The claims on your website and social media accounts establish that your products, some of which are available in multiple varieties 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).

The FDA also zeroed in on the Delta-8 aspects saying:

FDA has also observed a proliferation of products containing another cannabinoid, Delta-8 THC, and has recently expressed serious concerns about products containing Delta-8 THC that include: 1) Delta-8 THC products have not been evaluated or approved by FDA for safe use and may be marketed in ways that put the public health at risk; 2) FDA has received adverse event reports involving Delta-8 THC containing products; 3) Delta-8 THC has psychoactive and intoxicating effects; 4) FDA is concerned about the processes used to create the concentrations of Delta-8 THC claimed in the marketplace; and 5) FDA is concerned about Delta-8 THC products that may be consumed by children, as some packaging and labeling may appeal to children. See https://www.fda.gov/consumers/consumer-updates/5-things-know-about-delta-8-tetrahydrocannabinol-delta-8-thc. This letter is to inform you that your firm markets Delta-8 THC-containing products, and Delta-8 THC may pose a serious health risk to consumers.

The FDA also took issue with bringing “products into interstate commerce under section 301(ll) of the FD&C Act, 21 U.S.C. 331(ll).”

Mostly the FDA was concerned with companies making unsubstantiated claims about the products.

COVID Claims

The FDA noted that the Kingdom Harvest website said, “Studies Show Our Whole-Spectrum Extract Utilizing CBDa Can Prevent Infection From COVID-19.” The FDA says if a company makes a claim like this then the product is a drug and has to have the appropriate testing in order to make that claim. The FDA wrote, “These 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.”

Farm Animals

The FDA was also concerned in its warning letters that CBD products were being offered to farm animals that could produce a food products for humans. The FDA wrote,

To be legally marketed, a new animal drug must have an approved new animal drug application, conditionally approved new animal drug application, or index listing under sections 512, 571, and 572 of the FD&C Act, 21 U.S.C. §§ 360b, 360ccc, and 360ccc-1. These products are not approved or index listed by the FDA, and therefore these products are unsafe under section 512(a) of the FD&C Act, 21 U.S.C. § 360b(a), and adulterated under section 501(a)(5) of the FD&C Act 21 U.S.C. § 351(a)(5).

Cancer Claims

In addition to Covid claims, the FDA noted in its letter to Delta-8 Hemp that the company was making cancer claims. That letter highlighted a comment from the company’s website that said, “Delta-8 is known to be successful in many cancer treatments.” The FDA told the company, “Your Delta-8 THC products for humans are not generally recognized as safe and effective (GRASE) for their above-referenced uses and, therefore, these products are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p). ”

Mental Health

While many CBD companies suggest that the product helps anxiety, some of the companies in the latest batch of warning letters went even further. There were suggestions that it could help people suffering from schizophrenia and Alzheimer’s based on very small studies. The FDA is concerned that some patients would stop other medications and use these instead.

No Information

Of course, since the FDA hasn’t set any guidelines for CBD products, the companies aren’t able to introduce any information regarding dosage. The FDA complains the companies aren’t labeling the products correctly, but also won’t allow the companies to express these descriptions.

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


Dave HodesMarch 4, 2022
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13min13780

When you see various agencies of the U.S. government getting involved in psychedelics, or changing their stance even a little (such as the DEA), that signals that the industry has hit its stride. 

Avenues of development open up, investor confidence increases, and researchers sense the ability to achieve goals that not only science but government supports. It begins to feel like everyone is on the same page. 

Here’s a look at what various government agencies are doing about psychedelics:

 

DEA. The Drug Enforcement Administration seems to want to help the psychedelics industry more than ever, but can’t help adding caveats about what that progress looks like. For example, the DEA reported in the Federal Registry on October 18, 2021 that there has been a significant increase in the use of schedule I hallucinogenic controlled substances for research and clinical trial purposes (MDMA and psilocybin chief among them), and that it has approved new applications for schedule I research registrations and new applications for registration from manufacturers and corresponding quota applications to grow, synthesize, extract, and manufacture dosage forms containing specific schedule I hallucinogenic substances for clinical trial purposes. The DEA also reported that it supports increased production quotas proposed for 2022 compared with production quotas for these substances in 2021. That’s good news for the industry—followed by more bad news. On January 14, 2022, the DEA proposed placing five tryptamine hallucinogens(4-OH-DiPT, 5-MeO-AMT, 5-MeO-MiPT, 5-MeO-DET, and DiP) on schedule I of the Controlled Substances Act. If finalized, this action would impose the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule I controlled substances on anyone who handles (manufacture, distribute, reverse distribute, import, export, engage in research, conduct instructional activities or chemical analysis with, or possess), or proposes to handle these five specific controlled substances. That could be a problem for Field Trip, a psychedelics therapy company. “Field Trip’s FT-104 is a prodrug of 4-OH-DiPT, so this will add some paperwork and delays to their efforts in the U.S.,” Matt Baggott, co-founder and CEO of Tactogen, a pharmatech company, wrote in a tweet about the DEA news.It’s worth noting that HHS provided DEA with an analysis of these compounds in 2012 and DEA failed to act until now. This raises the question of whether this scheduling is in response to the increased interest in psychedelic medicine.”

 

FDA. Probably the most active government psychedelics supporter is the Food and Drug Administration because of the critical role it plays in assessing any drug that wants to be FDA-approved and sold to the public. The agency has picked up the pace in its work with psychedelics. But it is still charged with an exceptional sense of prudence when working to legitimize novel compounds. In a commentary published in the American Journal of Medicine in January, Attorney Matt Lamkin, associate professor at the University of Tulsa College of Law, discussed the role of the FDA as research into psychedelics explodes. “Incorporating psychedelic drugs into clinical practice will require peeling back multiple layers of legal prohibition, clarifying prescribing guidelines, and developing treatment models that work for drug makers, physicians, and payers.” He went on to cite various achievements of the FDA and psychedelics: granting breakthrough therapy status to expedite the development and review of multiple psychedelic drugs; approval in 2019 of esketamine as a therapy for treatment-resistant depression; the promising results from an FDA-approved phase 2 trial of psilocybin as a treatment for major depressive disorder; and in June, when researchers published results from a phase 3 trial—the final phase before seeking FDA approval—studying 3,4-methyl-enedioxymethamphetamine (MDMA) as a treatment for posttraumatic stress disorder. Still, Lamkin was cautious about how and what the FDA could do. “Although the psychedelic research revival is yielding promising results, challenges remain before these drugs will find their way into clinical practice. Yet this plodding process could enhance the likelihood that these therapies will actually take root,” Lamkin wrote. “Given the longstanding skepticism toward psychedelic interventions, moving too swiftly might risk a backlash that could further stall research. Proceeding both with caution and openness offers the best hope for harnessing the potential benefits of these drugs while mitigating their risks.”

 

NAS. The National Academies of Science, Engineering and Medicine is focusing more attention on the psychedelics arena. For example, on March 29, the NAS will be conducting a workshop exploring psychedelics and entactogens as treatments for psychiatric disorders. The NAS noted on its website about the workshop that, with activity and interest in this field continuing to grow, the workshop “will provide a venue to explore strategies for harnessing the potential of these agents to combat mental illness.” Invited speakers will discuss the neurobiology of the therapeutic effects, strategies for optimizing the safety, efficacy, and patient stratification, and lessons learned that may help the identification of new classes of therapeutic agents. The workshop will explore the unique challenges and considerations presented by compounds that induce profound changes in consciousness, including those related to clinical trial design, medical ethics, and the psychosocial contexts of drug administration. The workshop is sponsored by the Department of Health and Human Services and the National Science Foundation.

 

NIH. The National Institutes of Health discussed psychedelics favorably at the National Institutes of Health’s FY22 Budget and the State of Medical Research hearing before the Subcommittee on Labor, Health and Human Services Education and Related Agencies on May 26, 2021. “I think as we’ve learned more about how the brain works we began to realize that these are potential tools for research purposes and might be clinically beneficial,” Francis Collins, director of the NIH said, referring to psychedelics such as psilocybin and MDMA. Collins said there has been a resurgence of interest in psychedelic drugs, which for a while “were sort of considered not an area that researchers legitimately ought to go after.” Additionally, on October 20, 2021, Johns Hopkins Medicine announced that the National Institute on Drug Abuse (NIDA) within the NIH, had awarded a grant of $4 million to fund a study using psilocybin as a therapeutic agent for smoking cessation. It is the first grant awarded by the United States government for research on psilocybin for tobacco use in 50 years. The multi-site, three-year study will be led by researchers with Johns Hopkins Medicine in collaboration with researchers at the University of Alabama at Birmingham.

 

NSF. The National Science Foundation is stepping up its support of psychedelics studies. One example is a study on how psilocybin and LSD work on brain activity, funded in part by an NSF grant for a six year study of various interdisciplinary training elements for complex networks and systems. 

 

USDA. The U.S. Department of Agriculture is on the lookout for ketamine. According to a Consumer Reports analysis of data from the Food Safety and Inspection Service, a branch of the U.S. Department of Agriculture, trace amounts of ketamine may have appeared in the U.S. meat supply more often than was previously known, pointing to new testing technologies that can better show what’s in meat today. The data for Consumer Report’s assertion came from the USDA’s Food Safety and Inspection Service (FSIS), the agency responsible for ensuring the safety of the U.S. meat supply. Emilio Esteban, chief scientist for the FSIS, said that the results should be discounted because they came from unconfirmed screening tests. “These results are credible enough that you would expect the government to take the warning signs seriously,” says James E. Rogers, Ph.D., who was a microbiologist at the FSIS for 13 years before becoming director of food safety research and testing at Consumer Reports. “You would hope the results would prompt the agency to look into why these drugs may be present, what risks they could pose, and what could be done to protect consumers.”


Debra BorchardtFebruary 3, 2022
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5min6920

Psychedelic mental health company Novamind Inc. (OTCQB: NVMDF) announced it has been selected by the Ketamine Research Foundation (KRF) to host a phase II clinical trial investigating ketamine-assisted psychotherapy (KAP) for adults with life-threatening illness (the “Conscious Dying/Conscious Living Trial”).

Novamind said in a statement that the FDA approval of the study’s KAP protocol marks a first in the investigation of KAP for end-of-life patients and its potential to serve as a model of care for this difficult-to-treat population. Over the course of six weeks, study participants will undergo two KAP sessions at Novamind’s Murray, Utah research site under the supervision of clinical experts.

“This study is an important addition to the clinical care and research opportunities for patients within the Psychedelic Palliative Care program that we are building at Novamind,” said Dr. Paul Thielking, Chief Scientific Officer and Principal Investigator at Novamind’s Murray research site. “I’ve worked with this population for most of my career and, unfortunately, I’ve sometimes felt limited in what I can offer my patients to ease their emotional distress. The findings will contribute to the evidence for using KAP with patients who have a life-threatening illness and offer new insights into alternative treatments.”

According to the company, the mental health toll of a terminal illness is well-documented with between 24% to 70% of patients experiencing depression with significant negative impacts on quality of life.For patients with shortened life expectancy, ketamine may reduce symptoms of depression, anxiety and existential distress, and improve quality of life.

New Proposed Legislation

Two weeks ago Marijuana Moment reported that Bipartisan members of Congress sent a letter to the Drug Enforcement Administration (DEA) requesting that terminally ill patients be allowed to use psilocybin as an investigational treatment without the fear of federal prosecution.

“Rep. Earl Blumenauer (D-OR) started circulating a Dear Colleague letter to build support for the request last month. Now signed by a coalition of lawmakers on both sides of the aisle, the letter to DEA stresses that there are state and federal right-to-try (RTT) laws that should make it so certain patients can obtain the psychedelic given that it’s shown early potential in ongoing clinical trials.”

The Conscious Dying/Conscious Living Trial is sponsored by the KRF, a non-profit leader in ketamine research, advocacy and clinical training. Phil Wolfson, MD is the Founder and CEO of KRF and a pioneering practitioner and instructor of KAP. He is also a Principal Investigator for the Multidisciplinary Association for Psychedelic Studies (MAPS)-sponsored phase II study of MDMA-assisted psychotherapy for individuals with significant anxiety due to life-threatening illnesses.

Dr. Wolfson commented, “Ketamine is still considered a novel treatment option for psychiatric illness and can sometimes be seen as controversial. Now with FDA approval, we’re hopeful that this ground-breaking study will demonstrate KAP’s potential to relieve distress and serve as a model for practitioners of palliative care, hospice and mental health professionals engaged with those who are facing death, to assist in their attitudes and choices for their remaining time.”

StaffOctober 11, 2021
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4min25560

In a big “oops we goofed,”  the Food and Drug Administration (FDA)  took back its September 14 Marketing Denial Order for some of Turning Point Brands, Inc.  (NYSE: TPB) vape products. Turning Point said all of its proprietary vape products, including its Solace branded e-liquids, will continue to be marketed while they remain under review. They are currently under a pending Premarket Tobacco Product Applications (“PMTAs”) review.

Turning Point said that in its rescission letter the FDA stated, “Upon further review of the administrative record, FDA found relevant information that was not adequately assessed. Specifically, your applications did contain randomized controlled trials comparing tobacco-flavored ENDS to flavored ENDS as well as several cross-sectional surveys evaluating patterns of use, likelihood of use, and perceptions in current smokers, current ENDS users, former tobacco users, and never users, which require further review.” The letter further clarified that “at present, in light of the unusual circumstances, FDA has no intention of initiating an enforcement action against” the products.

“We are encouraged by the FDA’s decision to reconsider our product applications and look forward to engaging the agency as our PMTAs are reviewed,” said Larry Wexler, President and CEO, Turning Point Brands. “It is important that the PMTA process is transparent, purposeful, and evidence-based. Our organization dedicated significant time and resources in filing our applications in accordance with agency guidance. We remain hopeful that the depth and range of our studies and data will persuade the FDA that the continued marketing of our vapor products is appropriate for the protection of the public health and that the agency will ultimately preserve a diverse vapor market for the more than 30 million American adult smokers who may wish to transition from combustible cigarettes to lower risk alternatives.”

Turning Point had been selling vape products under the label Solace with flavors like Peach, Mango, and Marshmallow Crispy. These sugary flavors have been very popular with underage consumers and were a big selling point for the competitor Juul. Solace noted on its website that Federal law required e-liquid companies to submit a Premarket Tobacco Product Application (PMTA) to the U.S. Food and Drug Administration (FDA) in order to continue selling products in the United States. These applications require that e-liquid companies demonstrate that products are “appropriate for the protection of public health.”

Turning Point has reported spending $14 million in 2020 on the PMTA application according to the company’s annual filing. In 2019, the company spent  $2.2 million on the PMTA. Turning Point also said that as a result of the rescission letter, it withdrew both the petition for relief and motion to stay that it had filed with the 6th Circuit Court of Appeals.


StaffAugust 13, 2021
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8min16221

Charlotte’s Web (OTC: CWBHF) CEO Deanie Elsner addressed the company’s recent rejection letter by the FDA in the company’s earnings call on Thursday. Since the passage of the 2018 Farm Bill that legalized hemp, the issue of CBD products has remained in a grey area. The FDA has had several public meetings and accepted public comments on the subject, but it still hasn’t made any specific decisions.

Charlotte’s Web was specifically focused on a regulatory pathway for full spectrum hemp extract with naturally occurring CBD. CBD products remain unregulated as the industry has grown to become a $3 billion to $4 billion industry.

FDA Punts To Congress

“After 2.5 years, it has become increasingly more apparent that in the FDA’s own words, potential legislation might be appropriate to enable a framework for under which the FDA can regulate full spectrum hemp extracts as dietary supplements,” said Elsner. “During the second quarter of 2021, we put this thesis to test by formally submitting a new dietary ingredient notification to the FDA for our full spectrum hemp extract as they have been recommending. The FDA responded with an objection letter to our NDI notification. Their response substantially based on their drug preclusion provision reveals that legislation is required to enable the FDA to establish a regulatory oversight for full spectrum hemp extracts as dietary supplements. Both the House and the Senate have introduced bills that would recognize hemp CBD as a dietary supplement and we are encouraged by this progress.”

When asked about the specifics of the letter, Elsner went on to say, “I will start with we were disappointed and strongly disagreed with not just the conclusion that they advanced, but the reasoning for their conclusions, because their letter back to us contained a significant amount of factual inaccuracies. And so the first thing I would tell you to do is on our website in the IR section, we have posted our response to the FDA. And we laid out an excruciating detail why we think they need to create the record in terms of what we submitted and what they concluded.

Now, that said, they drew a conclusion based on two examples. One was, they can’t move forward with an NDI as a dietary supplement because CBD is precluded, because it’s already a drug. And as you know, six months prior to the hemp bill being signed into law in December 2018, a drug was approved that’s CBD isolate. The second reason why they objected to our NDI was that they expressed safety concerns. And I think that’s the part that we are looking for a correction on, because regarding safety, the conclusions drawn just don’t appear to be based on the data we provided in our NDI. So, that’s we are trying to get focused on. In terms of what does it mean, I think what you are getting to is, it is the industry has been caught in a little bit of a catch-22, because the FDA has not been clear about the process by which they want companies to go through to gain regulatory clarity. And Congress has been pointing to the FDA to take responsibility for this.

And so our decision was full transparency, to force the issue to see who has the next decision. And with the FDA objecting to our NDI, it becomes very clear that the regulatory process to get established has to start with Congress, legislative and the FDA to regulate the dietary supplement for CBD, and then FDA can regulate within. And so I am confident there is a way to do this. Over the last 18 months, we have met with the FDA, about eight to ten different times and our meetings were very constructive. I have got a great deal of respect for the FDA. But I think they are in a bit of a catch-22, because they have approved the drug. And they can’t seem to move away from that precedent. And so Congress has to act. And I think once Congress acts, the FDA can be very clear about the process. The process is scientific. It’s intense. There is a ton of data that we have got to do to submit for it. And I feel really good having gone through this knowing what they are looking for. But now we need Congress to act. And when that happens, I think the category will be able to submit NDIs and the whole thing will begin to open up.”

THC Challenge

Elsner was asked whether relying on Congress would be any better and she answered, “This is not just a CBD hemp industry challenge. This is a THC sector challenge, because we are going through with hemp extracts with naturally occurring CBD is exactly what the cannabis industry is going to have to do following us. And so this is not Congress, maybe or maybe not engaging on the hemp CBD industry. This is Congress looking at a category today, that is roughly $17 billion to $20 billion in total in the US across 11 states where cannabis is legal and CBD participates. And so some kind of resolution has to be landed for how both of these categories are regulated. And the FDA has to have clarity and perspective about how they want companies to produce safe products for consumers in a way that is holding manufacturers to a very high level of standard. And so we are doing this for ourselves, but doing this for our category. We are doing this in support of our consumers. But it’s the whole sector that is going to put the pressure for Congress to act and push the FDA to move forward. And we will continue to push both fronts.”


StaffMarch 22, 2021
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7min16860

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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3min16240

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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7min21450

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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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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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.


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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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