FDA Approves New Indication For Drug Containing An Active Ingredient Derived From Cannabis To Treat Seizures In Rare Genetic Disease

DISTRICT OF COLUMBIA: Last month, the U.S. Food and Drug Administration approved Epidiolex (cannabidiol) [CBD] oral solution for the treatment of seizures associated with tuberous sclerosis complex (TSC) in patients one year of age and older. Epidiolex was previously approved for the treatment of seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome (LGS) and Dravet syndrome (DS). This is the only FDA-approved drug that contains a purified drug substance derived from cannabis. It is also the second FDA approval of a drug for the treatment of seizures associated with TSC.

CBD is a chemical component of the Cannabis sativa plant. However, CBD does not cause intoxication or euphoria (the “high”) that comes from tetrahydrocannabinol (THC). It is THC (and not CBD) that is the primary psychoactive component of cannabis.

“The FDA continues to believe the drug approval process represents the best way to make new medicines, including any drugs derived from cannabis, available to patients in need of appropriate medical therapy such as the treatment of seizures associated with these rare conditions. This paradigm ensures new therapies are safe, effective, and manufactured to a high quality that provides uniform and reliable dosing for patients,” said Douglas Throckmorton, M.D., deputy center director for regulatory programs in the FDA’s Center for Drug Evaluation and Research. “The agency is committed to supporting rigorous scientific research on the potential medical uses of cannabis-derived products and working with product developers who are interested in bringing patients safe and effective, high quality products.”

TSC is a rare genetic disease that causes non-cancerous (benign) tumors to grow in the brain and other parts of the body like the eyes, heart, kidneys, lungs, and skin. TSC usually affects the central nervous system and can result in a combination of symptoms including seizures, developmental delay, and behavioral problems, although the signs and symptoms of the condition, as well as the severity of symptoms, vary widely. TSC affects about 1 in 6,000 people.

Epidiolex’s effectiveness for the treatment of seizures associated with TSC was established in a randomized, double-blind, placebo-controlled trial where 148 patients out of a total of 224 in the study received Epidiolex. The study measured the change from baseline in seizure frequency. In the study, patients treated with Epidiolex had a significantly greater reduction in the frequency of seizures during the treatment period than patients who received placebo (inactive treatment). This effect was seen within eight weeks and remained consistent throughout the 16-week treatment period.

The most common side effects that occurred in Epidiolex-treated patients with TSC in the clinical trial were: diarrhea, elevated liver enzymes, decreased appetite, sleepiness, fever, and vomiting. Additional side effects for patients with LGS, DS, or TSC include: liver injury, decreased weight, anemia, and increased creatinine.

Epidiolex must be dispensed with a patient Medication Guide that describes important information about the drug’s uses and risks. As is true for all drugs that currently treat epilepsy, including Epidiolex, the most serious risks may include an increase in suicidal thoughts and behavior, or thoughts of self-harm. Patients, their caregivers, and their families should be advised to monitor for any unusual changes in mood or behavior, such as worsening depression, suicidal thoughts or behavior. Patients, caregivers, and families should report behaviors of concern immediately to healthcare providers. Epidiolex also caused liver injury in some patients. Most cases were generally mild, but a risk of rare, but more severe liver injury exists. More severe liver injury can cause nausea, vomiting, abdominal pain, fatigue, anorexia, jaundice, and/or dark urine.

The FDA granted Priority Review designation for this application. The approval of Epidiolex was granted to Greenwich Biosciences Inc., of Carlsbad, California.

FDA Issues Draft Guidance To Encourage Cannabis-Related Clinical Research

DISTRICT OF COLUMBIA:  The following quote is attributed to FDA Principal Deputy Commissioner Amy Abernethy M.D., Ph.D.:

“A range of stakeholders have expressed interest in development of drugs that contain cannabis and compounds found in cannabis. Recent legislative changes have also opened new opportunities for cannabis clinical research. As that body of research progresses and grows, the FDA is working to support drug development in this area.

“It is critical that the FDA continues to do what we can to support the science needed to develop new drugs from cannabis. The FDA believes the drug approval process represents the best way to ensure that safe and effective new medicines, including any drugs that contain cannabis or cannabis-derived compounds, are available to patients in need of appropriate medical therapy.

“The agency is committed to supporting the development of these new drugs through the investigational new drug, drug review and drug approval processes – and one key element of this support involves development of guidance, like this one.”

  • The U.S. Food and Drug Administration last week issued “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research, Draft Guidance for Industry,” which describes the FDA’s current thinking on several topics relevant to clinical research related to the development of drugs containing cannabis or cannabis-derived compounds.
  • The draft guidance covers sources of cannabis for clinical research, information on quality considerations and recommendations regarding calculating tetrahydrocannabinol (THC) levels.
  • The draft guidance also introduces key FDA regulatory concepts to stakeholders who may be less familiar with the FDA and the FDA’s authorities.

FDA Advances Work Related To Cannabidiol Products With Focus On Protecting Public Health, Providing Market Clarity

DISTRICT OF COLUMBIA: Over the past year, the U.S. Food and Drug Administration has embarked on a comprehensive evaluation of cannabidiol (CBD) products, with a focus on educating the public about the risks and unknowns of these products, gathering the science needed to better understand both these safety concerns and potential benefits to inform our regulatory approach, as well as taking steps when necessary to address products that violate the law in ways that raise a variety of public health concerns.

Today, we are providing updates on our efforts in this area, including 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.

Educating the Public About Potential Risks of Using CBD

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.

But as the agency has stated before, 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.

We remain focused on educating the public about the number of questions that remain regarding CBD’s safety. There may be risks that need to be considered before using CBD products outside of the monitored setting of a prescription from your health care provider.

In particular, the agency recently updated the public on concerns about potential harm from CBD products, including potential liver injury, interactions with other drugs and male reproductive toxicity, as well as side effects such as drowsiness. In addition, there is still much we do not know about other potential risks. For example, other than the approved prescription drug, we know little about the potential effects of sustained and/or cumulative use of CBD, co-administration with other medicines, or the risks to vulnerable populations like children, pregnant and lactating women, the elderly, unborn children and certain animal populations. This does not mean that we know CBD is unsafe to these populations or under these circumstances, but given the gaps in our current knowledge, and the known risks that have been identified, we also are not at a point where we can conclude that unapproved CBD products are safe for use. We encourage Americans to consult with their health care providers before using CBD products.

We will continue to expand our educational efforts on this front. This includes consumers broadly, specific populations where there are additional, important health considerations, as well as health care professionals who must understand these risks when talking to their patients. We will also continue to update our online resources for consumers, researchers and industry, as well as sustain multiple lines of communication with Congress, industry, researchers and our regulatory partners at the federal, state, local, territorial, tribal and international levels to share and collect needed information and hear a variety of perspectives.

Closing Knowledge Gaps in Both Safety and Potential Benefits

The marketplace for CBD-containing products is quickly evolving and it is critical that we work together with stakeholders and industry to develop high-quality data to close the knowledge gaps about the science, safety and quality of many of these products, as well as further evaluate any potential benefits outside of the one FDA-approved drug product to treat two rare, severe pediatric epilepsy disorders.

To address the questions and concerns we’ve already raised, we’re seeking reliable and high-quality data. This includes data on, among other things: 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; and 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.

Given the importance of answering these questions, we’re exploring a number of ways to address the data gaps as quickly as possible. This includes encouraging, facilitating and initiating more research on CBD, providing venues for industry and researchers to share new data with the agency and identifying opportunities to further collaborate with our federal partners at Centers for Disease Control and Prevention, Substance Abuse and Mental Health Services Administration and National Institute on Drug Abuse on this important issue.

Importantly, the Agriculture Improvement Act of 2018 – which, among other things, changed federal law so that cannabis and cannabis derivatives with very low levels of the psychoactive intoxicating component of cannabis, delta-9 tetrahydrocannabinol (THC) are no longer controlled substances – has opened significant new opportunities for research, and as that body of research develops and grows, there will be considerably more information available. In particular, there’s been an increased interest in drug development from CBD and other compounds found in cannabis and we are working to support drug development as much as possible.

First, given all the research and activity in this space, we are taking new steps to provide a public and transparent way for stakeholders to provide new and emerging information to us in real time as it becomes available. To this end, in the coming days we are re-opening the public docket we established for our May 2019 public hearing. The docket provides a valuable conduit for submission of scientific data on CBD to the agency, so we have decided to extend the comment period indefinitely to allow the public to comment and to share relevant data with the agency. As the agency continues to move forward to explore viable pathways for CBD products outside the drug context, this extension will allow stakeholders to continue to provide relevant data as research in this area evolves.

This docket also includes a mechanism for a stakeholder to submit data or information that the stakeholder believes to be confidential. We hope that this will enable responsible industry participants, academic researchers, and other stakeholders to share relevant information with the FDA – including information about specific products, which could help inform appropriate regulatory steps.

We also are working to generate data to help inform our work in this area. For example, the FDA’s Office of the Chief Scientist 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.

As data become available that are high-quality, reliable and relevant to our evaluation of CBD products that fall under the FDA’s purview, we will be able to refine – and, perhaps in some cases, revise – our thinking and approaches.

Monitoring the Marketplace with a Focus on Greatest Risk to Public Harm

As we work to educate the public and close the knowledge gaps to further guide our approach to CBD products, we will continue to monitor the marketplace and take appropriate action against unlawful CBD products that pose a risk of harm to the public.

We have seen many CBD products being marketed with claims of therapeutic benefit, such as treating or curing serious diseases such as cancer and Alzheimer’s disease, or other drug claims, without having gone through the drug approval process. The proliferation of such products may deter consumers from seeking proven, safe medical therapies for serious illnesses – potentially endangering their health or life.

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.

As we move forward, we are currently evaluating issuance of a risk-based enforcement policy that would provide greater transparency and clarity regarding factors the agency intends to take into account in prioritizing enforcement decisions. Any enforcement policy would need to further the goals of protecting the public and providing more clarity to industry and the public regarding the FDA’s enforcement priorities while we take potential steps to establish a clear regulatory pathway.

Conclusion

Our ongoing efforts related to CBD, including the steps we’re announcing today, are in line with our mission to protect the public, foster innovation and promote consumer confidence. We recognize the significant public interest in CBD and we must work together with stakeholders and industry to develop high-quality data to close the substantial knowledge gaps about the science, safety and quality of many of these products. We are committed to working efficiently to further clarify our regulatory approach to these products – as always, using science as our guide and upholding our rigorous public health standards.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

OLCC Notice of Public Hearing: OAR 845-025-5760 Audit, Compliance, And Random Testing

OLCC

OREGON:  OLCC Notice of Public Hearing.

What: OAR 845-025-5760, Audit, Compliance, and Random Testing

When:  2:00 p.m. – 3:00 p.m., Monday, March 16, 2020

Where: Oregon Liquor Control Commission, 9079 SE McLoughlin Blvd., Portland, OR 97222

Public Notice & Proposed Rule Draft

The national outbreak of e-cigarette or vaping product use-associated lung injury (EVALI) has resulted in more than 2,800 hospitalizations and 68 deaths, including 2 deaths in Oregon. At this time neither the Centers for Disease Control and Prevention (CDC), the Federal Food and Drug Administration (FDA), nor the Oregon Health Authority (OHA) have determined the cause of the illness outbreak in Oregon. While studies using cases in other states have identified Vitamin E acetate as one likely cause in those states, there is no evidence of Vitamin E acetate being linked to cases in Oregon and the CDC and FDA have not ruled out other potential causes of the illness outbreak.

This rule is needed to assist the OLCC and OHA in the ongoing investigation of the cause of EVALI cases in Oregon as well as to prevent and respond to potential future outbreaks or risks to public safety due to additives, adulterants, microbiological contamination, heavy metals, or other contaminants.

In addition to the recent EVALI outbreak, undisclosed ingredients and additives have been discovered in marijuana products in violation of Commission rules. These ingredients and additives cause public health and safety issues and decrease transparency for members of the public using these products. These rule amendments will allow the OLCC to sample the products of marijuana licensees to determine whether they contain ingredients or additives. Further, the ability to randomly test acts as a deterrent and discouraging licensees from making marijuana items with illegal or unknown indigents, additives, solvents or pesticides.

Public comment period ends Sunday, March 22, 2020 at 11:55PM

 

 

 

FDA Warning Letters And Test Results For Cannabidiol-Related Products

MJLegal

DISTRICT OF COLUMBIA: Over the past several years, FDA has issued several warning letters to firms that market unapproved new drugs that allegedly contain cannabidiol (CBD).

As part of these actions, FDA has tested the chemical content of cannabinoid compounds in some of the products, and many were found to not contain the levels of CBD they claimed to contain. It is important to note that these products are not approved by FDA for the diagnosis, cure, mitigation, treatment, or prevention of any disease. Consumers should beware purchasing and using any such products.

FDA WARNING LETTTERS

FDA, FTC Warn Company Marketing Unapproved Cannabidiol Products With Unsubstantiated Claims

FDA is also working quickly to evaluate regulatory policies related to cannabis and cannabis-derived ingredients like CBD

DISTRICT OF COLUMBIA: The U.S. Food and Drug Administration and the Federal Trade Commission posted a joint warning letter 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 ear aches in infants, autism, attention-deficit/hyperactivity disorder (ADHD), as well as Parkinson’s and Alzheimer’s disease, among other conditions or diseases.

“Cannabis and cannabis-derived compounds are subject to the same laws and requirements as FDA-regulated products that contain any other substance. We are working to protect Americans from companies marketing products with unsubstantiated claims that they prevent, diagnose, treat, or cure a number of diseases or conditions. This is especially concerning when companies are peddling unproven CBD products for use in vulnerable populations like infants and children,” said Acting FDA Commissioner Ned Sharpless, M.D. “We’ve sent numerous warning letters that focus on matters of significant public health concern to CBD companies, and these actions should send a message to the broader market about complying with FDA requirements. As we examine potential regulatory pathways for the lawful marketing of cannabis products, protecting and promoting public health through sound, science-based decision-making remains our top priority. We appreciate the FTC joining us on these and other actions to protect consumers from fraudulent CBD products.”

As described in the warning letter issued to Rooted Apothecary, the company used product webpages, through its online store and social media websites, to make unfounded 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.

Examples of the unsupported claims made by the company include:

  • “Instead of synthetic chemical[s] that can have safety concerns, this blend uses the best of nature to help calm the inflammation and pain of teething, while also promoting sleepiness for your little one.”
  • “No matter what age, ear aches are a terrible, no good way to live each day! Our main priority was safety, effectiveness . . . as we formulated this for the entire family including our precious little ones. When the pain is bad, this roller goes to work for soothing pain, inflammation, and to battle against the bacterial/viral critters to blame.”
  • “Increasing evidence suggests that CBD oil is a powerful option for pain . . . anxiety . . . and autism . . . It seems like an attractive and safe option for children.”
  • “CBD oil may have neuroprotective properties and may protect against neurological conditions, such as Parkinson’s and Alzheimer’s disease.”
  • “[P]ossible uses for CBD include helping with skin problems such as acne, autism, ADHD, and even cancer. It’s often used in conjunction with traditional treatments to provide extra help. Children can use high amounts of CBD safely and without any risk.”

Additionally, under the Federal Trade Commission Act, it is unlawful to advertise that a product can prevent, treat, or cure human disease unless the advertiser possesses 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. More generally, to make or exaggerate such claims, whether directly or indirectly, through the use of a product name, website name, metatags, or other means, without rigorous scientific evidence sufficient to substantiate the claims, violates the FTC Act. The FTC is concerned that one or more of the efficacy claims cited may not be substantiated by competent and reliable scientific evidence. These products are also misbranded under the Federal Food, Drug, and Cosmetic (FD&C) Act, because the products’ labels and product information fail to include adequate directions for use. Drugs in the United States must contain directions explaining how a consumer can use a drug safely for its intended purpose. Under the law, there is an exemption for this labeling requirement for prescription drugs that have FDA-approved applications in effect. However, none of Rooted Apothecary’s products are FDA-approved.

The FDA and FTC have requested responses from Rooted Apothecary within 15 working days stating how the company will correct the violations. Failure to correct the violations promptly may result in legal action, including product seizure and/or injunction. Violations of the FTC Act may result in legal action seeking a Federal District Court injunction or administrative cease and desist order, and an order also may require that a company pay back money to consumers.

The FDA continues to be concerned about the proliferation of products claiming to contain CBD that are marketed for therapeutic or medical uses that have not been approved by the agency. The FDA approval process ensures that drugs on the market are safe and effective for their intended therapeutic uses. CBD is marketed in a variety of product types, such as oil drops, capsules, syrups, teas and topical lotions and creams. The FDA has not approved any CBD products other than one prescription human drug product to treat rare, severe forms of epilepsy. There is very limited information for other marketed CBD products, which likely differ in composition from the FDA-approved product and have not been evaluated for potential adverse effects on the body.

The FDA continues to explore potential pathways for various types of CBD products to be lawfully marketed. An important component of this work is obtaining and evaluating information to address outstanding questions related to the safety of CBD products while maintaining the FDA’s rigorous public health standards.

“The FDA is working quickly to further clarify our regulatory approach for products containing cannabis and cannabis-derived compounds like CBD while using all available resources to monitor the marketplace and protect public health by taking action as needed against companies,” said FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D. “We recognize that there is significant public interest in cannabis and cannabis-derived compounds; however, we must work together to fill in the knowledge gaps about the science, safety and quality of many of these products. We are committed to advancing our regulation of these products through an approach that, in line with our mission, prioritizes public health, fosters innovation and promotes consumer confidence.”

Unlike drugs approved by the FDA, the manufacturing process of unapproved CBD products has not been subject to FDA review as part of the drug approval process. Further, there has been no FDA evaluation of whether these products are effective for their intended use, what the proper dosage is, how they could interact with FDA-approved drugs, or whether they have dangerous side effects or other safety concerns. Consumers may put off getting important medical care, such as proper diagnosis, treatment and supportive care due to unsubstantiated claims associated with CBD products. For that reason, it’s important that consumers talk to a health care professional about the best way to treat diseases or conditions with existing, approved treatment options.

The FDA has previously sent warning letters to other companies illegally selling CBD products that claimed to prevent, diagnose, treat or cure serious diseases, such as cancer. Some of these products were in further violation of the FD&C Act because they were marketed as dietary supplements or because they involved the addition of CBD to food.

The FDA encourages health care professionals and consumers to report adverse reactions associated with these or similar products to the agency’s MedWatch program.

The FDA, an agency within the U.S. Department of Health and Human Services, promotes and protects the public health by, among other things, assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

 

WSLCB Issues Ban On Sale Of Flavored Vapor Products

To:         Cannabis Licensees

Fr:          Liquor and Cannabis Board

Re:         Sale of Flavored Vapor Products is Prohibited –  Effective Oct. 10, 2019 

This message is to follow up today’s Washington State Board of Health meeting where the Board of Health took action on Gov. Inslee’s Executive Order 19-03: Addressing the Vaping Use Public Health Crisis. It instituted emergency rules that direct action on Oct. 10, 2019, by both cannabis licensees and vapor product licensees. The Board of Health’s rules are available here in draft form. The only changes made were to WAC 246-80-030 regarding reporting requirements of cases to the Health Department. This change is Health-specific and not does pertain to regulated cannabis businesses.

 

Background

As you know, the Centers for Disease Control and Prevention (CDC), U.S. Food and Drug Administration (FDA), state and local health departments, and other clinical and public health partners are investigating a multistate outbreak of vape-associated lung injury associated with the use of both regulated and illicit vapor products. This investigation is ongoing and has not identified a single cause, but all reported cases have a history of using vapor products. Most patients with severe lung disease have reported a history of using vapor products containing THC. Some have reported the use of vapor products containing only nicotine.

Executive Order

On Sept. 27, 2019, Gov. Inslee issued Executive Order 19-03. This order directs the Liquor and Cannabis (LCB) and the Department of Health (Health) to immediately take certain actions to protect public health.

Those actions are reflected below as numbers 1 and 3. In addition, the agencies are directed to work together to draft legislative proposals to bring tighter regulation to the non-cannabis vapor industry.

Four actions have come forward that licensees and the LCB can do now while public health officials conduct their investigation:

  1. Signage. Prominently post this warning sign in retail locations. This required sign is co-branded with the Washington State Department of Health. A Spanish version, also available, may be posted as an additional sign.
  2. Clarify rule regarding additives on packaging and labeling. There is some confusion among industry members that certain additives, like terpenes, imported CBD, and other cannabinoids do not need to be disclosed on packaging. Current rules require all product components on packaging (WAC 314-55-105).
  3. Disclose to LCB all compounds (including ingredients, solvents, additives, etc.) used in the production and processing of products that are vaped and vaping devices themselves. Public health officials have requested assistance in gathering additional information about ingredients in vapor products.
  4.  Cooperate with the ongoing epidemiological investigation. Local, state and federal health agencies are looking into which products have been involved with Washington cases of disease. We ask for your cooperation if you are contacted by someone from a state or federal epidemiology team and/or a representative from your local health jurisdiction.

Action Directed Today

The sale of flavored vapor products by cannabis licensees is prohibited – effective Oct. 10, 2019. The definition of flavored vapor products is available in the Board of Health’s posted draft rules (linked above).

  1. The LCB directs processors to immediately cease sales of flavored vapor products.
  2. The LCB directs retailers to immediately cease sales of flavored vapor products.

The LCB is consulting with affected state agencies and will follow up soon with options for returning or destroying product.

Thank You for Cooperation

We appreciate the cooperation and collaboration demonstrated by members of in the cannabis industry on this important public health crisis.

Additional Information

For more information on this topic, please visit:

The Blinc Group And Think20 Labs Announce Research Partnership Focused On Cannabis Vaping Emissions

NEW YORK: The Blinc Group, the leading provider of customized vaping solutions for the Cannabis industry, and Think20 Labs, an analytical testing laboratory for Hemp and Cannabis, announced a research partnership. The objective of this research is to develop a vaping apparatus that helps identify possible dangerous compounds that are inhaled by consumers. More in-depth research will be conducted looking at how the chemicals in the matrices break down as they are vaporized while also analyzing which products can be recommended for safe consumption.

The research partnership combines The Blinc Group’s deep experience in vaping technologies with Think20 Labs’s expertise in pharmaceutical-grade analysis. The Blinc Group’s participation will be headed by the product standards work of Arnaud Dumas de Rauly, CEO of The Blinc Group, Chairman of the ISO Standards on Vaping Products and Chairman of CEN Standards on Vaping Products, and Think20 Labs’s participation will be managed by Conor Jenkins, the scientific director and lead bioinformatician of Think 20 Labs.

Research, development, and implementation of standardized test methods will include, among others, emissions of cannabinoids, terpenes, VOCs, carbonyl compounds, nitrosamines, and heavy metals.

“We are delighted to be joining forces with the forward-thinking science team at Think20 Labs, to research the creation of innovative, safe and tested cannabis vaping products. The Blinc Group and Think20 Labs share a commitment to responsible product development, based on science and experience, in order to address the current vaping issues. We look forward to beginning our work on this important partnership as The Blinc Group continues to strive for a professional, transparent, and sensibly-regulated cannabis industry,” said Arnaud Dumas de Rauly, CEO of The Blinc Group.

Conor Jenkins states: “The overall goal is to drive the regulations regarding these products and informing regulatory bodies of our findings in hopes that we can show an area that has been dangerously overlooked in this field.”

Centers For Disease Control: Initial State Findings Point To Clinical Similarities In Illnesses Among People Who Use E-cigarettes Or “Vape”

No single product linked to all cases of lung disease

DISTRICT OF COLUMBIA: Initial findings from the investigation into serious lung illnesses associated with e-cigarette products point to clinical similarities among those affected. Patients report similar exposures, symptoms and clinical findings and these align with the CDC health advisory released last week. While many of the patients, but not all, reported recent use of THC-containing products, some reported using both THC- and nicotine-containing products. A smaller group reported using nicotine only.

No evidence of infectious diseases has been identified in these patients, therefore lung illnesses are likely associated with a chemical exposure. However, it is too early to pinpoint a single product or substance common to all cases, according to authors of articles published today in the CDC’s Morbidity and Mortality Weekly Report (MMWR) and the New England Journal of Medicine.

“We are committed to finding out what is making people sick,” said Robert R. Redfield, MD, director of the Centers for Disease Control and Prevention. “All available information is being carefully analyzed, and these initial findings are helping us narrow the focus of our investigation and get us closer to the answers needed to save lives.”

CDC, FDA, and state partners are combining information about e-cigarette exposures, results from FDA testing of product samples, and clinical testing results to identify a cause or causes of these illnesses.

“The FDA appreciates the continued collaboration between our federal and state public health partners to get to the bottom of these distressing incidents and gather more information about any products or substances used. We are leaving no stone unturned in following any potential leads and we’re committed to taking appropriate actions as the facts emerge,” said Acting FDA Commissioner Ned Sharpless, M.D. “Our laboratory is working closely with our federal and state partners to identify the products or substances that may be causing the illnesses and have received more than 120 samples from the states so far. The FDA is analyzing these for a broad range of chemicals but no one substance, including Vitamin E acetate, has been identified in all of the samples tested. Importantly, identifying any compounds present in the samples will be one piece of the puzzle but won’t necessarily answer questions about causality, which makes our ongoing work critical.”

CDC launched a multi-state investigation into the lung illnesses on August 1, 2019, and has worked closely since then with FDA, states and other public health partners, and clinicians to determine the cause. As of today, more than 25 states have reported possible cases of lung illnesses associated with use of e-cigarette products (e.g., devices, liquids, refill pods, and cartridges).

At least two deaths have been reported to CDC. Additional cases of lung illness are being investigated to determine whether they are linked to e-cigarette use and have similar clinical features. This includes looking back for older cases based on CDC’s case definition. States are in the process of classifying possible cases, and this information will be reported next week.

What CDC is doing

CDC has created an incident command structure to respond to these illnesses and is working with FDA and states to investigate whether the illnesses may be linked to specific devices, ingredients, or contaminants in the devices, or substances associated with e-cigarette product use. On August 30, 2019, states were asked to submit data to CDC about lung illnesses associated with e-cigarette product use, as well as information about the types of e-cigarette products used. CDC is currently receiving data from affected states and will share updates as more information becomes available.

What health care providers can do

CDC encourages clinicians to immediately report possible cases of e-cigarette-associated lung disease to their local or state health department for further investigation. If e-cigarette product use is suspected as a possible cause for a patient’s lung disease, a detailed history of the substances used, the sources, and the devices used should be obtained, as outlined in the HAN (Health Alert Network), and efforts should be made to determine if any remaining product, devices, and liquids are available for testing.

What the public can do

While this investigation is ongoing, people should consider not using e-cigarette products. People who do use e-cigarette products should monitor themselves for symptoms (e.g., cough, shortness of breath, chest pain, nausea, vomiting, abdominal pain, fever) and promptly seek medical attention for any health concerns. Regardless of the ongoing investigation, people who use e-cigarette products should not buy these products off the street and should not modify e-cigarette products or add any substances that are not intended by the manufacturer. E-cigarette products should never be used by youth, young adults, pregnant women, or adults who do not currently use tobacco products.

If you are concerned about your health after using an e-cigarette product, contact your health care provider, or you can also call your local poison control center at 1-800-222-1222. Health care providers also can contact their local poison control center.

CDC and FDA encourage the public to submit detailed reports of any unexpected health or product issues related to tobacco or e-cigarette products to the FDA via the online Safety Reporting Portalexternal icon.

The reports released today in CDC’s MMWR include “Severe Pulmonary Disease Associated with Electronic-Cigarette-Product Use – Interim Guidance” by CDC authors and “Notes from the Field: An outbreak of e-cigarette associated acute lipoid pneumonia — North Carolina, July–August, 2019,” from North Carolina cliniciansThe New England Journal of Medicine today released “Preliminary Report: Pulmonary disease associated with e-cigarette use, Illinois and Wisconsin,” with authors from the two states and CDC co-authors.

More information about the investigation is available on the CDC website.

FDA Warns Consumers To Protect Themselves By Avoiding Tetrahydrocannabinol (THC)-Containing Vaping Products

FDA Warning

The FDA is providing consumers information to help protect themselves while health officials investigate recent illnesses following the use of vaping products.

DISTRICT OF COLUMBIA: Consumers are likely aware of the recent reports of respiratory illnesses — including some resulting in deaths – following the use of vaping products. The U.S. Food and Drug Administration (FDA) remains deeply concerned about these incidents and is working closely with the U.S. Centers for Disease Control and Prevention (CDC), as well as state and local public health partners to investigate them as quickly as possible.

While the work by federal and state health officials to identify more information about the products used, where they were obtained and what substances they contain is ongoing, the FDA is providing consumers with some information to help protect themselves.

In particular, many of the samples tested by the states or by the FDA as part of this ongoing investigation have been identified as vaping products containing tetrahydrocannabinol (or THC, a psychoactive component of the marijuana plant) and further, most of those samples with THC tested also contained significant amounts of Vitamin E acetate. Vitamin E acetate is a substance present in topical consumer products or dietary supplements, but data are limited about its effects after inhalation.

While the FDA does not have enough data presently to conclude that Vitamin E acetate is the cause of the lung injury in these cases, the agency believes it is prudent to avoid inhaling this substance. Because consumers cannot be sure whether any THC vaping products may contain Vitamin E acetate, consumers are urged to avoid buying vaping products on the street, and to refrain from using THC oil or modifying/adding any substances to products purchased in stores. Additionally, no youth should be using any vaping product, regardless of the substance.

At least one of the associated deaths that has been publicly disclosed External Link Disclaimer appears to have been related to illicit THC vaping products. In many cases of illness reported by the states, patients have acknowledged recent use of THC-containing vaping products while speaking to healthcare personnel, or in follow-up interviews by health department staff.

It’s important to note that more information is needed to better understand whether there’s a relationship between any specific products or substances and the reported illnesses. To help gather and analyze as much information as possible, the FDA’s laboratory is working closely with our federal and state partners to identify the products or substances that may be causing the illnesses.

The FDA is analyzing samples submitted by a number of states for the presence of a broad range of chemicals, including nicotine, THC and other cannabinoids along with cutting agents/diluents and other additives, pesticides, opioids, poisons, heavy metals and toxins.

No one substance has been identified in all of the samples tested. Importantly, identifying any compounds that are present in the samples will be one piece of the puzzle but will not necessarily answer questions about what is causing these illnesses.

Federal and state partners are following any potential leads, including the presence of Vitamin E acetate found in many of the samples containing THC. The FDA is committed to taking appropriate actions as the facts emerge and keeping the public informed as we have more information to share.

However, in the interim, we encourage consumers to help protect themselves and avoid buying vaping products of any kind on the street, and to refrain from using THC oil or modifying/adding any substances to products purchased in stores. If you continue to use these THC-containing vaping products, monitor yourself for symptoms (e.g., cough, shortness of breath, chest pain) and promptly seek medical attention if you have concerns about your health. If you are concerned about your health after using a vaping product, contact your health care provider, or you can also call your local poison control center at 1-800-222-1222. Health care providers also can contact their local poison control center.

CDC and the FDA encourage the public to submit detailed reports of any unexpected tobacco- or e-cigarette-related health or product issues to the FDA via the online Safety Reporting Portal.