HHS: Cannabis to Schedule III

The U.S. Department of Health and Human Services (HHS) has recommended reclassifying cannabis to Schedule III, or a lower-risk drug. Currently, cannabis is considered Schedule I under the Controlled Drugs and Substances Act. This places it in the same category as heroin. Schedule I drugs don’t have medical value and have a high potential for abuse. Last October, the Biden Administration initiated a process to examine whether cannabis belongs in this category. Despite legalization in many states (and medical cannabis […]

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Cannabis Analyzer Chosen by FDA for Quick, Accurate Product Testing

The U.S. Food and Drug Administration (FDA) announced on Aug. 18 that it has chosen a very specific company’s portable cannabis analyzer to be used to test cannabis plants as well as products.

The analyzer was created by Orange Photonics, which utilizes spectroscopy and liquid chromatography in its LightLab 3 High Sensitivity (HS) Cannabis Analyzer. The FDA plans to “…to play a pivotal role in its efforts to regulate the national cannabis industry,” a press release stated.

Previously, the LightLab 3 HS Cannabis Analyzer was chosen by the U.S. Customs and Border Protection Agency (CPB) in 2022 to be its chosen field-deployable analyzer.

“Previous to this award, the U.S. Customs and Border Protection’s Laboratories and Scientific Services conducted a multi-phase assessment of LightLab 3 Cannabis Analyzer,” said Orange Photonics President Stephanie McArdle. “Unlike general purpose, laboratory-based HPLCs, LightLab is built to analyze cannabinoids which translates into a simplified workflow, affordability, and impressive analytical capabilities.

Year-to-date data as of September 2021 showed that the analyzer helped law enforcement confiscate $2 billion worth of illicit cannabis plants and products. At the time, Josephine County Sheriff Detective Kile Henrich praised the technology for quickly identifying the differences between cannabis or hemp. “Any region that has a drug enforcement operation should use the LightLab Cannabis Analyzer,” said Henrich. “LightLab saves time on having to take confiscated cannabis to a crime lab, a process which can take 30 days versus minutes for a test on-site. It saves months and prevents future lawsuits.”

According to Orange Photonics, the LightLab 3 “decreases the burden on forensic laboratories” by allowing the device to be simple to use, and test plants and products on-site where they are grown or manufactured, to provide instant results.

“The public deserves to have complete confidence in the safety, labeling, and marketing standards of products on retail shelves. State regulatory agencies have successfully relied upon the LightLab 3 Cannabis Analyzer technology for years,” said McArdle. “The FDA’s adoption of LightLab 3 Cannabis Analyzer is a positive step as it continues to prioritize public health within the current regulatory landscape.”

Orange Photonics offers three versions of the analyzer: the LightLab 3 Cannabis Analyzer, LightLab 3 High Sensitivity, and LightLab 3 Law Enforcement version, which roughly analyzes in 10.5 minutes.

All of which can quickly analyze up to 19 cannabinoids, including Delta-9 THC, THCA, CBD, CBDA, CBN, CBG, and CBGA, in addition to others included in a “minors module.”

LightLab 3 can detect cannabis up to 0.5% (or 0.05% with the hemp compliance module), High Sensitivity up to 0.00017%/1.7ppm, and Law Enforcement version up to 0.5% (or 0.05% with the hemp compliance module).

What differs between each of the analyzers is the sample type. While the basic cannabis analyzer can test finished plant/flower, young plants, concentrates, tinctures, raffinate, and hemp compliance, the High Sensitivity version can also analyze beverage enhancers, baked goods, infused candies, pet treats, nano emulsions, and more. The Law Enforcement version focuses on dried plant/flower, young/wet plants, concentrates, edibles, and hemp compliance.

Orange Photonics’ product targets the need for quick and accurate product testing in order to maintain consumer safety. It cites the fact that over the past six years, the FDA has had to issue countless letters and safety notices to companies when they do not follow FDA regulations.

Orange Photonics plans to make numerous appearances at upcoming conventions through the rest of the year, including the California Cannabis Enforcement Summit (Aug. 22-24), TeeHC Open in Massachusetts (Sept. 8), International Drug Enforcement Conference XXXVII in Jamaica (Sept. 22), MJ Unpacked in Michigan (Oct. 10-12), and 12th Annual MJBizCon in Nevada (Nov. 28-Dec. 1).

While the LightLab 3 could play an important part in how the cannabis industry tests its products in the future, it does not affect the realm of testing in relation to the human body. Countless individuals have been punished due to THC being detected in their bloodstream long after they have consumed it.

The topic of cannabis being used as a performance-enhancing drug has been frequently revisited over the years, as many athletes have either come out in support of medical cannabis to treat sports-related conditions or dedicated themselves to the cause by creating their own cannabis brand. One of the most recent examples of this is with New Zealand-based rugby athlete, Isaia Walker-Leawere who received a one-month suspension and agreed to attend a treatment program.

Positive drug tests also negatively affect non-athletes frequently as well, with studies stating that positive workplace drug tests are at the highest levels in the past 25 years. Fortunately, some states are implementing rules to protect consumers. In Michigan, a civil service commission approved a new rule stating that no longer disqualify applicants for state positions in July.

Some legislators are also taking a stance on cannabis testing, such as Rep. Matt Gaetz recently called for putting an end to cannabis testing for military members last month. One New Jersey officer who tested positive for cannabis in 2022 was recently reinstated to his job with backpay.

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House Panel Calls On FDA To Regulate CBD For Foods, Beverages

Hemp advocates and industry leaders last week called on the federal government to ease access to cannabidiol as a House of Representatives subcommittee held a hearing to investigate the U.S. Food and Drug Administration’s refusal to regulate CBD as an ingredient in foods, beverages and dietary supplements.

At Thursday’s hearing of the House Oversight and Accountability Committee’s Subcommittee on Health Care and Financial Services, lawmakers and witnesses criticized the FDA’s refusal to regulate CBD and noted how the agency’s inaction on the subject has impacted individuals and families eager to take advantage of the cannabinoid’s health and wellness benefits. 

“Lack of a federal framework has led to the proliferation of unregulated products, some of which raise significant quality, safety, and other consumer protection concerns,” Jonathan Miller, general counsel for the industry group the U.S. Hemp Roundtable, told the members of the subcommittee.

In opening remarks prepared for the hearing, Republican Representative Lisa McClain, the chair of the subcommittee, noted that “if you buy a CBD consumer product off the shelf today, in many cases there’s no way for the average consumer to verify its purity or even the amount of CBD in it, or rely on FDA’s enforcement of regulations. 

“In fact, one study that tested almost 3,000 CBD products showed that only one-quarter of brands test their CBD products for purity and only sixteen percent of products tested contained exclusively what was stated on their labels,” McClain continued. “That’s because FDA hasn’t regulated CBD as a dietary supplement or food additive in the five years since hemp was legalized.”

Hemp Legalized In 2018

Congress legalized hemp agriculture and commerce five years ago with the passage of the 2018 Farm Bill. But since then, the FDA has refused to regulate hemp-derived CBD for use in foods, beverages and dietary supplements, and in January announced it would not do so without further legislation from Congress.

“This announcement has led to confusion and uncertainty in the market, which has suppressed the ability for good faith manufacturers to sell CBD products,” she said. “It only benefits bad actors who capitalize on the confusion and the flood of the market with potentially unsafe products. The FDA must do better and use their already existing authority to regulate how derived products you know actually do the job they were signed up to do.”

Witnesses also emphasized how the lack of a regulatory framework for hemp-derived CBD from the FDA has also contributed to the proliferation of products containing intoxicating cannabinoids, most prominently delta-8 THC, which are being sold in unregulated products, sometimes to minors. While none of the witnesses called for the criminalization of these products, they called for strict safety regulations to keep them out of the hands of children.

“In many states, including Kentucky, most delta-8 THC products are sold through unregulated market sources like convenience stores, smoke shops, gas stations, and even can be ordered online. These products are not reliably tested and have been found to contain many impurities,” said Richard A. Badaracco, president-elect of the Kentucky Narcotic Officers Association and a retired Drug Enforcement Administration agent. “Assuming these products remain legal, the optimal approach is following the lead of Kentucky, whose General Assembly this year passed legislation unanimously to strictly regulate these products and keep them out of the hands of minors.”

Paige Figi, founder of the Coalition for Access Now, has been an outspoken advocate of CBD for more than a decade after discovering it significantly reduced the seizures suffered by her daughter Charlotte, who died in 2020 at the age of 13 following a nearly lifelong battle with intractable epilepsy. After watching last week’s hearing from her home in Colorado Springs, Figi called on the FDA to ease access to CBD for families across the country.

“We have been united with families, athletes, seniors, veterans, and others who rely on the benefits of CBD for almost a decade. Today’s hearing shows that common sense, bipartisan reform to push the FDA to do its job and regulate hemp-derived CBD as a dietary supplement is close,” Figi wrote in an email to High Times. “The 45 million Americans who rely on the benefits CBD for their chronic conditions are encouraged that members of Congress will stand up for their constituents to pass legislation that will support access for patients now.”

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Lawmakers Introduce Bipartisan CBD Regulation Bill

A bipartisan group of lawmakers on Thursday introduced a bill to ensure hemp-derived CBD products are regulated by the U.S. Food and Drug Administration, while on the same day, a Republican representative announced a hearing to examine the agency’s refusal to regulate the cannabinoid following the legalization of hemp five years ago.

In 2018, Congress legalized hemp agriculture and commerce with the passage of that year’s Farm Bill. But since then, the FDA has refused to regulate hemp-derived CBD for use in foods, beverages and dietary supplements, and in January announced it would not do so without further legislation from Congress.

On July 20, U.S. Representative Earl Blumenauer and Senators Ron Wyden and Jeff Merkley, all Oregon Democrats, joined Kentucky Republican Senator Rand Paul to introduce the Hemp Access and Consumer Safety Act, a bill that would direct the FDA to regulate hemp-derived CBD as an ingredient for foods, beverages and dietary supplements. In a joint statement, the bipartisan group of lawmakers characterized the development as “an action that is essential to protecting consumer safety and treating hemp producers fairly.”

“Despite being legally grown in the United States for nearly five years, hemp and hemp-derived CBD are still in a regulatory gray zone that puts consumers at risk and holds producers back,” Wyden said in a joint statement from the lawmakers. “The FDA says it needs Congress to act. We’ve got the bill to ensure equal and safe access to hemp-derived CBD.”

Federal Law Limits CBD Uses

Currently, the Federal Food, Drug, and Cosmetics Act prohibits any new dietary ingredient, food or beverage from entering the market if it has been studied or approved as a drug. The FDA has the authority to exempt items from this prohibition but has not yet exempted hemp-derived CBD, despite congressional action to legalize the production and sale of the cannabinoid. By exempting hemp-derived CBD from the prohibition, the Hemp Access and Consumer Safety Act would allow the FDA to regulate hemp-derived CBD like all other new dietary ingredients, foods and beverages.

If passed, the legislation would give hemp-derived CBD products an opportunity to be used in dietary supplements, foods and beverages under the Federal Food, Drug and Cosmetic Act. The bill also includes provisions that prioritize consumer safety by requiring manufacturers to comply with all existing federal regulations for products that contain CBD and ensure such products are properly labeled.

Paul, who had a career as an ophthalmologist for more than 15 years before being elected to the Senate, noted many consumers are already using CBD products for their reputed health and wellness benefits.

“Hemp-derived CBD products and businesses have earned their recognition in the marketplace, but the FDA, unfortunately, hasn’t treated them like any other food additive or dietary supplement,” said Paul. “The Hemp Access and Consumer Safety Act directs the FDA to regulate hemp products properly and provides a huge relief to hemp farmers, processors, and merchants.”

The bipartisan bill is supported by stakeholders in the hemp and CBD industries, including the Oregon Farm Bureau, Wine and Spirits Wholesalers Association (WSWA), Vote Hemp, American Herbal Products Association (AHPA), Hemp Industries Association (HIA), National Hemp Growers Association, Realm of Caring, U.S. Hemp Authority (USHA), Veterinary Cannabis Society, Midwest Hemp Council, Colorado Hemp Association, Kentucky Hemp Association, Georgia Hemp Association, iHemp Michigan, and the Virginia Hemp Coalition.

“This bill provides a much-needed pathway for FDA to establish a clear and consistent framework for the production, marketing, and sale of hemp-derived CBD to ensure consumer safety while fostering a thriving, regulated market,” said Jonathan Miller, general counsel of the industry group the U.S. Hemp Roundtable. “We look forward to supporting his efforts and appreciate his longtime commitment to unlocking the full potential of the hemp industry.” 

Michigan Lawmaker Schedules Hearing

Also on Thursday, Michigan Republican Representative Lisa McClain, the chair of the House Subcommittee on Health Care and Financial Services, scheduled a hearing to investigate the FDA’s refusal to regulate CBD for use in dietary supplements, foods and drinks. The hearing, titled “Hemp in the Modern World: The Yearslong Wait for FDA Action,” will take place at the Rayburn House Office Building on Thursday, July 27.

“The FDA has failed for too long to do its job to ensure the safety of legalized hemp-derived products,” McCain said in a statement on Thursday. “Without these regulations, dangerous products could make their way to the shelves while safe and credible CBD products could be prevented from entering the market. We are going to investigate why exactly the FDA has decided to ignore their regulation responsibilities related to CBD and other areas of jurisdiction. We need to ensure that the FDA is not setting what would be a dangerous precedent and using this as an opportunity to seek more authority and resources from Congress.”

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FDA Issues Guidance for Psychedelics Clinical Trials

The US Food and Drug Administration (FDA) has issued new draft guidance that highlights key considerations for researchers conducting clinical trials of psychedelic drugs for the treatment of medical conditions. The move, which was announced by the agency on June 23, marks the first time the FDA has issued guidance for investigating psychedelics, including psilocybin, LSD and MDMA, which have shown potential as possible treatments for serious mental health conditions. The guidance “describes basic considerations throughout the drug development process including trial conduct, data collection, subject safety and new drug application requirements,” the agency said.

“Psychedelic drugs show initial promise as potential treatments for mood, anxiety and substance use disorders,” Tiffany Farchione, M.D., director of the Division of Psychiatry in the FDA’s Center for Drug Evaluation and Research, said in a statement from the agency. “However, these are still investigational products. Sponsors evaluating the therapeutic potential of these drugs should consider their unique characteristics when designing clinical studies.”

Psychedelics For Mental Health

Growing interest in the therapeutic potential of psychedelics has led to research evaluating the drugs as possible treatments for medical conditions, including depression, anxiety, substance misuse disorders and post-traumatic stress disorder (PTSD). Early studies have been promising, and the FDA has granted psilocybin and MDMA status as “breakthrough therapies,” a designation indicating that clinical evidence suggests a therapy shows a substantial improvement over standard treatments for a particular medical condition.

However, the FDA noted when it released the agency’s new draft guidance that studying psychedelics “presents a number of unique challenges that require careful consideration.” The guidelines were developed to advise researchers on study design and other considerations as they develop medications that contain psychedelics, including “classic psychedelics” such as psilocybin and lysergic acid diethylamide (LSD), which are typically understood to be drugs that act on the brain’s serotonin system, as well as “entactogens” or “empathogens” such as methylenedioxymethamphetamine (MDMA).

The FDA noted that many psychedelic drugs produce psychoactive effects that may make them more susceptible to misuse. The guidance also notes that research into Schedule 1 drugs such as psilocybin is subject to tighter controls and must comply with requirements set by the Drug Enforcement Administration (DEA).

“The evidentiary standard for establishing the effectiveness of psychedelic drugs is the same as for all other drugs,” the FDA said. “However, there are unique factors investigators may need to consider when designing their clinical trials if those trials are to be considered adequate and well-controlled. The draft guidance also addresses the role of psychotherapy in psychedelic drug development, considerations for safety monitoring and the importance of characterizing dose-response and the durability of any treatment effect.”

Lawmakers Applaud

Only days before the FDA issued its draft guidance for researching psychedelic drugs, a bipartisan trio of lawmakers in the US House of Representatives introduced legislation to direct the agency to take such action. The bill, H.R.4242, was filed on June 21 by Rep. Dan Crenshaw (R-TX) and Rep. Mariannette Miller-Meeks (R-IO), as well as California Democratic Rep. Ro Khanna. If passed, the legislation would direct the Secretary of Health and Human Services, working through the FDA, to release guidelines for research into medical conditions, including PTSD and traumatic brain injury. After the guidelines were released, the lawmakers behind the bill praised the FDA for taking the step.

“Many Veterans find guided use of psychedelics with assisted therapy as a way to successfully treat the excruciating, post-traumatic pain they face, with better outcomes and less medication side effects,” Miller-Meeks, a medical doctor, said in a statement on June 30. “As a physician, I know the importance of medical research and I am encouraged by the FDA’s support and guidance regarding psychedelic clinical trials. This important step gives our Veterans another option and hope when they feel they’ve run out of methods to cope.”

“I’m glad the FDA is taking this first step of issuing guidance for psychedelic clinical trials—and listening to my bipartisan legislation with Reps. Miller-Meeks and Khanna,” Crenshaw added. “It’s critical we get this right for the researchers doing this important scientific work. We need this guidance to expand clinical trial access so that we can push towards life-saving psychedelic therapies for our veterans, service members, and people living with PTSD, traumatic brain injury, and substance abuse disorder.”

The FDA published a notice about the new draft guidance for psychedelic research in the Federal Register on June 26. The proposal is now in the midst of a 60-day public comment period for interested parties to provide input on the draft and submit suggestions for the agency to consider before adopting a final version of the guidelines.

“By publishing this draft guidance, the FDA hopes to outline the challenges inherent in designing psychedelic drug development programs and provide information on how to address these challenges,” Farchione said. “The goal is to help researchers design studies that will yield interpretable results that will be capable of supporting future drug applications.”

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FDA Warns Companies About Illegally Selling Delta-8 ‘Copycat’ Edibles

Summary: The FDA has issued warnings to six companies for illegally selling Delta-8 ‘copycat’ edibles. These products often resemble snack foods and could be accidentally consumed by children in large quantities. The companies have been given 15 working days to respond with plans to address their violations and prevent recurrence.

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FDA Issues Warnings to Companies Selling Delta-8 ‘Copycat’ Edibles

The U.S. Food and Drug Administration (FDA) has issued warnings to six companies for illegally selling Delta-8 ‘Copycat’ edibles (edibles containing psychoactive delta-8 THC). In addition, we need to keep in mind, that the FDA has not approved delta-8 THC for any safe use. The products in question are often designed to resemble snack foods such as chips, cookies, candy, and gummies, which could be accidentally consumed by children in large quantities without realizing it.

So, is THC-A legal or not?

The FDA’s Principal Deputy Commissioner, Janet Woodcock, MD, stated that children are more vulnerable than adults to the effects of THC. Many children have been sickened and even hospitalized after eating ‘edibles’ containing it. The companies that received warning letters are Delta Munchies, Dr. Smoke, Exclusive Hemp Farms/Oshipt, Nikte’s Wholesale, North Carolina Hemp Exchange, and The Haunted Vapor Room. These companies must respond in writing within 15 working days with plans to address their violations and to prevent recurrence. Failure to comply could result in injunction or product seizure.

Recent studies have found a rapid increase in pediatric exposures to cannabis edibles. Samuel Levine, director of the FTC’s Bureau of Consumer Protection, called the marketing of edible THC products that can be easily mistaken by children for regular foods “reckless and illegal”. He emphasized that companies must ensure that their products are marketed safely and responsibly, especially when it comes to protecting the well-being of children.

Have you checked that new weed growing in your garden?

There are also concerns that adults could unintentionally consume these products or take a higher dose than expected, leading to serious consequences. The FDA advises consumers who suspect a product may have caused an illness or reaction to immediately contact their health care provider.

[Source: Healio]


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AI Disclaimer: This news update was created using AI tools. PsychePen is an AI author who is constantly improving. We appreciate your kindness and understanding as PsychePen continues to learn and develop. Please note that the provided information is derived from various sources and should not be considered as legal, financial, or medical advice.

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Can I Bring Cannabis on a Plane?

With Maryland’s adult-use cannabis law going into effect last week, the number of legal states has grown to 24. This containing wave of legalization has sparked an ever-increasing interest among travelers who wish to bring their cannabis on a plane to their destinations. And the stats are clear: The burning questions asked to Google include “Can you take weed on a plane,” which is up by 204% and “Bring CBD on a plane,” which is up by a whopping 374%.

In response to this surge in curiosity, Jonathan Bohun, a well-versed cannabis expert and the founder and CEO of WEEDAR, provides valuable insights and answers to five frequently asked questions regarding traveling with cannabis products. 

Can I Carry CBD Products on a Plane? 

According to the TSA, you may carry FDA-approved CBD products that contain less than 0.3% THC. These products, classified as hemp-derived CBD, are decriminalized at the federal level as they don’t induce psychoactive effects. However, it’s crucial to remember that state laws can vary and what may be legal at the federal level might still be restricted or prohibited in certain states. Therefore, it is always best to check the specific laws of your departure and destination states before you travel with marijuana to ensure compliance and avoid any potential complications.

Can I Bring Cannabis on a Plane? 

While many states have ok’d some form of legalization, whether adult use or medical, federal law still considers cannabis illegal. Therefore, as a general rule, carrying cannabis on a plane is always prohibited. However, local authorities may exercise discretion if the quantity carried falls within the legal limits specified by state law. It’s crucial to note that in states where cannabis possession remains illegal, travelers may face serious consequences, including potential jail time.

If you’re determined to bring cannabis on board, here are the key steps:

  • Thoroughly research the state laws of both your departure and destination to ensure compliance and avoid legal issues during your travels
  • Familiarize yourself with the rules and regulations set forth by the airline you are traveling with, as they may have specific policies regarding cannabis transportation

Will I Be Arrested if the TSA Catches Me with Cannabis? 

The primary focus of the Transportation Security Administration (TSA) is to maintain security and prevent potential threats, such as weapons or explosives. Although TSA agents are primarily concerned with these security risks, if they come across prohibited items, including cannabis, during the screening process, they’re obligated to involve local law enforcement. 

The specific consequences you may face will largely depend on local state laws. These can range from fines and confiscation of your stash to potential arrest, depending on the severity of the violation and the prevailing laws in that particular state.

Can I Carry Medical Marijuana on a Plane?

Under federal law, cannabis with more than 0.3% THC content is considered illegal. Consequently, the short answer is no; you cannot carry medical marijuana on a plane. However, if you’re traveling between states that have legalized medical marijuana, you may be able to show your valid medical card to the TSA. It is crucial to note that some states do not recognize out-of-state medical cards, so it’s advisable to confirm the recognition of your medical card in the state you’re visiting.

Do yourself a favor and double-check the policies of the airline you’re traveling with, as some carriers explicitly prohibit the transportation of medical cannabis, even if you possess a valid MMJ card which can result in real consequences.

Can I Board a Plane While High? 

Federal aviation regulations strictly prohibit individuals from boarding a plane while under the influence of any substance, including cannabis and alcohol. If you show up at the airport visibly intoxicated or impaired, there’s a high likelihood that you’ll be denied boarding. 

If you fear flying or experience travel-related anxiety, consider alternative options such as CBD, which can provide a calming effect without the potential psychoactive turbulence. So, sit back, relax and let your flight pass by in a soothing haze without the need for weed.

One final thought: As the legality and regulations surrounding cannabis can—and do—vary from state to state, it’s essential to understand the nuances before embarking on any journey that involves cannabis. So, it’s time to equip yourself with the knowledge surrounding the regulations of traveling with marijuana on a plane. 

The post Can I Bring Cannabis on a Plane? appeared first on Cannabis Now.

FDA Issues Draft Guidance For Clinical Studies On Psychedelics

The United States Food and Drug Administration, aka the FDA, issued the first-ever guidance for clinical studies on psychedelics, according to a news release issued Friday. They filed the 14-page document shortly after Congress introduced bipartisan legislation led by Texas Republican Representative Dan Crenshaw, directing the issuance of clinical trial guidelines.

They aimed the guidance specifically towards classical psychedelics, which include psilocybin, LSD, mescaline, and DMT, the psychoactive ingredient in ayahuasca, in addition to entactogens or empathogens such as MDMA. This means that it does not cover other drugs used therapeutically embraced by the psychedelic community, such as ketamine, which is technically a dissociative anesthetic that has hallucinogenic effects.

While the FDA guidance is new, research on the benefits of psychedelics is not. Applied Clinical Trials reports that there are currently 163 Phase I, II, or III studies on clinicaltrials.gov involving psychedelics. For instance, in January, MAPS Public Benefit Corporation, a biopharmaceutical company dedicated to psychedelic treatment, announced its Phase 3 clinical trial on MDMA-assisted therapy for post-traumatic stress disorder (PTSD) produced promising results.

“The Phase 3 confirmatory results support the development of MDMA-assisted therapy as a potentially new breakthrough therapy to treat individuals with PTSD—a patient population that is often left to suffer for years,” said Amy Emerson, chief executive officer of MAPS Public Benefit Corporation. MAPS plans to submit the new drug application to the FDA in the third quarter of 2023.

Like MAPS’ study on MDMA, psychedelic research to date has primarily been backed by private sponsors. Many of these may want nothing to do with the Feds and their infamously regressive views on psychedelics. The FDA approval process is expensive and riddled with red tape. Many companies may prefer to follow state guidelines and leave psychedelics, such as psilocybin, which researchers currently study for OCD, and alcohol use disorder, nestled in the safety of libertarian-esque gray areas. (Oregon and Colorado are the only states to decriminalize the supervised use of psychedelics). 

For example, let’s look at ketamine, which, as noted, is not technically a psychedelic. While Esketamine, or S-ketamine, the S enantiomer of ketamine, is FDA-approved as a nasal spray, many ketamine clinics and psychiatrists prefer to prescribe patients actual ketamine, off-label, because it’s not only more affordable but may work better than the version the FDA approved, which was only changed to S-ketamine in the first place so Johnson & Johnson could patent it under the brand name Spravato. 

However, if a substance earns FDA approval, it is easier to market and sell and could reach more consumers who trust that it’s met the FDA decision that the benefits outweigh the risk. For instance, Tryp Therapeutics is currently seeking FDA approval for psilocybin-assisted therapy to help those with irritable bowel syndrome (IBS).

While such studies show that psychedelics hold great therapeutic potential, as anyone with personal experience using psilocybin, MDMA, or other psychedelics can attest, the FDA asserts that they must address the challenges associated with designing clinical studies to evaluate the safety and effectiveness of psychedelics.

“Psychedelic drugs show initial promise as potential treatments for mood, anxiety and substance use disorders. However, these are still investigational products. Sponsors evaluating the therapeutic potential of these drugs should consider their unique characteristics when designing clinical studies,” said Tiffany Farchione, M.D., director of the Division of Psychiatry at CDER.1, Applied Clinical Trials reports

The guidance addresses the psychoactive and hallucinogenic effects of psychedelics, the potential for abuse, and the importance of conscientious safety measures. It includes considerations for the importance of characterizing dose-response and the durability of any treatments. The draft also tackles potential drug interactions for patients on antidepressants or mood stabilizers such as lithium. 

Additionally, for any Schedule I controlled psychedelics, the FDA states that the research must comply with applicable Drug Enforcement Administration (DEA) regulatory requirements. 

It also tackles the role of psychotherapy within a psychedelic treatment, what folks in the community often describe as integration, or the therapeutic process of a patient going through therapy with a professional to integrate their experience into everyday life, ensuring that it’s not just a one-time trip, but an ongoing treatment plan. 

If anyone has thoughts on the draft guidance, the FDA accepts public comments for 60 days. 

The post FDA Issues Draft Guidance For Clinical Studies On Psychedelics appeared first on High Times.

FDA Releases First Draft Guidance on Psychedelic Trials

The U.S. Food and Drug Administration (FDA) has published its inaugural draft guidance on clinical trials involving psychedelic drugs (Psychedelic trials). The guidance is designed to provide researchers with key considerations when investigating potential psychedelic treatments for medical conditions, including psychiatric and substance use disorders. This development comes amidst a surge of interest in the therapeutic potential of psychedelic drugs for conditions such as depression, post-traumatic stress disorder (PTSD), and substance use disorders.

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The draft guidance outlines the inherent challenges in psychedelic drug development, manufacturing, safety, and clinical trial conduct. It provides advice on study design, data collection, subject safety, and new drug application requirements. It also addresses the potential for abuse of these drugs, which is a drug safety issue that requires careful consideration and the implementation of sufficient safety measures to prevent misuse throughout clinical development.

The draft guidance presents considerations for industry in designing clinical trials for psychedelic drugs, addressing the unique challenges inherent in such studies. “By publishing this draft guidance, the FDA hopes to outline the challenges inherent in designing psychedelic drug development programs and provide information on how to address these challenges. The goal is to help researchers design studies that will yield interpretable results that will be capable of supporting future drug applications,” said Tiffany Farchione, M.D., director of the Division of Psychiatry in the FDA’s Center for Drug Evaluation and Research.

Set, Setting and DNA…

The term psychedelics in the draft guidance refers to “classic psychedelics” such as psilocybin, a naturally occurring hallucinogenic chemical found in certain mushrooms known as magic mushrooms, and lysergic acid diethylamide (LSD) that act on the brain’s serotonin system. The guidance also includes psychedelics such as 3,4-Methylenedioxymethamphetamine (MDMA), a potent empathogen–entactogen with stimulant properties.

The FDA also focuses on abuse potential assessments and compliance with Drug Enforcement Administration (DEA) regulations. Finally, the FDA outlines considerations that may be unique to clinical trials evaluating psychedelic drugs. For example, adequate and well-controlled (AWC) clinical trials and using a traditional placebo as a control might be “problematic for assessing efficacy”.

So, is THCA legal or not?

The FDA is encouraging the public to provide comments on the draft guidance within 60 days to ensure the agency considers them. This development is a significant step forward in the field of psychedelic research and could pave the way for more robust and comprehensive clinical trials in the future. [Source: FDA]

Read the full press release by the FDA here

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AI Disclaimer: This news update was created using AI tools. PsychePen is an AI author who is constantly improving. We appreciate your kindness and understanding as PsychePen continues to learn and develop. Please note that the provided information is derived from various sources and should not be considered as legal, financial, or medical advice.

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News Updates 6/23 – FDA Warns Stores to Stop Selling Elf Bar Disposables

Start your day with our News Update, where we bring you a comprehensive roundup of the latest headlines from the past 24 hours. In this edition, we cover the latest attempt of the FDA to force the ban on Elf Bar disposables and other teens’ favorite vapes. In addition we have mopre exciting news, such as Colorado Gov. that plans to issue pardons for Psychedelic drug convictions, Colorado Cannabis market shows first price rise since 2021, US house committee approves research for Medical Cannabis & Psychedelics and more interesting headlines.

Join us as we dive into the latest developments and insights shaping the cannabis and psychedelics industry

FDA Warns Stores to Stop Selling Elf Bar Disposables and Other Teens’ Favorite Vapes

The U.S. Food and Drug Administration (FDA) has issued official warning letters to 189 stores over claims that the retailers are selling illegal e-cigarettes and related products. Specifically, the FDA is cracking down on teens’ favorite vapes—Elf Bar disposables and Esco Bars disposables, which come in flavors known to appeal to youth, like gummy bear, bubblegum, and cola and are not authorized by the FDA.

Elf Bar disposables are the most popular disposable vapes among teens aged 16 to 19, according to the agency. The brand, made by Chinese company iMiracle Shenzhen, has been cited more than any other brand in recent accidental e-cig exposure and poisoning reports, most occurring among children younger than five. The FDA has indicated it plans to take additional steps to bring sellers in line if stores don’t stop peddling Elf Bar disposables and similar flavored vapes.

[Source: Gizmodo]

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E-cigarette Usage Soars During Pandemic, Especially Among Teens and Young Adults

A recent study by the Centers for Disease Control and Prevention (CDC) has found that e-cigarette usage has significantly increased during the pandemic, particularly among teens and young adults. The report shows that e-cigarette sales climbed 46.6% from January 2020 to December 2022, driven by non-tobacco flavored e-cigarette sales, such as menthol, fruit, and candy flavors. In 2022, just over 14% of high schoolers, or 2.14 million students, used e-cigarettes. The most popular e-cigarette brands have also shifted, with Vuse, known for its fruity e-liquid flavors, overtaking JUUL as the most popular e-cigarette brand as of December 2022. Meanwhile, Elf Bar disposables, a popular vaping device manufactured in China, has become a particular favorite among Gen Z smokers.

[Source: Quartz]

THCA, another popular compound is taking heat lately

Colorado Gov. Plans to Issue Pardons for Psychedelic Drug Convictions

In a significant move, Colorado Governor Jared Polis has announced plans to issue pardons for all criminal convictions in the state related to psychedelic drugs. The announcement was made during the Psychedelic Conference in Denver. This comes after Polis signed a bill last month to implement medical psilocybin legalization and decriminalize the personal use and cultivation of other natural psychedelics. The Governor also expressed his desire for insurance companies, including Medicare and Medicaid, to cover the cost of psychedelic therapies. The pardons are aimed at preventing individuals from being held back from employment opportunities due to past convictions.

[Source: Ganjapreneur]

Is it all in our gens?

US House Committee Approves Research for Medical Cannabis, Psychedelics

The House Armed Services Committee, led by Republicans, has approved amendments in a massive defense bill to fund research and a pilot program to study the effects of medical cannabis and psychedelics. The amendments were proposed by GOP Reps. Nancy Mace of South Carolina and Morgan Luttrell of Texas. The legislation was included in the National Defense Authorization Act (NDAA), which sets the annual budget and expenditures of the U.S. Department of Defense. The medical marijuana-related amendments require the program to cover individuals who receive services from the Veterans Affairs Department and the pilot program to be conducted in one or more states with an approved marijuana regulatory program. A clinical study assessing psychedelic treatments would enroll service members only with post-traumatic stress, traumatic brain injury, or chronic traumatic encephalopathy.

[Source: MJBizDaily]

Can i ask my doctor to give me LSD?

Colorado Cannabis Market Shows First Price Rise Since 2021, Ducking Deflation

After nearly a two-year stretch of deflation, marijuana prices in Colorado are showing the first signs of life since October 2021, according to the Colorado Department of Revenue. The retail price for a pound, which had plummeted from a peak of $1,731 in January 2021 to a historic low of $649 by April 2023, has risen to $703 in June 2023. This price hike breaks the two-year trend of slumping cannabis prices, which hovered around half of the rates seen before 2022. However, total marijuana sales in Colorado hit a five-year low, with monthly figures consistently falling between $125 million and $140 million since last winter. The challenging market conditions have forced smaller operators into consolidation due to a lack of capital-raise activity across the industry. Despite the sobering reality, the firm had anticipated that year-over-year comparisons should sting less by 2023 as the market continues to adjust.

[Source: Green Market Report]

Is there hope after all?

Canadian Recreational Cannabis Sales Grow 1.3% to CA$411.7 Million in April

Canadian consumers spent 1.3% more on legal recreational cannabis in April compared to March, with total monthly sales reaching CA$411.7 million ($313 million). When adjusted for the number of days per month, cannabis sales increased by 4.7% from March to April. On a year-over-year basis, cannabis sales grew 10.3% compared to April 2022. The increase in consumer cannabis spending was led by the westernmost province of British Columbia, Canada’s third-most valuable marijuana market after Ontario and Alberta. B.C. cannabis sales increased 8.7% on a month-over-month basis to CA$68.5 million. Cannabis sales in Yukon territory were flat at CA$925,000. Sales for the Northwest Territories and Nunavut were not reported by Statistics Canada. Canadian recreational cannabis sales have totaled nearly CA$1.6 billion from January through April of this year.

[Source: MJBizDaily]

Whats going up will go down, or not?

Canopy Growth Sees More Than $3 Billion in Losses

Canopy Growth Corporation, a leading player in the cannabis industry based in Canada, has reported a staggering loss of more than C$3 billion. The company’s revenue for the fourth quarter ending March 31, 2023, was C$87.54 million, a decline of 14% from the previous year. The net loss in the fourth quarter was a significant C$648 million, primarily driven by an increase in asset impairment and restructuring costs. For the full fiscal year, Canopy reported a 21% decrease in revenue, from 2022’s C$510 million to 2023’s revenue of C$402 million. The company attributes the fall in revenue to increased competition in the Canadian adult-use cannabis market, divestitures, and softer performance from certain brands. Despite the financial setbacks, Canopy Growth remains optimistic about its future, with plans to achieve breakeven to positive adjusted EBITDA in all businesses, except BioSteel, by the end of 2024.

[Source: Green Market Report]

Another one is going down…

Funding a Major Hurdle for Global Psychedelics Industry, Experts Warn

The global psychedelics industry is facing a significant financial hurdle as public psychedelics companies have spent almost all of the nearly $3 billion they have raised on drug development, with most still awaiting approval from the U.S. Food and Drug Administration to bring their services to market. This was the consensus among several financial experts at the Psychedelic Science 2023 conference in Denver. They noted that the companies require more funding to complete the drug approval process, a major challenge at a time when investor enthusiasm has cooled significantly. Some experts suggested that large pharmaceutical companies could be enlisted to help, despite the traditional tension between natural medicine activists and “Big Pharma”.

[Source: Green Market Report]

An expensive treatment isn’t a good solution

Twitch Bans Cannabis Product Advertising Despite Allowing Alcohol Ads

Online streaming platform Twitch, owned by Amazon, has updated its branding policies to prohibit cannabis companies from buying advertising or sponsoring streamers. Interestingly, the new policy allows for the promotion of alcohol products, provided they are marked as “mature content”. Twitch users are permitted to consume cannabis on-stream, as long as they are of legal age and located in a place where cannabis is legal. However, the platform’s tolerance for cannabis content appears to stop there. The updated policies also ban advertisements for tobacco products, weapons, adult-oriented products or services, certain financial services, and political content. Despite Twitch’s stance on cannabis, its parent company Amazon has recently shown support for national cannabis policy reforms, endorsing the 2021 MORE Act and the States Reform Act, and announcing it would stop drug testing its employees for cannabis.

[Source: Ganjapreneur]

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Marijuana Workers in California, Pennsylvania Join Unions

Marijuana distribution drivers in California and medical cannabis dispensary workers in Pennsylvania have voted to join unions, adding more momentum to the labor movement in the marijuana industry. Drivers at cannabis distribution company Amuse in Southern California voted overwhelmingly to join Teamsters Local 630. The union aims to secure a strong contract for the workers that addresses issues such as security, regular wage increases, respect, and a voice on the job. Meanwhile, 11 of 16 workers at Restore Integrative Wellness Center, a medical marijuana dispensary in Elkins Park, Pennsylvania, voted to join the United Food and Commercial Workers (UFCW) International Union Local 1776. This follows recent unionization of cannabis workers in California and Illinois.

[Source: MJBizDaily]

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AI Disclaimer: Our Daily News Updates are created using AI tools. PsychePen is an AI author who is constantly improving. We appreciate your kindness and understanding as PsychePen continues to learn and develop. Please note that the provided information is derived from various sources and should not be considered as legal, financial, or medical advice.

The post News Updates 6/23 – FDA Warns Stores to Stop Selling Elf Bar Disposables appeared first on Cannadelics.