Not all edibles hit the same. Diamond Shruumz chocolate bars are infused with hemp-derived CBD and delta-8, but whatever they’re putting in them is making people sick, according to an alert from the U.S. Food and Drug Administration (FDA).

The FDA issued an alert on June 7, warning people not to eat the chocolate bars. The FDA claims that eight people reported getting ill and six were hospitalized after eating the bars. The reported illnesses took place in Arizona, Indiana, Nevada, and Pennsylvania. Since the bars’ main ingredients were hemp-derived, they can be bought in nearly any state. The reported illnesses were not life-threatening.

“People who became ill after eating Diamond Shruumz-brand Microdosing Chocolate Bars reported a variety of severe symptoms including seizures, central nervous system depression (loss of consciousness, confusion, sleepiness), agitation, abnormal heart rates, hyper/hypotension, nausea, and vomiting.” It’s possible that the reported symptoms were simply delta-8 THC, but those types of products generally don’t lead to hospital visits.

The alert sent shockwaves throughout the media, with reports focusing on the danger of such products on platforms such as Daily Caller. Fox News reports that the chocolate bars contain a blend of nootropic ingredients including hemp-derived compounds.

“Diamond Shruumz- brand Microdosing Chocolate Bars can be purchased online and in person at a variety of retail locations nationwide including smoke/vape shops, and at retailers that sell hemp-derived products such as cannabidiol (CBD) or delta-8 tetrahydrocannabinol (delta-8 THC),” the alert reads. “The full list of retailers is currently unknown, and FDA recommends that people do not purchase or consume any flavor of Diamond Shruumz-brand Microdosing Chocolate Bars from any retail or online locations at this time.”

One microdose chocolate bar, Birthday Cake flavor, is marketed to be “energetic, chillaxed, and euphoric.” However the bars don’t contain any psilocybin or amanita mushroom ingredients.

“There is no presence of psilocybin, amanita or any scheduled drugs, ensuring a safe and enjoyable experience,” the chocolate bar product description reads. “Rest assured, our treats are not only free from psychedelic substances but our carefully crafted ingredients still offer an experience. This allows you to indulge in a uniquely crafted blend designed for your pleasure and peace of mind.”

But the product description also seems to suggest psychedelic, or at least psychoactive effects.

“Individuals can typically anticipate the onset of effects within an average timeframe of 30 minutes to 1 hour after consumption,” the product description reads. “However, it’s crucial to note that this duration can vary based on unique factors, including the person’s body size and metabolism.”

Products that appeal to children are the ones targeted the fastest by the FDA. It’s not clear whether the reported adverse effects from the Diamond Shruumz bars are linked to simply delta-8 THC or another ingredient. 

“This product may appeal to children and teenagers as it is marketed as a candy. Parents and caregivers should consider discussing the information in this advisory with their children and take extra care to avoid this product being consumed by younger people,” the report reads.

“Retailers should not sell or distribute Diamond Shruumz-brand Microdosing Chocolate Bars and should hold the product in a secure location until additional instructions can be provided on how to return or safely dispose of the product.”

FDA Flags Other Infused Edibles

The FDA has gone after edible makers simply for allegedly marketing products to children.

On May 13, 2022, the FDA issued a warning, sounding the alarm about lookalike products that mimic candy and more recently—children’s cereal.

Copycat products that were highlighted in the warning mimic Cap’n Crunch, Cocoa Pebbles, Cocoa Puffs, Froot Loops, Fruity Pebbles, Nerds Ropes, Starbursts, Sour Patch Kids, and Trix, among others.

There are two reasons not to support gray area cannabis products like these: the potential appeal to children being one, and the other being the ethical violation of blatantly ripping off the intellectual property of mainstream food companies. But the FDA was mainly concerned about the physical symptoms that could occur in children.

“The FDA is aware of multiple media reports describing children and adults who accidentally consumed copycat edible products containing THC and experienced adverse events,” the organization wrote. “Additionally, from January 2021 through April 24, 2022, the FDA received over 100 adverse event reports related to children and adults who consumed edible products containing THC.”

Symptoms to look out for include “hallucinations” and “vomiting.”

“Some individuals who ate these edible products reportedly experienced adverse events such as hallucinations, increased heart rate and vomiting, and many required medical intervention or hospital admission,” the warning continues. “Seven of the reports specifically mention the edible product to be a copycat of popular foods, such as Cocoa Pebbles, Nerds Rope, Skittles, Sour Patch Kids, and Starburst.”

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As it turns out, researching the efficacy of MDMA to treat PTSD may be pretty complicated. The initial efforts to secure governmental sanction for a psychedelic substance for mental health care, in this case, MDMA, are facing some serious scrutiny over the clinical trial process, the Washington Post reports. 

MDMA has long been lauded as a treatment for PTSD, which affects 6% of the U.S. population. Per a Multidisciplinary Association for Psychedelic Substances (MAPS) 2023 study on how the drug can treat PTSD, the researchers found that, as High Times reported, in the MDMA group, 86% showed improvement in their standard PTSD assessment. 69% of those in the placebo group also improved. A standard PTSD assessment evaluates the intensity of PTSD symptoms, which can include anxiety, phobias, insomnia, and emotional numbness, among others. When the study wrapped, 72% of people within the MDMA treatment group no longer matched the criteria for PTSD, compared to 48% of the placebo participants.

Given how awful PTSD can be and, to be honest, how fun (and effective) MDMA can be compared to other treatment methods, this research was generally met with enthusiasm. While SSRI antidepressants like Zoloft are FDA-approved to treat PTSD, research shows it’s not always effective. The study in question shows that it had a response rate of 60%, which is obviously lower than the 86% improvement rate that came with MDMA.

However, per an independent analysis into the reliability of patient studies that are backing the Food and Drug Administration (FDA) application for MDMA, apparently, it’s pretty tricky to discern how effective these results are. Compared to other treatments, there are some serious hurdles associated with studying and then implementing psychoactive substances such as MDMA. 

While the bliss that MDMA can bring is generally considered a plus, it may make it trickier to study. One of the biggest challenges that arose when looking at the MDMA trial is that participants in the placebo group, who received a fake version of MDMA, could tell they hadn’t received the real thing because they experienced no changes in perception or euphoria, so it was rather obvious that they were in the placebo group, as noted in a draft report by the nonprofit Institute for Clinical and Economic Review (ICER). This lack of “blinding” in the trial, crucial for assessing the drug’s impact, potentially compromises the validity of the results.

The second hiccup when studying MDMA for PTSD came from the possibility that therapists were skewing the results. They basically thought that the therapists who were a part of the trial, there for mental health support, were biased in favor of MDMA, perhaps along with the participants, many of whom had previous positive experiences with the drug and, as a result, couldn’t provide the neutral ground required for a reliable study. 

The report also highlighted worries that participants who received MDMA felt “pressured to report good outcomes and suppress bad outcomes,” per the Washington Post. It also pointed to a documented instance of therapist misconduct that heightened safety concerns. While MDMA can be used to treat PTSD for sexual assault survivors, the psychedelic community may have some damage control of their own that needs a reckoning. Apparently, the ICER staff talked to folks who were part of a New York Magazine podcast investigating the MAPS’s clinical trial, in particular, patients who said they were victimized by therapists or coerced into reporting beneficial outcomes. According to one account, a woman in a MAPS trial states she was abused by her assigned therapists. 

ICER staffers, after speaking with several former patients and individuals associated with MAPS trials, observed that some adverse effects mentioned in the trial were not captured in the data they reviewed. While MDMA could help relieve horrid symptoms of PTSD, which include self-harm and thoughts of suicide, both of those were also included in the side effects (for both the MDMA group and those who got a placebo). People who have taken MDMA recreationally sometimes speak of “suicide Tuesday,” aka the crash after enjoying the spike of the drug on the weekend, and not only does this appear to roar its head within the trials, but those who spoke on the subject voiced concerns that there may be underreporting of such negative side effects. 

While some of this seems shocking when laid out in print, remember that none of the adverse claims or concerns are news to those in the psychedelic community. There is no medicine that exists without side effects; the silver bullet is a myth. If one finds healing through psychedelics, enjoy it while understanding the well-established risks (and benefits) that come with such a medicine. 

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A higher dose version of naloxone, the nasal spray used to reverse opioid-induced overdoses, did not lead to more saved lives, according to a new study published earlier this month.

The findings, published by the Centers for Disease Control and Prevention, indicated that “no significant differences were found in the survival of aided persons” in the new eight-milligram naloxone.

According to the study, there were likewise no significant differences in “the number of doses administered by law enforcement by formulation, suggesting that, in this field test, the increased dosage did not provide added benefit, even in light of the increased prevalence of synthetic opioids, including fentanyl, in the drug supply.”

“Other studies have also found that [the] number of naloxone doses administered in response to overdose has not changed over time, even with 4-mg and other lower-potency formulations,” the study said. 

“In this study, persons who received the 8-mg product were more than twice as likely to experience postnaloxone opioid withdrawal signs and symptoms including vomiting, compared with those who received the 4-mg intranasal naloxone product. When vomiting was analyzed as an isolated sign, no significant differences between formulations were found. However, the high prevalence of vomiting as an isolated sign in both groups is concerning because of the risk of aspiration in sedated persons.”

Dr. Michael Dailey, one of the authors of the study, told the Associated Press that what “was really remarkable was the survival was the same, but the amount of withdrawal symptoms was significantly larger in the people that got the 8-milligram dose.”

The study was conducted between March 2022–August 2023, when the  “New York State Department of Health (NYSDOH) supplied some New York State Police (NYSP) troops with 8-mg intranasal naloxone” and “other troops continued to receive 4-mg intranasal naloxone to treat suspected opioid overdose,” the authors explained in the study’s abstract. 

“NYSP submitted detailed reports to NYSDOH when naloxone was administered. No significant differences were observed in survival, mean number of naloxone doses administered, prevalence of most postnaloxone signs and symptoms, postnaloxone anger or combativeness, or hospital transport refusal among 4-mg and 8-mg intranasal naloxone recipients; however, persons who received the 8-mg intranasal naloxone product had 2.51 times the risk for opioid withdrawal signs and symptoms, including vomiting, than did those who received the 4-mg intranasal naloxone product (95% CI = 1.51–4.18),” they explained. 

“This initial study suggests no benefits to law enforcement administration of higher-dose naloxone were identified; more research is needed to guide public health agencies in considering whether 8-mg intranasal naloxone confers additional benefits for community organizations.”

The authors noted that although the 8-mg naloxone was first approved by the Food and Drug Administration for emergency use in 2021, “no real-world data on use of the 8-mg product are available.”

“Harm reduction advocates and medical professionals have noted potential harms of higher-dose naloxone, including severe withdrawal signs and symptoms, which can result in refusal of medical care, rapid reuse of opioids, reluctance to use naloxone if witnessing an overdose, and respiratory complications, including pulmonary edema and consequences of aspiration of vomitus,” they said. 

“To evaluate this potential risk, in 2022, NYSDOH partnered with NYSP to field test 8-mg intranasal naloxone use by some NYSP troops. The aims of the study were to conduct real-world comparisons of survival, the average number of doses administered, presence of postnaloxone signs and symptoms, and hospital transport refusal among persons receiving the 8-mg or the 4-mg intranasal naloxone products.”

According to the Associated Press, “Dailey said the study did not lead him to endorse one product over another,” but he added that it is “important for us to recognize that the potential for increased side effects is real.”

The authors of the study also pointed out that their research was “subject to at least four limitations.” 

“First, responding law enforcement personnel are not medical providers, and inconsistencies in their classification of postnaloxone symptoms or behaviors might have occurred. However, NYSP personnel have been reporting using a similar form for several years and are experienced in assessing symptoms and behaviors. Second, the number of 8-mg intranasal naloxone administration reports included was limited because only three of 11 NYSP troops received this formulation. With an increased sample size, additional differences in outcomes between groups might have been observed,” they explained. “Third, no information could be compared about differences between groups on the type or dose of substance used before suspected overdose, vital signs, or demographics. Finally, because the data were gathered from New York State only, the opioid potency might not reflect that in other areas.”

Although the “study suggests that there are no benefits to law enforcement administration of higher-dose naloxone,” the authors said that “additional data are needed to guide public health agencies in considering whether the 8-mg intranasal naloxone product provides benefits compared with the usual 4-mg intranasal naloxone product among community organizations, including law enforcement, given the lack of difference in survival rates or number of naloxone doses administered and the increased prevalence of opioid withdrawal signs and symptoms, including vomiting, in 8-mg recipients, when compared with recipients of 4-mg intranasal naloxone.”

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An Illinois state senator recently introduced a bill to legalize the supervised therapeutic use of psilocybin, the primary psychedelic compound in magic mushrooms. The legislation, known as the Compassionate Use and Research of Entheogens (CURE) Act, was introduced by Democratic Senator Rachel Ventura earlier this month.

If passed, the legislation (Senate Bill 3695) would legalize the supervised therapeutic use of psilocybin for adults. The bill is an attempt to provide new alternative options for treatment-resistant conditions such as anxiety, depression, PTSD, substance abuse, eating disorders and other serious mental health conditions.

“As mental health concerns rise throughout our state and nation, it’s imperative to acknowledge that conventional treatments don’t always suffice,” Ventura said in a statement on February 14. “Psilocybin shows promise as a potential solution, particularly for those grappling with PTSD and other mental health disorders. The ongoing research and trials have yielded encouraging results.”

Although the legislation legalizes supervised psychedelic therapy, it does not allow for the sale, use, or personal possession of the drug. The bill would also establish the Illinois Psilocybin Advisory Board under the Department of Financial and Professional Regulation. The new state agency would create a training program, ethical standards and licensing requirements for psilocybin therapy practitioners.

“At the current pace, demand for therapeutic psychedelic experiences and retreats is far outpacing the supply of psychedelic guides, therapists and practitioners. We are asking that lawmakers in Illinois not let unnecessary barriers stand in the way of safe, compassionate access and quality assurance for psychedelic healing,” said Jean Lacy, founder of the Illinois Psychedelic Society. “Illinois has the opportunity to be a standard-setter for other states, creating training centers, developing standards of care, and providing a model for other states to follow. Illinois’ mental health crisis is growing and there are serious consequences to withholding these medicines from those who need it.”

FDA Designates Psilocybin As A Breakthrough Therapy

The U.S. Food and Drug Administration designated psilocybin treatment as a breakthrough therapy in 2018, indicating that the therapy has the potential to be a substantial improvement over existing options. Last year, the agency published its first draft guidance on clinical trials for psychedelics in a further indication of the progress being made exploring the potential of psilocybin and other psychedelic compounds to have a profound impact on the treatment of mental illness.

In 2021, Oregon became the first state to legalize the therapeutic use of psilocybin, followed by the passage of a similar measure by Colorado voters in 2022. Legislators in more conservative states are also taking action to reform psychedelics laws, including the approval of a psilocybin medical research bill by an Indiana Senate committee earlier this year.

Democratic Representative LaShawn Ford introduced similar legislation (House Bill 1) in the Illinois House of Representatives last year. Ford and Ventura are now working together “to develop robust legislation” to legalize psilocybin therapy in Illinois. The Senate bill is co-sponsored by fellow Democrats Senator Willie Preston and Senator Mike Porfirio. In the House, Representatives Jonathan Carroll, Harry Benton, and Kelly Cassidy, also all Democrats, have signed on as co-sponsors of the legislation.

The Law Enforcement Action Partnership (LEAP), a nonprofit organization made up of current and former law enforcement professionals advocating for the reform of drug prohibition laws, issued a statement in support of the CURE Act last week.

“Law Enforcement Action Partnership recognizes this bill as nothing short of life-saving. Providing a proven means for people to work through their traumas and live happier, healthier, and more productive lives,” said Dave Franco, a retired Chicago police officer. “The benefits for mental and behavioral health can also have sizable impacts on community health and public safety.”

Senate Bill 3695 was filed by Ventura on February 9. The measure has not yet been assigned to a legislative committee for consideration.

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Yet another state is cracking down on hemp-derived products, some of which have intoxicating effects, and South Carolina’s approach to food products that contain hemp is among the most extreme.

The South Carolina Department of Health and Environmental Control (DHEC) issued a warning in a letter dated Jan. 22, banning the manufacture, distribution, and sale of food and beverage products containing hemp-derived products as ingredients in the state’s marketplace.

While CBD products can easily be found in most states thanks to a lack of clarity in federal regulations, the U.S. Food & Drug Administration (FDA) has repeatedly warned that products containing CBD are illegal under the Federal Food, Drug, and Cosmetic Act. 

The FDA routinely issues warnings that adding CBD to a food means those products are adulterated, or against products with any sort of medical claims, but the agency has delayed finalizing rules.

“Therefore, the following hemp products are NOT APPROVED to be added to food or beverage products,” the letter reads. 

• Viable, non-sterilized hemp seeds, raw hemp leaves, and raw microgreens, and any other raw, unprocessed form of hemp biomass as they are considered “plant material” and may not be possessed without a Grower or Processor License 
• Pure CBD Isolate 
• Delta-8 THC, Delta-9 THC, or Delta-10 THC 
• THC-0 or any other derivative 
• “Full spectrum” whole-plant extract (i.e. “full spectrum hemp oil/extract” from biomass) if it includes health claims, or bears any sort of declaration of THC or CBD 
• Any hemp product that is NOT manufactured in a food-grade establishment inspected under GMP or cGMP regulations. 
• Any hemp or hemp-derived product that promotes its medical or health benefits

The only exceptions are basically hemp seed derivatives. “The FDA evaluated three Generally Recognized As Safe (GRAS) notices for hemp products and found that the use of such products as described in the notices is safe. Therefore, the following hemp products may be legally marketed in human foods and are APPROVED to be used as ingredients in food and beverage products,” the letter continues.

• Hulled hemp seed (GRAS Notice GRN No. 765; FDA Response Letter), 
• Hemp seed protein (GRAS Notice GRN No. 771; FDA Response Letter)
• Hemp seed oil (GRAS Notice GRN No. 778; FDA Response Letter) 

“While DHEC’s goal is to educate while we regulate this growing niche of manufacturers and distributors of foods and beverages containing hemp-derived products as ingredients, our obligation under the requirements of both federal and state law is to remove from commerce all food and beverage products containing non-conforming hemp-derived products as ingredients,” Sandra Craig, Director of the DEHC’s Division of Food and Lead Risk Assessments, said in a letter announcing the bans.

Sellers can use full-spectrum whole-plant extract as an ingredient in food and beverage products if and only if the hemp-derived ingredient meets the following requirements: 

• A “full spectrum” hemp oil or extract from biomass contains the naturally occurring ratios and array of phytonutrients found in hemp. 
• Using a full spectrum hemp oil as an ingredient must be referred to in the ingredients list on the food or beverage label as “Full Spectrum Hemp Oil” or “Full Spectrum Hemp Extract.” The label may not contain health claims and may not bear any sort of declaration of “THC”, “CBD”, or “Delta-9” products or isolates. 
• When companies in South Carolina receive their “full spectrum hemp oil/extract” from their approved supplier, it must contain no more than 0.3% Delta-9 THC, as evidenced by Certificates of Analysis (COAs). The use of concentrates or “work in progress hemp oil from biomass” containing more than 0.3% Delta-9 THC, is illegal. Companies may NOT use “crude” hemp-derived oil, “work in progress” hemp oils over 0.3% Delta-9 THC, non-food grade oils, or dilute hemp oils containing an illegal amount of THC (> 0.3%) to a “legal” level. Hemp products containing more than the legal limit of THC are no longer considered to be hemp but are a Schedule I Drug. Hemp products that contain more than 0.3% THC are NOT ALLOWED to be possessed by anyone in South Carolina, and they are NOT ALLOWED to be introduced into foods or beverages.

The letter also bans any mention of THC, dosages, and several other restrictions. The letter also reminds hemp sellers that only intrastate hemp product sales are allowed.

But they’re not only going after hemp-derived cannabinoid products that are synthetically derived from hemp biomass, and known for psychoactive effects—i.e. delta-8 THC, THC-O, etc.—they’re going after products with CBD, hemp leaves, plant material and more as well. Delta-8 THC only appears in nature in minute amounts, and intoxicating amounts have to be re-added to hemp via a refluxing process in a lab. This is why states are opting to either crack down on it or regulate it like marijuana. The 2018 Farm Bill opened a legal loophole, accidentally legalizing these ingredients. Delta-8 THC products seeped into the medical markets in some states.

At least a dozen other states are actively pursuing solutions to ban hemp-derived products in one form or another.

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The U.S. Food and Drug Administration last week announced the voluntary recall of a medicine used to treat attention deficit hyperactivity disorder (ADHD) and narcolepsy after the manufacturer of the drug revealed that the wrong pills were found in packages of the medication. The recall covers one lot of the drug Zenzedi, an ADHD and narcolepsy medication manufactured by Massachusetts-based Azurity Pharmaceuticals.

In a notice about the recall, the FDA noted that a pharmacist had reported finding pills of an antihistamine, carbinoxamine maleate, in a package of Zenzedi. The voluntary recall was announced by Azurity on January 24 and covers packages of Zenzedi 30 milligram tablets with lot number F230169A and an expiration date of June 2025.

The recalled medication was distributed nationwide through retail pharmacies. Pharmacies and drug wholesalers have reportedly pulled the drug from their shelves to comply with the recall. Customers who purchased packages of the recalled lot of Zenzedi are urged to return any remaining pills to the place of purchase. Patients who take the mislabeled medication and have adverse reactions are encouraged to see their doctor. 

Drugs Have Opposite Effects

The two drugs have opposite effects when taken, according to a report from CBS News. Carbinoxamine maleate is an antihistamine that is used to treat allergies and has a sedative effect on some patients, while Zenzedi, a brand name for the drug dextroamphetamine sulfate,  is a stimulant that generally increases a patient’s attentiveness. Zenzedi is used to treat narcolepsy, a sleep disorder that causes overwhelming daytime drowsiness, and ADHD.

The FDA added that patients who take carbinoxamine maleate instead of Zenzedi will experience undertreatment of their symptoms. Patients can also have a potentially deadly elevated risk of accidents or injuries and may have drowsiness, increased eye pressure, urinary obstruction and thyroid disorder, among other symptoms, according to the FDA’s recall notice.                                           

“Patients who take carbinoxamine instead of Zenzedi® will experience undertreatment of their symptoms, which may result in functional impairment and an increased risk of accidents or injury,” the FDA wrote in a notice about the recall. “Patients who unknowingly consume carbinoxamine could experience adverse events which include, but are not limited to, drowsiness, sleepiness, central nervous system (CNS) depression, increased eye pressure, enlarged prostate urinary obstruction, and thyroid disorder.”

Azurity Pharmaceuticals sent recall notification letters to drug wholesalers on January 4 via an overnight letter and has arranged for the return of all affected product at the wholesale level. The company said that no reports of serious injury have been made as a result of the mixup.   

Recall Comes During Shortage of ADHD Meds

The Zenzedi recall comes in the midst of a nationwide shortage of medications used to treat ADHD. The shortage has been affecting supplies of the drug Adderall since a manufacturer experienced production delays in Fall 2022, according to a report from CNN.

At least 11 manufacturers of Adderall or generic versions of the drug were listed on the FDA’s shortage list in September 2023. The shortage of ADHD medication has left many patients struggling to fill their prescriptions, according to healthcare professionals. 

“A lot of the young people that I’ve been treating have had difficulties getting their medications month to month,” Dr. Warren Ng, a professor of psychiatry at Columbia University Medical Center who also serves as president for the American Academy of Child and Adolescent Psychiatry, told CNN.

When taking their prescribed medication, many patients with ADHD are able to function better. But when they run out of their medication, it can have a tremendous impact on their self-esteem.

“I’ve seen kids who want to drop out of school, don’t want to continue with their educational path or drop out of college suddenly making the honor roll,” Ng said. And “instead of seeing, being seen as being lazy or dumb or slow, they can envision themselves really utilizing all of their mental, psychological and intellectual abilities to really see themselves for who they are, which is so much more.”

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An Alaska lawmaker has introduced a bill to create a task force to study the potential medical uses of psychedelic drugs including psilocybin and MDMA. The legislation, Senate Bill 166, was introduced earlier this month by Democratic state Senator Forrest Dunbar.

If passed by the legislature and signed into law by Republican Governor Mike Dunleavy, Dunbar’s bill would establish a task force that would be given one year to study how psychedelics might be used to address Alaska’s mental health challenges. The task force would investigate paths to legalize psychedelics, requirements for licensing and insurance, and barriers to access to the drugs.

“We want Alaska to have a regulatory framework to potentially allow medical providers to use the substances, which had been shown in sort of the early data of the tests to potentially have really positive impacts on people dealing with trauma and with addiction,” Dunbar said in a statement, according to a report from Alaska Public Media. 

The psychedelics task force created by the legislation would consist of people representing the healthcare needs of Alaska Natives, military veterans and survivors of domestic abuse and sexual assault. Dunbar said it is important to include Alaska Natives in the task force, noting that other states have not included representation of Indigenous communities and traditional healers in their discussions about psychedelics policy reform.

Dunbar introduced Senate Bill 166 in anticipation of a potential change in the legal status of psychedelic drugs at the federal level. Clinical research and other studies into psychedelics such as psilocybin and MDMA have shown that the drugs have potential therapeutic benefits, particularly for serious mental health conditions such as depression, PTSD, substance misuse disorders and anxiety. 

“It doesn’t work for everyone, but there are certainly people who could access these substances and potentially have life changing medical results,” Dunbar said.

Psychedelic Research Shows Promise

Research published in the peer-reviewed journal JAMA Psychiatry in 2020 found that psilocybin-assisted psychotherapy was an effective and quick-acting treatment for a group of 24 participants with major depressive disorder. A separate study published in 2016 determined that psilocybin treatment produced substantial and sustained decreases in depression and anxiety in patients with life-threatening cancer.

In 2017, the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for psychotherapy utilizing MDMA, the psychedelic drug commonly known as Ecstasy, indicating that the therapy is a significant improvement over existing treatments. Last month, MAPS Public Benefit Corporation (MAPS PBC), a subsidiary of the groundbreaking psychedelics nonprofit advocacy group the Multidisciplinary Association for Psychedelic Studies (MAPS), announced it had submitted an application seeking FDA approval for MDMA-assisted therapy. Only weeks later, the organization announced it had changed its name to Lykos Therapeutics and had raised $100 million in financing to develop psychedelic therapies.

As the research continues, Dunbar said it is important to address psychedelics policy including current prohibition and potential legalization so the drugs will be available to people who can benefit from them.

“The hope is because these are medical treatments that we would find a way to bill insurance like anything else,” Dunbar said. “How do we make sure we can bill Medicaid and bill private insurance? And I know the indigenous community in particular needs to think about, and will help guide the task force, so that we can make sure we’re getting funds into the traditional healers’ hands as well.”

Melissa Bradley, an epidemiologist based in Anchorage who studies psychedelic medicines, said that she became interested in the field after seeing the strong research data. She notes that psychedelic therapy is not an easy undertaking. Many patients find the experience challenging or upsetting during treatment, but long-lasting improvements in mental health have been reported for many patients. 

Most research into the therapeutic potential of psychedelics is conducted in a controlled environment. Although the method is effective, finding ways to use the drugs in other, less controlled settings could be the key to greatly expanding access to psychedelic therapy. 

“To really figure out the mystery of psychedelics is figuring out the mysteries of consciousness,” Bradley said. “And, we’re kind of poking at that, on the research side of things, but it’s also moving forward, in terms of policy. And so, it will be kind of a Wild West in terms of policy and regulations.”

Dunbar’s bill has been referred to the Senate Labor and Commerce Committee for consideration. Democratic State Representative Jennifer Armstrong has filed companion legislation to Senate Bill 166 in the Alaska House of Representatives, where the measure has been assigned to the Health and Social Services Committee. No hearings have yet been planned for the bills, but Dunbar said he hopes to have one scheduled for early February.

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Things are changing fast regarding how hemp is tolerated in agriculture and farming. The U.S. Food and Drug Administration’s veterinary arm, the FDA-Center for Veterinary Medicine’s (FDA-CVM), is responsible for assuring that animal drugs and medicated feeds are safe and effective. Officials that determine approved chicken feed ingredients recommended hemp seed meal for hens, under a tentative FDA-CVM approval, as evidence mounts showing hemp seed is not only safe but beneficial for healthy hens and eggs.

Hemp Feed Coalition (HFC)—a nonprofit that aims to federal approval for hemp grain products in animal feed—announced a “landmark achievement” with the tentative approval of Hemp Seed Meal (HSM) for Laying Hens at the recent Association of American Feed Control Officials (AAFCO) 2024 Mid-Year Meeting. 

“Hemp’s entry into animal feed will catalyze agricultural advancement,” HFC President and COO of Bish Enterprises, Andrew Bish. “It’s an opportunity for farmers to diversify, to develop more sustainable supply chains, and to reap the benefits of a new crop.”

The AAFCO guides state, federal and international feed regulators with ingredient definitions, label standards, and laboratory standards, and has done so for over 110 years. The AAFCO celebrated the recommendation for hemp seed feed during the first day of its Workshop & Board of Directors Meeting held on January 23-25 in Chattanooga, Tennessee.

Hemp Seed Meal is Healthy for Hens and Eggs

We already know that hemp seeds are packed with essential vitamins, minerals, healthy oils, and an impressive, high-quality protein profile. Now research confirms the nutritional value of hemp feed resembles that of soy and canola, and is believed to be safe. The data also shows the value of hemp seed is growing and could surpass typical feed sources.

Specifically, researchers found that hemp-fed hens lay eggs enriched with essential fatty acids such as ALA, DHA, and GLA, and increased amounts of Lutein. They are all known to promote better human health.

The safety of HSM has been validated after undergoing the FDA-CVM’s rigorous evaluation, and it will provide formulators and feed mills with the assurance they need that HSM is a safe and viable protein and fat source. 

“Data to support this application included the validated method and quantification of cannabinoids in both the ingredient and egg product, and it was verified that any potential cannabinoid contaminants did not transfer over to human food products,” the HFC’s announcement reads.

The Road Here

Federal officials are typically strict about any sort of medical claims on hemp products, including those intended for animals and livestock. 

Keep in mind that just over a year ago in May 2022, the FDA sent out warning letters to four hemp-derived CBD companies that were selling hemp products marketed for animals.

This will go before AAFCO’s Board and members for final approval, and then be adopted into the Official Publication later this year. This “historic milestone” took over three years to achieve and will allow processors to formulate with HSM in the diets of egg-laying hens as a source of protein and fat at an inclusion of no more than 20%. To see the ingredient definition in its entirety, visit the HFC’s website.

Crops like hemp, that are new to the agricultural world, provide benefits to soil, disease control, and farm flexibility. Furthermore, hemp requires lower input needs, resulting in a more sustainable supply chain overall. 

HFC shared their support for a more nutritious ingredient, reducing risk for farmers, and opening up the door to opportunities in the hemp market. 

HFC members are proud to support these efforts and lay the groundwork for hemp grain products in feed across species. Visit the MemberZone page to access additional data and resources, and to learn more about the benefits of HSM for laying hens.

Hemp Seed Feed by State

Late last year, a bill to allow hemp seeds in animal feed in New York was stopped in its tracks. Two New York measures would allow for hemp seeds to be part of animal feed meant for pets, horses and camelids, like llamas and alpacas and got the green light from the state Assembly and Senate earlier this year. 

In early December, Gov. Kathy Hochul (D) received the pair of bills, though she effectively stopped them in their tracks via veto, stating that there is a lack of information about using industrial hemp in this way and pushing for the state to study the topics in an “expeditious manner.”

Specifically, the measures would have allowed industrial hemp seed to be added to animal feed that includes seed hulls and seed meal. The bills would not have allowed for hemp seeds and additives to expand to other commercial livestock, most likely because of regulatory complications surrounding certain ingredients for animals used for human consumption.

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In a historic move Friday, officials from the U.S. Food and Drug Administration (FDA) said in documents that they support reclassifying cannabis as a Schedule III substance. This would make medical cannabis and the research supporting it legal at the federal level but still heavily regulated like hormone replacement therapy or ketamine.

The 252-page document recommended to the U.S. Drug Enforcement Administration (DEA) that cannabis should be reclassified from a Schedule I to Schedule III substance under the Controlled Substances Act (CSA). The documents start with a letter to DEA Administrator Anne Milgram, which reads that “marijuana meets the findings for control in Schedule III.”

The FDA’s Eight Factor Analysis (which are always the same) found cannabis “has a currently accepted medical use in treatment in the United States” and “is not an immediate precursor of another controlled substance.”

Under section 21 U.S.C. 811(b) of the CSA, the eight factors that are determinative of control of the drug are the following: 

1. Its actual or relative potential for abuse. 
2. Scientific evidence of its pharmacological effect, if known. 
3. The state of current scientific knowledge regarding the drug or other substance. 
4. Its history and current pattern of abuse. 
5. The scope, duration, and significance of abuse. 
6. What, if any, risk there is to public health. 
7. Its psychic or physiological dependence liability. 
8. Whether the substance is an immediate precursor of a substance already controlled.

Clearly cannabis has been deemed to have medical value, and the documents note that  43 U.S. jurisdictions are authorized to recommend the medical use of cannabis.

It marks the first time that the FDA has recommended that the Drug Enforcement Administration (DEA) place cannabis in Schedule III of the Controlled Substances Act (CSA). Medical and adult-use cannabis laws across America are generally based on laws at the state and local levels, and they’ve always existed in discord with federal law.

Keep in mind that Schedule III drugs are still heavily regulated and need prescriptions: Tylenol 3’s, ketamine, anabolic steroids, or testosterone. Schedule III substances are defined as drugs with a “moderate to low potential for physical and psychological dependence,” with less abuse potential than Schedule I and Schedule II drugs, but more than Schedule IV. Under Schedule III, Internal Revenue Code 280E (IRC 280E) would no longer apply to cannabis businesses, so you’d see things like tax deductions. Rescheduling to Schedule III, however, will not legalize state-level cannabis programs.

Cannabis Industry Reacts

Several organizations and cannabis companies sent statements to High Times. The National Cannabis Roundtable (NCR) applauded the historic acknowledgement that a federal agency has recommended cannabis be reclassified. The NCR announced that they have been instrumental in advocating for and informing the heads of the HHS in a memo, and the DEA in an open letter, as to the scientific facts and medical value of cannabis meriting its reclassification to at least Schedule III.

They acknowledged, however, the limitations of the authority of HHS and DOJ when it comes to the CSA and urged the DEA to follow the scientific findings of HHS and the FDA in this process. 

“A move to Schedule III would mean 280E no longer applies to regulated cannabis companies,” Saphira Galoob, Executive Director of the National Cannabis Roundtable, told High Times in an email. “Not only does this reduce the extreme tax burden currently faced by the industry, but it allows them to take advantage of critical tax credits on things like payroll and other routine businesses costs regularly used by other legal entities. Cannabis companies continue to face issues with access to capital and banking services, resulting in cash intense operations. The ability to reinvest more of their revenues in their operations, instead of a majority of all revenue going to taxes, will be extremely impactful for the regulated cannabis industry—particularly small and minority operators.”

Other active players in the industry reacted as well, acknowledging both the pros and cons of Schedule III.

“Health officials’ recommendation for the Drug Enforcement Administration (DEA) to reclassify cannabis from Schedule I to Schedule III of the Controlled Substances Act (CSA) is a pivotal moment for our industry,” Wurk CEO Deborah Saneman told High Times. “The relentless efforts of the cannabis sector to destigmatize the plant have played a crucial role in challenging the long-standing unjust classification of cannabis. Despite facing various challenges, the cannabis industry has demonstrated resilience, adapting swiftly while upholding exceptional standards. As a leading player in the industry, Wurk remains committed to sustaining our position as the most dependable payroll, HR, and time-keeping platform in the market.” 

“The recommendation to reclassify cannabis to a Schedule III substance is progress towards undoing generations of cannabis prohibition and a significant step in recognizing the plant’s medicinal and societal benefits,” Socrates Rosenfeld, co-founder and CEO of Jane Technologies, told High Times. “While this reclassification is not a ‘perfect’ solution, we will continue our mission until there is legal access around the world—and everyone in prison for cannabis is free. Still, this moment in history should be celebrated, and the end of cannabis prohibition has never felt closer to becoming a reality.” 

“As the son of a convicted cannabis smuggler,  reading the full report from HHS (akin to a confession) that finally said the hard part out loud regarding the cannabis plants medicinal and societal value left me feeling both vindicated and excited for the future of cannabis reform,” Brady Cobb, a Washington, D.C. lobbyist and CEO of Sunburn Cannabis told High Times. “This is a groundbreaking step forward in the 70 plus year fight to end the ill fated war on the cannabis plant, and I eagerly await the DEA’s ruling to hopefully reschedule cannabis to schedule III. If that happens, this budding market will finally have a chance to operate in the sunshine with access to banking, U.S. financial services,  much needed tax reform and this move would serve as a springboard to much needed criminal justice reforms as well.”

How it Happened

Last October 6, 2022, President Biden directed federal agencies to expeditiously consider reclassifying cannabis from the most restrictive category on the CSA schedule. Several organizations and businesses provided feedback on the FDA’s recent move.

The move was partly spurred by attorney Matthew C. Zorn, who sued the federal officials after using a Freedom of Information Act (FOIA) request to obtain the rescheduling memo. He’s done it before: In 2019, Dr. Sue Sisley of the Scottsdale Research Institute sued the DEA for blocking medical cannabis research. Two Texas-based attorneys, Shane Pennington and Zorn, took the case pro bono. NORML wrote that the DEA is essentially monopolizing cannabis research. Since cannabis is still illegal at the federal level, the National Institute of Drug Abuse (NIDA), the FDA, and the DEA have only allowed one man—Dr. Mahmoud ElSohly at the University of Mississippi—to grow cannabis for clinical studies. 

On Aug. 29, 2023, the U.S. Department of Health and Human Services (HHS) recommended to the DEA that cannabis be reclassified from a Schedule I drug to a Schedule III.

Schedule III would change everything, especially in terms of opening up the doors to cannabis research. Zorn first published the documents on his On Drugs blog on Friday. Before Friday, a highly redacted clip of the documents released to Zorn were released a month ago with a single page of it last October.

The industry grappled with the pros and cons Schedule III would bring as pressure mounts on the DEA to act on the recommendations from the HHS and FDA.

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The American Medical Association, aka the AMA, has recently implemented new standards to assign specific codes to psychedelic therapies. This move coincides with the Food and Drug Administration’s (otherwise known as the infamous FDA) ongoing review of an application to legalize MDMA as a prescription drug in the treatment of post-traumatic stress disorder (PTSD). These codes, known as Current Procedural Terminology (CPT) III, were established in July as a result of a collaboration between the AMA, the Multidisciplinary Association for Psychedelic Studies Public Benefit Corporation (MAPS), and COMPASS Pathways. 

On September 13, 2023, MAPS released the findings from their latest Phase 3 Trial, which investigates the effectiveness of MDMA-assisted therapy in treating PTSD. After intense expert peer review, these results were published in the esteemed journal Nature Medicine. The research involved 104 participants with PTSD. They were randomly assigned to receive either MDMA or a placebo pill across three sessions, each spaced a month apart, over a three-month period. Upon completion of the study, results found that 72% of the participants in the MDMA group no longer met the criteria for PTSD, in contrast to only 48% in the placebo group.

Effective starting on Monday, New Year’s Day of 2024, these codes aim to standardize psychedelic treatments and provide coverage and reimbursement for these therapies — contingent upon FDA approval, of course. 

Currently, it’s pretty impossible to get insurance to cover any psychedelic meds. This development would be a near miracle moment, an integration that previously seemed impossible to cover for many seekers or simply those trying to heal themselves. This added a financial barrier to entry for many people with PTSD, such as vets, who may have a more challenging time finding work to pay for the treatment, cruelly ironically, getting in their way of work and contributing to the economy in a way necessary to enjoy the treatment. 

The FDA is now evaluating a drug application submitted by MAPS. The FDA has a deadline of mid-February to determine whether to accept or reject this application. If granted, this would require the FDA to complete its evaluation within six months, as opposed to the typical 10-month review period.

“Having recently filed a new drug application for MDMA-assisted therapy for PTSD, these new CPT codes are an important step forward to pave the way for its future use should it be approved by the FDA,” Amy Emerson, CEO of MAPS PBC, said in a press release on Tuesday. “It is critical that there is a path to cover not only the MDMA but also the medication sessions should this novel investigational approach be approved.”

And now for some seemingly boring but crucial information: The CPT III codes are provisional classifications created to track the utilization of emerging technology. Their purpose is to make the reimbursement processes easier and support the accessibility of psychedelic therapies. If they’re deemed effective, these codes can become permanent CPT I codes, which would help facilitate the aforementioned coverage and reimbursement. Among the codes approved by the AMA, one is specifically designated for compensating healthcare professionals who oversee and intervene in psychedelic-assisted therapy. The other two are intended to reimburse ancillary health professionals and clinical staff involved in treatments.

If approved, MDMA would be the first FDA-approved psychedelic to treat a mental health condition. This comes after three decades of research into the medicine. Currently, ketamine, which is used off-label, is technically a dissociative anesthetic with hallucinogenic effects, but often embraced by the psychedelic community, it is the only federally legal similar medicine used to treat PTSD and treatment-resistant depression. 

Numerous studies have shown that psilocybin, the trippy ingredient in magic mushrooms, also has the potential to aid patients suffering from treatment-resistant depression, especially when combined with therapy.

In Oregon, the first state to legalize psilocybin (remember, it’s still illegal on a federal level), the demand for psilocybin services is so high that there are over 3,000 individuals on the waiting list to visit a legal psilocybin service center, which folks flocking from all over the world to seek treatment in a safe and monitored setting. Research also recently found that psilocybin could be a promising treatment for depression in bipolar patients. 

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