House Lawmakers Introduce Bipartisan CBD Regulation Bills

A bipartisan duo of US House legislators has introduced a pair of CBD regulation bill proposals to regulate the hemp-derived cannabinoid, arguing that the US Food and Drug Administration (FDA) has failed to regulate the popular cannabinoid despite the legalization of hemp with the 2018 Farm Bill. The two bills, which were introduced in the House of Representatives on March 17, are sponsored by Ohio Democratic Rep. Annie Craig and Rep. Morgan Griffith, a Republican from Virginia.

“The Food and Drug Administration has dragged its feet in properly regulating CBD and hemp-derived products on the market, creating confusion about its legal uses,” Griffith said in a statement from the congressman’s office. “Americans need better guidance and that’s why I’ve introduced these two pieces of legislation, which will create a pathway for regulation in both the food and dietary supplement spaces.”

The first measure, the Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act of 2023, would make hemp, cannabidiol (CBD) derived from hemp and other hemp-derived products lawful for use as a dietary supplement unless otherwise directed by the FDA. The second bill, the CBD Product Safety and Standardization Act, directs the FDA to establish rules to regulate CBD as the agency would for other food ingredients, including setting requirements for the quality and labeling of CBD products.

“In Minnesota, we’ve seen firsthand that our local governments and small businesses need more guidance when it comes to CBD and hemp-derived products,” Craig said. “That’s why I’ve partnered with Rep. Griffith on these bipartisan bills to better regulate CBD products, keep consumers safe and ensure our hemp farmers and businesses have the support they need.”

Interest in CBD exploded in the US after Congress legalized hemp with the passage of the 2018 Farm Bill. The cannabinoid is available in a range of consumer products, including vapes, tinctures and topicals, with consumers turning to CBD goods for a variety of health conditions, including pain, anxiety and sleep disorders. The FDA has oversight over CBD because it’s the active ingredient in Epidiolex, an oral formulation derived from cannabis that was approved by the agency to treat specific forms of childhood epilepsy in June 2018.

FDA Sought CBD Guidance From Congress In January

The introduction of the two CBD regulation bills comes after the FDA announced earlier this year that there are too many uncertainties about the safety of CBD for the agency to regulate the cannabinoid under its current structure. The FDA also called on Congress to provide further guidance on CBD, citing safety concerns about CBD, including the potential of the cannabis compound to cause liver damage and potential negative effects on the male reproductive system and on children and pregnant women.

“We haven’t found adequate evidence to determine how much CBD can be consumed, and for how long, before causing harm,” FDA Deputy Commissioner Dr. Janet Woodcock said in a statement from the agency on January 26, adding that “after careful review, the FDA has concluded that a new regulatory pathway for CBD is needed that balances individuals’ desire for access to CBD products with the regulatory oversight needed to manage risks.”

The FDA suggested several aspects of regulation for consideration by Congress, including packaging and labeling requirements, limits on CBD levels and testing for potency and safety. The agency also cited possible negative effects on pets and livestock, again looking to lawmakers for further guidance on the issue.

“CBD also poses risks to animals, and people could be unknowingly exposed to CBD through meat, milk and eggs from animals fed CBD,” Woodcock wrote. “Because it’s not apparent how CBD products could meet the safety standard for substances in animal food, we also don’t intend to pursue rulemaking allowing the use of CBD in animal food. A new regulatory pathway could provide access and oversight for certain CBD-containing products for animals.”

The new legislation from Griffith and Craig is supported by dozens of hemp and cannabis activists, businesses and nonprofit organizations, including the National Cannabis Industry Association, Americans for Safe Access, the Indigenous Cannabis Industry Association and the National Association of State Departments of Agriculture. Jonathan Miller, general counsel for the US Hemp Roundtable, said that the two bills are “critical legislation that’s integral for hemp farmers, CBD producers and consumers.”

“The FDA has made it clear that legislative action by Congress is needed to solve its CBD regulatory problem and these two bipartisan bills re-introduced by Reps. Griffith and Craig serve as the solution,” Miller said in a statement from the hemp industry trade group. “The FDA’s inaction over the past four years has had a devastating impact on US hemp growers, and has left thousands of unregulated products on the marketplace, raising health and safety concerns for consumers.”

The post House Lawmakers Introduce Bipartisan CBD Regulation Bills appeared first on Cannabis Now.

Legal Cocaine, Amanita Pee Method, Vape Bong & Drug Cartels – The Cannadelics Sunday Edition

Welcome to The Cannadelics Sunday Edition, Cannadelics’ weekly newsletter, sent every Sunday morning 11am est with the main stories of the week. This week we look into some unusual drug activities such as legal Cocaine, Amanita pee method, vape bong, drug cartels, Amanita HHC gummies, Cannabis chocolate, DEA & FDA, hemp in Argentina and more.

Don’t forget to check the article on the Amanita Pee Method as while it is not advised, it’s alot of fun to read about… Also see why there is legal Cocaine is Canada, even they didn’t really planned that to happen… Last, the Vape Bong is a new device. What is it and what makes it so special?

In our deals section, you could find rare opportunities on Amanita gummies, Knockout THC gummies, THCA flower and high-potency power 9 gummies. If you happen to like gummies, we have a great newsletter for you!

As always, beside the best stories of the week, our subscribers enjoy exclusive discounts on popular cannabis and psychedelic products. Take a look at our Deal Of The Day offers and subscribe today to our newsletter, or use the sign-in form below:


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The Cannadelics Sunday Edition (3/5/2023) – CA Legal Cocaine, Amanita Pee Method, Vape Bong & Drug Cartels and more

Hi,

Welcome to the Cannadelics Sunday edition, going out every Sunday with the top stories from the cannabis and psychedelics industries. This week we have a mixed bag of stories as well as a few deals from our deal-of-the-day segments.

Thanks for stopping by!


DEAL OF THE DAY

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THE WEEK IN REVIEW:

This week we have some exciting news, starting with a story about Canada selling legal cocaine, Amanita pee method, Psychedelic products at this year’s High Times Hemp Cup, DEA clarification on cannabinoid laws, Vape bong, Drug cartels and much more!


legal cocaine:

Stepping It Up: Canada Approved Two Companies to Sell Cocaine

Canada approved legal cocaine sales for two companies in BC
Canada approved legal cocaine sales for two companies in BC

Legal Cocaine???
One of the few substances we consider when we think of drug reform is cocaine. Yet in Canada, that’s exactly what is going on, as Health Canada just announced that they have made allowances for two companies to legally sell cocaine. Yes, Cocaine, the famous white central nervous system (CNS) stimulant people use for sun. This comes after British Columbia already decriminalized hard drugs within the province, as a way of dealing with the growing opioid use, and overdose rate.

Continue reading »


Amanita Mushroom Products at 2023 High Times Hemp Cup

Amanita Mushroom Products at 2023 High Times Hemp Cup Kits. But no legal cocaine...
Amanita Hemp Cup products
(Screenshot from hthempcup)

The 2023 High Times Hemp Cup is introducing a new product to the competition – Amanita Hemp Cup products that contain muscimol from Amanita muscaria mushrooms, combined with popular cannabinoids. The Amanita Hemp Cup products include gummies and pre-rolled joints containing muscimol combined with HHC, Delta 8 THC, and CBD.

Continue reading »


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The Vape Bong: Best of Both Worlds

Both bongs and vapes have become staple items in the world of cannabis. Both promote a somewhat cleaner way to consume cannabis than your average blunt or bowl out of a pipe, so it makes sense to combine the two into one super-product! The vape bong represents the best of both worlds, with most vape companies offering a bong attachment as an aftermarket product. Here’s more on how it works.

Continue reading »


Cannabis Chocolate: Does it Taste Like Weed?

cannabis chocolate
Cannabis Chocolate: Does it Taste Like Weed?

Although many people love both cannabis and chocolate, the flavor often leaves something to be desired, if they’re not prepared a certain way. the taste of infused treats can depend on various factors, including the quality of the product, the type of cannabis used, and the manufacturing process. In this article, we will explore these factors make for the best cannabis chocolate.

Continue reading »


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Additional Reading:

A few more articles for your reading pleasure, such as legal cocaine in Canada, Amanita pee method, Cannabinoid laws by the DEA, Vape bong, Drug cartels and more!

DEA & FDA: The Confusion Over Legal Drugs VS Legal Products

Does DEA or FDA determine legal products? What about legal cocaine?
DEA & FDA: The Confusion Over Legal Drugs VS Legal Products

It’s been an ongoing battle, but the DEA and FDA have released statement to clarify their stance on various cannabinoids. Are hemp-derived cannabinoids that are completely or partially synthetic, legal? Are the cannabinoids that show up in nature, but are only used for production as synthetics, legal? And what about the products that are made from these compounds? Are they legal? Short answer, no. But click the link to learn more.

Continue reading »


The Amanita Pee Method: Not Advised, But Fun to Read About

Would you drink amanita reindeer pee to get high?
Would you drink amanita reindeer pee to get high?

The amanita pee method is one of the older ways to get high off amanita mushrooms. Luckily, you don’t need to drink any pee just to have an amanita experience. Even back in the same general time period, many Siberians did what you can do today: boil the mushrooms to make a tea. However, the ancient pee method is quite interesting to learn about.

Continue reading »


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New Argentina Hemp Law Expected to Widen Domestic and Export Markets

New Argentina hemp law in place, Illegal Synthetics. What about legal Cocaine?
New Argentina Hemp Law Expected to Widen Domestic and Export Markets

With the help of activist groups like Mama Cultiva, Argentia forced its way into the medical cannabis market. Now, Argentina making even bigger moves by opening the doors for increased hemp production for both domestic and export markets. The announcement for the implementation of the Regulatory Agency for the Hemp and Medical Cannabis Industry (ARICCAME), came out on January 25th, with its first working group to start immediately.

Continue reading »


What is a Drug Cartel?

What is a Drug Cartel?

In the world of illegal substances, drug cartels are the kingpins. If you’ve ever heard of Pablo Escobar and his Medellin Cartel in Colombia, then you’ll have heard of these organizations. But that was then and this is now. Who are the current drug cartels to look out for? But not only that, what actually are they? We’re going to be explaining how drug cartels work, how they thrive and how they do or don’t get caught.

Continue reading »


DEAL OF THE DAY

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Keep Yourself Informed

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Get our weekly updates


News from the Week:


*** Ecuador Expanded Hemp Industry to Include More Industrial Uses

*** What’s The Deal with Shoddy Vape Carts Lately?

*** Brazil: Cannabis Startup Capital of the World?

*** 2023 Farm Bill Under Construction: What to Expect For Hemp

*** Does A Medical Setting Affect Psychedelic Treatment?

*** How Legal Cannabis Affects Pharmaceutical Sales


Legal cocaine, Amanita pee method, Drug cartels – Conclusion

We hope you enjoyed this week’s review. We work hard to find and verify the best products, so we may include affiliate links to support the maintenance and development of this site. 

Best, 
The Cannadelics team 

*** Disclaimer: As the legality of cannabinoids and psychedelics changes between state to state, you should always check with your local authorities first.

The post Legal Cocaine, Amanita Pee Method, Vape Bong & Drug Cartels – The Cannadelics Sunday Edition appeared first on Cannadelics.

Rhode Island Lawmakers Introduce Magic Mushroom Bill

If the federal government signs off on psilocybin, a pair of Rhode Island lawmakers want the state to be ready to benefit.

The bill under consideration would “decriminalize the use of so-called ‘magic mushrooms’ statewide,” according to local news station WPRI, although that would “[hinge] upon whether the Federal Drug Administration (FDA) approves psilocybin as a treatment for chronic mental health disorders.”

“Veterans and many others in our community are struggling with chronic [Post Traumatic Stress Disorder], depression and other mental health disorders that can be totally debilitating,” said Democratic state House Rep. Brandon Potter, as quoted by WPRI. “We should give them the freedom to try every tool available and not criminalize a natural, effective remedy.”

Potter is sponsoring the measure along with state Sen. Meghan Kallman, also a Democrat. It’s familiar territory for Potter.

Last year, Potter proposed a bill that would have also decriminalized psilocybin, although there was no provision in that legislation on FDA approval.

According to WPRI, this year’s proposal “would require the Rhode Island Department of Health to regulate the use of psilocybin as a treatment should it be approved by the FDA.”

“Psilocybin is not addictive,” Kallman said, as quoted by WPRI. “It’s naturally occurring and people have been using it recreationally and medicinally for thousands of years.”

“It is only illegal because, over 50 years ago, President Nixon associated it with his political opponents,” she added. “It’s time to undo that mistake and give our neighbors struggling with chronic mental illness, and all Rhode Islanders, the freedom to use psilocybin responsibly.”

Mushrooms and other psychedelics are fast emerging as the next front for legalization advocates, as the science and medical community continues to uncover more encouraging findings about their ability to treat disorders.

The state of Oregon legalized psilocybin for therapy in 2020 after voters there approved a ballot measure. Two years later, voters in Colorado did the same.

The changes in laws have coincided with a shift in attitudes about the drugs.

A poll in 2020 from the research firm Green Horizons found that 38% of American adults believed that psilocybin mushrooms should be legal in at least certain circumstances.

“When it comes to psychedelics, there are many parallels with the movement to legalize cannabis. In both cases, education is paramount,” Adriana Waterston, Green Horizon’s SVP of Insights and Strategy, said at the time. “Psychedelics, like cannabis, have been tied to a negative, highly stigmatized image for many years. Science, however, is showing us that psychedelics demonstrate tremendous promise for certain chronic psychological illnesses, even those that have been treatment-resistant. As we continue to study psychedelics and evidence for their benefits mounts, we can expect support for legalization to follow.”

The poll found that 25% of Americans believed that psilocybin mushrooms should be legal under limited circumstances –– perhaps as a medical or religious practice –– while 13% think they should be legalized outright.

As WPRI noted, “Current federal law classifies psilocybin as a Schedule 1 drug alongside fentanyl and cocaine, both of which are highly addictive,” while state law in Rhode Island puts the hallucinogen in the same category as heroin, cocaine and methamphetamine.”

The post Rhode Island Lawmakers Introduce Magic Mushroom Bill appeared first on High Times.

Will the FDA Regulate CBD?

Will the FDA regulate CBD? It’s a question on many minds as the FDA commissioner is to appear before the U.S. House Oversight Committee. Chairman of the Committee, James Comer, wants details on CBD. He said: “It’s not just their lack of action with respect to CBD and other types of hemp. It’s their inaction regarding a lot of areas of their jurisdiction … We’ve got an agency here that has a big budget, they have a lot of employees, […]

The post Will the FDA Regulate CBD? appeared first on Cannabis | Weed | Marijuana | News.

MDMA Treatment for PTSD Shows Promise in Clinical Trial

A biopharmaceutical company dedicated to psychedelic treatment announced last week that its clinical trial on MDMA-assisted therapy for post–traumatic stress disorder (“PTSD”) produced encouraging results.

The company, MAPS Public Benefit Corporation, said that it had completed “confirmatory phase three” of the multi-site study, which “met both the primary endpoint as measured by the change from baseline in Clinician-Administered PTSD Scale for DSM-5 (‘CAPS-5’) and the key secondary endpoint of improvement in functional impairment associated with PTSD as measured by the change from baseline in the Sheehan Disability Scale (‘SDS’).”

“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. 

Last week’s announcement comes after the company said in November that it had completed “the second of two Phase 3 pivotal trials.” 

“Now with two positive Phase 3 trials complete, we can add this important data to the new drug application which we expect to submit in the third quarter of this year,” Emerson said last week. 

The study, known as “MAPP2,” was “a randomized, double-blind, multi-site Phase 3 study of the efficacy and safety of MDMA-assisted therapy for the treatment of PTSD,” the company said last week.

“The study enrolled 121 participants and of those enrolled 104 were randomized to either a group that received 80 to 120 mg MDMA hydrochloride followed by a supplemental half-dose of 40 or 60 mg during three extended sessions of therapy, or a group that received placebo plus extended sessions of therapy. The MAPP2 study enrolled participants with PTSD for the 12-week treatment period. The MAPP2 participants reflected the U.S. demographics of those living with PTSD with people of color representing more than half of those enrolled in the study,” the company said in a press release. 

Founded in 2014, MAPS Public Benefit Corporation says that its vision is to create a “world where all people have opportunities to heal and grow through psychedelic medicines and therapies.​”

The company’s mission statement reads: “Lead the research, development, and integration of psychedelic medicines and therapies into the healthcare system, prioritizing purpose over profits.​”

That mission has been buttressed by the the U.S. Food and Drug Administration, which in 2017 “granted MDMA-assisted therapy Breakthrough Therapy designation, a process designed to expedite development and review of drugs intended to treat serious conditions and that demonstrate substantial improvement over available therapies,” the company said in last week’s press release.

“Reaching agreement with [the] FDA on the design of our Phase 3 program and having the ability to work closely with the agency has been a major priority for our team,” Emerson said in 2017. “Our Phase 2 data was extremely promising with a large effect size, and we are ready to move forward quickly. With breakthrough designation, we can now move even more efficiently through the development process in collaboration with the FDA to complete Phase 3.”

The company said last week that it “expects to submit the new drug application to the FDA in the third quarter of 2023.” 

“MAPS PBC plans to submit the full data set for publication in a peer-reviewed journal,” the press release said. “MDMA-assisted therapy has not been approved by any regulatory agency. The safety and efficacy of MDMA-assisted therapy have not been established for the treatment of PTSD.”

The post MDMA Treatment for PTSD Shows Promise in Clinical Trial appeared first on High Times.

FDA Mulls Over CBD Regulation

The Food and Drug Administration (FDA) is apparently eyeing new regulations for certain CBD products, with an announcement from the federal agency expected in the coming months. 

The Wall Street Journal, citing agency officials, reported this week that the FDA is “studying whether legal cannabis is safe in food or supplements and plans to make recommendations for how to regulate the growing number of cannabis-derived products in the coming months.” 

“Given what we know about the safety of CBD so far, it raises concerns for FDA about whether these existing regulatory pathways for food and dietary supplements are appropriate for this substance,” Janet Woodcock, the Food and Drug Administration’s principal deputy commissioner, told the Wall Street Journal.

According to the newspaper, Woodcock has “led the agency’s efforts looking at cannabis regulation.”

Reuters reports that, “after weighing the evidence on the compound’s safety, the FDA will decide within months how to regulate legal cannabis and whether that will require new agency rules or new legislation from Congress.” 

The outlet noted that, following the Wall Street Journal’s report on the news, “shares of U.S.-listed cannabis companies were down between 5% and 9% in afternoon trade.” 

CBD products have exploded in the American marketplace over the last four years following the passage of the 2018 Farm Bill, which legalized industrial hemp production. 

But the products have outpaced regulation, which has caused some state and federal officials to scramble in order to play catch up. 

Earlier this year, regulators in Idaho began enforcing a ban of CBD pet supplements, saying that the state’s “new law did not legalize hemp in every setting or product type.”

“Similarly, Idaho law does not recognize hemp as a feed or remedy ingredient. Safe levels of hemp and hemp-derived products in animal feed have not yet been established under federal or state law. As such, these products are not approved feed ingredients and cannot lawfully be added to or incorporated into commercial feed. This includes feeds, treats and remedies intended for pets, livestock, or any other animal,” the Idaho Department of Agriculture said in a memorandum. 

“As hemp manufacturing begins to take place in Idaho, ISDA is working with new hemp licensees and animal feed companies to understand what is legal in the state. Interest in hemp animal feeds and remedies has grown significantly, and these products are known to be available online and in retail stores. We recognize that some states have adopted laws and rules that allow for hemp to be included in human and animal foods,” the deparmtnet added.

The lack of regulation has resulted in some consumers being duped about the CBD products that they are buying.

A study from Johns Hopkins Medicine that was released in July found that many such products are incorrectly labeled. 

The researchers found that 18% of the products they analyzed contained 10% less CBD than what was advertised on the label, while another 58% contained 10% more CBD than what was listed. Less than a quarter of the products contained the same amount of CBD as was advertised. 

“Misleading labels can result in people using poorly regulated and expensive CBD products instead of FDA approved products that are established as safe and effective for a given health condition,” said the study’s lead author, Assistant Professor of Psychiatry and Behavioral Science at Johns Hopkins University School of Medicine, Tory Spindle.

“Recent research has shown that people who use CBD products containing even small amounts of THC could potentially test positive for cannabis using a conventional drug test,” Spindle added.

The post FDA Mulls Over CBD Regulation appeared first on High Times.

Google Updates Policy To Allow Hemp, CBD Products with Certification

Google released an announcement this month that explains an update to its “Dangerous Products and Services and Healthcare and Medicines.” As of Jan. 20, 2023, cannabis advertising will be allowed, but currently only in California, Colorado, and Puerto Rico.

Specifically, this update pertains to U.S. Food and Drug Administration (FDA)-approved products that contain CBD, or topical, hemp-derived CBD products with 0.3% or less THC. “Certain formats, including YouTube Masthead, will not be eligible for serving. CBD will be removed from the Unapproved Pharmaceuticals and Supplements list. All ads promoting other CBD-based products, including supplements, food additives, and inhalants, continue to be disallowed,” Google states.

Google is partnering with LegitScript to create a certification program for non-ingestible CBD manufacturers. LegitScript CEO Scott Roth explained how the certification aims to create a standard for the cannabis industry. “When people see the LegitScript seal on your product or website, they know that you operate safely and transparently,” said Roth. “In an industry that is still seeing widespread problems with products that are tainted, substandard, or illegal, it’s more important than ever to give consumers confidence that the CBD products they’re purchasing have been properly vetted.”

LegitScript works with other payment service providers such as Visa, Google, Bing, and Facebook. “LegitScript Certification lets the world know which healthcare merchants, CBD products and websites, and drug and alcohol addiction treatment facilities operate safely and transparently,” the company states in a press release. “The result? Certified merchants can stand out from the crowd, grow their online presence, and demonstrate credibility in high-risk industries. LegitScript is the leading third-party certification expert in these tightly regulated and complex sectors.”

LegitScript will charge a fee for processing and monitoring applicants (although the company’s website says that fees are waived through March 31, 2023). Applicants may submit their websites for a LegitScript certification in order to advertise on Google. After LegitScript certifies a website, they will be given “information on demonstrating your certified status,” such as a LegitScript “Seal of Approval” that can be displayed on a certified website.

LegitScript’s starting fees per CBD product vary between $650 for one to five products, decreasing for brackets including $600 for six to 50 products, $550 for 51 to 99, and finally $500 for 100 or more. There is also an annual monitoring fee that ranges between $750 to $1,000 depending on the number of CBD products as well. Full websites require an $800 fee per website, with either a $1,600 annual fee per website, or $2,250 annually for a “probationary website” for websites with “a past history of significant compliance issues.”

This move is a step in the right direction for hemp products, although there is currently no mention of expanding this new update to other states yet.

In the past, there have been some negative interactions between Google and cannabis-related content. In 2016, one Minnesota-based medical cannabis company fought against Google for banning it from advertising online due to having “dangerous products or services.” That same year, Google saw a 75% increase in cannabis searches online, and allowed games about the War on Drugs to be promoted on Google Play. 

In 2017, Google Docs temporarily labeled documents, including those relating to cannabis, as inappropriate (although the event was considered to be due to a coding error and was promptly fixed).

In July 2019, Google announced that cannabis products would be banned from the app store, and during the height of the vaping epidemic later that year, Apple also removed all vaping-related apps from the iOS store.

The post Google Updates Policy To Allow Hemp, CBD Products with Certification appeared first on High Times.

Is Delta-8 THC Dangerous? 

Is Delta-8 THC dangerous? What is it, and why does it have a bad reputation? Delta-8 THC is a psychoactive compound found in cannabis. As a minor cannabinoid, it is one of the many natural compounds found in cannabis that interact with our body’s endocannabinoid system. Delta-8 THC is similar to delta-9 THC, the primary psychoactive compound in cannabis. Like delta-9, delta-8 THC has medicinal and therapeutic benefits, from reducing anxiety and stress to improving appetite and nausea.  Thanks to […]

The post Is Delta-8 THC Dangerous?  appeared first on Cannabis | Weed | Marijuana | News.

FDA Takes First Step in Making NARCAN Available Over the Counter

As of Tuesday, certain naloxone products like NARCAN have been evaluated by the U.S. Food and Drug Administration and determined to be safe enough to potentially be sold over the counter in the near future.

“Today, the U.S. Food and Drug Administration issued a Federal Register notice, Safety and Effectiveness of Certain Naloxone Hydrochloride Drug Products for Nonprescription Use, that may help facilitate the development and approval of certain nonprescription naloxone drug products, including through the switch of certain naloxone drug products from prescription status to nonprescription status,” the FDA announcement said.

For those who don’t know, NARCAN is basically a nasal spray that acts as an anti-opiate of sorts. Naloxone is used alongside buprenorphine in the drug Suboxone which is used to treat the symptoms of opiate withdrawal. The key difference in NARCAN is that it’s naloxone by itself at a relatively high dose, which has absolutely no potential for abuse on its own.

“Naloxone is a medicine that rapidly reverses an opioid overdose. It is an opioid antagonist. This means that it attaches to opioid receptors and reverses and blocks the effects of other opioids. Naloxone can quickly restore normal breathing to a person if their breathing has slowed or stopped because of an opioid overdose. But, naloxone has no effect on someone who does not have opioids in their system, and it is not a treatment for opioid use disorder.” – Excerpt from the National Institute of Health website.

At the moment you aren’t necessarily required to have a prescription to obtain NARCAN but in most cases you need to get it directly from a pharmacist and it can be very expensive. I obtained four free doses through this program, but the point is most addicts simply don’t have the regular access to NARCAN that they require.

“Today’s action supports our efforts to combat the opioid overdose crisis by helping expand access to naloxone,” said FDA Commissioner Robert M. Califf, M.D. “The agency will keep overdose prevention and reduction in substance use disorders as a key priority and area of intense strategic focus for action as rapidly as possible.”

The FDA assessment won’t make NARCAN freely available just yet but it is an important first step toward making a dent in the 100,306 deaths of United States citizens from drug overdose in the 12 months leading up to April 2021. 

“This preliminary assessment is intended to facilitate development and approval of nonprescription naloxone products; however, it is not a final determination that certain naloxone drug products are safe and effective for nonprescription use, and it does not mandate an immediately effective switch to nonprescription/over-the-counter (OTC) availability for naloxone,” the FDA said.

If you or someone you love uses opiates, carrying NARCAN is an absolute necessity. The following is a list of signs a person might be experiencing an opiate overdose from the official NARCAN website:

  • Unusual sleepiness or unresponsiveness
  • Breathing will be slow or absent
  • Slow heartbeat or low blood pressure
  • Skin feels cold and clammy
  • Pupils are tiny
  • Nails and lips are blue

If someone is exhibiting these symptoms you simply aim the NARCAN nasal plunger into the person’s nose and press the plunger to release the naloxone. They may require two doses especially if more powerful opiates like fentanyl are involved. 

I realize people might be cautious to carry NARCAN if they don’t use opiates and don’t know anyone who does but trust me when I say that you absolutely know someone who uses opiates in secret and fentanyl is popping up in drugs that have nothing to do with opiates at all like cocaine or even cannabis in a couple isolated incidents. Carrying NARCAN can save the lives of your loved ones or even strangers and I tell everyone I know to carry it at all times.

The post FDA Takes First Step in Making NARCAN Available Over the Counter appeared first on High Times.

Need for Speed: FDA Issues Notice on Adderall Shortages

Anyone who is prescribed the ADHD and narcolepsy medication Adderall has been advised to seek alternative medication after a nationwide shortage was confirmed by the FDA last week, but the reasons behind the shortage remain a bit of a mystery.

The FDA didn’t give much of an explanation for the shortage other than to say one of the main manufacturers of Adderall (which is the brand name given to a particular combination of amphetamine and dextroamphetamine salts), Teva, was experiencing “ongoing intermittent manufacturing delays” and “other manufacturers continue to produce amphetamine mixed salts, but there is not sufficient supply to continue to meet U.S. market demand through those producers.”

The good news is, at the moment most of those delays are scheduled to be resolved by October or November, which is an updated ETA originally slated for March of 2023. This means we will likely avoid running out entirely. Nonetheless, the FDA did advise patients to seek alternative treatments all the same. 

A New York Times article cited the nationwide rise in ADHD as the main cause of the shortage, and it cannot be overstated that reported cases of ADHD are indeed on the rise. As a heavily regulated Schedule 2 drug, Adderall manufacture is often slow in response to demand because of the red tape required in order to produce it, so the rise in ADHD may indeed be to blame but in terms of the shortage of Adderall itself, it is likely a bit of a mixed bag.

The usual suspects when things are in short supply lately are COVID-related supply chain issues or the ongoing war in Ukraine, but Hamilton Morris, a journalist and scientific researcher known for his TV show Hamilton’s Pharmacopeia, indicated on Twitter that the Adderall shortage could be due to a shortage of nitroethane, one of the potential raw ingredients used to make it. One of the main distributors of nitroethane, Sigma Aldrich, has it listed as unavailable on their website. A phone call to the media department at Sigma Aldrich was, alas, not returned fast enough to meet my deadline.

Others disagreed, saying there’s no reason to believe there is a nitroethane shortage quite yet, but it would certainly explain things if it turns out to be true. Chemjobber, a blog dedicated to chemistry news and chemistry jobs, told High Times that while low nitroethane supply may be a potential factor, it’s essentially way more complicated than that.

“I strongly believe it is rarely API (active pharmaceutical ingredient) manufacturing that is the problem,” Chemjobber said. “That is a problem at the back of the chain, and there are 4-5 steps in front of it i.e. you could have a problem with tableting, or shipping, or labor etc.”

To that point, Teva did report earlier this year that they were having issues with labor shortages, a common complaint in the era of COVID-19. Thus, it’s not necessarily a shortage of one chemical as much as it seems to be a perfect storm of bad luck and the basic production limitations of any heavily regulated industry.

In terms of whether or not America will run out of Adderall, Chemjobber likened it to the toilet paper craze of early COVID and projected this too shall pass. It does also appear to be a good sign that Teva moved up its ETA by several months in the span of a week. Unfortunately, they didn’t call me back either.

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