Check out the Cannabis Science and Technology June Issue!

Part II of this series reviews the history of vape products, producing cannabis vapes, the myriad of extract types, and how temperature and hardware impact the user experience.

What’s in a Vape, Part II

Live from Cannabis Science Conference West!

Noid Knowledge, Ep 7:

Delta-8 and delta-10 have gained considerable traction over the past year. Although these cannabinoid isomers fall in an extreme grey area, consumers are driving up demand.

Cannabinoid Isomers Such as Delta-8: Navigating Regulations and Safety Concerns

Check out the Cannabis Science and Technology May Issue!

With the passing of Ballot Measure 109 in November 2020, Oregon legalized the manufacturing, transportation, delivery, sale, and purchase of psilocybin products. Several other cities have decriminalized, yet Oregon is the only state to legalize psilocybin mushrooms. We are expecting roll-outs of regulations similar to those of cannabis with a focus on compliance to keep the public safe and companies in business. With so many other types of psychedelics (entheogens), we will dive further into common psychedelics, cities that have decriminalized, and the future compliance of hallucinogenic plant and fungi. The Oregon-proposed rules have been released, and all information about their psilocybin program can be found 

 (1). This is a very exciting time for the industry!

Psychedelics are often grouped together to include natural plants and fungi—and some include synthetic substances. These hallucinogenic plants and fungi are often referred to as “entheogens”: 

 (creates). Entheogens means “creating the divine within.” If you were to chat with a person who is well acquainted with psychedelics, they’d likely say entheogens are natural plants that provide you with a spiritual experience (2). In an article published by 

 magazine word “entheogen” was created in the 1950s to rebrand “psychedelic” to reframe value and perceived validity in a more positive, neutral term (2). Articulating an immense spiritual experience through one word can be difficult, however the word “entheogen” feels right.

While the recent political attention has been on mushrooms containing psilocybin and psilocin, there are plenty of other psychedelic natural plants. Surprisingly, there are thousands of plants and fungi that induce psychotropic effects. Below is a short list of the most common entheogens, some are detailed in various decriminalization movements.

 – yes, the crawling vine plant that blossoms beautiful bright purple-blue flowers. Beware, some seeds are coated with an antifungal chemical.

 – has been demonstrated to interrupt substance use disorders

 – also known as sage, but not the same sage found in your cupboard

 – a synthetic chemical comprised of a substance found in ergot fungus

 – a striking cactus that can grow anywhere between 10–20 feet tall and blooms impressive white flowers

 – the earliest record of peyote is dated back to 3780–3660 BCE in ancient Native American tombs

 – described as a profound and transformative experience

“Decriminalize Nature” is a common phrase we see from cities attempting to pass decriminalization. Within the last two years, there have been multiple cities and states making changes to decriminalize nature, specifically entheogens!

Cities across the United States are decriminalizing entheogens. Reminder: these cities have not fully legalized any commercial activity (except the state of Oregon). Please note that there are sometimes religious exemptions for using of psychedelics in different states and tribal lands as well.

2019 – Denver, Colorado decriminalized psilocybin mushrooms

2019 – Oakland, California decriminalized psilocybin mushrooms and peyote

2020 – Santa Cruz, California decriminalized psilocybin mushrooms

2020 – Ann Arbor, Michigan decriminalized entheogenic plants or plant compounds

2020 – state of Oregon LEGALIZED psilocybin mushrooms via Ballot Measure 109

2020 – District of Columbia decriminalized psilocybin mushrooms, ayahuasca, and mescaline

2021 – Washtenaw County, Michigan decriminalized entheogenic plants

2021 – Somerville, Massachusetts decriminalized the possession of entheogenic plants, including psilocybin mushrooms and ibogaine

2021 – Cambridge, Massachusetts decriminalized entheogenic plants and fungi like ayahuasca, ibogaine, and psilocybin mushrooms

2021 – Northampton, Massachusetts decriminalized entheogens like psilocybin and ayahuasca

2021 – Seattle, Washington decriminalized enforcing all entheogen-related activities

2021 – Detroit, Michigan is the latest city to decriminalize, making the personal possession and therapeutic use of entheogenic plants by adults the city’s lowest law-enforcement priority

Potential Future Compliance with Entheogens

The only state to legalize entheogens, specifically psilocybin mushrooms, is Oregon at this time. The Oregon Health Authority Public Health Division’s Center for Health Protection (OHA) created a new section called “Oregon Psilocybin Services” to handle the regulatory roll-out. The OHA will regulate the manufacturing, transportation, delivery, sale, and purchase of psilocybin products. The section will determine the regulatory framework and implementation over a two-year time frame. The OHA will begin taking applications for licenses beginning January 2, 2023. Although we are extremely grateful for Oregon’s legalization, the community does not yet have a well-painted picture of how psilocybin will be regulated.There are a lot of issues that the proposed rules have that will need to be addressed before their finalized version is released.

Keep in mind that regulations are not set in stone and are more of a work in progress. Just because something isn’t working for us now, doesn’t mean it can’t change. Consider for a minute the Colorado cannabis regulations. They have changed several times and we still are changing them every year. When you legalize something for the first time it won’t be perfect, so make sure you speak up when regulations are open to public comment in the future, so we can try to find a more efficient set of regulations that will benefit the industry as a whole.

We believe the future set of Oregon’s psilocybin regulations will be a combination of current guidelines used by other regulated industries. This may include combining several sets of regulations: cannabis regulations, the US Department of Agriculture (USDA), current good manufacturing practices (cGMP), good agricultural and collecting practice (GACP), and Food and Drug Administration (FDA) along with unique local or city specific requirements.

Aspects of current cannabis regulations may be imposed on the psilocybin legalized community. A major part adopted from cannabis may include the traceability and reporting of mushrooms. Traceability is encouraged from the FDA yet heavily enforced from cannabis state regulators. The mushroom traceability program may incorporate aspects from the manufacturer, laboratory, service center, and facilitator license types all the way through the customer. Most states require cannabis companies to use a state-issued traceability platform to help track each product with the intention of limiting products entering the non-regulated market.

The USDA has a division that provides audits for the production of non-psychedelic mushrooms. Although the USDA doesn’t regulate the mushroom industry, the department provides audit programs and good agricultural practices. These guidelines may provide the psilocybin community insight into how Oregon may regulate mushroom cultivation best practices.

The FDA has established standards for the growing, harvesting, packing, and holding of produce for human consumption. Yes, the FDA categorizes mushrooms as produce. This falls under FDA’s Produce Safety Rule. These standards may support many aspects of the psilocybin industry to ensure the safety of the product and ultimately the safety of the end consumer.

The FDA’s cGMPs would be applicable once the mushroom is harvested from the growing medium and then processed. These are the same cGMPs that are applicable in any traditional food or hemp product manufacturing facility. cGMP requires a systematic quality approach to manufacturing, including the development and implementation of procedures and documentation for the design, monitoring, and control of all manufacturing processes. Not only does cGMP help businesses prevent hazards such as contamination or errors, but it also ensures that products are safe for consumers, every time.

The other set of regulations that are also relevant are GACP in fungi cultivation facilities. There are several accredited certification companies that are offering a mushroom cultivation specific GACP certification. Many companies that are wanting to get into psilocybin are already working towards this certification in their functional mushroom cultivations to stand out when putting in an application for psylocibin production. It’s definitely a good idea to think about implementing these practices from the start to be able to better compete once licenses become available.

Though these are only projected applicable standards and regulations, it gives the entheogen community a head start on which sets of regulations to apply. We will ultimately have to wait and see how Oregon rolls out their long development period to see their finalized regulations. I personally have high hopes for all the possibilities of this amazing industry!

https://www.oregon.gov/oha/PH/PREVENTIONWELLNESS/Pages/Oregon-Psilocybin-Services.aspx

https://doubleblindmag.com/what-does-entheogen-actually-mean/

Kim Stuck is the CEO and founder of Allay Consulting. Direct correspondence to: 

Articles

Psychedelics, also known as entheogens. Everyone has an opinion. From the superb kaleidoscope shapes, or making that concert even more memorable, or to digging a bit deeper within yourself for self-healing—entheogens can be a game changer. For some, these experiences are life changing, especially if it means improving well-being and life satisfaction. Thanks to many published clinical trials, the benefits of using entheogens such as psilocybin include reducing anxiety and depression, successful addiction interruption, post-traumatic stress disorder (PTSD) treatment, and many others. With increased awareness of the benefits of psilocybin and other entheogens, we are observing an acceptance of entheogens followed by decriminalization and future legalization. 

Entheogens and What Future Compliance May Look Like

Recently, Leafreport, an Israeli company that provides reviews of cannabidiol (CBD) companies and products, released their 2022 transparency report for 4384 CBD products, which included products intended for human and animal consumption. According to their report, Leafreport conducted their research by examining the certificates of analysis (CoA) of 188 brands as advertised on their websites (1). The purity and potency aspects that Leafreport examined were the percentage of products that had been tested for pesticides, heavy metals, and microbes, plus products that fell within the acceptable variance level.

Some of the key findings Leafreport noted were (1):

7% of brands tested all their products for microbes, pesticides, and heavy metals

28% of brands did not carry out any testing for pesticides (such as glyphosate)

26% did not test for the presence of any heavy metals (such as arsenic)

24% did not test for microbes (like bacteria)

Only 12% of brands had all their products fall within acceptable potency variance limits (+/-10%)

In comparison to their 2021 report, Leafreport stated that, “transparency within the CBD industry appears to be stagnating and deteriorating in several critical respects” (1). For example, the report stated that “88% of brands had at least one product measure beyond acceptable potency variance levels in 2022 in comparison to 84% in 2021” (1).

However, there were some small improvements from 2021. For example, the report stated that “the number of brands that carry out no purity testing has dropped from 25% to 20%. The number of brands that carry out absolutely no testing at all has dropped from three brands in 2021 to two this year” (1). Additionally, just “two brands carried out no lab testing at all for either purity or potency, compared to three brands in 2021.”

Leafreport also provided a detailed list of the CBD brands that tested all their products for potency, microbes, heavy metals, and pesticides, plus a list of brands that tested all their products for potency.

https://www.leafreport.com/education/cbd-market-transparency-report-only-7-of-brands-test-for-pesticides-heavy-metals-and-microbes-16349

Recently, Leafreport, an Israeli company that provides reviews and comparisons of cannabidiol (CBD) companies and products, released their 2022 report on their transparency analysis for 4384 CBD products.

Leafreport Releases Results of Transparency Analysis of Cannabidiol Products

BrandTech Scientific recently introduced a new logo for its Vacuubrand line of oil-free diaphragm pumps, oil-free screw pumps, rotary vane pumps, complete pumping units, flexible vacuum systems, and solutions for local area networks. According to the company, you will see the new branding rolled out across the US and Canadian through all the BrandTech Scientific touchpoints in the coming months.

 or watch the video representing the transformation from the old to the new Vacuubrand logo: 

https://www.vacuubrand.com/tmpshare/Vacuubrand_Logo_Morphing.mp4

BrandTech Scientific introduces a new logo for its Vacuubrand product line

BrandTech Scientific Launches New Logo for Vacuubrand

For its first time hosting an event in California, the Cannabis Science Conference West chose Long Beach, California as the destination and held the event from May 18–20, 2022. Joining the analytical, medical, cultivation, and hemp tracks this year, the new psychedelics track made its debut. The conference included dozens of presentations, more than 80 exhibitors, plus an interactive workshop—the Canna Boot Camp, which gave attendees an inside look into cultivation, pre-processing, sample prep, analytical testing, extraction, and more. In addition, longtime medical cannabis advocate Montel Williams gave an inspiring and motivational plenary address about the future of the cannabis reform movement.

There were so many informative talks and connections made across the full, two-day event. Speakers gathered from across the country (and globe) to share their research and best practices with attendees. Here, we highlight one session from each track.

The analytical track featured more than 20 speakers during the two-day track. One such interesting presentation was given by Kimberly Stuck, founder of Allay Consulting, LLC. Drawing from her experience as a former restaurant and wholesale food inspector and the first cannabis public health investigator, Stuck gave an informative and detailed presentation on how to create safe facilities, mitigate risks, and how to be prepared for FDA regulation when federal legalization happens.

The medical track featured more than 16 speakers and four engrossing panel discussions on topics ranging from cannabis nurses, veterans, clinical directors, and pediatrics. The panel discussion on parents’ perspectives on pediatric cannabis included Dr. Jennifer Anderson of Bison Family Medical Centre; Janie Maedler of Rylie’s Sunshine; Tracy Ryan of NKore Therapeutics; and Rhonda Moeller, and was moderated by Dr. Bonni Goldstein, Medical Director of Canna-Centers Wellness and Education. The powerful and deeply personal discussion explored their efforts to shape legislation, advocate for access to medical cannabis, and ultimately provide the best care for children facing illness.

The one-day cultivation track featured 10 different speakers covering key topics for anyone involved in building facilities and growing plants. Autumn Karcey of Alchemy 29 gave a keynote presentation on how to make sustainable decisions in facility design, specifically how environmental parameters can determine the selection between indoor, outdoor, and greenhouse facilities. She also explored the differences between commercialization and craft cannabis, plus how cultivators can raise standards while still staying competitive by lowering their overall cost of goods sold.

The one-day hemp track featured more than 10 speakers. The notable keynote address in this track was given by Scheril Murray Powell, Esq. of Green Sustainable Strong LLC on how to successfully expand the hemp cannabinoids business and market in other countries. She covered the strengths, weaknesses, and threats of entering a new market; how to handle challenges with selling and shipping products to various countries while navigating their specific laws; and advice on how to be a good ambassador when marketing a product.

As stated above, the newly launched psychedelics track featured two-days of talks from 14 speakers as well as an interesting panel discussion on a nurse's role in the space. One of the keynote presentations in this track was given by Alison Draisin, Lead Psychotherapist at the AIMS Institute, in which she explained the new modalities of psychotherapy at the Institute: cannabis and psychedelic assisted therapy. She described how the Institute uses ketamine to support patients moving forward with psychological issues, plus the skills needed for clinicians to consider when using cannabis or psychedelics with their patients or clients.

Join us for Cannabis Science Conference East in Baltimore, Maryland September 14–16, 2022. For more information on Cannabis Science Conferences, please visit 

https://www.cannabisscienceconference.com/

. To stay up to date on the latest information and to view photos and video from the conference, follow on social media: 

https://www.facebook.com/CannaScienceConference

https://www.instagram.com/cannabisscienceconference/?hl=en

https://www.linkedin.com/company/cannabis-science-conference

Cannabis Science Conference West was held in Long Beach, California from May 18–20, 2022. Here we provide a few highlights from the event. 

Cannabis Science Conference West 2022: A Few Highlights of Bridging the Gaps Between Cannabis, Science, and Medicine 

Global distributor of specialty chemicals and equipment, Ellsworth Corporation, announced their recent acquisition of TapeCase Ltd (1). A 3M preferred converter, TapeCase designs, converts, manufactures, and distributes highly-engineered adhesive tape products (2). In a June press release, Ellsworth Corporation stated (1), “TapeCase’s converting services and tape offerings will complement the Ellsworth Corporation portfolio of products and services, which includes B2B distribution of adhesives and specialty chemicals, dispensing equipment, custom formulation, and repackaging.”

“TapeCase’s culture aligns with Ellsworth Corporation, being a family-owned company,” said Roger Lee, President of Global Ellsworth Adhesives (1). “We are excited to provide this value-added service to our customers, and it is a testament to our customer-first mentality. We continue to add services which will assist our customers to work with us end-to-end, from specification to delivery.”

https://www.ellsworth.com/promotions/ellsworth-corporation-announces-the-acquisition-of-tapecase-converting-services/

Ellsworth Corporation, a global distributor of specialty chemicals and equipment, recently announced their acquisition of TapeCase Ltd., a distributor of adhesive tape products. 

Ellsworth Corporation Acquires TapeCase Ltd.

There is much discussion as to whether these isomers, as an edible, meet the definition of a controlled substance. To make it more confusing, these cannabinoids are derived from the legal hemp plant, so there is much to unravel here.

When it comes to isomers as a whole, in the 2018 Farm Bill, hemp is defined as “any part of that plant, including the seeds thereof and all derivatives, extracts, cannabinoids, isomers, acids, salts, and salts of isomers, whether growing or not, with a delta-9 tetrahydrocannabinol concentration of not more than 0.3 percent on a dry weight basis.” It appears the loophole falls with the clearly defined “delta-9” and not the broad definition “tetrahydrocannabinol (THC).” If delta-8 and delta-10 do not contain delta-9 and are derived from hemp, what’s the issue? The issue is that these hemp-derived isomers have a psychoactive effect, hence regulatory oversight is inevitable. To make matters more confusing (or more clear-cut for some), the Drug Enforcement Administration (DEA) issued an interim rule declaring, “all synthetically derived THC remain Schedule I Controlled Substance.” That is until May 19, 2022.

On this date, there was a court ruling in California regarding delta-8 vapes, and it was found that delta-8 THC derived from hemp is lawful and eligible for trademark protection, a federal appeals court ruled in a vaping dispute. The three-judge panel sided with a company called 

 and said that delta-8 THC is not a controlled substance under federal law if it comes from hemp. The ruling still did not address the legality of selling edible delta-8 THC products unfortunately. It seems that the responsibility to regulate these products will still fall to states for now, and vape products now fall to the FDA to regulate.

States Have Unique Stances on The Allowance of Cannabinoid Isomers

Currently, 15 states have banned these isomers and many more are under review. Many companies selling delta-8 and delta-10 are doing so online where states do not have clear regulatory oversight. However, states are continuing to crack down and this may not be allowed much longer. Manufacturers of these products interpret the 2018 Farm Bill as allowing these isomers, however, because they are chemically created and not extracted from raw hemp plant material. The legality of these isomers as an edible seems to depend on which state you reside in and on varying interpretation of the regulations. States are taking notice; some states have issued strict bans on these products, while some states are still allowing production and distribution. Here are examples of where some states are in allowing these cannabinoids. Since Delta-8 was one of the first to emerge, most of these breakdowns are delta-8 focused. Please realize that due to the new FDA stance these could change at any time.

As of May 14, 2021, the Colorado Department of Public Health and Environment (CDPHE) and the Marijuana Enforcement Department (MED) recently published bulletins revealing that THC isomers such as delta-8 and delta-10 cannot be manufactured in Colorado or used in Colorado cannabis products. CDPHE further explained that chemically modifying or converting any naturally occurring cannabinoids from industrial hemp is non-compliant with the statutory definition of “industrial hemp product.”

Though Arizona regulations do not reference delta-8, their regulations reference general “tetrahydrocannabinols.” Due to this use of the general term, delta-8 is technically considered a controlled substance in Arizona. That being said, according to their particular laws, you could make your own delta-8 and even share it with your friends, but you can't sell it. Technically, you are only allowed to sell any derived intoxicating cannabinoid in a licensed dispensary.

Kentucky is well-known for their hemp cultivation. Would a state that is deeply involved in the hemp industry allow such cannabinoids like delta-8? Well, for now it is allowed, but many lawmakers and the department of agriculture are trying to ban it. Because it has been allowed for so long, this would upset many businesses in the hemp industry.

In contrast with states taking an abrupt illegal stance, Florida is quite the opposite. According to the Florida Department of Agriculture and Consumer Services, “Delta 8: At this time, any hemp product intended for human or animal ingestion or inhalation which is sold in Florida must comply with all Florida statutes and rules.” It appears Florida has not banned delta-8 or delta-10 products.

Delta-8 is allowed in Texas, for now. The Texas Department of Health and Human Services recently announced that delta-8 is a controlled substance, and is therefore illegal. Cannabidiol (CBD) and hemp companies decided to go against this claim in court. While there are no laws expressly prohibiting the usage of delta-8 cannabinoids, there are also no laws outright legalizing its usage. This leaves delta-8 in a legal grey area, which is currently being fought from one side and then the other in court.

Consumer Safety Concerns with These Cannabinoids

If you are a manufacturer or distributor of these cannabinoid isomers, we encourage you to do your research and consult with an attorney. It is much better to be safe than sorry in these kinds of scenarios. Allay Consulting has several different clients that are operating in states where these derivative cannabinoids are allowed, and most of them are even taking it to the next level when it comes to compliance by getting certifications such as current good manufacturing practice (cGMP) and International Organization for Standardization (ISO) 9001. To me this shows that not all of these companies are “fly by night,” but are actual good businesspeople who want to do right by their customers. Many want to create safe products, and I am excited to say that those are the companies that will last when the Food and Drug Administration (FDA) does start to get involved.

There are plenty of legal issues surrounding delta-8 and delta-10, but are these products safe to consume? This topic should speak not only the consumer but also the manufacturers and distributors. We needed a cannabis chemist’s perspective for the safety coverage of these isomers. Josh Jones, PhD, is an organic chemist and founder of Jonesing Labs. Josh further explained, “As for the current production of Δ8-THC, or other THC isomers converted from hemp cannabinoids (or simpler starting materials), these reactions should be performed using pharmaceutical (expensive!) production techniques to minimize unintended side-reactions and to understand impurity profiles. But I don’t know of any producers or hemp testing labs that offer comprehensive impurity profiling of such reaction products. If this could be done, then we’d likely not have the concern we do over semi-synthetic conversions in the cannabis markets. Still the Wild West…”

It seems there are unknown amounts of residual catalysts in cannabinoid isomers. If these products are not regulated and not held to rigid testing requirements, consumers may be subjected to dangerous by-products. As with all products, do your research before buying, producing, and selling these cannabinoid isomers.

I personally believe that there is a place in this industry for all derived cannabinoid products, but the issue for me is that they are not being correctly regulated. Sine the FDA still hasn’t given any guidance or regulations to the industry regarding health and safety of CBD products, they don’t have a foundation to stand on when looking at these other isomers. Proper regulation is necessary for the survival of this industry, and local and state health departments many times don’t have the bandwidth or resources to regulate these cannabinoids. Regulation technically should fall to the FDA since hemp-derived cannabinoids are technically federally legal. There are potentially thousands of these derived cannabinoids that have still yet to be discovered, so these will be the first of many that will need to be properly regulated. Hopefully the government starts to act sooner rather than later to prevent more gray areas that could potentially cause unsafe products.

Many aren’t looking forward to this kind of regulation, but without it we are endangering the future of the hemp and cannabis industry as a whole. When something goes wrong that causes a bulletin, recall, disposal, or—God forbid—a death, it makes our industry look bad in its entirety and steers new customers away from wanting to buy products. As an industry we need to realize that consumer and product safety now falls to company owners, and we need to take responsibility for how we are handling products. Putting in place a good product safety plan, becoming FDA compliant, or getting cGMP certification will put your cannabinoid company miles ahead, and will protect you in the long run.

 is the CEO and founder of Allay Consulting. Direct correspondence to: 

Delta-8 and delta-10 have gained considerable traction over the past year. Although these cannabinoid isomers fall in an extreme grey area, consumers are driving up demand. They can be purchased in many different forms and are commonly found in vaping products, gummies, and tinctures. Since these isomers are commonly derived from hemp extract, many consumers see delta-8 and delta-10 as a lawful hemp-derived good that provides a psychoactive effect. Per a new stance from the federal government, vaping products with these isomers fall under the 2018 Farm Bill. Even with the Food and Drug Administration’s (FDA) stance regarding the 2018 Farm Bill exempting hemp from the Controlled Substances Act (CSA), the popular edible cannabinoid isomers are not automatically legal.

On May 19, 2022 a federal appeals court ruled in a California vaping dispute that delta-8 tetrahydrocannabinol (THC) derived from hemp is “lawful” and eligible for trademark protection (1). The three-judge panel wrote that products containing delta-8 THC are generally legal because federal law defines hemp as “any part of” the cannabis plant, including “all derivatives, extracts, [and] cannabinoids,” that contains less than 0.3% delta-9 THC by weight (2).

Delta-8 THC is an isomer of the psychoactive cannabinoid that occurs naturally in the cannabis plant, delta-9 THC. Delta-8 THC can be synthesized from cannabidiol (CBD), giving rise to products that offer intoxicating effects without needing to be sourced from cannabis, which remains illegal under federal law (1).

The ruling does not address the legality of selling consumable delta-8 THC product, however (1). The confusion over delta-8 THC’s legality under federal law has prompted many states to limit or restrict how it can be sold. Though Congress legalized hemp derivatives such as delta-8 THC, it also directed the US Food and Drug Administration (FDA) to oversee how those products could be sold. The FDA has declined to authorize any cannabinoid products without a prescription, and the agency issued a consumer alert last September warning that delta-8 THC “may have potentially harmful by-products (contaminants) due to the chemicals used in the process.” The Drug Enforcement Administration, meanwhile, signaled late last year that delta-8 THC was legal (2).

For more on this topic, please see our June installment of the “Stuck on Compliance” blog by Kim Stuck at: 

https://www.cannabissciencetech.com/blogs/stuck-on-compliance

https://mjbizdaily.com/federal-appeals-court-delta-8-thc-products-from-hemp-are-lawful/

https://www.marijuanamoment.net/delta-8-thc-products-are-federally-legal-just-like-hemp-appeals-court-rules/

On May 19, 2022 a federal appeals court ruled in a California vaping dispute that delta-8 tetrahydrocannabinol (THC) derived from hemp is “lawful.”

US Appeals Court Rules Hemp-Derived Delta-8 THC Products Legal 

CannMed held their 2022 annual conference in Pasadena, California from May 3–5. The event, fully in person, included a full-day medical practicum workshop, dozens of exhibitors, and thought-provoking keynote presentations in the four focus areas of medicine, science, cultivation, and safety. Attendees and presenters had the chance to network and mingle at the VIP dinner and the cocktail hour. Several presenters and guests were interviewed throughout the conference the at the CannMed Coffee Talk Lounge, including Megan L’Heureux, Group Editorial Director for 

A few interesting talks to note included the presentation by Jaime Brambila of Grace Health and Wellness titled “Raising Awareness: The Successful Implementation of Natural Plant Based Medicines Used as Adjunct Therapies with Standard Treatments for Metastatic Breast Cancer.” Brambila shared his wife, Nicole DiMonda’s, personal journey through cancer treatment and the success she had with medical cannabis and psychedelics. At the end, DiMonda shared a passionate statement about how this industry helped save her life. DiMonda and Brambila have partnered with several universities and research groups to expand their experience into clinical trials for others.

In addition, Dr. Marion McNabb of the Cannabis Center of Excellence highlighted some of the initial findings from her healthcare provider study in which her company surveyed healthcare professionals across the country on their knowledge and interest surrounding medical cannabis. The study is still open to healthcare providers through August 2022. Some of Dr. McNabb’s initial findings include:

354 healthcare providers responded, the majority of whom were nurses

42% of respondents also reported using medical cannabis themselves

37% believe cannabis can be a first line treatment

Alongside presentations on the medical aspects of cannabis, there were also many talks on the latest advancements in cultivation, testing, extraction, and research. Seth Crawford, co-founder of Oregon CBD, explained in his keynote address, “Cannabis 2022: The Golden Age of Discovery?” the methods of selective breeding of certain hemp plants on his farms, plus the potential innovations these seeds and plants can provide to farmers and researchers.

Grace Bandong, Scientific Strategy Leader for Contaminants for Eurofins Food Integrity and Innovations, gave another keynote presentation titled “Risk Based Hazards Analysis: A Tool for Building a Comprehensive Analytical Testing Program.” Bandong’s presentation explained how to create an effective yet economical risk-based framework of analysis of products, plus an explanation of the unexpected threats that hazards such as mycotoxins, heavy metals, and pesticides can pose to products.

For more information on CannMed or to learn more about the talks and speakers from this year’s event, please visit: 

https://cannmedevents.com/cannmed-schedule/

CannMed held their 2022 medical practicum and science conference in Pasadena, California from May 3 – 5.

CannMed’s 2022 Conference Further Promotes Mission to Inspire Science, Community, and Hope

On June 14–15, 2022, Natoli Engineering Company will be offering a two-day seminar called “Tablet Press & Tooling: Applied Learning Experience” at their headquarters in St. Charles, Missouri. The seminar will reportedly teach students best practices for tablet press operation and maintenance. The course, which is offered a few times each year, is fully comprehensive, and provides students with the latest knowledge, research, and technology in tablet compression tooling. Supervisors, quality assurance and quality control personnel, and maintenance technicians at any stage are encouraged to attend.

Assembly and disassembly of all main components of a rotary tablet press

Relationships among maintenance, inspections, operations, and troubleshooting

On June 14–15, Natoli Engineering Company, a manufacturer of tablet compression tooling, is offering hands-on training on how to sharpen skills in tablet press setup, operation, and maintenance procedures.

Natoli Engineering Company Schedules New Two-Day Seminar Training for Tablet Press Operation and Maintenance

Have you ever found a foreign object in your food, or woken up not feeling too good from the previous days’ food? Each year in the United States, 1 in 6 people get sick from foodborne disease, 128,000 are hospitalized, and 3000 on average die. In the United States, we have seen large recalls involving listeria in cantaloupes, salmonella in peanut butter, metal pieces in ground beef, and, more recently, cannabis recalls because of potentially unhealthy levels of molds, yeasts, pesticides, and heavy metals.

In the cannabis industry there seems to be a misconception that your company will never have a recall in its lifetime, or that there isn’t any possibility that it will ever happen to you. In reality, all wholesale food companies and cannabis companies experience at least one or multiple recalls during their lifetime. It isn’t about 

. And when it happens, how will your company handle it? If your company is prepared and has good protocols in place, then you can prevent a recall or make it far less detrimental to the company if you happen to go through one.

In efforts to protect consumers, the Food and Drug Administration (FDA) as well as local and state regulatory authorities publish product recalls to notify consumers of confirmed and potentially contaminated products. The recall could stem from your own product or an outside manufacturer; think of in-house manufactured ingredients, out-of-house added ingredients, or primary packaging. What to expect from a recall may differ from state to state, but the overall process is similar to the FDA’s. We hope to clarify what to expect during a recall and how this can prepare you for dealing with this type of situation.

Keep in mind that a recall is not always your company’s fault, but that doesn’t mean that your company isn’t the one that has to deal with it or be the one announced in the press releases and bulletins when it does. We see this a lot when a company isn’t protecting itself by testing all products (yes, again) before using them in their products. This means all ingredients including cannabis products. As much as I hate to say it, certificates of analysis (CoAs) aren’t always telling you the truth, so we always recommend conducting your own third-party testing for new vendors for at least a few months before trusting CoAs. These kinds of precautions could save you millions down the line, even though there is a cost associated with extra testing.

We also see this when companies are using white labelers to create their products. If your company name is on the containers being recalled, then it's your brand that is affected negatively by it. Unfortunately, you don’t always have control of what is happening in a white label facility, so we highly recommend routine third-party food safety audits or making sure the company has current good manufacturing practices (cGMP) certification before engaging with them. You have to protect your brand at all costs, and be wary of taking someone’s word for being “compliant” or for being cGMP certified. Stating that you are “complaint” really doesn’t mean anything since there isn’t anyone checking to see if you are staying compliant with cGMP standards. If a company really is cGMP certified, they should be able to easily supply you with an actual, up-to-date certification. Please do not take anything at face value. I have seen the worst of it – ask for proof of everything.

The very early steps of a recall start with determining the need for a recall.You may conduct a voluntary recall on your own or you may receive a notification that your product is at fault, which could also lead to a recall. This could include a simple consumer complaint, consumer social media post, hospital visit, or worse…death. No matter the origin, your product could be the linking connection to the complaints.

Let’s say a regulatory authority notifies you that your product is the common source of illness. What is next? You must quickly identify which products are associated with the complaints. Maybe a common ingredient, common manufacturing date, equipment, staff, packaging material, or so on. You will need to be able to identify which products are included in the recall. Let us hope your traceability is on point! Having a strong product traceability program will expedite identifying which products need to be recalled and which consumers need to be notified. If traceability is not in place, the recall could expand past the identified product to include “any and all” products.

Once the product is identified, you must contact and notify any consumers, wholesalers, and distributors to whom the product was sold. This could include contact via phone call, mass email correspondence, social media posts, press releases, and the most profound is the FDA publishing the recall on a national level. Expect product returns, reimbursements, and disposals for the recalled product.

After publishing the recall and receiving returned product back, what’s next? An investigation must be conducted on the recalled product to determine the root cause for the incident. This root cause will help determine how to best move forward.Once investigated, a corrective action must take place. You may choose to rework the product or you may choose to dispose of the product. Either decision must be based on science and have a clear path of documentation. Adhering to a corrective action preventive action (CAPA) plan is key to correcting the impacted product and ensuring it doesn’t happen again.

You’re not done just yet; the next step is preventing this from occurring again. Understanding the root cause of the nonconforming product will reveal options for preventing a similar disruption in the future. Perhaps an ingredient was purchased from an unapproved supplier, a product failed testing or was not tested, equipment malfunctioned, sanitizer chemical was too concentrated, and so on. The list goes on and on.

A recall is never ideal, but you can control how smoothly a recall flows. Remember to work with your local or state government regulatory agencies when conducting a recall. Additionally, you can prepare for potential recalls by promoting current good manufacturing practices throughout the facility, utilizing an approved supplier program, applying a CAPA plan, consumer complaint and non-conforming operating procedures, and have a complete recall plan in place. 

In the cannabis industry there seems to be a misconception that your company will never have a recall in its lifetime, or that there isn’t any possibility it will ever happen to you. In reality, all cannabis companies experience at least one or multiple recalls during their lifetime. It isn’t about if it will happen, it’s more of a when. And when it happens, how will your company handle it?

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