Colorado’s New Hemp Regulations Increase Contaminant Testing

Colorado’s New Hemp Regulations Increase Contaminant Testing

Hemp-infused products will soon undergo pesticide testing similar to that of their marijuana counterparts.

A lack of federal guidance since hemp’s federal legalization in 2018 has left Colorado to regulate CBD and hemp-derived extracts on its own. Following a glut in the industry from an oversupply of hemp biomass, the Colorado Department of Public Health and Environment began rolling out hemp regulations in April.

The new rules are set to take effect in full on October 1, but testing has already begun for 106 different pesticides, as well as heavy metals and other residual solvents used in the hemp extraction process, according to Jeff Lawrence, CDPHE director of environmental health and sustainability. Ingredients derived from hemp and intended for consumption, including food, drinks, cosmetics and pet products, will be subject to the testing.

“Ultimately, this is a public-health issue. In 2018, when, statutorily, these products were allowed, we said it would be treated like every other food and dietary supplement requirement,” Lawrence explains.

list of areas where Colorado’s hemp rules needed reform was laid out by a state-approved panel earlier this year, including guidelines for new CBD and hemp-derived extract testing. On top of contaminant testing, the new regulations require an exact percentage of THC content to be included on hemp product labels.

The CBD craze might be calming down, but Lawrence says Colorado wants to help legitimize a still-growing hemp industry, by enforcing universal standards similar to safety regulations already enforced by the United States Food and Drug Administration.

The regulations don’t apply to industrial hemp products not intended for human consumption, such as textiles, fuel and other industrial materials. Hemp-derived smokable products are excluded, as well, including those with modified cannabinoids like Delta-8 THC.

“We don’t want to burden the industry,” Lawrence says. “But what we’ve learned is that there are things in hemp products that we obviously need to be considerate of. Since the inception of hemp, Colorado has been a leader in this industry. This will provide some better guidance.”

 

The first rollout of regulations began in April, with most testing requirements for heavy metals, microbial and residual solvents going into effect July 1; pesticide testing had a delayed implementation date, but is expected to begin rolling out by August 1.

“For quality brands and manufacturers who have already been doing full panel testing, this won’t be a very big change for them,” says Lisa Stemmer, marketing director for Colorado’s only state-certified hemp testing lab, Botanacor Laboratories. “I could certainly see it being a bit intimidating for those who are newer to the industry, but overall, I think it’s a positive thing.

“We’re talking about having CBD as a regulated nutritional supplement and food additive. I think what CDPHE recognizes is that this is going to be enforced at the federal level at some point, and now we’re just prepared with a head start.”

At the moment, Colorado has just one state-certified testing lab for hemp contaminants, with a second lab based in California, InfiniteCAL, currently waiting approval from the CDPHE. Because hemp can now cross state lines, facilities in other states could pursue state certification in Colorado, Stemmer adds.

Hemp farmers and business prospects rushed into a promising market in 2018 after federal legalization. But that unregulated, booming market eventually resulted in an overabundance of goods. The new regulations could slow down Colorado’s contribution to this excess, according to Stemmer.

“[Companies] are being more strategic and thoughtful about what they’re producing, so they might not be producing as much, but they’re producing much better quality,” she says.

Colorado Hemp Education Association co-founder Jackie Chenoweth suggests that although the regulations might slow down the CBD side of the hemp industry, they could highlight the plant’s versatility to produce goods not intended for consumption, like fabric, paper, plastics and fuel.

“This plant could literally save us from ourselves if it were grown and utilized to make thousands of everyday products,” Chenoweth says.

Read the Full Article

What is phytol and is it safe to vape?

What is phytol and is it safe to vape?

On June 23, Canada’s cannabis regulatory agency, Health Canada, released a private document requested under the Access to Information Act (AIA), that country’s version of the US government’s Freedom of Information Act.

An alarming study of the vape additive phytol has rocked the cannabis vaping world.

The document in question was a 2020 safety study of the vape cartridge additive phytol. The study was conducted by Canopy Growth, one of Canada’s largest cannabis companies.

The data contained in that report has rocked the cannabis vaping world.

Phytol is a terpene that’s sometimes used to add flavor to vape cartridges, usually by adding it to a mix of cannabis oil and the common thinning agent propylene glycol.

The AIA request had been requested by David Heldreth, the former chief science officer of True Terpenes, a major phytol reseller. Heldreth’s friend Andrew Freedman, a Canadian citizen and vape expert, actually obtained the report.

CEO/founder of both Panacea Plant Sciences and Ziese Farms, Heldreth first grew concerned about phytol in August 2020 when Tokyo Smoke, the chain of Canadian cannabis stores owned by Canopy Growth, suddenly pulled all vape cartridges that contained phytol from its shelves.

Five months later, Heldreth became increasingly alarmed when the medical journal Inhalation Toxicology reported findings that indicated phytol was not as benign as propylene glycol. “Phytol, not propylene glycol, causes severe pulmonary injury…,” the study reported.

“I wouldn’t use a product that contains it.”
– David Heldreth, terpene scientist, regarding phytol

The Inhalation Toxicology article was based on research done by Canopy Growth scientists. The study sparked an alarming headline in the trade publication MJ Biz Daily: “Phytol cited as potentially dangerous cannabis vape ingredient.”

After filing an AIA request with Health Canada (which regulates cannabis nationwide), Heldreth finally received the full study in June of this year. Its contents floored him. The data was far worse than he imagined.

Phytol, according to the data in the study, appeared unsafe to inhale. When he spoke recently to Leafly, Heldreth made his opinion very clear: “I wouldn’t use a product that contains it.”

Jump to a section

Why is phytol a concern?

Since the 2010s, humanity has engaged in a massive, uncontrolled field trial of electronic drug-delivery systems known as vaporizers.

“This is something we should be sounding the alarm on.”
– Kyle Boyar, KB Consultations

People young and old are experimenting with liquid chemical mixtures never found in nature, aerosolized by cheap electronic hardware and misted directly into the body’s sensitive lung tissue.

“The science is just so far behind,” Robert Strongin, professor of chemistry at Portland State University, recently told Leafly. “We’re all guinea pigs now.”

In 2019, simmering quality control issues with illicit THC vape pens boiled over into a public health crisis. Vape consumers across America fell sick with what became known as VAPI, or EVALI, a lung distress that injured 2,807 people and killed 68 of them over a period of about six months. Leafly’s investigative reporting helped expose the culprit: vitamin E acetate, which had been added to illicit vape cartridges to boost profits.

Counterfeit THC vape and JUUL pods for sale in downtown LA. (David Downs/Leafly)
Counterfeit THC vape and JUUL pods for sale in downtown LA. (David Downs/Leafly)
Sickened lungs show up as cloudy on the left x-ray, and clear after treatment of one suspected VAPI patient in Utah. (Courtesy University of Utah)
Certain vape additives are associated with lung injury, which shows up as cloudy on the left x-ray, and clear after treatment of one suspected VAPI patient in Utah. (Courtesy University of Utah)

The vape lung crisis largely ended by February 2020, because consumers heeded media warnings, threw out their tainted vapes, and illicit pen factories stopped using heavy cuts of vitamin E acetate.

The Centers for Disease Control stated the number one thing state regulators should do to prevent future outbreaks was “ensure chemicals of concern didn’t enter the vapor supply.”

State regulators have not heeded the CDC’s advice. Few states have instituted any rules around the ingredients in cannabis or tobacco vape cartridges, aside from attempting to ban flavored carts—a move aimed at preventing minors from vaping, and not done out of concern for the health of adult vapers.

“It’s very risky, some of these ingredients,” said Strongin. “It’s just a shame we don’t know more about them.”

Given that cautionary experience with vape cartridge additives, Leafly asked experts to take a look at the raw phytol data from the Canopy study, and answer an urgent question: Is phytol safe to vape?

What is phytol?

Phytol is a diterpene alcohol that appears naturally in trace amounts in raw cannabis plants. It’s an aromatic plant oil, though it’s not a pleasant-smelling one. It can smell grassy in its natural state. Synthetic phytol, which is more commonly used in commercial applications, is odorless.

Outside the cannabis industry, phytol is used as a chemical in products like shampoos, household cleaners, and detergents.

In the cannabis industry (both legal and illicit), vape cartridge manufacturers can use phytol to dilute pure cannabis oil. It’s part of a class of cheap diluents that are most often used by vape cart makers in the illicit market, because illicit carts contain no lab-verified potency data on their labels.

Using phytol to cut cannabis oil in a state-licensed vape cart makes less economic sense, because licensed manufacturers are required to print their lab-verified THC levels on the cartridge package. Thus, a consumer can easily see that a cartridge thinned with phytol contains less THC than a competing product.

The chemical structure of phytol makes it a potential problem in the lung.
The chemical structure of phytol makes it a potential problem in the lung.

Phytol is not difficult to obtain. It’s a colorless or pale yellow liquid sold as a wholesale product to almost anyone who wants it on the internet. In fact, phytol is just a Google search away for anyone with a credit card and a delivery address. It sells for about $100 per liquid ounce, comparable to cannabis oil, but far more available. Phytol allows dealers to stretch their supply of THC oil further, experts said.

Dominic Black, lead account manager at Infinite Chemical Analysis Labs in San Diego, CA, explained, “For example, if someone has 50 liters of [cannabis] distillate and mixes it with 50 liters of phytol, they now have 100 liters of product to sell.”

In illicit markets, where lab-verified THC potency isn’t required, consumers don’t know they’re getting a diluted product—and one that may harm their lungs.

What did the Canopy Growth study find?

The Canopy report determined that certain levels of phytol inhalation hurt lung tissue in lab rats, and did not locate levels of exposure that could be deemed safe.

Results were so alarming that researchers ended the 14-day study after only two days.

A Canopy spokesperson said the company originally commissioned the study as part of its due diligence responsibility as a cannabis vape cartridge manufacturer and retailer. Canopy says it has never used phytol in any of its in-house products, but became both curious and concerned when officials noted the substance turning up in vape carts made by other manufacturers.

Until then, there was no data comparing the toxicity of inhaled phytol versus propylene glycol (PG). Propylene glycol is a commonly-used diluent in legally licensed cannabis vape cartridges. It’s used to thin cannabis oil and allow it to easily contact a vape device’s heating element, which vaporizes the mixture.

Canopy contracted with researchers in New Mexico, who gave lab rats a misted mixture of phytol and air, or propylene glycol and air, or just air. Researchers planned to run the experiment for 14 days, exposing the rats to phytol, or PG, for either 30 minutes or 1, 2, 4, or 6 hours.

A screenshot of the Canopy inhalation toxicology report from 2020, showing rat lungs filtering phytol from the test air.
A screenshot of the Canopy inhalation toxicology report from 2020, showing rat lungs filtering phytol from the test air.

But by day two, all the phytol rats had died or were suffering so badly—gasping, unresponsive—that lab scientists euthanized them. Directors halted the phytol arm of the trial. The PG rats finished their 14 days of exposure and all survived, with no lasting effects.

Among the findings from phytol-exposed rat autopsies:

  • There was “acute toxicity in all dose groups.”
  • Phytol caused “severely purple” lungs that were “hemorrhaging.”
  • The rats’ nose, throat, and lung tissue had melted away in a process called necrosis.
Canopy researcher's conclusions.
Canopy researchers’ conclusions.

The study results alarmed Kyle Boyar, head of KB Consultations. Boyar is also the vice-chair of cannabis chemistry for the American Chemical Society. “It’s pretty bad,” Boyar told Leafly. “It’s something we should be sounding the alarm on.”

Matthew Elmes is the director of scientific affairs at CannaCraft, a legal vape cartridge maker in California. He said phytol “appeared to have relatively high pulmonary toxicity. At the very least, based on these preclinical results, I think it certainly should not be considered for use as any sort of vape diluent!”

It’s important to make clear that Canopy Growth is not the villain in this story. By all accounts, Canopy officials practiced basic, responsible, and ethical drug development 101. And the scary fact is, that’s surprisingly rare in the cannabis industry.

What level of phytol inhalation is safe?

Nobody knows yet if any level of phytol inhalation is safe.

Experts generally agree there’s not enough research to conclude if the substance is safe to inhale in any amount. The Canopy report was the first to really detail the cutting agent’s potential harm to humans. Heavy users of vape pens in illicit markets—where exposure to heavily diluted vape carts is generally higher—are likely the most at risk of potential phytol lung damage.

The results were so alarming that in 2020, Canopy Growth immediately stopped selling all third-party vape cartridges containing phytol.

“For the safety of consumers, we do not believe [phytol] should be used in any vape products,” a Canopy Growth spokesperson told Leafly. “The findings of the study were clear that concentrated phytol resulted in adverse effects to the study animals.”

Is the Canopy study applicable to humans?

Experts say the amount of phytol the rats inhaled may not directly translate to vaping humans—but warrants real caution.

Imagine five vape carts, one-gram size, all completely filled with phytol. Now imagine that mixture misted into a one-meter cubic box, which is about the size of a large garage freezer chest. That’s the concentration of phytol these rats were getting.

But is that a little or a lot?

Marcu said it’s a typical concentration for an exploratory toxicology study. Menthol, for example, will kill 50% of rats exposed to a concentration of about 5,200 milligrams per cubic meter of air of it. Menthol has been added to tobacco cigarettes for decades. The US Food and Drug Administration (FDA) recently proposed a ban on all menthol cigarettes, but that ban was announced largely in terms of making tobacco smoking less attractive, and wasn’t so much about the harmful health effects of menthol itself.

Read the Full Article

States Move To Ban Delta-8 THC

States Move To Ban Delta-8 THC

An increasing number of states are banning Delta-8 THC as federal regulators verify its legality.

Delta-8 THC has become very popular, prompting more jurisdictions to restrict access to the commodity, which is often generated from hemp extracts.

Varying Responses

To limit market access, outright restrictions are being implemented and measures to prohibit the products are being considered.

According to U.S. Hemp Authority President Marielle Weintraub, states will continue to restrict Delta-8 THC and other products like it because the cannabinoid is classified as a restricted narcotic under federal law.

“Do not make or sell Delta-8 products unless you have a permit to make or sell THC as a controlled substance,” said Weintraub. “A state-licensed adult recreational or medicinal marijuana operator is the correct avenue for the lawful manufacturing and sale of Delta-8 products. Hemp businesses who fail to do so risk facing FDA, FTC, USDA, and EPA sanctions, as well as possible enforcement actions from the DEA and state law enforcement and regulators.”

Hemp operators who manufacture Delta-8 THC will be prevented from certifying products through the US Hemp Authority, according to Weintraub.

Confusion Reigns Supreme

Because of conflicting restrictions, the legal status of Delta-8 THC, as well as Delta-10 THC, has been unclear.

Proponents of Delta-8 and Delta-10 THC products contend that all hemp-derived cannabinoids fit under the definition of hemp, which is now a lawful crop and no longer a controlled narcotic, according to the 2018 Farm Bill.

However, in late 2020, the United States Drug Enforcement Administration released an interim final rule stating that “all synthetically derived (THC) controlled narcotics remain Schedule I prohibited drugs.”

According to the DEA, Delta-8 THC is a prohibited substance since it is made from hemp-derived CBD rather than being taken directly from the hemp plant.

“From a chemist’s standpoint, it’s evident that using a catalyst to isomerize CBD to Delta-8 THC is a chemical process,” said Erik Paulson, lab manager at Infinite Chemical Analysis Labs. “By definition, every product of a chemical reaction like this is a synthetic chemical.”

At least five states have considered or are currently updating their laws to specifically regulate Delta-8 THC, joining at least 11 other states that already have laws in place addressing the minor cannabinoid. Delta-8 THC can cause psychoactive effects in some people despite being less potent than the Delta 9-THC found in marijuana.

Alaska, Arkansas, Arizona, Colorado, Delaware, Idaho, Iowa, Mississippi, Montana, Rhode Island, and Utah are among the states that have outright banned Delta-8 THC.

However, because Delta-8, Delta-10, and Delta-9 THC, are still listed on the DEA’s Prohibited Narcotics List as Schedule 1 controlled substances, they are still banned in all 50 states, according to Paulson.

“Because Delta-9 is the only cannabinoid officially included in the 2018 Farm Bill, some have construed it as the legalization of these other cannabinoids,” Paulson added.

The following is a list of state Delta-8 measures:

Alabama

Alabama hemp business stakeholders applauded state lawmakers in late April for rejecting proposed amendments that would have designated Delta-8 and Delta-10 THC products as controlled substances.

The Alabama Senate Judiciary Committee approved an amendment to be put on to a bill that would have prohibited Delta-8 and Delta-10 THC as well as the antidepressant Tianeptine in the state.

According to Alabama Political Reporter, the bill’s author deleted the change after members of the Alabama hemp industry complained.

However, a similar amendment to the state’s medical marijuana bill was suggested, which would have classified all THC as a controlled substance in the state.

The House Health Committee tabled the measure, which was supported by state Attorney General Steve Marshall.

Illinois

In mid-April, the Illinois House of Representatives enacted a bill regulating Delta-8 THC and other products.

State Rep. Bob Morgan, the bill’s sponsor, called the items a “public health disaster.”

Thousands of consumers in Illinois are purchasing CBD, Delta-8, and other hemp derivative products with no means of knowing what they contain. Some products may not contain any CBD or hemp at all, according to Morgan.

Illinois legalized recreational marijuana in 2019.

Kentucky

Kentucky, a leading hemp producer, made headlines last month when its agriculture department emphasized that Delta-8 THC is a controlled narcotic.

“Distributing products containing (Delta-8) is illegal, and distributing such products could lead to your expulsion from the Hemp Licensing Program as well as potential criminal prosecution,” Agriculture Commissioner Ryan Quarles wrote in a letter to Kentucky hemp license holders in response to inquiries to the state agriculture department.

Because Delta-8 THC is a Schedule I banned substance under federal law, it remains a Schedule I controlled substance under state law, according to Quarles, who added that Kentucky has not approved any legislation to create an exemption to the state’s Controlled Substances Act.

North Dakota

In late April, the North Dakota Attorney General’s office proposed revisions to the state’s hemp regulations in response to an increased demand for Delta-8 THC.

According to Fargo TV station KVRR, one portion of the state’s plan would instantly criminalize Delta-8 THC.

Hemp growers are urging legislators to examine legislation that do not prohibit people from consuming Delta-8 for medical purposes.

Oregon

Though Oregon legalized recreational marijuana in 2014, it does not have the same restrictions in place for Delta-8 THC, which has caused alarm in the hemp business and among state regulators who want to see more research on the impacts of the minor cannabinoid.

The Oregon Liquor Control Commission, which regulates cannabis, would be empowered to establish strength limits on artificially created cannabinoids and clarify testing standards for consumable items containing hemp-derived cannabinoids under a bill proposed in the state House.

According to Portland TV station KOIN, the measure, which has bipartisan backing, would create a task group to investigate how new cannabis products containing Delta-8 THC fit into Oregon’s legal cannabis market.

In written remarks, Hemp Industries Association President Rick Trojan stated that the law would “overnight kill Oregon’s hemp industry.”

It “doesn’t make sense,” Trojan added, to subject federally lawful hemp goods to the same “burdensome rules” as federally banned marijuana.

Vermont

Vermont’s state officials recently informed people of the legal status of Delta-8 THC.

The Vermont Agency of Agriculture, Farms and Markets said in an email to registered hemp growers on April 23 that Delta-8 THC products are illegal under the state’s published rules, which prohibit processors from using “synthetic cannabinoids in the production of any hemp product or hemp-infused product.”

Making Delta-8 THC products in Vermont would be illegal, according to the FDA.

Washington

According to a policy statement issued last week by the Washington Liquor and Cannabis Board (WLCB), the regulatory body that supervises cannabis products, lab-created hemp products are temporarily forbidden in the state.

However, the board’s opinion is “advisory,” and more discussion is needed regarding whether federal drug laws apply to hemp-derived chemicals like Delta-8 THC and Delta-10 THC.

The WLCB announced on April 29 that it will collaborate with enterprises that produce and sell cannabis products as part of a formal rule-making process that will start this month.

The restriction was prompted by safety concerns, a lack of mandatory testing standards, and restrictions on potency and concentration percentages, according to the board’s statement.

The state’s licensed marijuana growers urged the restriction of Delta-8 THC products, claiming that cheaper, illicit products were driving them out of business, according to The (Spokane) Spokesman-Review.

However, not everyone in the marijuana sector in Washington is opposed to Delta-8 THC.

The Washington Cannabusiness Association requested in a February letter to the WLCB that its policy not fully rule out Delta-8 THC.

Vicki Christophersen, the association’s executive director, commented, “The focus should be on bringing all things cannabis into the regulated system in a safe manner; this includes Delta-8 THC.”

Read the Full Article

Latest Cannabinoid in the Spotlight: Delta-10 THC

Latest Cannabinoid in the Spotlight: Delta-10 THC

By now, many in the industry are aware of the recent craze surrounding delta-8 tetrahydrocannabinol (THC), a natural component of cannabis that has burst into popularity over the past several months.

And it seems as soon as the industry has gained a solid understanding of delta-8, another THC compound has come into the spotlight: delta-10 THC. 

Similar to delta-8, delta-10 is a minor cannabinoid that exists in trace amounts in hemp and cannabis, according to ACS Laboratory, a cannabis, hemp and cannabidiol (CBD) testing laboratory in Florida.

As previously reported by Hemp Grower, delta-8 is said to have a relaxing effect and produces some psychotropic effects that are believed to be less potent than delta-9.

Roger Brown, the president and founder of ACS Laboratory, describes the effects of delta-10 to be the opposite of delta-8, based on his personal experience.

“For myself, I don’t utilize or smoke marijuana, but I tried delta-8 and delta-10 products that we tested as an experiment, and for me, delta-10 had no psychoactive effects; it was more like a mood enhancer,” he says.

Erik Paulson, senior analyst at Infinite Chemical Analysis Labs, an analytical cannabis and CBD testing lab with locations in California and Michigan, says he’s heard consumers compare delta-10’s effects to sativa cannabis varieties, which are traditionally known for being energizing and uplifting, and delta-8 effects to indica varieties, which are associated with relaxation.

However, Paulson says he’s unsure if there’s any scientific evidence behind that, adding,  “It could just be that the higher psychoactivity of delta-8 is causing more of a pronounced sedative effect compared to delta-10.”

At this point, Paulson and Brown both say there is some published research on delta-10, though it is minimal.

A pigeon study conducted in the 1980s by Raphael Mechoulam, a cannabis research pioneer, studied the effects of delta-10 compared to delta-9 on pigeons. The study found that delta-10 may have some psychoactive effects, but the effects are much less potent than delta-9.

However, “there’s not as much known about delta-10 in terms of the psychoactivity and its effects on the human body,” Paulson says.

Where it Comes From

Like delta-8, delta-10 can be converted in a laboratory from delta-9 or CBD, Paulson says.

Delta-10 is typically produced more predominantly through extraction or converted from delta-9 through isomerization, he says. Transforming delta-9 to delta-10 (or delta-8) is possible because they have the same chemical compounds, just different structures.

According to Extraction Magazine, extractors would waste a significant amount of time and plant material trying to extract delta-10 from natural varieties, so it is more likely produced via isomerization. Delta-10 appears in such small amounts that laboratories often misidentify the compound for [cannabichromene] CBC or [cannabicyclol] CBL using standard high-performance liquid chromatography (HPLC) methods.

“You can create any delta you want—delta-8, delta-9, or delta-10—by chemically altering CBD isolate or CBD crude,” David Reckles, president of Private Label Hemp Lab, a hemp testing and manufacturing lab in Florida, told ACS Laboratory. “If you’re using crude CBD, you’ll generally create the reaction through carbon and vitamin C derivatives. If you’re using an isolate, you’ll incorporate solvents and acids.”

RELATED: Understanding Delta-8-THC: Where Does It Come From?

Delta-10 vs. Delta-8 and Delta-9: Chemical Differences

Delta-10 is an isomer of delta-9, Brown says.

Paulson says when one begins to isolate delta-9 or, more commonly, convert THC to CBD, they’ll start to discover the additional isomers (or different classifications of THC).

“Really, all THC isomers chemically have the same basic structure,” he says. “It’s just the placement of one bond that differs between the different isomers.”

For example, as previously reported by Hemp Grower, “delta-8 has a double bond on the 8th carbon chain, and delta-9 has a double bond on the 9th carbon chain.”

Delta-10 follows the same pattern and has a double bond on the 10th carbon chain. And while this seems like a “small distinction, it’s enough to produce slightly different cognitive and physical effects,” Hemp Grower previously reported.

Brown says that a significant difference is delta-8 can essentially only produce one compound, whereas delta-10 can produce up to six different isomers (variations of the same compound).

“What we call delta-10 is really a mixture of two different types of compounds, and then within that, they might have different configurations,” Paulson says. “So, there’s just a lot of different compounds, and that’s one of the reasons why it’s so challenging to quantify accurately. So, in terms of psychoactivity, instead of having to test one compound, you have to test six.” 

Legal Status

According to ACS Laboratory, “Delta-10 THC derived from cannabis is [federally] illegal because marijuana is a schedule 1 controlled substance. However, delta-10 derived from hemp extract exists in a legal gray zone.”

And Brown agrees, arguing that the Agriculture Improvement Act of 2018 (the 2018 Farm Bill) is very “specific to delta-9,” and if a delta-8 or delta-10 product derived from hemp contains less than 0.3% total THC (defined as delta-9 THC plus tetrahydrocannabinolic acid (THCA), its acidic version), then it’s considered “legal.”

The Drug Enforcement Administration’s (DEA) response to the 2018 Farm Bill is: “All synthetically derived tetrahydrocannabinols remain schedule 1 controlled substances.”

“So, in our mind, all tetrahydrocannabinols cannabinoids are considered federally illegal,” Paulson says. “We’re not placing a judgment on that, whether it’s right to do that or not. I just think there hasn’t been a lot of legal challenges to these laws and to that point, people keep on producing delta-8 and delta-10 products….”

More than 12 states have already begun to implement delta-8 bans, while very few states, including New York, Colorado and Alabama, have started to crack down on delta-10.

And Paulson says while delta-10 may currently be “flying under the radar,” he thinks it’s only a “matter of time” before there’s increased regulation.

Read the Full Article

Cannabis Industry Leaders Speak With CLR on Current Delta 8 Issues In The Industry

Cannabis Industry Leaders Speak With CLR on Current Delta 8 Issues In The Industry

Dr. Stuart Titus, Ph.D., is an industry innovator who has been involved in the growth of many companies in the cannabis industry, and started his relationship with Medical Marijuana Inc. by becoming its seventh investor. Titus’ is also a Wall Street veteran, where he was a bond trader for 11 years. Dr. Titus earned his undergraduate degree at Rollins College, and his Ph.D. from the Open International University.

 

“We were the first to create a U.S. pipeline of hemp-based CBD products to Brazil, Mexico and other countries, and we’ve had tremendous demand for our products. As we expand this pipeline in the coming years, we really believe we’ll see economic improvement not just in the United States, but all over the world.”

Dr. Titus has been involved in the development and investment of several industry-leading cannabis and industrial hemp businesses during his most recent career. Dr. Titus developed several prominent cannabis companies, including HempMeds, KannaLife Sciences Inc, and Kannaway, LLC.

Titus’ diverse background in both finance and healthcare is the impetus behind his strong passion to help others by supporting the greater cannabis industry. A graduate of Rollins College in Winter Park, Florida, Titus majored in economics and minored in business administration. He got his start on Wall Street where he worked as a bond trader for eleven years, managing a trading and underwriting department as a V.P. for CS First Boston Corp. Titus then went on to earn his PhD from Open International University, an educational organization affiliated with the World Health Organization.

Dr. Titus holds a Fellowship with the American Academy of Pain Management and clinical association with the American Association of Integrative Medicine. He practiced as a British Physiotherapist for over fifteen years, running clinics that specialized in integrative pain management and injury rehabilitation, treating over 40,000 patients. His first-hand experience with therapeutic hemp oil products as nutritional supplements led him to Medical Marijuana Inc. and drives him to continue to support the emerging cannabis medical marijuana and industrial hemp industries in the United States and abroad.

 

 

Colorado’s MED has just banned the sale of Delta 8 in rec retail. Do you think after the new rules in OR, WA & now  CO that we will see Delta 8 regulated in every state? 

Yes, I believe that Delta 8 will be regulated at both the federal level as well as at the state level.

What are your views of the regulation of Delta 8? 

We support the Hemp Roundtable’s statements on psychoactive hemp and that it should be regulated separately from hemp, CBD, CBG and other non-psychoactive or non-intoxicating cannabinoids. Although, more like beer and wine as compared to hard liquor in the alcohol industry, we realize the immense popularity of Delta-8. We believe it should not be scheduled as a drug or narcotic, but that there should be some form of regulation to keep it from being abused.

Should we just see it as something not too dissimilar from Delta 9 and leave it be or is the fact that it needs processing to manufacture mean that it should be regulated as another compound?  

There is the federal analog rule which may have application/implication for the scheduling of Delta-8. This has not yet been enforced or brought to a court of law  and again I will make the analogy to beer and wine in the alcohol industry (equivalent to Delta-8) vs hard liquor (more equivalent to Delta-9).

We believe there is a benefit to Delta-8 but there should be labeling or warnings on packages so that consumers are informed of potential minor intoxication effects. We support Delta-8 but feel that it is not the same as CBD or CBG in that these cannabinoids should be treated as dietary supplements (if new Senate legislation passes). Delta-8 would not be a dietary supplement, but it should be available for sale in grocery stores, convenience stores and smoke shops.

Do you think these new regulations will be challenged in the courts? 

Yes, I believe there will be court cases on Delta-8 unless Congress decides to regulate ahead of any potential litigation. So far, there have been no problems (no reported adverse effects) with the sale of Delta-8, although this is quite “new” within the past few months.

Are there states that you think they’ll let Delta 8 run and be sold along with other recreational products?  

I would believe that the cannabis industry, separate from the Hemp and CBD industries, would want Delta-8 to be sold alongside its more traditional Delta-9 products. It is quite popular and will bring more consumers, especially if a state were to regulate it so that Delta-8 would ONLY be available in dispensaries. If the Federal Analogue Rule were to be more strictly enforced, then this may be the only pathway to legally sell Delta-8.

In an ideal scenario for the industry, Delta-8 would be regulated in a similar manner to beer and wine and then sold at grocery or convenience stores, as the effects and abuse potential is similar.  With Delta 9, there are greater adverse effect risks and these should be explained at dispensaries that will carry and sell such products.

As and when Federal regulation comes along, would you expect to see Delta 8 provisions written into a cannabis omnibus bill?  

Delta-8 could be part of this future cannabis omnibus bill or it may be left out and regulated separately. This depends on how far they would want to go, as hemp is a form of cannabis too.  Already, we regulate hemp separately from marijuana forms of cannabis. I have also seen a Delta-10 product and this would definitely be part of the overall Cannabis Omnibus Bill of the future as the potency of Delta-10 increases beyond that of Delta-9. If Delta-8 continues with its popularity, then it may require a separate regulation, such as “cannabis light” – again the beer and wine analogy vs hard liquor in the alcohol industry.

Delta 8 appears to be the new bogeyman of cannabis or should we say those who aren’t that keen on cannabis. What is your view of the compound, something to celebrate or not?  

Delta 8 is something to be celebrated as it takes marijuana forms of cannabis into everyday usage.  Many people chose to relax after work with a beer or glass of wine and D8 provides this slight relaxation effect within the fringes of the intoxicating cannabis arena (Delta 9).
With Delta 8, one is not going to have an anxious or paranoia episode as can be common for newcomers to marijuana forms of cannabis – especially with high concentration of THC that is readily available today. D8 may well assist with relaxation and sleep.
The enormous popularity in such a short period of time reflects changing consumer preferences and D8 provides the perfect solution to lower regulations for innovative forms of cannabis.  Here, we could easily support the federal regulation of Delta 8 just as beer and alcohol are more lightly regulated vs hard liquor in the alcohol industry. My view – this is definitely an innovation in cannabis to celebrate!

Delta-8 appears to us at Cannabis Law Report, the canary in the coal mine for new cannabis compounds. Is it important to think very carefully how 8 is regulated and managed as a template for the many other compounds yet to come?  

We used to have “medicinal alcohol” in our country, and this was only available via a doctor’s prescription during the Prohibition Era. Long-term use of alcohol is quite harmful and severe liver/brain toxicity can lead to severe health impairment. Cannabis has been stigmatized but long-term use is far less toxic to the body than alcohol. So, if we are going to regulate alcohol but allow for its sale, we certainly should allow a cannabis form of relaxation that shows far less long-term harm. With Delta 8, we have a great opportunity to finally do cannabis justice and have Delta-8 sold in a similar manner to beer and wine.

Do you think there would be such a fuss about 8 if it didn’t get people “high”?  

The slight “high” seems to be part of the appeal  but the relaxation and sleep benefits also carry broad appeal as well. But the “fuss” is largely about the huge consumer demand and the slightly intoxicating effect for sure. The States would be eager to tax its sale, but hopefully smart enough to allow for free-market activities.

How do you think the sector should start educating legislators and law enforcement about the many different compounds that are yet to be manufactured from the plant and how do we try to stay away from a new “reefer madness” over time a new compound is discovered?  

The cannabis train has long since left the station and regulators are now just trying to catch up by advancing their knowledge of cannabis and cannabinoids. In 1996, California legalized medical cannabis yet today, with 37 US States allowing for medical cannabis sales, we still do not have an overall comprehensive cannabis/cannabinoid education program. Consumers, regulators, and legislators remain in the dark on cannabis. In my testimony before the FDA, I mentioned that with the use of CBD, people anecdotally feel less stress, less nervous and better able to cope with the pressures of society today.  They also sleep better and aren’t as bothered by “Musculo-Skeletal Discomfort”.

Over time, the science and research on CBD now supports its usage as many studies are showing benefits for health as well as for quality of life. I went as far as to mention that non-psychoactive cannabinoids provide essential and vital nutrients that support our highest levels of health and wellness.

Bottom line,  there definitely needs to be more formal cannabis-based education so that we can all get up to speed with the incredible demand for cannabis products by the consuming public. The legal cannabis industry is expected to exceed $40 billion in 2021 and CBD sales should reach $5 billion. With the size of markets and tax revenue streams assured into the future, one would think that states or the federal government would provide funding or grants for those groups to educate the general public, legislators, regulators and even the medical community.  Overall, knowledge and education of cannabis are sorely lacking.

We also asked David Marelius of  Infinite Chemical Analysis labs the same questions

David Marelius, PhD. CSO

Born and raised in San Diego, Dave attended San Diego State University in 2009 where he received his bachelor’s degree in chemistry. Dave then went on to earn his Phd from the joint doctoral program between SDSU and the University of California, San Diego, where, for his graduate work, he utilized organic and organometallic synthesis to make catalysts for water splitting, the conversion of water into oxygen and hydrogen for energy storage. As a graduate student, he received the IPMI Richard Rubin Memorial Scholarship in 2014 for his research in precious metals. He decided to apply his knowledge and experience to the cannabis industry, and has assisted in developing industry- leading methods of analyses for cannabis and hemp testing since co-founding the lab in 2016.

CO’s MED has just banned the sale of Delta 8 in rec retail. Do you think after the new rules in OR, WA & now  CO that we will see Delta 8 regulated in every state ?

It’s no surprise to InfiniteCAL that Delta 8-THC is becoming more regulated every day, and we believe that it should be regulated nationwide. The products available on the market have been produced by synthetically converting cannabidiol (CBD) with potentially harmful catalysts to Delta 8-THC.

This procedure is a complex process that will also create other byproducts like Delta 9-THC and other compounds that have yet to be identified. If Delta 8-THC products are available for purchase, they need to be tested by a cannabis lab to ensure the products are safe and inform consumers what they are putting in their bodies.

What are your views of the regulation of Delta 8 .. Should we just see it as something not to dissimilar from Delta 9 and leave it be or is the fact that is needs processing to manufacture mean that it should be regulated as another compound

Delta 8-THC is a psychoactive cannabinoid, just like Delta 9-THC, and legislators should regulate it as such. It seems completely backwards that an unregulated product that gets people “high” and is synthesized in a lab can be sold at gas stations and smoke shops but naturally derived Delta 9-THC must go through rigorous safety testing and can only be sold and handled by licensed companies.

InfiniteCAL has seen cannabis products fail for high lead levels, the presence of mold, and carcinogenic pesticides. Regulators in legalized states have established guidelines to weed out these harmful products, so why isn’t the same being done for CBD and Delta 8-THC?

Do you think these new regs will be challenged in the courts?

Based on the amount of claims companies make about Delta 8-THC being federally legal, it’s only a matter of time until someone tries to challenge the new regulations in court.

However, Delta 8-THC is explicitly listed on the DEA 7370 Controlled Substance list, so it’s hard to imagine the cases ending in any other way than saying Delta 8-THC should be regulated like cannabis. 

Are there states that you think they’ll let Delta 8 run and be sold alongside other rec products?

To InfiniteCAL, selling Delta 8-THC products in licensed dispensaries makes the most sense. Based on the way it’s produced, Delta 8-THC should be batch tested to ensure consumer safety. We already see products with Delta 8-THC submitted at the state compliance level in California.

The California Department of Public Health (CDPH) regulations stipulate that any cannabinoids that make up 5 percent or more of a product must be labeled. The only cannabinoid that has a limit for how much is allowed is Delta 9-THC. Every cannabinoid has its potential benefits, so as long as it is tracked through the METRC seed-to-sale software and passes state-mandated testing, producers should be able to sell these unique products at the retail level.

As and when Federal regulation comes along, would you expect to see Delta 8 provisions written into a cannabisomnibus bill?

InfiniteCAL believes that cannabis will be federally legalized in the near future. When the time comes, these regulations must address naturally derived cannabinoids compared to synthetically derived cannabinoids. Delta 8-THC isn’t the only cannabinoid that one can create in a lab.

Regulations must be drafted in a way to prioritize public safety. More research is needed before these products become widely available at the retail level.

Delta 8 appears to be the new boogeyman of cannabis or should we say those who aren’t that keen on cannabis. What is your view of the compound, something to celebrate or not?

The alarming part about Delta 8-THC is that someone is creating it in a lab instead of it naturally occurring in the plant. One thing you hear from lobbyists and activists pushing for legalization is that cannabis is great because it’s this all-natural plant that can be used as an alternative for prescription drugs.

One of the many processes of making Delta 8-THC includes converting pure CBD isolate with a catalyst such as hydrochloric acid or sulphuric acid, to name a few, which, if not appropriately neutralized, can be very harmful to consumers. With no research or clinical trials conducted on the effects of consuming these compounds, there is an elevated amount of risk selling Delta 8-THC products. Safety needs to be the number one priority when evaluating whether or not these products should be available for purchase.

Delta 8, appears to us at Cannabis Law Report, the canary in the coal mine for new cannabis compounds. Is it important to think very carefully how 8 is regulated and managed as a template for the many other compounds yet to come?

Absolutely, with over 150 cannabinoids identified in the cannabis plant, there is no doubt that various cannabinoids will ride the Delta 8 popularity train. It’s vital to create regulation in anticipation of unique products instead of catching up after it’s available to the public. Regulators should use the current Delta 8 market as a learning opportunity to address synthetic versus naturally derived compounds, psychoactive versus non-psychoactive cannabinoids, and the necessity of ensuring consumer safety as the industry continues to develop new products.

Do you think there would be such a fuss about 8 if it didn’t get people “high”? 

Yes, Delta 8-THC would cause just as much of a fuss if it didn’t get people “high.” The issue is that it’s synthetically produced and not naturally occurring. Some chemicals potentially used to synthesize Delta 8 can be extremely harmful to consumers, especially when considering these compounds are being combusted and inhaled.

These chemicals include reagents like acids or catalysts, and consuming these compounds can cause serious illness. During the 2019-2020 vaping lung illness outbreak, there were 60 deaths reported due to Vitamin E acetate and other adulterants being added to vape cartridges. It should be the goal of everyone in the industry to take every step possible to prevent another vape crisis.

Research on whether or not new products are safe for consumption needs to be conducted prior to their availability on the market.

How do you think the sector should start educating legislators and law enforcement about the many different compounds that are yet to be manufactured from the plant and how do we try to stay away from a new “reefer madness” every time a new compound is discovered?

Based on the way cannabis has been treated in the United States, activists and researchers must take it upon themselves to educate legislators and law enforcement when new cannabinoids come to market.

InfiniteCAL is on the National Association of Cannabis Businesses (NACB) advisory board composed of other experts from across the industry. This advisory board recently announced that it adopted National Standards on Indoor Cultivation for cultivators across the country to learn about and implement the best practices for indoor cultivation. Legislators and law enforcement should work closely with the experts at NACB to understand the proposed standards and build them into future regulation.

We’d like to thank both Stuart & David for taking the time to answer our questions and look forward to approaching them again as new cannabis compounds  hit the market.

Read the Full Article

Infinite Chemical Analysis Lab