Colorado’s New Hemp Regulations Increase Contaminant Testing

Colorado’s New Hemp Regulations Increase Contaminant Testing

Earlier this year, the Colorado Department of Public Health and Environment (CDPHE) announced a plan to introduce new testing rules for the state’s growing hemp industry. Under the new regulations, hemp products must be tested for residual solvents, heavy metals and pesticides, in addition to making sure they contain less than 0.3% THC.

The CDPHE are planning on a gradual rollout to prevent any supply chain issues or a lab testing bottleneck, similar to what we’ve seen in other states launching new testing requirements in years past, such as Arizona or California. Well, the Colorado rollout appears to be hitting similar snags and because of supply chain issues related to instruments and consumables in laboratories, the implementation of those testing rules is somewhat delayed. What was originally supposed to be implemented over the summer was pushed back to an October 1 deadline, and that deadline has now been pushed back to 2022.


The pesticide testing list to be implemented January 1, 2022

As a result of supply chain shortages and the learning curve to test for such a wide range of pesticides, Colorado is opening hemp testing to out-of-state labs in an effort to stay on schedule with the rollout. Dillon Burns, lab manager at InfiniteCAL, a cannabis testing company with locations in California and Michigan, just completed an audit with the CDPHE in their work to get certified and start conducting hemp testing for businesses in Colorado.

Burns says they’re well-acquainted with the list of pesticides because of how similar the list is to California’s requirements. “For the pesticide testing rules that were supposed to go into effect on August 1st, it’s basically the same list as California just with slightly different action levels,” says Burns. “I would say these action limits are generally stricter – they have much lower LOQs [limits of quantification].”


The pesticide testing list (continued) to be implemented January 1, 2022

Come January 1, 2022, they are expecting an additional 40 pesticides to be required under the new rules. “But currently, it’s still unclear when these regulations will actually go into effect,” says Burns. The full pesticide testing list is currently slated to be implemented on April 1, 2022.

The supply chain issues referenced above have a lot to do with what the state is asking labs to test for. Previously, most of the pesticides tested for under Colorado’s adult use and medical cannabis programs could be analyzed with an LC/MS. A handful of pesticides on the new list do require GC/MS, says Burns. It’s entirely possible that a lot of labs in Colorado just don’t have a GC/MS or are in the process of training staff and developing methods for using the new instrument. “Cleanliness of these instruments is such a priority that it takes time to acquire the right skill set for it,” says Burns.


Dillon Burns, Lab Manager at InfiniteCAL

The new testing rollout isn’t just another compliance hurdle for the cannabis industry; these rules are about protecting public health. Dillon Burns said he’s seen hiccups in California with the amount of new hemp farmers getting into the space. “The hemp products we’ve tested in California often fail for pesticides,” says Burns. It’s a lot easier in most states to get a license for growing hemp than it would be for growing adult use cannabis. “You’ll see a lot more novice growers getting into hemp farming without a background in it. They’ll fail for things they just haven’t considered, like environmental drift. We see a lot of fails in CA. Hemp is bioaccumulating so it presents a lot of problems. If they’re not required to look for it, they weren’t monitoring it.”

When asked how the market might react to the new rules, Burns was confident that Colorado knows what they’re doing. “I don’t anticipate that [a testing bottleneck] happening here. The regulators are reasonable, supportive of the industry and opening it up to out-of-state labs should help in preventing that.”

Read the Full Article

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

Infinite Chemical Analysis Lab