House Lawmakers Introduce Bipartisan CBD Regulation Bills

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

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

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

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

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

FDA Sought CBD Guidance From Congress In January

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

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

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

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

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

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

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DEA Rules Delta-8 And Delta-9 THCO Are Controlled Substances

The Drug Enforcement Administration (DEA) ruled earlier this week that the cannabinoids delta-8 THCO and delta-9 THCO are controlled substances that are illegal under federal law, even if they’re synthesized from legal hemp. The two cannabinoids, which don’t occur naturally but can be synthesized from hemp, have become popular in some markets across the country, particularly in states that haven’t yet legalized adult-use cannabis. 

The 2018 Farm Bill legalized hemp and products derived from it, leading to a significant increase in the cultivation of the crop as farmers and processors sought to take advantage of consumer interest in CBD. Since then, products made with the novel cannabinoid delta-8 THC, which naturally occurs in cannabis in trace amounts and can be synthesized in large quantities from CBD, have also become popular. Last year a federal court ruled that delta-8 THC is legal when derived from hemp. Products containing the intoxicating cannabinoid have become popular from coast to coast, with availability in specialty shops, convenience stores and gas stations, among other retailers.

In 2022, attorney Rod Kight sent a letter to the DEA inquiring about the legal status of delta-8 THCO and delta-9 THCO, according to a report from Marijuana Moment. After he repeated the request earlier this month, the DEA sent a response letter to Kight on February 13, saying that the two cannabinoids “do not occur naturally in the cannabis plant and can only be obtained synthetically, and therefore do not fall under the definition of hemp.”

In the letter, Terrence L. Boos, the chief of the DEA’s Drug & Chemical Evaluation Section of the Diversion Control Division, wrote that “delta-9-THCO and delta-8-THCO are tetrahydrocannabinols having similar chemical structures and pharmacological activities to those contained in the cannabis plant. Thus, delta-9-THCO and delta-8-THCO meet the definition of “tetrahydrocannabinols,” and they (and products containing delta-9-THCO and delta-8- THCO) are controlled in schedule I” of the federal Controlled Substances Act.

In a blog post about the letter from the DEA, Kight wrote “although I don’t always agree with the DEA’s view on cannabis matters, I agree with this opinion and, frankly, am not surprised. This is what I’ve been saying for a while. I’ve been concerned about the proliferation of THC acetate ester (THCO) for a while. It has always been my view that THCO is a controlled substance under federal law. Although it can be made from cannabinoids from hemp, THCO isn’t naturally expressed by the hemp plant. It’s a laboratory creation that doesn’t occur in nature, at least not from the hemp plant.”

Shawn Hauser, a partner at the cannabis and psychedelics law firm Vicente Sederberg LLP, says that the DEA’s ruling doesn’t impact the regulated cannabis industry because of the plant’s continued illegality under federal law. The determination could, however, lead states to only allow synthetic cannabinoids under cannabis regulatory regimes rather than permitting them under hemp regulations. 

Definition Required Around Term “Synthetic” Cannabinoid

The determination is also significant because while the DEA has been clear in its Interim Final Rule implementing the 2018 Farm Bill that the agency doesn’t consider “synthetic” hemp products to be legal hemp and were therefore federally illegal controlled substances, it didn’t define the term “synthetic” as the term is applied to cannabinoids. Hauser notes that without further clarification or enforcement action, the Interim Final Rule led to confusion among the industry and consumers about the legality of novel cannabinoids that don’t occur naturally in the hemp plant.

“This federal ambiguity and a growing and innovating hemp market resulted in states taking varying approaches as to how they define and regulate ‘synthetic’ cannabinoids, and substantial confusion for industry, consumers and regulators as to the legality and safety of certain products,” Hauser says. “While this provides some long-overdue clarity as to the illegality of certain cannabinoids not naturally occurring in the plant under the Controlled Substances Act, this determination underscores the mess the DEA and FDA have created in failing to appropriately regulate both synthetic and natural cannabinoids to ensure consumer safety.”

Advocates contend that consumer and producer confusion about the legality of novel cannabinoids could be eliminated with the federal legalization of marijuana. Once prohibition is lifted and natural cannabinoids are available to the public, demand for intoxicating novel cannabinoids would likely dry up.

“Whether they’re synthetic or naturally occurring, psychoactive cannabinoids need to be regulated responsibly to protect public health and safety,” Aaron Smith, CEO of the National Cannabis Industry Association (NCIA), said in a statement. “The only way to successfully achieve that end is to finally end national prohibition, enact sensible regulations at the federal level and allow state cannabis laws continue to work across the country.”

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Delta’s Dawn

Most people over the age of 21 are familiar with the abbreviation “THC,” but odds are, many of them couldn’t tell you what it means or how it works. THC stands for tetrahydrocannabinol — it’s the compound in the cannabis plant that gives you that prototypical euphoric cannabis high. 

The cannabis plant also produces THCA, short for tetrahydrocannabinolic-acid, in the arrangement known as delta-9 THCA. However, the THCA and THC molecules can be forced into other arrangements, called isomers. Delta-9 THC, delta-8 THC and delta-10 THC are all examples of such isomers. A tiny shift in atoms means the molecules all interact with the endocannabinoid system differently, consequently producing different mental and physical effects.  

Delta-8 extract.

Delta-9 THC is mostly known for its euphoric and intoxicating qualities that lead to that classic cannabis high. Anecdotal reports clearly indicate that delta-9 THC provides consumers with a much stronger and longer-lasting effect than its isomers, delta-8 and delta-10. Delta-8 has been reported to produce a slightly relaxing high that’s short-lived and delta-10 reportedly creates a slight intoxication, but mainly helps to boost energy. But there are potential dangers affiliated with all three delta isomers.

Increasingly, brands across the U.S. are highlighting the various THC isomers featured in their hemp-based products, giving way to increased press and ensuing questions from consumers. Since the passing of the Farm Bill in 2018, CBD and hemp-based products have grown exponentially within the country’s marketplaces. Touting the myriad benefits of hemp and CBD, these products can be found anywhere from Saks Fifth Avenue to the local gas station. The heightened media attention stems from the surfacing of these unfamiliar isomers in hemp products — especially delta-8 THC. To date, hemp products have only included the cannabinoid cannabidiol (CBD), so the presence of THC isomers in hemp products has been extraordinarily controversial. 

This leads us to the most logical of questions: How are these companies producing THC isomers from hemp?

THC Isomers
Delta-8 extracted and processed in Washington state. PHOTO Gracie Malley for Cannabis Now.

Converting Molecules 

Delta-9 THC is a non-polar lipid, which is derived from the cannabis plant by way of delta-9-THCA. THC isomers can be naturally found in the cannabis plant; however, cannabis is bred genetically for the production of delta-9-THCA. This means that in order to reach high concentrations of THC isomers (as seen in many of the products entering the hemp market) a delta-9 THC or CBD molecule must undergo a process to convert the compound from delta-9 THC or CBD to delta-8 THC or delta-10 THC.

Basic chemistry, using chemical synthesis or temperature and pressure, can be applied to these molecules to manipulate one into the other. Chemical synthesis can yield much higher concentrations of these isomers at a much higher rate of efficiency than the plant naturally produces. So, hemp and CBD manufacturers are turning to chemical synthesis by using various solvents and acids to synthesize the production of these isomers for their products. 

As media coverage sheds light on these processes, industry members, consumers and governmental agencies are becoming increasingly concerned. Their collective lack of understanding related to whether operators are equipped to properly handle these solvents and acids is at the root of all of the hullabaloo surrounding isomers.

Delta-9 THC, delta-8 THC and delta-10 THC are all examples of isomers. A tiny shift in atoms means the molecules all interact with the endocannabinoid system differently, consequently producing different mental and physical effects.  

An important step in producing consumer products is ensuring that there are no harmful chemicals in the end product prior to releasing the product to market. Can these manufacturers properly remove all residual solvents from the synthesized product? Are there harmful byproducts being produced and remaining in the final product? Are these operators equipped to test for dangerous chemicals
and byproducts? 

Without regulation in the hemp and CBD market, manufacturers aren’t required by anyone to test for these residual solvents. Consumer safety is of the utmost importance, everyone surely agrees, yet customers are left unaware of the potential risks involved with these unregulated products.

Potential Risks

Risks of inhaling, ingesting or topically applying products with mid-high concentrations of solvents can result in irritation of the lungs or skin. These risks are compounded by the fact that this chemical synthesis process has jeopardized the success of local, legal cannabis markets. 

THC Isomers
Delta-8 extract.

Investigations are underway as licensed manufacturers in regulated markets have stopped sourcing locally grown THC cannabis biomass and are instead sourcing hemp CBD extract from out-of-state or international sources and converting the CBD from hemp into delta-9 THC. Not only are consumers at risk, but the local regulated cannabis industry is also at risk. Because of this shift in purchasing, small business owners are losing customers, as they’re unable to compete with hemp prices. Additionally, tax dollars that would otherwise be collected from the local suppliers aren’t going to the states they should.

By harnessing the power of chemistry, companies such as Heylo, a Seattle-based licensed cannabis processor, are creating products that highlight the positive effects of THC isomers without utilizing solvents. Heylo’s cannabis oil, The New Workout Plan, has more than 20% delta-10 THC, which is produced from delta-9 THC dominant cannabis plant material, extracted through CO2 extraction, and converted to delta-10 THC.

Some states and legal markets have quickly taken action to ensure delta-9 THC products are produced from legal and regulated sources. This will support the health of the legal medical and recreational markets, but only time will tell how the distribution of CBD and THC isomer products will be affected. Consumer safety is of the utmost importance as this industry is being built. I encourage everyone to be an informed industry member and consumer, and to find products you can trust.

Lo Friesen is an environmental chemist, product developer and botanical extraction thought leader. She’s the Founder/CEO of Heylo, a licensed cannabis processor in the state of Washington.

This story was originally published in the print edition of Cannabis Now.

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FDA Hires New Cannabis Policy Advisor

The US Food and Drug Administration could be signaling a new direction in the regulation of cannabis with the recent hiring of Norman Birenbaum as senior public health advisor at the agency’s Center for Regulatory Programs. In the position, a first for the FDA, he will advise the agency on cannabis research and regulatory policy. The FDA appointed Birenbaum, who formerly led cannabis regulation efforts in two states, on September 26.

Birenbaum is an experienced cannabis regulator, serving for four years as the head of the hemp and medical marijuana programs in Rhode Island, where he created the state’s Office of Cannabis Regulation. At the end of 2019, he was appointed New York’s first Director of Cannabis Programs, leading efforts to develop policy and regulate the state’s hemp and medicinal cannabis programs for more than two years. 

While still at the helm of New York’s cannabis oversight efforts, Birenbaum joined with cannabis regulators from 18 additional states to form the Cannabis Regulators Association (CANNRA), serving as the inaugural president of the group. As more states opted into the legalization of cannabis, the group was formed to facilitate collaboration between regulators and help stakeholders find objective data and evidence-based approaches to policymaking and implementation of regulation.

“The Cannabis Regulators Association will provide a much needed forum for regulators to engage with each other to identify and develop best practices, create model policies that safeguard public health and safety, and promote regulatory certainty for industry participants,” Birenbaum said in a statement from CANNRA when the group launched two years ago.

In his new position with the federal government, Birenbaum will be tasked with “advancing [the FDA’s] efforts related to research and regulation of cannabis,” according to an agency announcement cited by Stat

Dr. Douglas Throckmorton, FDA deputy director for regulatory programs, said that Birenbaum’s wealth of experience in cannabis policy analysis and legislative outreach will help the agency form partnerships and collaborate with policymakers and stakeholders including the healthcare community, patients and patient advocacy groups, according to a report from Financial Assets.

Birenbaum’s Appointment Widely Praised by Cannabis Community

Birenbaum’s appointment as an FDA cannabis policy advisor has been well-received by hemp and cannabis policy reform advocates. Shawn Hauser, a partner at Vicente Sederberg LLP and co-chair of the law firm’s Hemp and Cannabinoids Department, wrote in an email to Cannabis Now that his hiring and subsequent efforts could lead to further action on both marijuana and hemp policy reform.

“Given Mr. Birenbaum’s significant experience and leadership in the regulated cannabis industry, especially overseeing NY’s robust medical marijuana and hemp programs and founding CANRA, I’m optimistic that this is a very positive step forward for responsible and sensible regulation of cannabis and hemp at the federal level, including for long overdue federal oversight over CBD and other hemp-derived cannabinoids.” Hauser wrote.

Jonathan Miller, general counsel for the US Hemp Roundtable, said that the move to hire Birenbaum could signal a new willingness by the FDA to regulate CBD. Despite the legalization of hemp agriculture by Congress with the passage of the 2018 Farm Bill, the agency has still not issued regulations to allow for the legal use of the cannabinoid.

“After four years of inaction, we are hopeful that the appointment of Norman Birenbaum by the FDA signals a positive step forward for the regulation of hemp-derived cannabinoids such as CBD,” Miller said in a statement from the hemp industry trade group. “We appreciated working with Birenbaum on the development on New York’s landmark regulatory regime for hemp, and we look forward to working closely with him on the development of a regulatory framework for CBD products to ensure consumer safety and product quality across the country.”

And Morgan Fox, the political director for the National Association for the Reform of Marijuana Laws (NORML), also applauded the move by the FDA.

“Given the agency’s relatively ineffective approach to this issue over the years, it is good to see them being more proactive and bringing on people with actual cannabis experience,” Fox told L.A. Weekly. “The FDA’s work related to cannabis is likely going to increase and become more complicated in the not-too-distant future, and it should be preparing for this now by continuing to bring on additional staff with a wide array of expertise in the space.”

Birenbaum’s hiring by the FDA continues its measured pace of action on cannabis regulation. In May, the agency announced that Principal Deputy Commissioner Janet Woodcock would chair the agency’s Cannabis Products Council, an intra-agency group tasked with working on cannabis product policy, enforcement and outreach issues, as well as helping the FDA implement a data collection plan for cannabis products.

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Science Confirms: You Can’t Get High on CBD

Can CBD get you high?

It’s not quite right to say that CBD—or cannabidiol, which, after THC, is the best-known and most abundant cannabinoid (“active ingredient”) found in the cannabis plant—isn’t “psychoactive.” Of course, CBD has some effect on the mind; if it didn’t, why would CBD, which adherents say helps alleviate brain-powered problems including insomnia and anxiety, be so popular?

What is right is to say is that unlike THC, CBD is “non-intoxicating.” In fact, CBD is non-intoxicating to a such a degree that you can consume great gobs of the stuff and still be relied upon to safely operate a motor vehicle, according to a recent study.

So, can CBD get you high? No. However, this isn’t to say that CBD isn’t without some risks, biological as well as legal. Depending on what CBD formulation a patient is using, and depending on what state they’re in, they may indeed be able to operate a motor vehicle without any issue while on an epic amount of CBD — while still running the risk of a “cannabis DUI” charge. And depending on what other pharmaceuticals and other drugs a patient may be taking; CBD does carry some risks.

Safe at any Speed

In this most recent study, researchers in Australia—where doctors have written more than 55,000 prescriptions for medicinal CBD since medical cannabis was legalized in 2016—gave doses of either a placebo or synthetically derived CBD ranging from 15 milligrams to 1,500 milligrams to 17 study participants. Each participant was then asked to perform basic tasks in a driving simulator between 45 to 75 minutes after taking their dose, and then again between 3.5 to 4 hours later.

And, according to findings published last month in the Journal of Psychopharmacology, even a massive, prescription-only dose of CBD “has no impact on people’s driving or cognitive abilities,” as the University of Sydney, where the lead researchers are employed, reported in a news release.

The question of can CBD get you high? has been answered: Not only did the study participants report no feeling of intoxication, but they also exhibited no signs of intoxication whatsoever.

These findings are consistent with past research, and they “suggest that unlike some other drugs, CBD can be used without the risk of being unable to operate a motor vehicle,” said Danielle McCartney, the lead researcher and a professor at the University of Sydney’s School of Psychology. “This could certainly make CBD more appealing than other therapies to some patients (e.g., those with jobs requiring them to operate heavy machinery).

Previous research found that low doses of vaporized CBD also had no impact on driving ability. But the CBD used in the study isn’t the CBD most people are using.

What’s in Your CBD?

In Australia, it’s already legal for consumers to drive a car while using CBD. The same is true in the US, where neither state nor the federal government imposes any limits on how much CBD can be in the human body while operating a vehicle.

But the same isn’t true for THC. In theory, it’s possible to consume enough CBD oil to trigger a positive result for THC in a drug test, as well as exceed the “per se” limit for cannabis intoxication in states that still have a per se limit.

That’s because in the US, “hemp” is classified as cannabis with 0.3 percent or less THC. While formulations and ratios will vary—and while product quality and consistency are issues that continue to bedevil the CBD industry—what this means is that a CBD product will likely have some THC, and the larger a dose of CBD, the larger the potential dose of THC.

While that still probably won’t be enough THC to create any kind of intoxicating effect, or at least an effect that the user would recognize as THC-driven intoxication—in part because CBD is a THC agonist, and tends to ameliorate or even eliminate THC’s psychoactive properties—patients in a situation where a drug test could trigger loss of employment or housing should be aware of the risk of a positive drug test, said Dr. Sherry Yafai, a Santa-Monica, CA-based physician and board member of the Society of Cannabis Clinicians.

“It’s really important to highlight that,” Yafai told Cannabis Now. “I bring this up because I do have patients who test positive for THC after using a CBD product, and then get booted out of their pain-management doctor’s office.”

Yafai, who wasn’t involved with the Australian study, was also surprised that study participants reported “no lethargy or sleepiness” even at high doses. “That’s a little bit strange,” she said. “Practically speaking, a 1500 milligram dose will make most people tired for a couple of days.”

That said, this latest study is the latest demonstration of what should now be accepted as gospel: CBD is non-intoxicating.

“That’s been shown over and over again,” she said. “CBD shouldn’t be considered a drug of intoxication.”

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Are Delta-8 THC Products Actually Dangerous?

Last Tuesday, the federal Centers for Disease Control and Prevention and Food and Drug Administration published a warning to the public “regarding the potential health risks of using Delta-8 THC products.”

Part of their reasoning for putting out a statement was due to “an uptick in adverse event reports to the FDA and the nation’s poison control centers.”

Questionable Side Effects

Cannabis isn’t supposed to give you a hangover. But that’s exactly what the Delta-8 THC gummies—purchased from a gas station, copped at a smoke shop, or ordered online —did to one of Greg Gerdeman’s friends.

“They took one and felt totally hung over the next day,” recounted Gerdeman, a biochemist and researcher and member of the Society of Cannabis Clinicians. “They were like, ‘What was that?’”

Investigating that question is what interests Gerdeman. As a “lesser known” cannabinoid, known to science for decades, Delta-8 THC—now famous and in vogue in the past year, since it can be derived from hemp, and thus federally legal—is safe and therapeutic. So that wasn’t the problem.

The culprit, Gerdeman suspects, was whatever else was in the gummy: Impurities, possibly, like residual solvents from the chemical synthesis process in which CBD isolate is converted to Delta-8 THC.

Or something else entirely different, like one of the still-unknown isomers created during that process.

As for exactly what that was, and what it could do to the human body? Nobody knows. And that, along with a high probability for contamination with toxic solvents, is the problem with Delta-8 THC products. According to Gerdeman and his SCC colleagues these dangerous unknowns are an enormous potential liability for the burgeoning hemp industry, for which Delta-8 THC products are of vital importance.

Consensus For Concern

Since former President Donald Trump signed the 2018 Farm Bill into law, legalizing hemp cultivation and production in the U.S., the hemp industry has grown by leaps and bounds, but has largely failed to find profitable traction. In late 2019, with hemp companies overproducing and extraction companies sitting on mounds of unsold CBD isolate, a savior appeared in the guise of Delta-8 THC.

Molecularly very similar to Delta-9 THC found in adult-use cannabis (and banned by the federal Controlled Substances Act), Delta-8 THC acts on the brain and body in a similar fashion. And conveniently, can be derived from CBD isolate via a relatively simple chemical process.

But the cannabis industry has moved faster than either regulatory agencies or researchers. Late last month, the SCC—which includes other respected cannabis researchers such as Dr. Ethan Russo—released a “consensus” paper on Delta-8 THC products.

Untrained Chemists, Unknown Compounds

According to the SCC, the “untrained garage chemists” that are making Delta-8 THC products—which, with few exceptions, are not regulated by states and are not marketed or sold with any assurance of potency or quality control—may be selling products contaminated with solvents like the “light hydrocarbons” used in the extraction process.

More troubling, perhaps, is the science experiment Delta-8 THC product users are conducting on themselves—knowingly or not. According to the SCC, the conversion process creates “a number of molecular isomers that do not exist in nature” and that have yet to be fully identified in lab analyses.

And “we have no knowledge” how these “unidentifiable… isomers behave in the body,” according to the SCC’s consensus statement. Do they cause hangovers? Will they interact poorly with other drugs? How much of them are in Delta-8 products made from CBD isolate with 80 percent purity? These are questions consumers should ask, but product makers themselves likely have no idea.

“What’s most often underappreciated and completely glossed over in all of the sort of bubblegum ‘What is Delta 8’ stories out there, are the impurities that are created by the synthetic process,” Gerdeman said. “The fact that it can be done so cheaply and with a lot of side products that are completely unknown to nature… that’s what I am mostly concerned with.”

“I’m not concerned about Delta 8 as a molecule,” he added. “We know very well cannabinoids are remarkably safe and therapeutic molecules.”

“What I am most concerned about is, chemists are cooking together products and they’re able to sell their work in the public marketplace when it’s only met internal controls,” Gerdeman said.

Hemp Industry Aware

While Delta-8 product makers claim their wares are safe and pass muster, hemp advocates are aware of the issues raised by the SCC.

“Truly it’s something that has never been in the food or supplement supply chain, and that’s a problem from a regulatory standpoint,” said Bob Hoban, a Denver-based attorney who specializes in the hemp industry and has advocated for hemp legalization. “These new isomers are not found in trace quantities in hemp seed oil, or hemp seed, or anything that was previously allowed under federal law.”

“That’s concerning to the public, and it should be,” Hoban added.

Though there are examples in medical literature of dangerous and potentially deadly interactions with CBD products, there are no such examples yet of a Delta-8 product causing health problems. This could partially be because Delta-8 is still so new.

For years the federal government has pondered product-safety standards for products containing hemp derived CBD. The federal Food and Drug Administration may add Delta-8 products to regulations and may issue regulations Delta-8 product makers don’t like if Delta-8 product makers fail to self-regulate.

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Meet THC-free: The Latest Innovation from Dosist

Transparency, quality, innovation and trust are four of the most important cornerstones of building brand loyalty. And in the realm of cannabis, this sentiment is paramount. Companies that provide education and innovation with their product portfolios are the brands that see repeat customers and hold on to coveted positions at the top of the game. 

Dosist is one such company. Founded in 2016, the modern wellness company is globally recognized for their dose-controlled cannabis therapy, used to help people manage their health and happiness. According to Gunner Winston, CEO of dosist, the company’s fundamental premise is improving people’s lives. The team works hard to destigmatize the negative stereotypes around cannabis and cannabis consumers, breaking down decades of the ‘reefer madness’ reinforcement around cannabis prohibition.

“Cannabis is such a wonderful plant that we owe it to the world to make it more understood and more trusted. That’s really important,” Winston said.

Trust and Transparency 

Dosist is a lifestyle performance brand, meaning “when you sleep better, you perform better the next day,” said Winston, explaining that when people are able to find time to relax, whether it’s at night or during the day, they can consequently perform better in their endeavors. 

“People need to realize that controlled amounts of cannabis can be very helpful to your life,” he said. “Our goal is to really take cannabis, which is this gift from Mother Nature, and then make it accessible and more powerful to everybody.” 

Dosist focuses on providing customers with education around the benefits of cannabis, rather than marketing its products.  

“Cannabis can be an absolutely wonderful and powerful experience for so many different people. Dosist helps people know that it’s OK to step inside this category. Then, once you’re here, there are a variety of other products in the category.” 

Product Innovation 

For nearly five years, dosist’s proprietary pen has been delivering dose-controlled, THC-powered cannabinoid therapy via disposable vape pens, each one finely tuned to meet customer needs.  

And as cannabis continues to evolve, so too has dosist’s product portfolio. To meet the needs of cannabis consumers, dosist developed an innovative line of consumption verticals including a new range of wellness-focused sublingual drops. The drops, available in sleep, calm, and relief, are offered under their new label, dosist thc-free, marking dosist’s official entry into the CBD marketplace. To provide ease of access to customers, dosist also launched its first e-Commerce platform, which ships the THC-free line nationwide. 

In true dosist style, cannabinoid therapy has been taken one step further with the addition of more isolates, including CBG and CBN, to its hemp-derived thc-free blends. Additionally, a proprietary self-microemulsifying drug delivery system (SMEDDS) enhances the formula’s bioavailability to increase the drops’ efficacy and efficiency.  

“Consumers want different consumption options, and they want different formats,” Winston explained. “Some people appreciate the benefits and fast-acting elements of inhalation. Other people prefer an edible. Some people that prefer not to ingest anything at all will want a topical. We try to bring innovative and differentiated controlled products to the market to give consumers more accessibility and choice.” 

Winston believes fundamental obstacles exist for people who might be interested in cannabis but are “nervous about THC, and who might prefer THC-free products.”  

A range of gummies that utilize the company’s nanotechnology will first be introduced in California in the new year, and then rolled out across the country in both THC and THC-free options. 

Issues around pollution and waste in the cannabis industry need to be addressed by all manufacturers to create a more sustainable sector. Dosist recognized this as an opportunity for innovation and developed a new rechargeable pen — the dose controller – to sit alongside their original disposable pen and other products on dispensary shelves in California, Canada, Nevada and Colorado. 

The Importance of Regulated Products 

It’s no secret that the vape crisis of 2019 made a lot of vape pen enthusiasts nervous about their chosen method of consumption. Black market THC products created a public health problem that resulted in 60 deaths and more than 2,711 hospitalized cases reported from a vaping-related pulmonary illness, which swept across the country. The situation was a tragic reminder that while everyone may not agree with the finer details, regulated markets give consumers access to safer products. 

“These kinds of things happen when governments continue to allow unregulated markets,” said Winston, who believes responsible regulations are important. 

“If you don’t have regulated products, and you’re putting something in your body, it’s very, very risky,” he said. “People are going to find a way to use cannabis. It’s been shown. So, stomping out the illicit market in favor of a regulated market is really, really important.”

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How CBD Oil Can Result in a Failed Drug Test

When most people think about getting drug tested for a job, they tend to think the test is looking for drugs like cocaine or cannabis. They might assume that hemp-derived CBD oil purchased over the counter from a convenience store won’t cause any problems, given it’s not supposed to contain any THC. But is it safe for someone to use CBD-rich products derived from hemp (with 0.3% THC or less) before a drug test? In reality, it’s risky, though the reasons why are complicated.

In order to understand the conundrum, it’s important to understand what the drug tests are looking for. Tests look for the analytes of drugs, rather that the presence of the drug itself. So, instead of testing for “cannabis” (which contains over 100 cannabinoids), tests look for just two of the cannabinoids: THCA and THC.

Tests aren’t looking for CBD, but given that there is currently no FDA regulation on CBD products (except the seizure drug Epidiolex), there’s no certainty that hemp-derived CBD oil is actually THC free. And over the past few months, reports have surfaced that people in multiple states have been fired or not hired due to testing positive for THC after using CBD-rich hemp products.

Guy DuBeau, a Wisconsin-based attorney who has written legal advice for people whose CBD usage resulted in a failed drug test, said that a big reason these failures happen is because hemp-derived CBD products are not regulated.

“You are getting companies importing stuff that is supposed to test as hemp, but it actually tests at three to four times the amount of THC it should have,” DuBeau said.

Annie Rouse, co-founder of the online CBD shop Anavii Market and a member of the Hemp Industries Association’s board of directors, agrees that regulation is the way to go.

“This is something we need to figure out on the federal level so people can actively take CBD,” Rouse said, adding that she has been “in conversations with Sen. Mitch McConnell’s office,” specifically about the issue of raising the testing limit for THCA on Department of Transportation drug tests.

PHOTO Canna Obscura

Currently, the Department of Transportation mandates a very low testing limit of 50 nanograms of THC per milliliter (ng/mL) of blood. Rouse has proposed to McConnell’s office that the department raise its testing limit to mirror the World Anti-Doping Agency (WADA), who does the drug testing for Olympic athletes. In 2013, WADA increased its testing limit to 150 ng/mL of THC.

“I am a small person and I take 100 milligrams of CBD a day,” Rouse said. In that dose of CBD, there’s a small enough amount of THC where Rouse said she “would fail a drug test by the [Department of Transportation], even though I am not actually taking THC and not being intoxicated by it.”

An individual’s body type and metabolism matter, too. “If you have more muscle and less fat, cannabinoids will not stay in your body as long,” said Rouse.

None of the experts Cannabis Now spoke to could say if the method of consumption of hemp-derived CBD, including edibles, topicals, tinctures and vapes, would affect test results,

Ultimately, the experts recommended that if you are using high doses of CBD products that contain trace amounts of THC, you should discontinue use at least a week before you anticipate a drug test to minimize the risk of a false positive. Rouse suggests that if you get one, request “a confirmatory test,” which does a better job of distinguishing between different cannabinoids, but also has a lower limit of 15 ng/mL.

Given the prevalence of this issue, Rouse’s home state of Kentucky is currently considering a bill, which, if passed, would give CBD users in that state protections in hiring and firing. However, as Rouse said, the drug-testing reform and CBD regulations would have to be enacted at the federal level, not just in the states, before people can consume hemp-derived CBD worry-free.

TELL US, has CBD ever given you a false positive on a drug test?

Originally published in the print edition of Cannabis Now. LEARN MORE

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Safer CBD Products & Education are Key for Cannabidiol Life

Education and transparency are key when you’re looking for new CBD brands. The rise in popularity of the non-psychotropic cannabinoid in recent years has seen an unregulated market flooded with inferior products that aren’t rigorously testing. Cannabidiol Life wants to help educate you, the consumer, on how and why the cannabinoid can be utilized as a health and wellness supplement and why you should consider purchasing from their extensive range of quality, full-spectrum CBD products.

Cannabidiol Life is more than just another company selling hemp-derived CBD products. They pride themselves on being a reliable, trustworthy resource for hemp consumers, wholesalers and distributors alike. They believe in transparency and safety — that people should know what they are buying before doing so.

Florida-based Cannabidiol Life started off as a CBD educational website in December 2016 and was used by the National Hemp Association as the go-to source for “CBD Education & Product Guides.”  The company shifted gears in 2017 and launched their own products with a simple philosophy: people, planet, profit.

People: Help and take care of people first… always. Cannabidiol Life has created the “Hemp For Hope Foundation” (a non-profit organization), providing free CBD capsules to those with proven/diagnosed medical conditions.

Planet: Take care of our planet. Hemp is a renewable, natural resource that will help preserve our planet for future generations; if we utilize it to its fullest potential. They have also added solar energy to their Florida facility as part of their green initiative.

Profit: Only after the first two are emphasized and acted upon first, can a company truly profit.

Their mission? To provide easy and informed access to the highest quality hemp-derived CBD products at the very best price.

“We always put others first and this is something we don’t just speak about, we live by it,” says Chris Visser owner and president. “It is the foundation of everything we live by and stand which is our current formula for being the difference we want to see in this world.”

Cannabidiol Life adheres to strict practices of production that keeps the consumer safe.

All their products are rigorously tested using an in-house 2019 high-performance liquid chromatography (HPLC) cannabis potency testing machine. A patented hemp extraction method helped Cannabidiol Life take home the “Best CBD Capsule” award at the 2018 CBD Expo. Additionally, Cannabidiol Life is USDA certified organic, FDA registered and GMP certified.

Knowledge is power, so Cannabidiol Life has included a comprehensive CBD education database on their website. From CBD 101 to explaining the difference between broad spectrum and full spectrum CBD products, dosage advise and product guides, if you have a question, you’ll likely find the answer here.

Cannabidiol Life has a product for all your CBD needs. Topicals include massage oil, facial serum, bath bombs and body butter. If ingestibles are your thing, you can choose from gel caps, bottled water, infused chocolate and a variety of mouth-watering gummies. Tincture fans can choose from various potencies of CBD oils, plus CBD oils with added CBN or CBG isolate. Additionally, there is a range of products for vape users including CBD pens, vape refills, as well as pet products and more.

Plus, use the code CannabisNow30 at checkout to receive 30% off your purchase.

Your health and your quality of life is important to Cannabidiol Life, especially in a non-regulated industry where harmful products are being sold nationwide.

TELL US, what’s your favorite way to consume CBD?

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3 CBD Salves for First-Time Users

In the already-saturated CBD ointment market, here are three hemp-based CBD salves, reviewed with the first-time buyer in mind.

We all need a little salve in our lives. Whether we’ve sprained an ankle, bruised a hip or just slept crooked on a large throw pillow, our bodies continually experience distress. Combine those aches with age and we can begin to feel forever inflamed.

Here’s what we concluded after we tried three new-to-us hemp CBD salves.

1) Salvation CBD Skin Salve by Inesscents $14.99

FOR THE TRAVELING HEART. Inesscents is notable right away for the standards and principles they claim to be upholding, including making their products and salves from all organic ingredients. Their salves are made from a long list of flowers and herbs we recognize and can actually pronounce, with no weird fillers or peculiar additives.

The company is also a B-Corp, certified as a fair trade company and supportive of philanthropic efforts throughout the farming community. The customer service was also impeccable, as they sent HEMP an email with all the necessary third-party testing results (per batch) and certifications showing their commitment to a quality product.

About the salve: The CBD travel stick, or “salvation CBD skin salve,” has an easy applicator — think a super-wide tube of lip balm — making for a clean coating on your skin, without messy fingers.

The sticks come in three separate remedies, each with its own color and smell. The green salve has the most mellow pungency, while the orange and red have more flavorful odors of cloves and peppermint.

The red “Hot Freeze” was our favorite in the bunch, as it left the cool feeling of ice, but warmed up after several minutes to provide long-lasting relief. It’s perfect for a kinked neck or sore back. This was our favorite all-around rub because of the integrity of the brand, amazing customer service, easy travel applicator, overall relaxing properties and all-organic ingredients.

SPECS: 0.5 ounces per stick with 40-50mg CBD.

2) Plus CBD Oil $35.95

Plus CBD Oil Balm HEMP

CLEAN AND PROFESSIONAL. The mild, earthy scent of Plus CBD Oil’s original salve is more mellow than the other brands reviewed. Perhaps as a consequence, we didn’t feel as much relief or icy-hot feel as when using the other two brands.

Plus CBD Oil is a big player in the industry; they’re a bestselling hemp CBD/phytocannabinoid brand and currently rank in the top 10 of all supplements sold over the last 52 weeks (according to SPINS data analytics, who compiled barcode purchase data). By contacting their marketing department, HEMP was able to obtain third-party certifications via our product’s batch number for all of their European-grown hemp, which was extremely helpful.

Although their CBD and hemp pass the test, we were a bit disappointed that none of their products are certified organic and a few of the ingredients sound like a list from a chemist, rather than ingredients in a skin care product. However, no heavy metals or additional residues were added after their CO2 extraction process.

The natural scent was pleasant for day or work-time applications and less harsh on the eyes if you use it on your neck. This salve would be better suited for massages and before bed as it won’t make your sheets or body smell unreasonably minty. For increased soreness, we would have enjoyed more menthol to create that soothing cooling feeling.

SPECS: 1.3 ounces with 50mg CBDA/CBD.

3) Ova Muscle Rub $19.99

Ova Hemp Muscle Rub

LACKING TRANSPARENCY. Innovative’s Ova Muscle Rub had the most powerful scent and produced a very similar effect to the popular Biofreeze gel, with camphor and menthol crystals for alleviating pain. Of the three brands we tested, it offered the strongest pain relief.

It’s a shame that this brand was incapable of producing any third-party certifications for their hemp or CBD products. They claim on their website to use organic hemp from the EU with all organic ingredients, but we were unable to get any test results after numerous calls and emails. We really enjoyed the effects of the product, but have a hard time granting the salve our full stamp of approval without receiving any details on their extraction process or organic claims. The only test results we saw on their website are from 2015 and, when we mentioned that to a service rep on the phone, they seemed puzzled. We hope to revise our statements regarding this brand in the future, but as of now, we can’t fully endorse it.

SPECS: 0.5 ounces with 70mg of supercritical CO2 extracted cannabidiol from hemp.

This article was originally published in HEMP.

TELL US, what do you think about topicals?

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