What Are Health Risks of Vaping CBD?

By Roger Chriss, PNN Columnist

An outbreak of lung illnesses linked to vaping is raising important questions about the safety of vaping cannabis products. The cause is still unclear, but the CDC reports about 76% percent of the patients who became ill vaped products containing THC – the psychoactive ingredient in cannabis. Only about 17% reported vaping a cannabidiol (CBD) product.

At present, very little is known about CBD vaping safety. The World Health Organization’s 2017 report on cannabidiol looked at oral, sublingual and intranasal routes of administration. When the WHO wrote that “CBD is generally well tolerated with a good safety profile,” it was not considering vaping at all.

The Food and Drug Administration still considers CBD in food and drugs sold commercially to be illegal, unless the product falls under the Food, Drug and Cosmetic Act. Vaping CBD does not, and so there has been no testing or regulatory action.

There have been no good human studies on CBD vaping. Research generally looks at CBD in edibles and liquids, or smoked using traditional means.

It is not known what happens to CBD under vaping temperatures, if there are thermal degradants, or important chemical reactions between CBD and other ingredients in vaping liquids or other drugs.

A recent lung tissue study found concerning results about inhaling CBD while using steroids. CBD helps reduce inflammation, but “acts as an antagonist with steroids, overriding the anti-inflammatory potential of steroids when used in combination.”

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Last year Vice reported on public health warnings in North Carolina after 90 people became sick with headaches, nausea, hallucinations and other health problems after vaping CBD products. Adulterants appear to have been the problem, and Vice noted that vape oils are poorly regulated and sometimes contain chemicals that “when heated in a vape and inhaled, can cause serious lung irritation.”

A recent study on the quality of CBD liquids used in e-cigarettes is also concerning, finding that “the quality control of manufacturers and the relative safety of these products is uncertain.”

An AP investigation last month found that in lab tests on 30 CBD vape products, ten samples contained synthetic marijuana such as K2 or spice, while others had no CBD at all.

Some states with legalized cannabis do require testing of CBD vapes. But it’s not clear what to test for, and even the lab methods for testing have yet to be validated. It is also not known which cutting agents, adulterants and contaminants should be cause for concern. Lung tissue is fragile, vulnerable in ways the GI tract is not, and not well studied. So testing regimes may ultimately require information we currently lack.

Oversight of cannabis testing is limited. California’s Sequoia Analytical Labs was found to be falsifying lab results last year. Plus, many CBD vapes come from the gray or black markets, or are home-brewed, making attempts at quality control irrelevant. As a result, CBD vaping safety is an open question, assuming it is even possible to make a safe CBD vape.

Fortunately, new research may help. Researchers are testing vaporized cannabis extracts on rats. This will allow for studying the effects of THC and CBD in animal models in a way that closely mimics human behavior.

Such information is urgently needed. Animal studies on vaping are raising concerns about lung cancer risk, but such research may not be representative of how humans vape, limiting their value.

There is ongoing debate on what CBD is good for. And now we also have to consider how CBD should be administered. It may be possible to create a low-risk CBD vape product. But at present we don’t really know how to do it.

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Roger Chriss lives with Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society.

Roger is a technical consultant in Washington state, where he specializes in mathematics and research.

The information in this column is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Has Vaping Hysteria Gone Too Far?

By Anna Maria Barry-Jester and Jenny Gold, Kaiser Health News

On Sept. 16, Tulare County in California announced the nation’s seventh death from vaping-related illness. Its advisory warned about “the dangerous effects of using electronic cigarettes, or e-cigarettes.”

As federal and state health officials struggle to identify what exactly is causing the deadly outbreak, vaping advocates are stepping into the void and crafting an alternative narrative that is being echoed broadly in online communities.

The people getting sick, according to their version of events, all vaped THC — the psychoactive ingredient in cannabis — using products bought on an illicit black market. They also contend federal officials have seized on the crisis to crack down on a nicotine vaping culture they don’t appreciate or understand, a culture proponents insist has helped them and millions of others quit smoking.

As of Oct. 1, the federal Centers for Disease Control and Prevention had identified more than 1,000 cases of vaping-related lung illness in 48 states. Eighteen people have died, including two in California. Of the 578 patients who have reported using specific products, most said they had vaped THC, but a significant portion — 17% — said they had used only nicotine.

CDC officials maintain they can’t identify one product or chemical culprit, and while they recently began emphasizing the risks of vaping THC, they continue to warn against any vape use at all.

Meanwhile, cities and states have responded with a divergent mix of warnings and bans. Michigan, New York and Rhode Island have moved to ban most flavored nicotine vaping products. The California Department of Public Health recently warned against all vaping devices, and the governor of Massachusetts issued a four-month ban on all vaping products.

The actions have sparked a backlash among hundreds of thousands of people who say they’ve been vaping for years without a problem. Compounding their distrust: the political calls to ban flavored nicotine products even though the vast majority of illnesses identified appear to involve people who were vaping THC.

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They see a government out to quash nicotine vaping because its popularity with teens has caused a public outcry, ignoring the adults who find it a pleasing alternative to cigarettes. When it comes to vaping, they have stopped looking to the CDC for advice.

Debbye Saladine-Thompson is a registered nurse in Michigan who was a smoker for 32 years before she switched to vaping. She now manages the Michigan Facebook page for Consumer Advocates for Smoke-Free Alternatives Association (CASAA), a nonprofit that advocates for access to e-cigarettes and receives industry funding.

“I do not trust the CDC. Not anymore” Saladine-Thompson said. “I cannot trust an agency that says the product that I and so many people have been using for 10 years and hasn’t caused one death is now causing hundreds of illnesses. No, I do not believe that.”

Online vaping forums are roiling with accusatory messages suspicious of the government response. In Facebook groups, including one called ‘BLACK MARKET THC CARTRIDGES CAUSED THIS QUIT LYING ABOUT VAPOR PRODUCTS,’ vapers have expressed outrage over the bans on nicotine products while cigarettes remain readily available. They’re organizing phone calls to legislators and rallies at state capitols.

“We’re living and dying by these decisions,” said Kristin Noll-Marsh, the member coordinator for CASAA who moderates the group’s national Facebook group. “This vaping panic of 2019 is gonna go down in the history books as being like flat Earth, bloodletting and burning witches.”

CDC Messaging Criticized

Throughout the outbreak, the CDC has said that people who vape to quit smoking should not return to cigarettes. But the emphasis on all vaping devices drowns out that warning, said Dr. Michael Siegel, a professor at Boston University and proponent of e-cigarettes as a smoking cessation tool.

“In an outbreak investigation like this one, you have to be as specific as possible if you want people to listen. If you say ‘Just don’t vape,’ that’s not telling anyone anything they don’t already know.”

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Many also are critical of the messaging used by the CDC, states and some media outlets, saying they are out of touch with vaping culture and its terminology. Public officials often use one word — e-cigarettes — to describe what to people who vape is a wide range of products with different names.

People who see headlines about illnesses linked to “e-cigarettes” may not know it applies to them, said Jim McDonald, a journalist with Vaping360, a consumer news site. “Cannabis vapers don’t use the term e-cigarettes. They never, never use that term.”

Even among e-cigarettes, a term many equate with nicotine delivery devices, people differentiate between cartridge-based devices like Juul and the handheld “mods,” which tend to be larger and produce more vapor. E-liquids can come prepackaged in ready-to-use form or can be mixed in stores or at home. Whether cannabis is legal and regulated also varies among states.

The problem with the alternative narrative, say doctors who are treating patients, is that it’s not clear whether only illicit THC is to blame. Dr. Dixie Harris, a critical care pulmonologist with Intermountain Healthcare in Utah, has been reporting five to seven cases a week for the past six weeks. While many patients have reported using illicit THC, she also has had patients who have fallen ill after using products purchased at licensed medical dispensaries in states where cannabis is regulated.

A new study looking at lung tissue samples from 17 patients found the damage resembled chemical burns and included two samples from people who fell ill before the outbreak. The findings cast doubt on a popular theory that vitamin E oil, which has been used as a thickening agent in THC oil, is the culprit.

The investigation is challenging on many fronts. Vaping — both legal and illicit, nicotine and cannabis — has exploded in the past few years with little regulation. There are hundreds of products, do-it-yourself kits and home brews. The potential culprits are many: popular flavorings in nicotine vapes never tested for inhalation. Oils used to dilute THC. Contaminants. Pesticides. Possible toxic residue from the containers themselves.

The CDC is grappling with a dearth of information. The process of alerting the many agencies and entities involved — doctors, hospitals, law enforcement, public health departments — has been slow.

Among 86 cases in Illinois and Wisconsin, where the outbreak first was identified and investigators are further along in their work, people reported using 234 different products involving both nicotine and cannabis, according to a report published last month. Those products, in turn, involved a variety of brands, numerous supply chains and packaging without listed ingredients.

Dr. Anne Schuchat, principal deputy director of the CDC, said the agency wasn’t narrowing the investigation only to cannabis, stressing it needed to “have an open mind” to understand the possible risks.

“Personally, with all the data that I’ve been seeing,” Schuchat said Friday, “I don’t know what ‘safe’ is right now.”

Kaiser Health News, a nonprofit health newsroom whose stories appear in news outlets nationwide, is an editorially independent part of the Kaiser Family Foundation.

The Risks of Vaping THC

By Roger Chriss, PNN Columnist

An outbreak of vaping-associated pulmonary illness is getting national attention. Over 800 people have been sickened and 12 have died.

The CDC reported last week that vaping products containing tetrahydrocannabinol (THC) -- the psychoactive compound in marijuana – were involved in 77 percent of the illnesses. Several states responded with bans on vaping products and health alerts on vaping THC.

What do we know about the risks of vaping?

Vaping THC is so new that there is very little research. An animal study on vaping THC was published earlier this year. Performed on male and female rats, the study found that “repeated THC vapor inhalation in adolescent rats results in lasting consequences observable in adulthood."

Specifically, both sexes became tolerant to THC and male rats ate more. Interestingly, THC use did not change oxycodone self-administration in either sex, but increased fentanyl self-administration in female rats. There is no mention of lung effects.

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While vaping with e-cigarettes is relatively new, inhaling THC via cannabis smoking is old. And there is an extensive literature on multiple harms.

A recent study of nearly 9,000 people found that regular cannabis use was significantly associated with greater risk of respiratory diseases such as asthma, chronic obstructive pulmonary disease (COPD) and pneumonia. The study used blood work to confirm use and had a control group, making its results more reliable than a simple population survey.

According to the National Institute on Drug Use, cannabis smoke contains multiple carcinogens and inhalation causes lung inflammation, increased airway resistance and hyperinflated lungs, a symptom of COPD

Josh Bloom at the American Council of Science and Health writes that the solubility and boiling point of THC and CBD in cannabis vaping products may play a role in the lung illnesses.

But complicating matters is the presence of other subtsances in vaping liquids and in the devices themselves. A newly published study in Scientific Reports on aerosols in tank-style e-cigarettes found levels of chromium, lead and nickel, all known carcinogens, in excess of OSHA permissible exposure limits.

Most cases of vaping-associated pulmonary illness involve illicit products. But one fatal case in Oregon involved someone who bought vaping products at two state-licensed cannabis dispensaries.

Some vaping illnesses involve people who report no use of THC products at all, though investigators are finding that these self-reports are not necessarily accurate. According to STAT News, eight patients in Wisconsin initially said they didn’t use THC products, but were later found to have used the drug.

In other words, we may not know what people were really vaping. Given that vaping THC is federally illegal and only marginally regulated in states where cannabis is legal, investigating the role of THC in the vaping outbreak is challenging.

But the emerging risks have led states like Washington to ban all flavored vaping products. And the FDA has asked the DEA to pursue criminal charges against anyone who sells illicit vaping products.

For patients who use cannabis products for pain relief, there are better alternatives than vaping. The Arthritis Foundation recently released new guidelines that recommend CBD oils and tinctures that can be taken orally.

It is not clear what this means for the cannabis industry. But Joe Tierney, known as the "Gentleman Toker,” told the Washingtonian that he would be shutting down his cannabis website.

“I don’t feel good about the industry any longer,” Tierney said. “I don’t think it’s safe to consume cannabis anywhere after all of my travels.”

Sorting out the risks of THC vaping will take time. At present there is only circumstantial evidence and intriguing ideas. It is possible that THC is one of several different causes or is just guilty by association. Beyond that, we have the unknowns of vaping itself, which may be too novel for anyone to fully understand the risks.

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Roger Chriss lives with Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society. Roger is a technical consultant in Washington state, where he specializes in mathematics and research.

The information in this column is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Study: THC More Effective Than CBD in Treating Pain

By Pat Anson, PNN Editor

The psychoactive ingredient in marijuana -- tetrahydrocannabinol (THC) – is more effective than cannabidiol (CBD) in treating chronic pain and other medical conditions, according to a new study that challenges the widespread belief that THC is harmful and has limited value in medical cannabis products.

Researchers at the University of New Mexico used the Releaf App, a mobile software program, to analyze self-reported data from over 3,300 people who logged their responses in nearly 20,000 user sessions to a variety of cannabis products, including natural dried flower, edibles, tinctures and ointments.

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Dried flower was the most commonly used product and was generally associated with greater pain relief than other cannabis products, regardless of the amount of THC.

"Despite the conventional wisdom, both in the popular press and much of the scientific community that only CBD has medical benefits while THC merely makes one high, our results suggest that THC may be more important than CBD in generating therapeutic benefits,” said Jacob Miguel Vigil, PhD, a professor in UNM’s Department of Psychology.

“In our study, CBD appears to have little effect at all, while THC generates measurable improvements in symptom relief. These findings justify the immediate de-scheduling of all types of cannabis, in addition to hemp, so that cannabis with THC can be more widely accessible for pharmaceutical use by the general public.”

Hemp is a strain of marijuana that was legalized by Congress in the 2018 Farm Bill. It has very low levels of THC, but is being grown commercially as a source for CBD.

UNM researchers found that indica strains of cannabis were more effective than sativa strains in treating pain and insomnia. Both strains have substantially higher levels of THC than hemp, but are illegal Schedule I controlled substances under federal law.

“Only THC potency levels showed independent associations with symptom relief and experiences of both positive and negative side effects, with higher levels (of THC) resulting in larger effects,” Vigil said.

Researchers say the relative weakness of CBD in treating symptoms may be due to inaccurate labeling of CBD content in cannabis products, which is a widespread industry problem. It’s also possible that THC simply heightens the experience or awareness of symptom relief.

Vigil published his findings in the journal Scientific Reports. Three of his co-authors developed the Releaf App, which has collected information from cannabis users since 2016. The app is an important data source for researchers, who are currently limited in conducting clinical studies of cannabis because of federal regulations.

Two previous studies by Vigil using data from the Releaf App found that cannabis provides significant relief from a wide range of symptoms associated with chronic pain, including insomnia, seizures, depression, anxiety and fatigue.

CBD Is Now Regulated and That May Be a Good Thing

By Roger Chriss, PNN Columnist

The legal status of cannabidiol (CBD) is changing. Once classified exclusively as a Schedule I drug under the Controlled Substances Act, CBD is now legal under federal law. And this means regulation.

The 2018 Farm Bill removed hemp from Schedule I. Hemp is a strain of marijuana with very low levels of THC, but high amounts of CBD.  This has opened the door to a legal market for CBD products, including food and supplements. But there’s a catch. The FDA has strict regulations about CBD being used in dietary supplements or promoted as medical treatments.

“It’s unlawful under the FD&C Act (Federal Food, Drug, and Cosmetic Act) to introduce food containing added CBD or THC into interstate commerce, or to market CBD or THC products as, or in, dietary supplements, regardless of whether the substances are hemp-derived,” FDA commissioner Scott Gottlieb, MD, said in a December 2018 statement.

“Among other things, the FDA requires a cannabis product (hemp-derived or otherwise) that is marketed with a claim of therapeutic benefit, or with any other disease claim, to be approved by the FDA for its intended use before it may be introduced into interstate commerce. This is the same standard to which we hold any product marketed as a drug for human or animal use.”

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 The FDA has a FAQ page about cannabis that answers some basic questions:

"Can products that contain THC or cannabidiol (CBD) be sold as dietary supplements? A. No."

"Is it legal, in interstate commerce, to sell a food to which THC or CBD has been added? A. No."

The FDA has reason to be concerned. Product quality for CBD products is iffy at best. An investigation by the NBC affiliate in Miami (see “Patients Are Being Duped”) found that 20 of 35 CBD products tested had less than half the amount of CBD advertised on the label. Some samples had no CBD at all.

Other recent analyses have found THC, pesticides, synthetic cannabinoids and toxic solvents in CBD products.

Moreover, a lack of regulatory oversight has led to an abundance of false, misleading or unsubstantiated claims. A recent review of CBD in the Journal of Clinical Pharmacology found that “CBD has been touted for many ailments for which it has not been studied, and in those diseases with evaluable human data, it generally has weak or very weak evidence.”

There is a lot of research on CBD going back years. The FDA’s approval of the CBD-based drug Epidiolex for rare childhood seizure disorders and a 2018 review that found potential for treating multiple sclerosis symptoms are important indicators of CBD’s medical value. At the same time, researchers have found no benefit in treating spinal cord injury, Crohn’s disease and osteoarthritis.

Yet CBD is now being widely promoted as a wellness product, and added to everything from coffee and pastries to bath oils and mascara. So it is not surprising that the FDA is concerned that people may be duped or put at risk.

The FDA is not alone in this. The New York City Department of Health has banned CBD products from being sold in bars and restaurants. Maine, New York, and Ohio are also banning CBD edibles.

For medically complicated people with chronic illness, regulation could be beneficial. At present these patients face significant risks with CBD products. Tainted CBD may cause unexpected allergic reactions or drug interactions. And contaminated CBD could trigger a positive result on a urine drug test, a common part of pain management amid the opioid crisis. Regulatory oversight could help reduce these risks. 

The legal and regulatory landscape surrounding CBD is shifting quickly. The FDA and state government agencies are watching closely and starting to intervene. This may flush out bad actors in the CBD marketplace and improve product quality and reliability. A stable marketplace with reliable products may be a net gain for the people who stand to benefit the most from CBD.

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Roger Chriss lives with Ehlers Danlos syndrome and is a proud member of the Ehlers-Danlos Society. Roger is a technical consultant in Washington state, where he specializes in mathematics and research.

The information in this column should not be considered as professional medical advice, diagnosis or treatment. It is for informational purposes only and represents the author’s opinions alone. It does not inherently express or reflect the views, opinions and/or positions of Pain News Network.

Cannabis Somewhat Effective in Treating MS

By Pat Anson, PNN Editor

Medical cannabis is mildly effective in relieving pain and other symptoms in patients with multiple sclerosis (MS), according to a new study published in JAMA Network Open.

Spanish researchers analyzed 17 clinical trials involving over 3,100 patients – one of the largest reviews to date on the efficacy of cannabinoids in treating MS. Overall, they found that cannabis was safe, but had limited effectiveness in relieving pain, muscle spasticity and bladder dysfunction.

“Small but statistically significant differences were found in favor of cannabinoids for all 3 symptoms,” Marissa Slaven, MD, and Oren Levine, MD, of Ontario’s McMaster University said in a JAMA commentary. “The authors conclude that cannabinoids provide a mild reduction in subjective outcome assessment of uncertain clinical significance and that they are safe.”

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MS is a chronic and incurable disease which attacks the body’s central nervous system, causing numbness in the limbs, difficulty walking, paralysis, loss of vision, fatigue and pain.

Medications and disease modifying drugs currently used to treat MS can cost tens of thousands of dollars a year – so a low-cost alternative treatment would be welcomed by many patients.

Four different medical cannabinoids were used in the 17 trials that were evaluated. They contained different levels of cannabidiol (CBD) and tetrahydrocannabinol (THC), the active ingredient in marijuana that makes people high. A lot of uncertainty remains about whether CBD or THC are more effective in relieving MS symptoms – something the JAMA study failed to resolve.

“It is critical that researchers gain a deeper understanding of both of the major (THC and CBD) and minor components of this therapy to unlock its full potential,” said Slaven.

“Given the relative safety of these agents, lack of strong evidence of other effective treatment options, and increasing access in some jurisdictions, it may seem appealing to include cannabinoids in the armamentarium of therapies for MS. But carefully conducted, high-quality studies with thought given to the biologic activity of different cannabis components are still required to inform on the benefits of cannabinoids for patients with MS.  

"The bottom line is there is certainly something happening with cannabinoids in regard to symptoms," Nicholas LaRocca, vice president of healthcare delivery and policy research at the National Multiple Sclerosis Society, told HealthDay. "In spite of very strong interest in cannabinoid therapy, we really have relatively little in terms of good research to guide us in terms of what does and what doesn't work, what works for which types of individuals, and so forth."

A small study was recently launched in Australia that might answer some of those questions. Emerald Health Pharmaceuticals of San Diego is using a synthetic version of CBD – called EHP-101 -- to treat about 100 people who suffer from MS or scleroderma, another autoimmune disease. The placebo controlled Phase I trial is meant to determine whether EHP-101 is safe and has any side effects. Results are expected next year.

Most Cannabidiol Oils Sold Online Mislabeled

By Pat Anson, Editor

With opioid medication increasingly harder to obtain and other types of pain relievers often ineffective, many chronic pain sufferers have turned to cannabidiol-based medication for relief.

But a new study published in JAMA has found that nearly 70 percent of all cannabidiol (CBD) products sold online are either over or under-labeled. Researchers say a number of CBD products that are used to treat pain, anxiety, epilepsy and other medical conditions also contain high-levels of tetrahydrocannabinol (THC), the substance in marijuana that makes people high.

“The biggest implication is that many of these patients may not be getting the proper dosage; they’re either not getting enough for it to be effective or they’re getting too much,” said lead author Marcel Bonn-Miller, PhD, an adjunct professor of psychology at the Perelman School of Medicine at the University of Pennsylvania

“This is a medication that is often used for children with epilepsy, so parents could be giving their child THC without even knowing it.”

Like THC, CBD is one of the active ingredients in marijuana, but it is not generally known to produce euphoria or make people high. CBD is currently classified as a Schedule I controlled substance by the federal government, even though it has been legalized for medicinal use in 29 states and the District of Columbia.

DRUG POLICY ALLIANCE

DRUG POLICY ALLIANCE

Bonn-Miller says the mislabeling and poor quality control of CBD products is a direct result of inadequate regulation.

“The big problem, with this being something that is not federally legal, is that the needed quality assurance oversight from the Food and Drug Administration is not available. There are currently no standards for producing, testing, or labeling these oils,” Bonn-Miller said. “There is no way to know what is actually in the bottle. It’s crazy to have less oversight and information about a product being widely used for medicinal purposes, especially in very ill children, than a Hershey bar.”

Bonn-Miller and his colleagues searched the Internet and purchased 84 CBD products from 31 different companies. They found that four out of ten products were under-labeled, meaning they contained a higher concentration of CBD than indicated. Another 26 percent of products purchased were over-labeled, meaning they contained a lower concentration of CBD than indicated.

Only 30 percent of CBD products purchased contained an actual CBD content that was within 10% of the amount listed on the product label. THC was detected in 21% of the samples.

“This is a wake up call for the CBD industry to standardize their products,” said co-author Jahan Marcu, PhD, Chief Science Officer for Americans for Safe Access (ASA).

“CBD product manufacturers need to adopt best practices and accept guidance from AHPA (American Herbal Products Association) and other groups to improve consistency and safety for consumers.”

ASA and AHPA supports the Patient Focused Certification (PFC) program, a non-profit, peer reviewed, third party certification program for the medical cannabis industry. Products that carry the PFC label have met their standards and been certified.

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“I am constantly contacted for suggestions for a safe company that sells CBD - and it would be helpful to steer people in the right direction,” said Ellen Lenox Smith, a medical marijuana user, advocate and PNN columnist.

“Although less or more CBD won't hurt you, it makes sense to develop a method for people to know they are getting the correct product that is being claimed. If THC is found in the product, then someone out there is not abiding by the law and is using a form of cannabis, thus breaking the law.”

The problem isn’t limited to CBD oils and extracts. In a previous study, Bonn-Miller and his colleagues analyzed cannabinoid dose and label accuracy in edible marijuana products and found similar discrepancies. He hopes this and future studies will call attention to the impact of inconsistent cannabis product labelling.

“Future research should be focused on making sure people are paying attention to this issue and encouraging regulation in this rapidly expanding industry,” Bonn-Miller said.