Melatonin and Cannabis Products Often Mislabeled

By Pat Anson, PNN Editor

If you use cannabis for pain relief or take melatonin to help you sleep at night, you may want to check the label and ask the manufacturer just how accurate the list of ingredients is.  Or think twice before buying it.

Two more studies are raising doubts about the accuracy of label claims on cannabis products and melatonin supplements, which are often marketed with unsupported claims about their health benefits.

In the first study, published this week in JAMA, researchers analyzed 25 melatonin gummy products, including 5 gummies that also contained cannabidiol (CBD). Melatonin is a natural hormone produced by the brain at night to help induce sleep. Supplements containing synthetic melatonin and/or CBD are often marketed as products that improve sleep, reduce anxiety, and promote relaxation.

Researchers found that only 3 of the 25 gummies contained enough melatonin to be within 10% of the labeled amount – with one product containing 347% more melatonin than what was listed, a potentially dangerous amount. Another gummy contained no melatonin at all, just CBD.

“The great majority of melatonin gummy products were inaccurately labeled, with most products exceeding the declared amount of melatonin and CBD,” wrote lead author Pieter Cohen, MD, an associate professor at Harvard Medical School and an internist at Cambridge Health Alliance. “Given these findings, clinicians should advise parents that pediatric use of melatonin gummies may result in ingestion of unpredictable quantities of melatonin and CBD.”

Pediatric use is concerning because calls to U.S. Poison Control Centers about children ingesting melatonin have increased five-fold over the past decade, resulting in nearly 28,000 emergency room visits, over 4,000 hospitalizations and two deaths.

Researchers say it takes just 0.1 mg to 0.3 mg of melatonin to increase plasma levels beyond the normal nighttime range in young adults. The amount of melatonin found in the gummies was much higher, including one product containing 13.1 mg of melatonin.

“Consuming melatonin gummies as directed could expose children to between 40 and 130 times higher quantities of melatonin,” they said. “With respect to CBD, the drug is FDA approved to treat refractory seizures caused by 3 rare genetic disorders, but the FDA has not approved the use of CBD for any indication in healthy children.”

The JAMA report is believed to be the first U.S. study to quantify the amount of melatonin in over-the-counter supplements. A 2017 Canadian analysis of melatonin products had similar findings, with the actual dose of melatonin ranging from 17% to 478% of the amount listed on the label. Neither the U.S. or Canadian studies identified the melatonin brands that were tested.

Too Little THC

It wasn’t too much, but too little tetrahydrocannabinol (THC) that University of Northern Colorado researchers found in 23 cannabis flower products purchased at state-licensed dispensaries. The study findings, recently published in the journal PLOS One, show that nearly 70% of the flower samples had THC levels at least 15% lower than what was listed on their labels.

Inaccurate labeling has long been a problem in the cannabis industry. Some growers and merchants resort to “lab shopping” to seek out product testing laboratories that generate the most desirable results – which means inflated levels of THC.  There’s a financial incentive to do so, because cannabis products containing high amounts of THC usually sell at a higher price.

One of the flower samples, purchased at a Denver dispensary and sold under the brand name “OG Kush 2,” had only half the amount of THC listed on its label.  

“Given our results it is urgent that steps are taken to increase label accuracy of Cannabis being sold to the public. The lack of accurate reporting of THC potency can have impacts on medical patients controlling dosage, recreational consumers expecting an effect aligned with price, and trust in the industry as a whole,” researchers said.

“Although we have no power to change the current system, we hope highlighting this issue and educating consumers will affect the change needed to remedy inflated potency of flower products. Addressing this discrepancy will require both changes to the regulatory system and consumer awareness that reported THC potencies are frequently inflated.”

Although 38 states and Washington DC have legalized medical or recreational cannabis, there is little consistency in labeling, regulating or testing cannabis. The researchers called for more regulatory oversight of cannabis and standardized testing protocols.

Nearly Half of CBD Oils Are Mislabeled

By Pat Anson, PNN Editor

CBD oils derived from hemp are increasingly being used to relieve painful conditions. Studies have found the oils effective in treating migraines and fibromylagia, and recent research found that a proprietary blend of CBD oil helped relieve symptoms in 9 out of 10 people suffering from chronic pain.

But a new study at the University of Kentucky College of Medicine found that nearly half of the CBD oil products tested in a lab were mislabeled. Of the 80 CBD oils purchased online or in retail stores, only 43 had concentrations of cannabidiols that were within 10% of their label claims – an accuracy rate of just 54 percent.

One oil had a CBD concentration that was 159% higher than its label indicated. Another oil had only 17% of the CBD it was supposed to have.

“As most consumers are using CBD products as therapeutic treatments for some types of medical condition, the dosing is important when considering the potential for CBD accumulation, elevation of liver enzymes, and drug-drug interactions,” lead author Erin Johnson reported in the Journal of Cannabis Research.  

“The findings reported here emphasize the continued need for clear and consistent regulation from federal and state agencies to ensure label accuracy of CBD products and subsequent enforcement. These results also indicate the need for continued development of good manufacturing practices and testing standards.”

In a separate analysis of the same CBD oils, Johnson and her colleagues found that most contained trace amounts of THC (tetrahydrocannabinol), the psychoactive substance in cannabis. Five of the 21 CBD oils that were labeled "THC Free" contained detectable levels of THC.

"THC is not allowed at the Olympics. It's not allowed in many sports organizations. But athletes use CBD because it helps them recover, and it helps them with different facets of their training," co-author Shanna Babalonis said in a press release. "So I think that one of the key takeaways from this work is to say that the public needs to question whether there's THC in their CBD products."

The two studies are certainly not the first to find that cannabis products are often mislabeled. They point to a continuing problem since passage of the 2018 Farm Bill, which legalized hemp under federal law. Although hemp contains only trace amounts of THC, cannabis companies have found ways to tweak its chemical composition to produce concentrated levels of delta-8 THC, which has a mild psychoactive and intoxicating effect.

The FDA considers delta-8 THC to be an unapproved drug, but because it comes from hemp – a legal substance – its regulatory status is unclear. Recently, the FDA sent the first warning letters to five cannabis companies, not for mislabeling, but for making unsubstantiated medical claims about delta-8 THC.  

Until the FDA or individual states confront the widespread mislabeling of CBD products, industry insiders say it’s likely to continue. 

“The mislabeling of Delta-8 products is not surprising but is a result of poor quality controls that are present through the category. Delta 8 can be unsafe for people to use, especially if it not labeled. This is due to the psychoactive component of Delta 8,” said John McDonagh, CEO of CBD producer NextEvo Naturals.  

“Some states have started to regulate Delta 8 to take it off the market. The FDA is limited as it doesn’t have sufficient enforcement resources, so the best solution for now is for states to take action.”

With Little Regulation, Many CBD Products Are Mislabeled

By Pat Anson, PNN Editor

CBD (cannabidiol) is being touted as a treatment for nearly everything these days, from pain and anxiety to insomnia and high blood pressure. There’s even talk about CBD as a potential treatment for COVID-19.

But how much do we really know about the CBD edibles, beverages, oils and other products being sold over-the-counter without a prescription? Are the labels accurate? Are they really free of THC (tetrahydrocannabinol), marijuana’s psychoactive ingredient, as some manufacturers claim?

A new study by researchers at the University of Wisconsin School of Pharmacy should give pause to consumers who put their faith in labels and a cannabis industry that is largely unregulated. The researchers bought 39 CBD products from retail stores in southwest Wisconsin and analyzed them in a laboratory.

Their findings, recently published in the journal Epilepsy & Behavior, found that the vast majority of CBD product labels are inaccurate, containing either too much CBD, too little or none at all. And some products that claimed to be “THC Free” contained enough to give you a good buzz, whether you wanted it or not.

“Our data demonstrate that despite warning letters issued by FDA over the past few years a substantial number of readily available CBD formulations continue to be mislabeled,” researchers reported. “In some cases, products labeled as having CBD contained virtually no active ingredient. This was particularly true for the aqueous (beverage) products.”

Of the 21 CBD-infused beverages that were tested, only one was accurately labeled. The vast majority (78%) were “over-labeled” – meaning they contained less than 90% of the CBD they were supposed to have. The rest (14%) were “under-labeled” – meaning they had 110% or more CBD than the label indicated.

Other products tested, such as edibles, oils and transdermal patches, weren’t much better. Only about a third of the oils (36%) were appropriately labeled with the right amount of CBD, and one oil made by HempLucid contained enough THC to cause intoxication if someone consumed less than half a bottle.

“We found that over half of the studied oil-based products contained measurable THC. This may be of concern not only for the potential of adverse, or at least unexpected, CNS effects, but THC contamination may also create difficulty for patients who are subject to testing for illicit drugs by their employers, parole officers, and even by their own providers in some states as a prerequisite for continued prescribing of controlled substances,” researchers warned.

The concern about THC showing up in drug tests isn’t an idle one. A recent study at Massachusetts General Hospital found THC in nearly 80% of the urine samples from patients who reported using CBD products, including some who thought they were only consuming CBD.

A recent study by Leafreport had findings that were similar to the University of Wisconsin study. Out of 221 CBD products tested, 60% didn’t match their label claims. On average, the CBD content was off from the label by nearly 25 percent.

Although the 2018 Farm Bill legalized the use of hemp-based products that contain less than 0.3% of THC, the FDA has yet to adopt new rules to regulate the cannabis industry. The FDA says it cannot issue regulations until more is known about the safety of CBD products, so for now the agency is “monitoring the marketplace” and only rarely taking enforcement action.

The FDA is well aware of the discrepancies in CBD labeling. A 2021 study by the agency of 147 cannabis products found that less than half contained CBD within 20% of their label declarations. But as long as a company doesn’t make therapeutic claims about their CBD products or call them food supplements, the FDA will probably leave them alone, even if their labels are inaccurate.