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Quality Assurance? Quality Catastrophe

Quality Assurance? Quality Catastrophe
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By Tamir Bresler

Investigating the Cataclysmic Mislabeling of CBD Dosage

As we discussed in last week’s article, the decision by the World Anti-Doping Agency (WADA) to remove CBD from the Prohibited Substances List will have ramifications for every major sport organization in the country and in the world.The NBA has already taken this one step further and discussed becoming the first major sports organization to allow cannabis use for its players. The UFC has recently published a Q&A that describe the changes ensuing from the WADA revision. And we’re certain that as time goes on more success stories will emerge from the medicinal use of CBD.

However, the self-regulation of products has created some concerns that athletes who express an interest in starting to use CBD should be aware of.Even though THC has been shown to contribute meaningfully to the medicinal activity of cannabis extracts1, it remains prohibited by WADA for athletes in-competition.Since THC is still a prohibited substance, athletes using these products could be disqualified from competing if they test positive for its presence. Since THC can be detected in the body days and even weeks after consumption, it’s imperative that athletes only consume CBD products that are completely clear of its psychoactive cousin. However, that may be more challenging than it appears.

It turns out that not all CBD products do a great job of purifying the THC out of their extracts. A recent study by the Journal of the American Medical Association (JAMA) found THC (up to 6.43 mg/mL) in more than 20% of CBD products marketed online2. To confirm these findings, the U-Penn-led group identified and analyzed 84 unique products from 31 companies available for online retail purchase that included CBD content on their packaging (identically-formulated products that were packaged differently by the same brand were excluded).That concentration is shockingly high for products that are purportedly THC-free, and is certain to cause users to test positive even weeks after their use.

“The actual CBD content in many overlabeled products was so low, it was essentially zero.”

Besides finding THC in a considerable number of the products, the deviation in actual CBD concentration from that reported on the labels was nothing less than catastrophic. Even allowing a ±10% variance in product labeling (i.e. cannabinoid content accurately labeled = 90%-110%, underlabeled >110%, and overlabeled <90%), only twenty-six (31%) of the tested products were labeled correctly. Of the 58 mislabeled products, 43% were underlabeled (more CBD than reported) and 26% were overlabeled. Accuracy of labeling seemed to vary by product type. Vaporization liquids, with an almost 90% mislabel rate, were the least accurate, followed by tinctures (75% mislabeled), and ending with CBD oil (55% mislabeled). It’s noteworthy that the actual CBD content in many overlabeledproducts was so low, it wasessentially zero (negligible or less than 1%). Notably, this gross mislabeling is similar in magnitude to levels that triggered warning letters to 14 businesses in 2015-2016 from the FDA.

It’s important to note that the results of this study reinforce results by a previous product labeling accuracy study of cannabinoid (THC) content in edible medical cannabis products3. The earlier study similarly found that only 17% (N=75) of edibles purchased at medicinal cannabis stores accurately reported their THC content on the labels.These dosage deviations represent an outstanding safety concern, as a regulatory system that ensures accurate reporting and dosing does not yet exist for CBD.

So, what’s left to do? First of all, don’t buy CBD online. The FDA does not approve adding CBD to food or dietary supplements. Section 301(ll) of the Federal Food, Drugs, and Cosmetics (FD&C) Act prohibits “the introduction… into interstate commerce any food to which has been added… a drug or a biological product for which substantial clinical investigations have been instituted…”4 So buying CBD products online is already a grey area, and there isn’t enough transparency in the distribution process to know what product you will receive.

Second, do some research on the company you want to buy CBD from. Is the CBD from cannabis or hemp? Do they have a GMP and ISO certification? Are their products made with isolate or whole extract? Finally, make sure to only buy CBD products from reputable sources. Check with your dispensary or health store to make sure the CBD has been tested for THC and for accurate dosing. Don’t be shy asking to see the test yourself; a reputable company will have no problem presenting one to you.

For several reasons, from pain relief to anti inflammation and anxiety, athletes all over the world want to medicate with CBD instead of traditional pharmaceuticals. Even though the CBD industry still has challenges to overcome, the fact that WADA has reclassified it to allow athletes access to its therapeutic roots is a big win.

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