GT Dave: 'I’m not saying CBD shouldn’t be regulated, just that it shouldn’t be regulated like a drug'
“Almost all large chains such as Kroger, Safeway and Whole Foods currently have a ‘no’ policy on CBD until further regulatory guidance or clarification is provided,” said GT, who has recently launched a new line of sparkling beverages called Dream Catcher.
One version contains 25mg of CBD via a broad spectrum hemp extract, while the other hemp-free version contains L-Theanine, beta glucan, and alpha GPC instead. Both have a base of sparkling water, raw apple cider vinegar, caffeine from coffeeberry, vitamins B and C, and plant extracts.
“There are two kinds of Dream Catchers [MSRP $3.29-$3.99/10oz bottle] in the market because the CBD world is very uncertain state by state and even city by city, so we created two products. A hemp one with CBD, and a non-hemp one,” GT told FoodNavigator-USA.
“All this adds in a layer of complexity to our distribution and sourcing model, so if you have a state that can sell it and is fine with it but a retailer that’s in multiple states, the retailer will err on the side of caution, so that’s why we have come up with two formulas.”
He added: “We are seeing some chains [New Seasons, Fresh Thyme, Earth Fare etc] pick up the hemp version. But it's typically chains that have a presence in hemp-friendly states. The labeling has also evolved. Originally, it had CBD on the front of the bottle, but now we say 25 mg hemp on the front of the bottle.
“It’s doing very well, but we’re excited about it for numerous reasons aside from CBD. It’s a clean, raw, product in a beautiful glass bottle that provides an alternative to soda or even products like LaCroix, and has additional functional properties.”
Does it make sense to combine CBD and caffeine in the same formulation?
But does it make sense to combine CBD, which is purported to reduce anxiety and promote relaxation, with a stimulant such as caffeine?
“I’ve been using CBD for almost five years and when you take it on its own, it can make you tired and a little drowsy,” said GT.
“No one wants to feel sleepy in the middle of the day, but they might want to have a little anxiety or anti-stress in the middle of the day, so the caffeine counters the sleepiness, but you still get the calming effect. The net result is what we call calm, clear, focused energy.
“Unlike an energy drink that can create heart palpitations and anxiety, Dream Catcher does the reverse. It takes the edge off your stress and anxiety but keeps you stable from an energy standpoint so you can drink it at work before a meeting, or before the gym.”
‘I believe the current position that the FDA has taken was honestly kind of forced on them’
Asked about the FDA’s approach to CBD, he said: “I believe the current position that the FDA has taken was honestly kind of forced on them, because CBD came out of nowhere, and the next thing you know everyone was running around and putting it in everything and claiming it as a cure all, which is not good.
“You see this sloppy negligent marketing where people and brands are claiming everything, which turns it into snake oil. There’s always a level of discomfort in something that’s brand new because the rules haven’t been written, yet.
“I think that the FDA is concerned about all the [unsubstantiated disease] claims, as well as people putting a dash of CBD in a bottle of water and charging $12 for it, but it’s also overwhelmed, and it takes a long time to make decisions. Even [updating] the Nutrition Facts panel has taken years, so CBD unfortunately won’t escape that bureaucracy and that lethargic pace.”
What’s the legal pathway for CBD? First wave of comments in FDA docket highlights the challenge ahead
GT’s is “currently looking into what kind of presence we will have” at the FDA’s May 31 public meeting on cannabis and cannabinoids, said GT, who said that, “to me, CBD is another plant-based medicine that has been demonized through the association with cannabis to be something that’s bad, dangerous, deregulated.”
He added: “I’m not saying that it shouldn’t be regulated, just that it shouldn’t be regulated like a drug, but like any other food ingredient, such as caffeine, for example.”
In an April 2 statement, the FDA expressed concerns about companies making “egregious medical claims” about CBD’s alleged curative powers, but also noted that its review of the marketing application for Epidiolex (an approved drug containing isolated CBD) had “identified certain safety risks, including the potential for liver injury.”
It also referred to “unresolved questions regarding the cumulative exposure to CBD if people access it across a broad range of consumer products,” and questioned “whether some threshold level of CBD could be allowed in foods without undermining the drug approval process or diminishing commercial incentives for further clinical study of the relevant drug substance.”
The first wave of comments in the docket from chronic pain sufferers, doctors, hemp companies and various other stakeholders, reflected a wide mix of views (deadline July 2). Here is a selection below:
Bradley Sorock: My partner takes CBD for anxiety and has benefited greatly from it. I hope we don't limit how it's marketed as the word should get out [about] all the benefits. I know there is good CBD and ineffective CBD, as is the case with many other products, it's a matter of weeding that out on our own. THC is a different story, and while it's much safer than alcohol, I would agree it should be limited to similar regulations like alcohol, as it is recreational.
Patrick Hinson: CBD is snake oil. I felt nothing beneficial from taking it. The big hype is mostly a placebo effect that people are experiencing. THC on the other hand is a real and powerful drug that can treat PTSD, anxiety and depression. It should be legalized and controlled as a schedule III drug.
Kenneth Finn, MD: The FDA needs more bite than bark when it comes to public health and safety. Allowing CBD to be infused into consumer food products as well as allowing false medical claims to persist needs to cease. There is potential public harm as it relates to these products and the Farm Bill has only muddied the waters, putting public health at risk. Where are the warnings for pregnant and breastfeeding mothers, children, possible allergies? The list goes on.
Christy Brown: A lot of the comments here do not give specifics or brands or say whether there have been clinical trials for the efficacy of these products, but only provide anecdotes. The National Academy of Sciences 2017 report of the health effects of cannabis has listed only a few specific conditions for which cannabis (of any kind) has been proven effective as medicine and the proof is moderate at best.
Also it is not clear that these products are manufactured with consistency of ingredients or tested for contents or absence of pesticides, mold or other harmful ingredients. The FDA needs to do a better job of testing and regulating these products.
The federal government has been absent enforcing the law and has allowed unscrupulous people to make all kinds of claims about these products to make money. Please protect the public by using science to guide your decisions, not politics.
Rick Ranum: Please stop giving the pharmaceutical industry control over common substances. All substances are chemical compounds. Giving the industry control over CBD oil is like giving them control over olive oil, castor oil, and many other common substances. Whether the subject is fecal transplants or rubbing oils on our bodies, just because a substance is beneficial to health does not merit handing it over to the pharmaceutical industry to dispense for sums of money that make it a benefit for only the well insured or wealthy. Please come to a place of common sense and cut your complicity with the pharmaceutical industry.
Dawn Wilson Do the right thing. CBD saves lives and works with our natural receptors in our body. Don't let big pharma and greed control a natural substance that is derived from plants. Our endocannabinoid system has receptors that benefit from CBD. It can help many illnesses and cut down our enormous health care costs in this country by healing the root causes for disease and not just putting band-aids on the symptoms.
Subir Grewal President, Hemp Knowledge LLC Simply banning all hemp-derived products that do not contain 100% CBD as dietary supplements or food ingredients would be an unwise move that would effectively grant a monopoly of a natural, non-psychoactive, and non-addictive substance to large pharmaceutical companies
The focus of the FDA in approaching this issue should be two-fold:
1) Establishing guidelines for defining and separating medication from OTC dietary supplements, based on percentage of CBD content and whether enriched, isolated CBD is part of the product. 100% pure CBD that is isolated can be considered a competitor to Epidiolex, but full-spectrum unadulterated products can be considered legally separate.
2) Regulating hemp-derived supplements so they do not make medical claims, are free of harmful additives and contain less than 0.3% THC. This can be done through either a process of registration with the FDA with regular testing, random testing, or some other form of regulation.
Rod Birney MD: As a physician I hope CBD is completely legalized. I would treat it like any other herbal product, just keeping people from making false claims about its actions.
Anon: I suffer from severe chronic pain, anxiety and depression. CBD and hemp has been one of the only (if not, THE only) natural medicine that had actually helped me. It has no side effects and gives me the ability to function when I may not be able to, even more than traditional medications I have tried and I know I am not the only one.
Jim Bootz: CBD didn't suddenly become fashionable in the past decade, or even the past half-century, to use cannabis as medicine. It was listed in the U.S. Pharmacopeia up to and as late as 1942. Why was it a medicine for so long before it came into common use as a recreational drug? Those who insist on keeping the brakes on continue to say "We don't know enough about it," and then drop the discussion there. We do know a lot about it. It's been in use as a medicine around the world for centuries.
Since the floodgates have already been opened on the CBD as cure-all market, start regulating it so that people who buy CBD actually get CBD. If the current level of regulation for CBD is anything like pet medicine, where a glucosamine capsule might have anywhere between 20-70% of the amount of glucosamine shown on the label, we might as well just call it a placebo. And put very strict controls over imported CBD products.
Brightfield stands by bullish CBD forecasts: ‘The potential market growth is staggering’
Speaking to FoodNavigator-USA last month, Bethany Gomez, managing director at CBD/cannabis market researcher Brightfield Group – which has raised eyebrows by predicting the CBD market could be worth a jaw-dropping $22bn by 2022 [this includes pharma/petcare/topicals etc] – claimed CBD was poised to become the “next healthcare phenomenon,” despite the lack of clinical data.
“It sits so nicely within so many industry verticals. And with virtually no major investments taking place, extremely limited advertising, and few distribution channels available, hemp CBD drove over $600m in [US] sales last year because consumers have found that it works despite these barriers and the dearth of research to support it.”
Put another way, despite the lack of clinical data and the legal uncertainty - which have prevented brands from launching big ad campaigns or consumer education platforms about CBD – the market has grown at a meteoric pace pretty much via word of mouth, boosted by the “occasional celebrity shout-outs and the odd doctor recommendation,” said Gomez.
"However, the larger CPG companies are not yet ready to jump in until there is a tangible pathway from the FDA. The science will also come. Now that it's no longer a controlled substance, we expect to see a lot more clinical trials around CBD."
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