The tie up with LIFEAID is the “first of many such partnerships with noteworthy food and beverage brands,” says Ojai Energetics founder and CEO Will Kleidon, who claims his hemp extracts - manufactured via a patented nano-encapsulation process – deliver a “faster absorbing, more bioavailable and potent water-soluble CBD” delivering discernible effects in 30 seconds… as opposed to 30 minutes.
“We’ve been around since 2014, before most people had even heard of CBD. Our goal is to be a force of transparency and science in a field where those things are often lacking.”
Kleidon’s extracts - which are free of synthetic or synthetically modified compounds and third-party batch tested for volatile organic compounds, pesticides, herbicides, microbes, terpenes and cannabinoids - are protected by issued patents (click HERE and HERE).
Right now, they are primarily used in the firm’s own consumer products (elixirs, coconut oil, sports gels – sold online via its website and some independent retailers), but are increasingly in demand from CPG brands such as LIFEAID, says Kleidon.
“We’ve got explosive growth just from word of mouth; our formulas work so effectively that we’re now in R&D with some of the biggest beverage companies on the planet, one of which has 10 SKUs formulated and four ready to go out of the gate... when the FDA provides regulatory clarity.
“We have the intellectual property, and we've built the infrastructure, and great relationships with big box retailers, so we can scale rapidly once there’s clarity from the FDA [which said in November that it would provide details of its strategy for regulating CBD "in the coming weeks"].”
LIFEAID CBD contains 20mg of organic water-soluble broad-spectrum (THC-free) extract from Ojai Energetics. The product – which is marketed as a dietary supplement – contains rosemary and lemon balm and is sweetened with stevia and agave nectar. Each 12oz can contains 40 calories.
“This [LIFEAID CBD launch] is a textbook example of how to extend a brand into CBD, without putting all your eggs in the CBD basket," Arthur Gallego, principal, Gallego & Co. Marketing Consultants, who has been working with LIFEAID, told FoodNavigator-USA.
"I've worked with other brands that have introduced a CBD product but didn't have the e-commerce audience to support it before retail doors opened."
He added: “A big factor in LIFEAID CBD's sales success is LIFEAID’s large and engaged social media following, particularly the FITAID drink, which is a staple of CrossFit. The activity and intensity of that social media following, and the brand's already strong direct to consumer business (which is up 30% year-on-year), is what drove the first run's sell-out on e-commerce.
"The brand has an enviable mix of retail and direct to consumer.
“The new LIFEAID CBD drink complements a fitness- and performance-conscious lifestyle. The new drink was responsibly formulated, with functionality in mind, as all LIFEAID drinks offer a functional benefit and some level of nutrition.
"The LIFEAID brand markets its new CBD drink solely as an option to, or addition to, general beverage consumption or fitness-related consumption. LIFEAID does not market its CBD drink as a curative nor as a pharmaceutical, and only markets the product to adults.”
We’re not using any solvents
Current commercial-scale options for the first extraction (which generates a crude extract) are supercritical CO2, steam distillation, or solvent extraction with ethanol or butane. After that, many companies further refine their crude hemp extracts to remove waxes or chlorophyll or other unwanted components using hexane or ethanol washes in subzero temperatures (winterization), which can leave solvent residues if it is not done correctly, claims Kleidon.
“At Ojai Energetics, we run it though the CO2 process more than once, but we don’t further process it via a winterization process and we’re not using any solvents; we don’t need to because we have a patented encapsulation process; we’re the only company I’m aware of that’s certified organic with a solubilized hemp extract [Ojai Energetics is not using synthetic emulsifiers such as polyethylene glycol to make its colloid structures, and instead uses saponins from a certified organic plant].”
Encapsulation techniques, liposomal, colloidal
When it comes to encapsulation techniques designed to enable hemp extracts (which are fat soluble) into something water soluble that will work in a beverage, for example, liposomes are not ideal, he argues.
“If you use a liposomal formulation for a hemp extract, yes, you’re diminishing the particle size, so you’ll see a small increase in bioavailability, and you might start feeling the effects in 15-20 minutes, but cannabinoids like fat, so they’ll just sit in the fatty bilayer [of the liposome, which has an aqueous center, a fatty bilayer, and a water-friendly shell], as there’s not much motivation for them to leave.
“So liposomes are better than nothing in terms of onset time, but they’re not perfect. They have a similar pharmacokinetic profile to curcuminoids [in liposome form], which have an almost identical molecular weight, so with liposomal cannabinoids and curcuminoids, you get about an eight-fold increase in bioavailability.”
With a CBD isolate, you can nano-mill the particles down to sub-micron levels, which will suspend in water, but are not very stable, he claims. "That will deliver about a three-fold increase in bioavailability, but the onset time is even slower than with a liposome, at around 25 minutes."
‘We’re allowing you to get the most out of your product by not expelling 90% of the cannabinoids you paid for’
At Ojai Energetics, however, Kleidon deploys a colloidal method, where a 40-nanometer wide water shell wraps around a fatty core of cannabinoid rich hemp oil (an oil in water emulsion), which he claims is rapidly absorbed, with most users feeling the effects in 30 seconds, with a 20x improvement in bioavailability.
While the company has not conducted human pharmacokinetic studies to prove this claimed boost in bioavailability (ie. how much is getting into the bloodstream, how much is excreted, and how much is utilized by the cells (blood, urine, and fecal analysis?), such testing is in the works, he says.
“We’re allowing you to get the most out of your product by not expelling 90% of the cannabinoids you paid for."
You can’t talk about dosage without talking about bioavailability
But if most of the CBD contained in foods and supplements is being expelled, why do so many people claim to experience effects from small doses?
“We need more data, but a good chunk of that is probably placebo,” speculates Kleidon, who also believes that some of the effects people are experiencing may also be down to low levels of THC rather than CBD.
As he likes to stress however, you can’t talk about dosage without talking about bioavailability. In other words, a low dose that is highly bioavailable will have more impact than a higher dose that is not, adding to the challenge facing regulators trying to determine a ‘safe’ dose.
“We’ve had people say to us that they’ve tried CBD before and not felt any effects, and then they’ve tried our product and said it’s the first time they've had results.”
The ‘entourage effect’
As for the science – which is notably lacking when it comes to human clinical studies exploring the health benefits of small doses of hemp extracts – Kleidon acknowledges that much of the data comes from drug trials using high doses of isolated CBD, but claims that more evidence is emerging of the so-called ‘entourage’ effect (coined by Israeli cannabinoid researcher Dr Raphael Mechoulam at the Hebrew University of Jerusalem) whereby cannabinoids, terpenes and other components in cannabis plants may work synergistically.
He also cites a 2015 mouse study published in Pharmacology & Pharmacy showing that a CBD-rich extract had a stronger anti-inflammatory effect than a purified CBD isolate alone.
‘The CBD used in Epidiolex is a 97% molecularly pure, crystalline form of cannabidiol; it’s materially different from a botanical hemp extract that contains CBD’
So what about the elephant in the room, ie. that the FDA has repeatedly said the CBD is not a legal dietary ingredient in foods or supplements because it was first investigated as a drug?
When it comes to the regulatory minefield CBD firms are wading through, Kleidon argues that the exclusionary clause – whereby CBD cannot be considered a legal dietary ingredient because it was first investigated as a drug – doesn’t apply here.
Like many players in the CBD space, Kleidon argues that the broad or full spectrum hemp extracts currently being used in foods and supplements are legally different articles to the isolated CBD first investigated as a drug, and therefore legal, provided firms can prove they are safe via existing regulatory tools (GRAS determinations, NDIs, food additive petitions, observing GMPs etc).
“The CBD used in [the drug] Epidiolex is a 97% molecularly pure, crystalline form of cannabidiol, it’s materially different from a botanical hemp extract that contains CBD and is legally a distinct article.”
(Editor's note: Some firms such as Manitoba Harvest and CV Sciences have put together GRAS determinations for their hemp extracts but have not submitted them to the FDA given the lack of legal clarity over their regulatory status. The FDA, meanwhile, put out a statement in November 2019 noting that it "cannot conclude that CBD is generally recognized as safe (GRAS) among qualified experts for its use in human or animal food".)