‘No CBD isolate’ and ‘zero THC’ claims indicative on ongoing regulatory uncertainty

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CBD’s troubled history as a ‘not quite legal’ dietary ingredient

The unsettled regulatory picture erodes the underpinning for these products on two fronts. One one hand, the US Food and Drug Administration continues to maintain that CBD is not a legal dietary ingredient and should not be used in foods or supplements, the thousands of such products on the market notwithstanding. One reason for this position is the approval in 2018 of a drug called Epidiolex based on an isolated form of CBD that is used to treat intractable forms of childhood epilepsy.  Many product formulators have taken the ‘full spectrum’ hemp extract route, thinking that FDA is leaning toward the position that isolated forms of CBD should be reserved for drug applications.  A recent analysis of warning letters by the American Herbal Prdoucts Alliance bears out the notion that FDA has a target on the use of ‘CBD’ on labels​.

Thus is born the ‘no isolated CBD’ claim.  This has appeared in marketing language for the announcement this week that AIDP will begin selling a full spectrum hemp extract from European manufacturer Verdant Oasis, whose product is named Panoramic Entourage Oil. 

Lauren Clardy, vice president of branded ingredients at AIDP, echoed what many other product formulators in the industry have to say about a full spectrum hemp extract. It’s about the health benefits, not about seeking regulatory cover, though such a claim might also confer that as a side benefit.

Entourage effect

“The phytocannabinoids (CBN, CBG, CBC, CBD, etc.) and terpenoids (limonene, α-pinene, linalool, β-caryophyllene, etc.) are reported to have unique properties that contribute therapeutically  to the entourage of hemp.  The synergistic effect of all the phytocannabinoids and terpenes is greater than the single magic bullet approach,”​ Clardy told NutraIngredients-USA.

The other bit of regulatory troubled water that laps at the foundations of the CBD market is the fact that one form of the raw material — Cannabis sativa bred for and grown in such a way as to express high THC levels — is a federally controlled substance while another form — ‘industrial hemp,’ or cannabis plants that have less than 0.3% THC content by dry weight — is a federally approved crop.

What about THC?

There are concerns among some consumers that incorrectly made CBD products could have enough THC in them to cause users to fail a drug test.  The prominence of drug testing seems to be fading as more and more jurisdictions pass laws legalizing marijuana. But such tests are still mandated by some professions regardless of location, including pilots and operators of other transportation and construction equipment, some professional and international sports and others. And a number of consumers would prefer to avoid any trace of the psychoactive substance if they can.

So now comes the ‘zero THC’ claim.  In a recent statement, multi level marketing firm Nature’s Sunshine announced it is extend its line of hemp products it brands as Qemp (for quality hemp) with a new offering called Qemp Zero, for zero THC.  Finished goods manufacturer Thorne Research, which uses the Verdant Oasis oil, done not make the zero THC claim per se.  But in a video on teh product the company does say, “We can say with total confidence that a person can use this product and not worry about taking a urine test.”

At the 2019 NoCo Hemp Expo (the 2020 event was canceled because of the pandemic), the issue of ‘hot’ products (those with too much THC) was openly discussed in a panel session. Dilution with MCT oil was one of the solutions offered, though it would seem that might also affect the CBD dosages.

Not going ‘hot’ is not easy to do

Steven Hoffman, principal in the consulting firm Compass Natural Marketing, has worked on hemp ballot initiative and  cooperated in putting on the NoCo Hemp Expo in Colorado.  Hoffman said there is growing concern that the 0.3% barrier for industrial hemp is very difficult to achieve from agricultural perspective and puts farmers in a bind.

“It’s very difficult to get 0% THC in hemp.  The 0.3% level has the effect of turning farmers into inadvertent criminals. If their crop comes in ‘hot,’ or between 0.3% and 0.5% THC, they have to destroy it.  And if it’s over 0.5% they’ve crossed that line,” ​Hoffman said.

“What we are advocating for is what we are calling the 1% solution, in other words, 1% THC by dry weight.  That is still not enough to be psychoactive, but is much more achievable in the field,”​ Hoffman said.

Industry veteran Frank Lampe, who has launched his  consulting firm called Lampe & Associates Marketing Communications after a stint with the United Natural Products Alliance, said it makes perfect sense that forward-thinking CBD innovators would be trying to differentiate themselves from medical and recreational marijuana, and from their peers who would prefer not to use the acronym THC at all.

“Based on an informal review of new product introductions in the CBD space, the ‘no-THC’ label appears to be on the rise. This makes sense as recentNew Frontier Data statistics show highly favorable impressions of CBD overall in the US—much higher than that for psychoactive cannabis. But without consistent and enforceable federal regulations and testing protocols in place, it is and will remain a buyer-beware marketplace,”​ Lampe said.

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