Experts recommend kratom & CBD players file NDIs first, before asking for new product category

By Hank Schultz

- Last updated on GMT

iStock frank600
iStock frank600

Related tags Dietary ingredient Food and drug administration

Some proponents of botanicals such as kratom or CBDs have chafed under regulatory restrictions that have forestalled wider acceptance and availability. But the full market is potentially available for those companies willing to go through accepted channels, experts say.

Marketers of kratom and CBD seem to be attempting to search out a middle ground, a place for botanical components that have demonstrated efficacy, and perhaps a magnitude of effect that is a cut above the average dietary ingredient that is in the marketplace. It appears they are pining for some sort of phytomedicine category that might be analogous to the traditional herbal medicine categories as they exist in Europe, for example. Such a category does not exist in the current regulatory structure in the United States.

Personal story drives kratom group’s founder

One advocate who rues the current situation is Susan Ash, founder and director of the American Kratom Association (AKA).  Ash said her concern is personal, which led her to found the organization, which she said is funded for the most part by small donations of individual devotees of the botanical.  Ash credits her use of kratom in helping her to wean herself of off opioid pain relievers and helping her on her road to recovering from crippling pain brought on by Lyme Disease.

“I started using it because I was having withdrawal symptoms after I’d run out of my pain medication,” ​Ash told NutraIngredents-USA. Ash said the botanical, which she takes by brewing a tea from the leaves, has been effective enough for her that she can contemplate reentering the full time workforce.  Ash, who has a masters degree in forestry and had worked in the nonprofit sector prior to being diagnosed with Lyme Disease 2010, had to step back from full time work because her symptoms became unmanageable.

“I have been using kratom for three years and in that time I haven’t had to increase my dose,” ​Ash said.

Listing push based on outmoded data

Kratom has run into high profile difficulty because of the move by the Drug Enforcement Administration to place the botanical on its schedule 1 of controlled substances via an emergency listing.  After significant push-back from lawmakers and other stakeholders, DEA reverted to a more formal listing proposal, in which comments were solicited from interested parties. AKA submitted a lengthy comment document that was supported by a paper from a drug expert​ to support its contention that the botanical does not belong on the list which includes drugs like heroin and cocaine.  DEA’s move was widely seen as spurred by the Food and Drug Administration, which in 2014 slapped an import ban on the botanical. Ash said her organization believes that regulators’ concerns about the botanical were based on faulty, outmoded science.

“I have never seen evidence of hallucinations,”​ Ash said. “Some of this is coming from a 1975 paper that was observing Thai laborers who said they were using kratom. These were people who were working out in the sun and may have been dehydrated or had other drugs in their system.”

On its website AKA has this to say about its view of the botanical and where it stands in the marketplace:
“Kratom ​(Mitragyna speciosa) is a natural analgesic which has been used for hundreds of years to safely alleviate pain, combat fatigue and help with the effects of anxiety and depression. Unfortunately, the spread of misinformation, both scientific and anecdotal, about Kratom has created a challenging regulatory environment.”

CBD under similar cloud

CBD, or cannabidiol, a non-narcotic fraction of cannabis, is in a similar regulatory limbo. The underlying plant, Cannabis sativa​, is itself on the schedule 1 list, meaning there are few friends of this plant among regulators at the federal level. The many states that have passed medical marijuana laws and the three that have passed recreation use laws have freed up the market to some extent. But CBD still labors under an FDA ruling that it is not a legal dietary ingredient​, a ruling based in part on a pre-existing Investigational New Drug application on the the molecule by English company GW Pharmaceutical. 

In the case of both kratom and CBD, despite the botanicals’ other regulatory problems (possible schedule 1 listing and import ban for kratom, schedule 1 listing and prior IND for CBD), FDA has also said that it believes that New Dietary Ingredient notifications should be filed on these ingredients. And perhaps, rather than trying to find an unoccupied regulatory niche, that’s where proponents should start, some experts have said.

American Botanical Council founder and executive director Mark Blumenthal said that a phytomedicine-type category was contemplated for the US at one time.

“ABC looked into the possibility of developing a phytomedicine category back in the early 90s prior to the passage of DSHEA, so this is not a new conversation,”​ he said.   

Stillbirth of herbal medicine

At that time an attempt was made by some industry stakeholders to see if the regulations regarding OTC drugs could be applied to herbal medicines. At least two applications were actually filed, one on valerian as a sleep aid and another on ginger for motion sickness,  Blumenthal said, but FDA never moved on them, leading to the conclusion that it was a doomed effort.  The result was to focus attention on the development of and passage of DSHEA, which provides an potential avenue to market for botanicals like kratom and CBD if developers are willing to put in the work.  And Blumenthal said some advocates of these botanicals might be careful for what they wish for.  A phytomedicine category, if such a thing could be instituted in the US, would certainly require more upfront investment to get a product on the market that fits into that positioning than would filing a NDI notification.

“If people are interested in getting some sort of special regulatory category for kratom or whatever that might allow for drug or disease-type claims, it’s ironic that they don’t seem willing to first go through the lower bar of filing a NDIN,”​ he said. (Ash, for her part, said she believes at least one kratom company has in fact started in on the NDI Notification filing process.)

Existing path provides safe avenue to market

Beth Lambert, CEO of Herbalist & Alchemist, a company that manufactures a line of tinctures, said some of the push she has seen for both kratom and CBD has been from marketers who are seeking a way to make an end run around existing regulations.

“They want to just be able to make claims, I think especially for kratom,”​ she said. “We don’t have a history of use in this country for kratom.  There is a construct that we have developed in this country for things that don’t have a traditional use history or hadn’t been sold here.

“We have a lot of other pain relief type herbs that have been used for a long time.  There really hasn’t been much science on kratom.  Most of the information is anecdotal.  We don’t live a free-for-all type place and in a lot of ways that’s for good reason.  I think it’s a little unfair for these advocates to have so little faith in the regulatory system,”​ Lambert said.

Cal Bewicke, president of San Francisco-based ingredient supplier Ethical Naturals, said he’d looked into the CBD space but concluded that without an NDI filing in one’s pocket, the issue was too cloudy, though that hasn’t stopped many marketers of the products.  Bewicke said he didn’t really buy the notion that some proponents have rested their case on that since hemp has been approved as a food that CBD, an extract of hemp, should be good to go.

“There are a lot of places where you can buy CBDs,”​ Bewicke said. “But I asked questions like, how would you get insurance coverage? The problem when you get into CBDs is they are really new products;  they are a very highly purified extract from a particular plant.  If you are going to be selling very highly purified extracts that have not been used before then you are going to have to prove their safety.”

The long arm of schedule 1

The question of what should—or shouldn’t—go onto the schedule 1 list is huge complicating factor for both botanicals, Blumenthal said.  In particular for CBD, the IND filing notwithstanding, he said the data surrounding its efficacy particularly in indications such as pain relief, traumatic brain injury, suppression of seizures among others would auger well for its future in the market if the molecule were a derivative of almost any other plant.

“If CBD had been found in another plant it would be consider a miracle cure, a miracle functional food or a miracle drug,”​ he said.

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1 comment

Why no mention of the botanical drugs category?

Posted by Ken,

Any of the claims referred to in the article are legally restricted to drugs, whether for CBD or kratom. Marketed for the claims made for them in this article, it wouldn't matter if they both passed the requirements for NDIs or not; they would still be drug claims. Provided sufficient evidence of safety and effectiveness and a reasonable risk to benefit ratio, they could both be developed for FDA approval under the regulatory category of "botanical drugs". Based on the evidence from human clinical trials, disease treatment and prevention claims would then permitted, but, safe or not, they would never be allowed for the same products if sold and regulated as dietary supplements.

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