6 Dezember 2018

Comments on WHO’s Critical Reviews of CBD and Extracts and Tinctures of cannabis, and EIHA recommendations to WHO on low-THC preparations from industrial hemp

EIHA formally objects to the reasoning of the Experts

On July 23, 2018, WHO published outcomes of 40th meeting of Expert Committee on Drug Dependence (ECDD) with its final recommendations on Cannabidiol. On November 12, 2018, a 41st session of ECDD convened again at WHO headquarters in Geneva to discuss Critical reviews on Cannabis and resin, Extracts and tinctures of cannabis, Delta9-THC and isomers of THC. As EIHA was allowed to submit a written statement to WHO experts for the third time in 18 months, EIHA aligned again with FAAAT and ICCI experts to have its formal say.

WHO applies stronger approach to cannabis than to opium!

Besides its shaky preparation process, EIHA generally welcomes the final outcome: pure Cannabidiol has been given a clear “carte blanche” by the 40th ECDD as published in a Note Verbal to the United Nations Secretary-General dated July 23rd, 2018. “While opium alkaloids like morphine, codeine or thebaine are narcotic drugs, other substances extractable from opium, such as noscapine and papaverine, are not under international control. If noscapine and papaverine extracted from opium are not narcotic drugs, then CBD, even when prepared from an extract of cannabis, should not be considered as a narcotic drug either”, says Mr Pavel Pachta, member of ICCI team and former official at International Narcotics Control Board.

EIHA formally objects to the reasoning of the Experts according to which “…if prepared as an extract or tincture of cannabis [Cannabidiol] is controlled in Schedule I of the 1961 Single Convention on Narcotic Drugs.”

“The similar lapse of logic could be demonstrated on Delta9-THC, medicinally called Dronabinol. It was placed under Schedule II of the 1971 Convention on Psychotropic Substances back in 1991, and was until recently almost entirely produced synthetically. But we already see generic producers of naturally isolated Dronabinol. Following the logic currently used by the WHO on CBD, should a natural THC also fall under the Schedule I of the 1961 Convention on Narcotic drugs for being considered a Cannabis extract? Certainly not!”, argues Dr Bernhard Beitzke, a member of the EIHA Advisory Committee.

“Calling isolated and purified Cannabidiol an “extract of cannabis” does not hold up to principles of any of the relevant international standards: the nomenclature of organic chemistry (IUPAC) system, Chemical Abstracts Service (CAS), as well as WTO Harmonized System Codes. What matters, is the content of a drug component and the substance’s effect, not the origin of the substance or its manufacturing procedure“, concludes Boris Baňas, until recently a Board member of EIHA.

A highly purified substance derived from a plant extract is equivalent to the synthetically produced substance. On these same grounds, purified Cannabidiol (CBD) obtained from the herbal source is NOT an Extract of “cannabis” and therefore is NOT scheduled under the Single Convention (1961).

WHO does not use clear nomenclature when discussing extracts of cannabis

WHO uses a much too broad definition, that comprises the whole plant Cannabis sativa. The Single Convention differentiates between “cannabis” and Cannabis plant, and thus an “Extract and tincture of cannabis” is an extract/tincture from the flowering or fruiting tops only, and not from Cannabis plant as a whole or from other parts of the Cannabis plant. “Extract of cannabis” is different from “Cannabis sativa, ext.”, and the cannabis plant is not a scheduled drug.

EIHA objects to the inclusion of hempseed oil and hemp essential oil into a Critical Review of extracts of cannabis.

EIHA also objects that there was very little mention on extract of cannabis plants very low in THC nowadays used in several industrial sectors worldwide.

Proposal for the Scheduling of extracts and tinctures from industrial hemp low in THC
The current status and definition of extracts of Cannabis sativa L. implies severe drawbacks for the industrial hemp sectors around the globe.
As industrial use of hemp has been always exempted from control measures of the Single Convention, EIHA recommends to experts to consider that

  • all extracts of “the Cannabis sativa L. plant” that are not extracts of “cannabis”, regardless of their purpose, should continue being exempted from any scheduling;
  • Extracts (or tinctures) of “cannabis” for medicinal products, but also for foods and food supplements, pet-foods and cosmetics should be exempted from any scheduling, provided they have a maximum content of 0.2 weight-% of total Delta9-THC;
  • WHO should recommend to national authorities to establish evidence-based regulations on extracts of the Cannabis sativa L. (plant) for foods and food supplements based on an Acute Reference Dose (ARfD) for human consumption of max. 7 μg (micrograms) of ∆9-THC per kilogram of body weight per day. This value is in line with an earlier proposal of EIHA:
    http://eiha.org/media/2014/08/18-12-04_EIHA_contribution_41th_ECDD.pdf

Press release as PDF file: 18-12-05 PR WHO CBD

Source: European Industrial Hemp Association, press release, 2018-12-05.

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