The comment, posted yesterday, raises a host of concerns about delta-8 THC, an intoxicating cannabinoid portion of cannabis. (Exactly how this molecule was poisoned is a matter of debate.) The comment notes that the main reason formula makers bring products to market is a perceived loophole in regulations surrounding CBD and full-spectrum hemp extracts.
Only delta-9 THC has been called in law specifically
When the 2018 Farm Bill was signed into law, it was removed cannabisFrom the DEA’s List of Schedule I Controlled Substances. However, Delta-9 THC (the main intoxicating part of the plant) has remained on the list.
Until now, it has not been possible from the point of view of crop breeding to develop a cultivar of the plant devoid of delta-9 THC. The minimum “compatible” synthetic raw material is less than 0.3% delta-9 THC by dry weight.
But because this molecule was specifically called for—and not others—in federal regulations, it opened the door to the isolation and development of other narcotics.
CBD (cannabidiol) was the first of its kind in this party, mostly because there is a growing amount of research supporting its effects and that cannabis is relatively available in the parent plant. But research at the plant continues to accumulate at an increasing rate.
A little searching for cannabis It was done in the United States during the years of federal embargo, mostly because legal hurdles made it cumbersome and expensive. The only legally available research material was cannabis grown at the University of Mississippi which was said to have a lower concentration of cannabis compared to strains being developed by plant breeders around the world.
Micro-breeding cannabinoids with little science and quality information
Now additional fractions appear in the front including CBG (Cannabistrol), CBN (Cannabinol) and others. The problem, says the USP, is that with Delta-8 THC (and some of these other small cannabinoids), product development is way ahead of science. There is so little delta-8 THC in the plant naturally that even among heavy recreational marijuana users the overall exposure was low. For consumers of delta-8 THC final products, this is no longer true. These consumers actually became guinea pigs.
“These products may be within the maximum amount of delta-9 THC allowed in cannabis, but may pose public health risks due to the intoxicating effects of delta-8 THC at high levels of exposure and potential product quality issues.”Comment explains.
Tread synthetic materials on unmapped ground
Additionally, the paper notes that most, if not all, of what is on the market has been industrially produced.
“Products classified as containing delta-8 THC have a high potential for being synthetically derived, because it is not generally thought to be economically feasible to extract naturally occurring delta-8, given the low concentrations found in hemp and hemp,”Comment explains.
This is most commonly done by chemically changing the CBD molecule. The USP said the manufacturing quality of these processes is unknown. The commentary stated that this process involves strong acids and catalysts and such harsh reaction conditions can give rise to unwanted and/or uncharacterized by-products and impurities.
“The fact of the matter is that so little is known about products labeled as delta 8, that the FDA and CDC have issued product alerts. Depending on how the products are produced, unknown impurities may be introduced, including: It is secondary and synthetic cannabinoid compounds that do not occur naturally in cannabis,” said Dr. Ikhlas Khan, Ph.D., chair of the USP Expert Panel on Cannabis. Dr. Khan also heads the National Center for Natural Products Research at the University of Mississippi.
A call for validated methods, more science
The USP comment puts forward the following action points:
- Clinical research investigating small cannabinoids, such as delta-8-tetrahydrocannabinol.
- Products labeled delta-8 THC must be tested for synthetic impurities and impurity levels must be controlled until they are proven to be safe.
- The need for systematic clinical investigations supported by high quality research materials and methods.
- Recognize the emerging concerns of new materials. The use of small cannabis and its compounds should be subject to systematic clinical and clinical investigations.
Flooding the market with unverified products
“Products containing delta-8 can be found at gas stations and convenience stores and are readily available online without any warnings or warranties, providing consumers with a false sense of security that these products are safe to consume.”David Vaillencourt, CEO of GMP Collective and a member of ASTM International notes.
“Synthetically derived hemp is not necessarily inherently unsafe if its quality is controlled and proven to be safe. By using general quality standards, we can help control the quality of products and set appropriate limits for impurities,” Dr. Nandakumara Sarma, director of Dietary Supplements and Herbal Medicines for the University of the South Pacific, said.
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