The existence of substantial clinical investigations regarding CBD has been made public. For example, two such substantial clinical investigations include GW Pharmaceuticals’ investigations regarding Sativex and Epidiolex. (See Sativex Commences US Phase II/III Clinical Trial in Cancer Pain and GW Pharmaceuticals Receives Investigational New Drug (IND) from FDA for Phase 2/3 Clinical Trial of Epidiolex in the Treatment of Dravet Syndrome ).
And the final nail in industrial hemp’s proverbial coffin: Federal law in the United States prohibits the use of hemp leaves and flowers to make drug products. That said, isolating CBD nullifies these distinctions, rendering its source irrelevant as CBD isolate contains nothing but CBD. In this case, the differences between industrial hemp and whole-plant marijuana are far less significant.
“CBD oil can contain some THC or it can contain none,” Romanowski says. “It really depends on how it is processed.” Regardless, though, it’s not enough to be psychoactive. And CBD oil derived from hemp is particularly low in — in fact, hemp is (in part) legally defined by having no more than .3% of the chemical. Kush Mascara contains CBD-rich cannabis oil derived from hemp and does not contain THC.
One area where CBD is clearly helpful: the treatment of seizures associated with one form of epilepsy. A 2017 New England Journal of Medicine study found ingesting oral CBD dramatically cut down most patients’ seizure frequency—a finding that prompted the FDA to support the approval of one CBD drug for use in the treatment of some epilepsy patients.
With that said, I'm definitely intrigued enough by the subtle effects to continue taking the oil and possibly even to up the dosage to the recommended two full droppers of the 30mL bottle per day for a week or so. Plus, I take comfort in knowing that it's an all-natural treatment for anxiety that's responsibly grown on family farms in Colorado. Something that's safe, legal, requires no prescription, and makes me less anxious, less scatterbrained, and more focused? I'm definitely on board.
There is an exception to sections 201(ff)(3)(B)(i) and (ii) if the substance was "marketed as" a dietary supplement or as a conventional food before the drug was approved or before the new drug investigations were authorized, as applicable. However, based on available evidence, FDA has concluded that this is not the case for THC or CBD. For more information on this provision, including an explanation of the phrase "marketed as," see Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.
Based on client feedback, as well as our own R&D, we have chosen to use Grape Seed Oil, which has a very high content of polyunsaturated fats, and is rich in Omega 3-6 as well as Omega-9 essential fatty acids. Grape Seed Oil is NOT recognized as an allergen by Health Canada (HC) or the Canadian Food Inspection Agency (CFIA); however, some people may have sensitivities to it.
Given CBD’s reputation as a popular, artisanal remedy, one would think that Epidiolex would command a lot of “off label” attention. After all, physicians often prescribe pharmaceuticals off label to treat conditions that were not the actual focus of clinical trials. But the costly price tag for Epidiolex (more than $30,000 annually) precludes off label prescribing as well as affordable access for tens of millions of Americans without health insurance.
^ Hayakawa K, Mishima K, Nozako M, Ogata A, Hazekawa M, Liu AX, Fujioka M, Abe K, Hasebe N, Egashira N, Iwasaki K, Fujiwara M (March 2007). "Repeated treatment with cannabidiol but not Delta9-tetrahydrocannabinol has a neuroprotective effect without the development of tolerance". Neuropharmacology. 52 (4): 1079–87. doi:10.1016/j.neuropharm.2006.11.005. PMID 17320118.
^ Nadulski T, Pragst F, Weinberg G, Roser P, Schnelle M, Fronk EM, Stadelmann AM (December 2005). "Randomized, double-blind, placebo-controlled study about the effects of cannabidiol (CBD) on the pharmacokinetics of Delta9-tetrahydrocannabinol (THC) after oral application of THC verses standardized cannabis extract". Ther Drug Monit. 27 (6): 799–810. PMID 16306858.
Choosing CBD products isn’t as simple as picking something off the dispensary shelf and then walking out the door. Consumers should be aware that a handful of hemp products on the market pay lip service to governmental regulations by labeling themselves as hemp, despite containing cannabinoids and terpenoids. Some CBD products are completely devoid of cannabinoids including CBD, despite package labeling. The FDA purchased a number of CBD products online in 2015 and 2016 to test them for the presence of CBD and other cannabinoids. They found that the amount of CBD these products claimed on their labels was markedly inaccurate; some didn’t even contain CBD.
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