Despite FDA’s strong language against hemp cannabidiol (CBD), sales and demand for the controversial cannabinoid are skyrocketing. Here are some of the most promising health areas.
Can products that contain cannabidiol (CBD), a non-psychoactive variety of Cannabis sativa, be sold as dietary supplements? The short answer is no, according to FDA’s webpage, “FDA and Marijuana: Questions and Answers.” But the agency’s justification for that position raises a few additional questions.
In the sentences following its negative opinion, FDA states that CBD products are excluded from its dietary supplement definition because of existing authorizations for investigational new cannabis drugs (INDs)-namely, GW Pharmaceuticals' Sativex and Epidiolex. An exception can only be made, FDA says, if the substance in question (CBD) was marketed as a dietary supplement or conventional food prior to those INDs. Well, according to FDA’s references, the IND authorizations became public on November 26, 2007 and May 24, 2014 for Sativex and Epidiolex, respectively. Those dates appear much too late to fit the IND preclusion to many in the CBD supplements industry, including CBD oil supplier CV Sciences (Las Vegas). Here’s what the firm had to say about FDA’s exclusion of CBD:
“Based on that criteria, notwithstanding the FDA’s Q&A Posting, it is our opinion, which is broadly shared by the marketplace, that CBD has been marketed as a dietary supplement prior to commencement and public notice of any substantial clinical investigations instituted on CBD, as the investigations that were publicized were not substantial as they were limited in number and preliminary in nature, thereby rendering the IND preclusion inapplicable.”
Perhaps it’s this lack of clear legal language, coupled with FDA’s lack of resources and extensive safety data, that has CBD sales and demand skyrocketing in spite of the agency’s position. The controversial cannabinoid is now appearing in proprietary oils, energy drinks, and cocktails, among other new markets. On top of that, steady traction behind hemp in food products is only helping CBD’s cause.
Regardless of the mixed opinions surrounding marijuana, CBD has proven to be non-psychoactive and safe for use. Although it might not be for everyone, there’s no question the legal language needs to be made clearer. In the meantime, CBD supporters will continue to push forward with new products and an ever-increasing consumer base. And if you look at the following research on various health conditions, that consumer base is poised to grow even bigger in the years to come.
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1. Food and Drug Administration (FDA), “FDA and Marijuana: Questions and Answers,” Questions #12 and #14, www.fda.gov/NewsEvents/PublicHealthFocus/ucm421168.htm, last accessed September 4, 2016.
Psychosis and Schizophrenia
Although CBD has been established as a non-psychoactive component of cannabis, its anti-psychotic effect is less understood but of equal interest. Preliminary data and case reports suggest that CBD, as an anti-psychotic compound, may be helpful in psychosis and schizophrenia management.(2â4)
Research is still needed to fully elucidate how CBD interacts with portions of the brain responsible for psychotic events, but early data and indications of fewer side effects than antipsychotic drugs should provide reason to consider CBD for such health purposes. Furthermore, some experts are concerned that psychiatric patients can develop resistance to pharmaceutical antipsychotics-an effect that hasn’t yet been observed with CBD.
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2. Fakhoury M et al., “Could cannabidiol be used as an alternative to antipsychotics?” Journal of Psychiatric Research, vol. 80 (September 2016): 14â21.
3. Gururajan A et al., “Does cannabidiol have a role in the treatment of schizophrenia?” Schizophrenia Research, published online June 30, 2016.
4. Shannon S et al., “Cannabidiol oil for decreasing addictive use of marijuana: a case report,” Integrative Medicine, vol. 14, no. 6 (December 2015): 31â35.
Because CBD has demonstrated neuro-protective and anti-inflammatory properties, researchers have speculated (for years, now) that CBD may be useful in protecting brain tissues, thereby reducing risk of Alzheimer’s disease or curbing further cognitive degradation.(5â7) In recent years, animal models show reduced memory impairment in mice supplementing with CBD-even among mice whose genes have been altered to serve as models of Alzheimer’s disease.(8â9)
As researchers advocate for greater attention to CBD for this purpose, it will be interesting to see how studies progress towards evaluating CBD’s effect on Alzheimer’s disease in human populations.
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5. Booz GW et al., “Cannabidiol as an emergent therapeutic strategy for lessening the impact of inflammation on oxidative stress,” Free Radical Biology and Medicine, published online January 14, 2011.
6. Karl T et al., “The therapeutic potential of the endocannabinoid system for Alzheimer’s disease,” Expert Opinion on Therapeutic Targets, vol. 16, no. 4 (April 2012): 407â420.
7. Karl T et al., “The therapeutic potential of the phytocannabinoid cannabidiol for Alzheimer’s disease,” Behavioral Pharmacology, published online July 28, 2016.
8. Cheng D et al., “Long-term cannabidiol treatment prevents the development of social recognition memory deficients in Alzheimer’s disease transgenic mice,” Journal of Alzheimer’s Disease, vol. 42, no. 4 (2014): 1383â1396.
9. Cheng D et al., “Chronic cannabidiol treatment improves social and object recognition in double transgenic APPswe/PS1âE9 mice,” Psychopharmacology (Berlin), vol. 231, no. 15 (August 2014): 3009â3017.
Pediatric Inflammatory Bowel Disease
With cognitive health at the center of CBD research, there’s still potential for CBD’s influence on human health to go further. In particular, researchers at the University of Colorado with gastrointestinal and pediatric specialties have decided it’s time to start discussing cannabis use in relation to pediatric inflammatory bowel disease (IBD). Although not directly mentioning cannabidiol, researchers stated in the Journal of Pediatric Gastroenterology and Nutrition that cannabis may have both beneficial and harmful effects in children with IBD, based on their experience in interacting with such patients. However, current federal legislation does limit researchers’ ability to conduct related research in this area.(10)
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10. Hoffenberg EJ et al., “Cannabis and pediatric inflammatory bowel disease: change blossoms a mile high,” Journal of Pediatric Gastroenterology and Nutrition, published online August 30, 2016.
Skin creams containing hemp oil are performing well in a few studies, and not necessarily because of their omega fatty acid content. At least one study has found regular industrial hemp oil may reduce sebum and erythema (reddening of the skin). Another recent independent study found that a CBD-rich cream, developed by CannaCeuticals, improves self-reports of skin appearance in 100% of subjects.(11) Impressed with the results, a North American marketing company named Laguna Blends recently signed a letter of intent to acquire the cosmetic hemp brand.
With potential starting to show for hemp in skin health, the cosmetics category represents a whole new market to exploit. Reassuringly, the creation of a diverse range of hemp-rich emulsions appears quite possible under the right conditions.(12)
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11. Ali A et al., “The safety and efficacy of 3% cannabis seeds extract cream for reduction of human cheek skin sebum and erythema content,” Pakistan Journal of Pharmaceutical Sciences, vol. 28, no. 4 (July 2015): 1389â1395.
12. Kowalska M et al., “Stability of cosmetic emulsion containing different amounts of hemp oil,” International Journal of Cosmetic Science, vol. 37, no. 4 (August 2015): 408â416.
Although CBD oils are relatively new, hemp foods are well established in health markets, where the crop is revered for its protein content. A plump market already exists for hemp protein isolate, but in order to keep hemp competitive with the likes of soy and pea, research must continue to validate the ingredient. With that in mind, researchers in the UK recently performed a heat-stability test on hemp protein isolates in order to understand how they withstand the intense conditions of the human digestion system after prior heat treatment. Using a simulated environment meant to mimic the human gut, researchers found that hemp protein isolates should remain soluble and stable in the body, so long as they’re kept below 80Â° C in manufacturing.(13)
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13. Raikos V et al., “Denaturation and oxidative stability of hemp seed (Cannabis sativa L.) protein isolate as affected by heat treatment,” Plant Foods for Human Nutrition, vol. 70, no. 3 (September 2015): 304â309.