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NaturPro Comments to FDA on the Safety of CBD

Oct
10

NaturPro Comments to FDA on the Safety of CBD

Date: September 14, 2017

To: FDA

From: Blake Ebersole, Carmel,  Indiana  email: blake.ebersole@gmail.com

Re: Entire Comments for The Food and Drug Administration (FDA) Notice: International Drug Scheduling; Convention on Psychotropic Substances; Single Convention on Narcotic Drugs; Ocfentanil, Carfentanil, Pregabalin, Tramadol, Cannabidiol, Ketamine, and Eleven Other Substances; Request for Comments

To Whom It May Concern:

I strongly urge you to consider all available evidence to deschedule CBD and hemp-based products, permitting them to be regulated like similar products.

I was only slightly surprised to see FDA seeking comment on CBD, among a list of highly addictive and unsafe substances. It was telling that the other substances on the list are prime examples of a U.S. healthcare system that has repeatedly failed to adequately provide for its people, and that many consider CBD to be a potential solution.

I am in full support of common sense regulations for the use of CBD and other cannabis derived products, as part of foods, dietary ingredients and medicines, especially where they are benchmarked to similar requirements for these regulated products.  I have observed, attempting to be as objective as possible, that cannabidiol (CBD) and related cannabinoids, appear to be safe, tolerable and effective across a wide range of doses, in both adults and in children who are healthy, as well as those with the occasional ache or pain, in addition to those with severely compromised health conditions.  CBD is likely to be safe, and I understand there has already been significant research to support its safety on a level with other permitted food additives or dietary ingredients.

For the past 10+ years, I have managed R&D, scientific, FDA regulatory and compliance activities for natural and plant-based products used in supplements, foods and medicines.  For the past three years, I have consulted to support standards development for CBD and cannabis, supporting various government, NGO’s and responsible industry members.  I have helped with qualification and production processes for CBD using FDA GMP’s for food and supplements, as well as state and local regulations. I have also audited analytical laboratories testing programs for cannabinoids and contaminants, and have reviewed much of the published toxicology and clinical data.  Initially a skeptic of the therapeutic potential of CBD, my mind has gradually changed after personal communications with more than one hundred people who have tried either cannabidiol alone, or in combination with THC or marijuana.

CBD does not offer the psychoactivity, the ‘high’ or addictive potential of THC. In fact, it is well known among recreational marijuana users that CBD dulls the euphoric effect that is typically the goal of recreational marijuana use. Although CBD is being sold in marijuana products in states that permit marijuana, (overwhelmingly by people who use marijuana for legitimate medical reasons), the only use of CBD outside the state-run marijuana programs are from hemp-derived materials which contain only trace to very low levels of THC – not enough to cause a ‘high’ or euphoric effect.  In general, products which contain a predominant amount of CBD do not also contain any appreciable amount of THC considered significant or helpful for a recreational user.  The use of CBD as recreational is therefore very limited. Surprisingly, the predominant use of CBD recreationally is as a substitute for marijuana, alcohol or prescription opiate use.  The handful of published clinical studies on CBD and cigarette smoking cessation are consistent with these anecdotal reports, suggesting that part of the potential of CBD lies in its apparent ability to reduce or replace marijuana, alcohol or drug use and abuse.

I have never heard from so many people with complicated, unresolved health conditions, who claim that a non-pharmaceutical intervention completely changed their life for the better.  As the most frequent example, CBD appears to work for a large percentage of people with chronic pain or debilitating inflammatory or autoimmune issues who don’t respond to NSAIDS, and who are afraid of (or have been addicted to) opiates. Until the pain management and the resulting prescription opiate problem is resolved in the U.S. CBD should be considered a front-line natural remedy, much like turmeric, fish oil, glucosamine or aspirin has already been found effective for by millions of Americans.

CBD appears to support a number of health conditions that span healthy, pre-disease and disease states.  CBD, both with or without THC and other cannabinoids, has been a life-changer for untold thousands of people.  CBD clearly has a potential for therapeutic use, in most cases significantly improving quality of life for people who have not found any solutions in the conventional healthcare system.  Notwithstanding the clear therapeutic value of marijuana and THC that was outlined in the National Academies of Sciences Institutes of Medicine analysis titled “The Health Effects of Cannabis and Cannabinoids: The Current State of Evidence and Recommendations for Research” published on January 12, 2017 and located at http://nationalacademies.org/hmd/Activities/PublicHealth/MarijuanaHealthEffects.aspx, CBD has also immense promise, subject to a number of human and animal studies conducted outside the U.S. for more than 50 years.

I have personally observed the cultivation and manufacturing practices of many firms as a quality management consultant, and I have also supported the development manufacturing processes and quality management systems for CBD products that are legal under relevant and appropriate regulations, which meet the already established food safety requirements required by FDA.  Existing cultivation and production processes around the globe have reliably produced hemp and cannabis products that are safe for human consumption. The quality and safety of these products will only improve under existing regulations, like those in place for dietary supplements.

As a regulatory compliance consultant, one issue I can understand is the inability for regulators to determine whether a cannabis plant is industrial hemp, or marijuana. However, the answer to many for this issue is clear: there currently exist valid methods for testing samples to the 0.3% THC threshold that defines marijuana by law. Because most CBD products and raw materials do not contain more than 0.3% THC, it should be easy for industry and regulators to discern a federally legal product from an illegal one. I have coordinated analytical testing on CBD products as a consultant for identity, potency  and impurities such as pesticides, residual solvents, and microbiology, and I have found these labs meet the same requirements expected of FDA-regulated food and supplement industries. There are several labs in the U.S. who are capable to perform testing for CBD products, and use validated analytical methods yielding reliable results, meeting general requirements for method validity, as per AOAC, FDA and other applicable guidelines. I have also not observed the types and levels of contaminants any different from those found in foods and dietary supplements.  In many cases, CBD products meet dietary supplement requirements, even if they have not been required.

Cannabis cultivation and oil production present a minimal level of food safety risk.  Because water is rarely (if ever) used to process raw plant materials, or extract oil-based products containing CBD, issues with waterborne pathogens are unlikely. The lack of clear regulations for CBD products does pose a potential threat to public safety, however. Due to the CBD gray market that has grown overnight, and the low barriers to entry for these as well as food and supplement products, there are presumed to be many small manufacturing facilities that are under the radar, who have not been inspected or registered with state or FDA agencies. These facilities may be performing packaging of end products that do not have the quality management programs or preventive controls required to ensure product safety in today’s world. Therefore, it is important for regulators and industry to work together toward responsible and appropriate regulations that would require a similar level of control to those found for food or dietary supplements.

CBD enjoys a likely long history of human consumption, which unfortunately is not well documented. There is a strong case that humans have historically consumed CBD as part of cannabis remedies, along with THC, since both are the predominant cannabinoids present in hemp and marijuana. Presumedly, the content of CBD in hemp varieties that were historically used as fiber and medicine, particularly those grown in eastern Europe and South Asia continuously for the past century, reflect a composition containing a substantial amount of CBD.   It is possible that the pre-modern medical use of hemp as pain relief was due to CBD activity in addition to THC or the other cannabinoids or constituents that are naturally occurring in the hemp and cannabis plants.  It is also scientific fact that humans and animals possess receptors for which cannabinoids from plants serve as ligands. There are few (if any) plants with such a long-time history of widespread human consumption, for which there have been specific receptors identified in the body.  Simply, the story of cannabis and human’s voracious consumption of it should be part of any risk-based analysis of its modern use.

Of course, there are many poisonous or addictive natural products which are banned, just like there are many harmful ones that are legal: tobacco, alcohol, and caffeine are widely accepted as being helpful for everyday life, and these enjoy the benefits of common sense regulations.  It is absurd to consider marijuana worse than these substances, and without any accepted medical use under Schedule 1.  It should be considered an even more criminal act that CBD is considered in this same list, conveniently lumped under the umbrella of marijuana. To me, this represents a deliberate suppression of our freedom to pursue life, liberty and happiness that was granted by our country’s founders.

In my view, and I believe in the view of many other scientists and physicians who have also seen first-hand the health outcomes with CBD use, the benefits of CBD far outweigh the risks.  I urge FDA to carefully learn and consider the benefit versus the risk to permitting CBD products under an existing regulatory guideline, such as that for dietary supplements (21 CFR 111). As a second, but less attractive option, state-led regulatory efforts under legal recreational and medical marijuana, are rapidly becoming equipped to handle CBD products, despite the absence of federal support.

Although economic development is outside the scope of this comment, you may have heard that CBD is made from hemp, which many believe could have a major economic impact on America’s farmers and reduce our reliance on fossil fuels.

I strongly urge you to consider all the comments on this board, and your duty to promote public safety, and deschedule CBD and hemp-based products, permitting them to be regulated like all other similar products.

Blake Ebersole
President
NaturPro Scientific LLC
Carmel, Indiana

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