The Hazy Science of CBD

As governments and regulatory bodies loosen their rules on hemp-related products, including the legalization of marijuana, the cannabidiol, or CBD, market has grown at remarkably high rates. One projection by BDS analytics and Arcview Market Research puts the overall CBD market at $20 billion by 20241. Combining the CBD market with the legal marijuana market, projections by BDS hit $45 billion2. Industries affected by the legalization of cannibus-related products include cosmetics, food and beverage, and jewelry and pharmaceuticals, and with the rapid expansion of this market, a large section of the US economy will be involved in CBD use or production by 2024.

As of 2019, many channels of CBD distribution are untracked – driven by small dispensaries and independent cannabis farmers who are typically missed by USDA and USFDA regulations as a result of loopholes in the Farm Bill of 2014, thereby posing a potential threat to consumers. Legal CBD can be extracted or purified from hemp variations of Cannabis sativa plants, whereas marijuana variations of Cannabis sativa, which also produce CBD, are currently outlawed for consumer use by the Federal government. Legal hemp plants are not regulated federally and consumer products from these plants are often not regulated at any level, leading to potential safety issues for consumers. Based on USFDA tracing of products from 2015-2019, many CBD-based products do not contain the amount of CBD they claim (Bon Miller et al., 2017). That is, many CBD products may be of uncertain composition and origin due to potentially improper preparation. Furthermore, many of these products also contain measurable amounts of tetrahydrocannabinol (THC), which accounts for the psychoactive properties of marijuana (Bon Miller et al., 2017) and is currently outlawed by the US federal government.

In addition to not complying with the label composition guidelines as required by Federal Regulations under 21 CFR, many of these CBD products make unproven claims about the efficacy and potential uses of CBD. Under the FD&C Act (or 21 CFR), a cosmetic is defined as “1) articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance, and (2) articles intended for use as a component of any such articles; except that such term shall not include soap.”3 Many of the claims for CBD seen on the market are not consistent with cosmetics and might fall under the category of a drug which is defined as: A product intended to affect the structure or function of the body, or to diagnose, cure, mitigate, treat or prevent disease, it is a drug, or possibly both a cosmetic and a drug (sometimes called a cosmeceutical). That is, many of these CBD products are not approved by the USFDA and the potential risk to consumers cannot be quantified by the authority of the USFDA.

CBD has only been approved by the USFDA in a highly purified form for the treatment of two rare epileptic disorders as the drug Epidiolex (Devinsky et al., 2018). Other uses of CBD are not approved due to lack of systematic testing and USFDA review, including double-blind placebo controls monitored by the USFDA. Despite the lack of scientific validation, claims for CBD range across the entire spectrum of human diseases. The scientific literature enumerates a number of different potential uses, ranging from an adjuvant to standard cancer therapy to decreasing inflammation, with dispensaries making additional claims not supported by the scientific evidence (see Russo, 2016 and Hildebrand, 2018). These studies are largely preliminary and preclinical and do not approach the necessary standard for approved use (Laprarie et al., 2015). Combined with the lack of monitoring of CBD products in terms of supply chain and composition, the consumer is exposed to multiple potential risks from CBD that have not been quantified.


Citations

1 BDS analytics report on CBD market. https://bdsanalytics.com/u-s-cbd-market-anticipated-to-reach-20-billion-in-sales-by-2024/. Visited 1/16/2020

2 Ibid.

3 US Code Title 21 Chapter 9: https://uscode.house.gov/view.xhtml?path=/prelim@title21/chapter9&edition= prelim. Visited 1/16/2020


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AUTHORS

Dr. Christopher Spaeth, Senior Consultant
Dr. Christopher Spaeth holds a B.S in Comprehensive Science with a minor in Russian language and a Ph.D. in Cell and Molecular Biology with a focus on Neuroscience, Pharmacology, and Toxicology. During his post-doctoral fellowship, Dr. Spaeth performed ground-breaking research while teaching as an adjunct professor of Neuroscience and as a market analyst of early-stage pharmaceutical companies. He has over 16 years of experience in toxicology, neuroscience, genetics, and molecular biology and multiple publications in peer-reviewed journals.

He has extensive laboratory research experience and broad-based training in genetics, molecular and cellular biology, neuroscience, oil-based interactions with biological systems, such as those mediating dermal penetration of substances, and conserved pathways of cell traffic and cell barrier function. He has taught at the university level and has been awarded multiple grants from the US National Institute of Health and the National Institute of Drug Abuse.

As a cosmetic toxicologist at a leading cosmetic company, he has extensive experience with hazard assessments, dose and exposure assessments, risk assessments and management, and communicating these results to stakeholders across all business units as it relates to cosmetic skincare products. He has written hundreds of safety assessments of cosmetic ingredients for products currently on the market.

Dr. Scott Drouin, Senior Consultant
Dr. Scott Drouin is a senior toxicology consultant with over 22 years of experience in Toxicology, Immunology, Lung Physiology, infectious disease, food testing, and laboratory sciences.

As part of the Rimkus Toxicology and Food Safety practice group, Dr. Drouin leads cases involving exposure to drugs, alcohol, and contaminants in food; as well as human exposure to environmental substances; and employs toxicological principles to corroborate medical facts documented in exposure cases against known health endpoints to substantiate allegations and determine alternative causation.

Dr. Drouin specializes in cases investigating respiratory diseases. Specifically, those related to air-born exposure to environmental substances including viruses (COVID-19), bacteria, mold, chemicals, asbestos, and carcinogens. His specialty lies in assessing the risk of developing respiratory illnesses, pneumonia, environmental allergies, asthma, and lung diseases from exposures to such environmental contaminants. Furthermore, Dr. Drouin can evaluate clinical testing procedures related to lung diseases and, by applying toxicological principles to these cases, can tie in the medical documentation as it may or may not relate to the alleged exposure. Air is a dynamic medium and constantly changing, as is the diversity and concentration of contaminants it contains at any one time. Thus, Dr. Drouin also evaluates respiratory exposure potential from a global perspective to help the client understand the potential alternative causation and can communicate these complex issues to the client.

Rimkus Consulting Group
http://www.rimkus.com/

Rimkus Consulting Group, Inc., a US-based international consulting firm, brings over 300 professionals to bear on your consulting and expert witness needs. You can learn about our company history, explore the wide range of practice areas we deal in, and see what kinds of assignments we've had recently. Even our long-time clients are often surprised to learn the breadth of our services. You probably will be as well. We have been in the forensics business since 1983, offering our clients an array of experts that spans virtually all engineering disciplines, many scientific disciplines and forensic business analysis. With this broad range of expertise, plus the years of experience our staff members bring into play, we are able to address virtually any problem our clients bring to us. We further augment our full-time staff with a select group of contractors with unique education or experience to address those more esoteric needs that come up from time to time. We offer our clients the services of an extensive list of seasoned professionals to meet their needs.



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