On Thursday, November 5, and Monday, November 9, respectively, I attended "CBD: Wonder Ingredient or Potential Snake Oil?"—a virtual workshop that covered topics related to the cannabidiol (CBD) industry overthe course of two half-day sessions. Cannabidiol is a non-psychoactive (non-mind-altering) compound found in the cannabis plant— otherwise known as marijuana. The seminar could not have been timelier given the fact that on Tuesday, November 3, 2020, New Jersey voters approved Public Question 1, which legalizedthe use of adult recreational marijuana in the state—a decision that could boost the New Jersey economy by as much as $126 million annually. This event was made possible by the Rutgers University Center for Dermal Research and its esteemed director, Dr. Bozena Michniak-Kohn, and focused on issues ranging from regulation to manufacturing to intellectual property.
CBD: Wonder Ingredient or Potential Snake Oil? Day 1
To kick off this insightful event, Dr. Daniel Siegel, a clinical professor of dermatology at SUNY and Chief Scientific Officer (CSO) for the scientific advisory board of Greenway Therapeutics—a medically focused biopharma company—gave a presentation titled “Therapeutic Potential of Cannabinoids in Dermatology and Beyond.”
Siegel, along with Greenway Therapeutics president and CEO Michael Milane, MD, has pioneered a new product called CannoTM Cream, which features a nanoparticulate CBD cream that seems to be effective and fast-acting in reducing redness and inflammation of the skin.
Continuing the momentum from the first speaker, David Steinberg, president of Steinberg & Associates, a cosmetic regulatory consulting firm specializing in concept-to-market compliance for topical and OTC products, gave a comprehensive overview of the CBD regulatory landscape.
Next, Keith Woelfel, the director of research and development (R&D) for Caliper Foods, a consumer packaged goods (CPG) company, addressed a truly complex topic in his presentation “CBD: CMC (chemistry, manufacturing, and controls) Challenges.” He provided insight into a critical issue, which is the irregularity of testing for purity and extract percentages of CBD. Different labs may come up with different results, and the exact science for testing still needs to be refined, streamlined, and regulated into one singular system. Caliper has made it their mission to refine and master this process. Rounding out the first half-day session, Shahnam Sharareh, Esq., a patent attorney with , enlightened us about the many intellectual property issues surrounding the CBD industry.
Day 1: Summary - CBD can be a wonder ingredient if used for the right purposes. The industry is working its way through some regulatory struggles, which are exacerbated by companies making unchecked and unverified claims about the benefits of their products. By coming together and setting the best practices for testing and processing, the industry can head in the right direction.
CBD: Wonder Ingredient or Potential Snake Oil? Day 2
The second session on November 9 began with a panel discussion, “Corporate Banking, Employment, and Investment Considerations,’ which featured several partners of law firm Fox Rothschild LLP, which specializes (among other things) in cannabis law, environmental law, intellectual property, and regulatory and compliance issues . Moderated by Shahnam Sharareh, who also holds a doctorate in pharmacy (PharmD), panelists included attorneys Jonathan Lagarenne, who discussed corporate banking, Bob Nagle, who discussed employment and HR considerations, and Mark Yacura, who discussed regulatory and due-diligence considerations.
After a brief break, Fox Rothschild LLP partner Joshua Horn gave a comprehensive overview of the ever-evolving CBD landscape in his presentation “CBD Update on the Latest Importation, Transportation, and Intrastate Sales and the Ever-evolving Matrix of State Compliance Regulations,” and referenced industry stakeholders including the United States Department of Agriculture (USDA) and US Food and Drug Administration (FDA). The FDA has had to tighten restrictions on serious claims made by companies that produce CBD ingestible—statements such as, “this CBD tablet will cure your cancer!” However, they have not really tackled the topical field (lotions, creams, etc.).
A high-level view of the CBD process from farm to consumer.
In the final session, Robert Falcone, senior manager of regulatory affairs at Prestige Consumer Healthcare, outlined many FDA and USDA perspectives on CBD and hemp-derived CBD products. We explored how the 2014 Farm Bill initiated a pilot program for hemp growth and usage, and how the 2018 Farm Bill expanded upon that for commercial production. There are still many questions that remain about the safety of CBD, and Dr. Falcone posed some of the more interesting, intricate, and important questions that require research and clinical trials in order to answer.
Day 2: Summary While CBD can definitely be of use and is not outright harmful to the body, it is important to study every aspect of the chemical and how it may affect the body over a long period of time. Another amazing development in the world of CBD has been the approval of Epidiolex—the first CBD drug approved by the FDA which can be used for individuals with two subtypes of epilepsy that are commonly associated with seizures.
Final Takeaways:
CBD has the potential to be a wonder ingredient that might be able to help with anxiety, pain, and skin disorders. However, the field is saturated with products that make false claims that—while harmless to the consumer (aside from the money they waste buying a product that has no benefits)—serve to discredit the true value and curative properties that many CBD produces may possess. In this sense, CBD can be a snake oil. More safety studies, tighter regulation, and investigation into how CBD works and helps in the body will help pave the way for CBD to distinguish its place as a medical therapy. In the meantime, there are a number of CBD products out there that can be a useful remedy, just make sure to do your due diligence and research as a consumer!