Thanks to the FDA, We May Soon See CBD Regulation in the U.S.
Scott Gottlieb, Commissioner of the Food and Drug Administration (FDA), gave medical cannabis industry professionals cause for reserved excitement recently with a speech he gave at the annual conference for National Association of State Departments of Agriculture.
Many of us are familiar with the FDA for its role in protecting public health by ensuring the safety of our food and cosmetics, but it is also tasked with ensuring the safety, efficacy, and security of human and veterinary drugs, biological products and medical devices. Interestingly, cannabis-derived products fall under both of the organization’s purview, given that it is legalized as medication in most states, exists in edible forms like chocolate, coffee and tea, and is also considered a controlled substance under federal law.
Building a Stable Foundation for CBD
Gottlieb's reference to the FDA’s interest in CBD regulation development was not made behind closed doors; in fact, the audience for Gottlieb’s speech included the majority of the United States’ key food safety, economic well-being, farming, infrastructure, food regulation, and agricultural market development decision-makers.
In his speech, Gottlieb specifically referenced cannabis, emphasizing the amount of interest “among NASDA members in the regulatory framework for products derived from cannabis.” In building this “framework,” the FDA may be forced to consider routes that expand upon and reinvent some of the traditional patterns for the introduction of formal regulation.
According to Gottlieb, there is an increased desire at the FDA to represent public input when it comes to regulation for CBD products, specifically regarding “information on the science and safety behind CBD.” This is far from the norm when it comes to how FDA regulations are introduced, vetted, and implemented. Typically, feedback from the general public is ignored in favor of testing procedures and the outcomes of clinical trials.
Gottlieb further explained that the FDA is “also interested in hearing from stakeholders and talking to Congress on possible alternative approaches to make sure that we have an appropriately efficient and predictable regulatory framework for regulating CBD products.” Of course, scientific studies with cannabis will continue taking place and most likely will be expanded, though including outside entities and the concerned populace in building a foundation for cannabis and CBD regulation remains largely unprecedented.
Sharing the FDA’s Concerns
In reference to the passage of the 2018 Agricultural Improvement Act (also known as the Farm Bill), the impact of which we discussed here, the Commissioner spoke of the removal of hemp’s connection with cannabis as concerns the Controlled Substances Act. A caveat to hemp’s re-classifying came in the form of the FDA’s continued ability to regulate any present or future products containing either cannabis or compounds derived from the substance.
The FDA appears most concerned with any advertising of unproven health benefits relating to the use of cannabis or those affiliated compounds. For those of us in the industry that value professionalism and transparency and rely strictly on scientifically-proven data in working with medical cannabis, the FDA’s purported concerns in this area are well understood. As our Doctor Jane team continues to conduct extensive research and utilizes only proven methodology, it becomes increasingly difficult to combat misinformation and misrepresentation surrounding treatment with medical cannabis.
The fact that the FDA is preparing a “framework” for regulation despite these concerns, however, inspires hope for the future of medical cannabis’ public representation, though what that framework will look like and how it will be implemented remain to be seen.
Today’s blog is written by Rick Weyback, MD, founder and president of Doctor Jane and our licensed medical cannabis physician. If you are considering cannabis treatment or are wondering if medical cannabis may be right for you, please contact the team here at Doctor Jane at your earliest convenience.
About Doctor Jane
Doctor Jane is South Florida’s most discreet, professional, and convenient concierge medical cannabis practice. Dr. Luis Enrique R. Liogier-Weyback and his wife, Katie Liogier-Weyback, B.S., R.N., founded Doctor Jane on the core tenets of bringing personal, convenient, professional and discreet patient care to the medical cannabis treatment process. Doctor Jane provides South Florida patients and their caregivers with a safe space where they can exercise their right to access medical cannabis therapy in an environment of their choosing, free from stigma and complications.