This new year holds the promise of significant changes in the landscape of the hemp industry in the United States. Monumental events of 2018 set the stage for regulations to change and a burgeoning CBD industry to flourish. The 2018 Farm Bill was passed on December 20, 2018, and initiated a paradigm shift in the way that hemp and its derivatives are viewed in the US.
Hemp, cannabis containing no more the 0.3% THC, is no longer considered a controlled substance on the federal level. It is now an agricultural commodity that is open for interstate commerce. Not only was the plant itself removed from the Controlled Substances Act, but also any extracts, cannabinoids and derivatives; meaning that CBD products derived from hemp are able to be sold and traded across the country. The DEA is no longer overseeing the interstate commerce of hemp and derivatives, and state and tribal law is not permitted to interfere with interstate transport of hemp products no matter what restrictions are present in their jurisdictions. Regulations over the production of hemp still exist with state agricultural programs having the option of implementing licensing plans that must be approved by the USDA. In states that do not choose to have their own programs in place, producers may apply for a license directly with the USDA. Producers of hemp and derivative products now have the opportunity to establish and grow their businesses as federally regulated companies such as banks and pharmacies can now have peace of mind when engaging in activities with the industry.
Despite the changes brought by the passing of the Farm Bill, the FDA has maintained it’s established position that CBD cannot be used in foods or dietary supplements. The stance of the agency is based on the preclusion of CBD as a dietary ingredient due to the approval of an Investigational New Drug (IND) status for Epidiolex (a pharmaceutical form of CBD). Essentially, the FDA believes CBD was a drug ingredient prior to being used as a dietary ingredient and therefore is considered a drug. Many stakeholders in the industry hold that CBD was in fact marketed in foods and dietary supplements prior to the IND being obtained and that it meets the definition of a dietary ingredient as outlined by the Dietary Supplement Health and Education Act.
Although the FDA has issued warning letters to companies selling CBD supplements and foods, these were based on the claims that were being made concerning the mitigation of diseases and not based on the inclusion of CBD as an ingredient. The FDA has yet to issue a recall of CBD products to pull them from the shelves. In fact, the agency issued a statement shortly after the signing of the Farm Bill indicating that “pathways remain available for the FDA to consider whether there are circumstances in which certain cannabis-derived compounds might be permitted in a food or dietary supplement.” This willingness to find a path around an IND preclusion is not something that the FDA has done before. They further indicated that they will be open to holding meetings with stakeholders to hear about their experiences and challenges and evaluate any matters concerning public safety. The aim of such meetings is to develop predictable and efficient regulatory pathways that would allow products to be lawfully sold by producers that meet the requirements of law. This brings an optimistic outlook to the US hemp industry and many hope to see the regulations evolve to allow an already thriving industry boom.
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Andrew Charrette, Sr. Mgr Regulatory Affairs, KGK Science
Andrew Charrette leads the regulatory affairs division of KGK Science and has an in-depth knowledge of the cannabis regulations in North America and Europe. He has experience in submitting Cannabis Research License applications to Health Canada under the new Cannabis Act, organizing over 50 submissions to Health Canada and has provided consulting for numerous product claims as well as NDIN and GRAS submissions to the US FDA. Andrew received his undergraduate degree in Pharmacology and Physiology from the University of Western Ontario and later obtained a master’s degree in Neuroscience from the University of Ottawa.