How to Reduce Your Regulatory Risk in the Renaissance of Hemp-Derived “Ceutical” Products

With recent regulatory changes to state and national laws, cannabis is undergoing a period of rediscovery and attraction from big pharma, nutraceutical manufacturers, food companies, and retailers. Hemp was a vital crop and form of currency in the American colonies, but tobacco and cotton pushed hemp to the side as a major cash crop by the late 1800s. The re-evaluation of U.S. and Canadian medical marijuana laws over the past decade has driven novel innovation in food products with hemp-derived cannabinoids such as cannabidiol (CBD). Chronic CBD users represent 7% of the American population, and North American use rates are expected to rise as access to hemp-derived CBD food products increases. In preclinical studies, CBD shows potential therapeutic efficacy against a diverse array of clinical conditions. Chronic pain is the most studied indication for CBD intervention. Other than rare seizures, there are major research gaps in our understanding of CBD efficacy for most medical conditions touted in marketing. Investment to substantiate even basic structure-function claims (occasional pain, sleeplessness, anxiety, and inflammation) is lacking. If efficacy is the “yin” then safety is the “yang” as both must be evaluated in concert in clinical trials. 

Clinical studies provide valuable safety information in humans on markers of toxicity, which can be used by toxicologists for determining the No Observed Adverse Effect Level (NOAEL) of a test article. Safety data is critical to regulatory authorities like US FDA and Health Canada to assess the serving level at which botanical constituents like hemp-derived cannabinoids are safe for human consumption in healthy populations. Safety evidence serves as the fundamental basis as to why a given serving level and frequency of consumption were chosen on the label by manufacturers. Food and dietary supplement contract manufacturers and own label distributors are responsible for knowing the NOAEL of their new dietary ingredient contained in their product. CBD is no exception but has a higher hill to climb than a typical New Dietary Ingredient.

CBD is not permitted to be used in US food products. While US efforts through the Agriculture Appropriations Bill are under way to create a pathway to market in foods, we know very little in terms of safety and efficacy outside of intended use in patients with rare seizure disorders. Once permitted through regulation by the Department of Health and Human Services Secretary, CBD would still be considered a new dietary ingredient that was never sold in interstate commerce in the US prior to October 15, 1994. Safety assessments from preclinical rodent studies and clinical trials will become critical for regulators at FDA’s Center for Food Safety and Applied Nutrition. Manufacturers and distributors will require their own NDI notifications (NDINs) as a license plate for moving CBD products in interstate commerce. Licensing agreements between own label distributors and contract manufacturers over a CBD product and its corresponding NDIN license plate will become critical. Safety and efficacy will be the only means with which to reduce regulatory risk in the near future. Foods, unlike drugs, cannot be marketed to patients with diseases, a pathway fraught with dire regulatory risks and consequences. Foods, including dietary supplements, are marketed for ingestion by healthy adults.

Developing successful clinical trial protocols with non-disease endpoints to permit properly qualified structure function claims and to acquire safety data in humans requires expertise from a clinical research organization with extensive scientific and FDA-regulatory experience. Owning the competent and reliable science behind each claim will be critical when marketing to tech-savvy, information-consuming millennials, the largest group of CBD users, and future generations to come. Owning the science behind the claims also creates the real value proposition and incentive for merger and acquisition activity, which has been solid in the dietary supplement industry. Composing comprehensive identity and safety dossiers, incorporating preclinical and clinical safety data, will be the blueprint for success and reducing your regulatory risk. Time will tell whether this CBD renaissance is met with the appropriate scientific rigor in both efficacy and safety to mature from a cottage industry. Or will it be a short-lived, Shakespearean tragedy, the latest ingredient to shine and tarnish over time at trade shows?

Speakers

Mal Evans, DVM, PhD, Chief Science Officer, KGK Science

Recognized at the international level for her work in chronobiology and nutraceutical science, Dr. Mal Evans is a leading scientist in the health and wellness sector and a field expert in developing protocols which translate study sponsor ideas into journal manuscripts with the highest impact rating. Throughout her career, she has spearheaded unique and innovative research initiatives, creating an entirely new model for the measurement of nutrients. Additionally, Dr. Evans continuously challenges traditional thought by regulatory agencies as to what constitutes competent and reliable scientific evidence to substantiate a claim to further the scientific acumen of the nutrition industry. As the CSO of KGK Science, she is responsible for overseeing the company’s research operations.

Message Presenter

Corey Hilmas, MD, PhD, Chief Regulatory Officer, KGK Science

Dr. Corey Hilmas is a respected scientist and former federal regulator with many years of US federal service. He is a recipient of the FDA Commissioner’s Award of Merit for trial work on behalf of the US government. He is an industry-recognized regulatory expert with an intimate knowledge of the dietary supplement industry and US FDA. He was a principal investigator for preclinical safety and efficacy assessment. Dr. Hilmas oversaw the development and implementation of all scientific, regulatory, educational, and compliance programs in his previous employment, writing over 65 comments to 10 federal and state agencies. Dr. Hilmas also worked on the Supplement Safety & Compliance Initiative (SSCI), assisting with drafting technical benchmarking guidance and governance documents to establish the initial groundwork of the organization. Dr. Hilmas also acted as the Executive Director for the Natural Products Foundation, where he provided regulatory solutions, wrote warning letters to identify non-compliant products for federal regulators, and tested random products for GMP compliance through the NPF TruLabel Program.

Additionally, Dr. Hilmas has drafted chemistry/safety dossiers and Citizen Petitions; served as a toxicology reviewer at the FDA’s Center for Food Safety and Applied Nutrition (CFSAN); managed enforcement related to Good Manufacturing Practices (GMPs), labeling, claims, dietary ingredient safety, and imports/exports; and acted as a federal expert witness in food cases that went to trial.

Message Presenter