Rx and non-Rx Cannabinoids: A dual path regulatory framework for market access and product quality, to better support the needs of healthcare and selfcare

Speaking at the Analytical Cannabis Expo East Online 2020 back in October, Rob Dhoble, Managing Director at Havas ECS discussed a dual regulatory framework path to improve the needs of healthcare and selfcare.

Many Americans utilize OTC remedies in an attempt to fill the Rx affordability gap. In fact, 31% of surveyed adults report that they or a family member have relied upon home remedies or over-the-counter drugs instead of going to see a doctor, and 18% report not filling an Rx due to cost and taking an OTC product instead.

With large populations of individuals living with unmet and poorly met chronic medical needs, and the availability of relatively few FDA approved prescription cannabinoids, each narrowly labeled, and the widespread commercial availability of federally unregulated non-Rx cannabis products and non-intoxicating cannabinoids such as cannabigerol (CBG) and cannabidiol (CBD), our healthcare marketplace urgently requires a dual-path approach to ensure affordability, and market access to quality Rx and quality non-Rx cannabinoids for use under direction of medical professionals, and for use as non-Rx cannabinoids comprising ”selfcare”. Specifically, a new “brief summary” non-Rx cannabinoid requirement is proposed, uniformly depicted on product packaging and within product advertising, to summarize the presence or absence of:

• independent laboratory assessed listing of product ingredients including CBD, THC, and other cannabinoids; linalool, myrcene, and other terpenes, inert ingredients, and the absence of contaminants
• identification of ingredients as being botanical, synthetic, or bio-synthetic
• cGMP FDA compliance in manufacturing and packaging, including package expiration
• bioavailability data in how dose/serving size relates to absorption and blood levels