Getting it right: Understanding the CBD regulatory landscape
Hemp seeds and hemp stalk have never been controlled substances in the United States, so hemp seed oil, hemp milk and hemp-based cosmetics have been popular and legal natural products for decades. On Dec. 20, Congress passed the Farm Bill, which removed the entire hemp plant — and its extracts — from the Controlled Substances Act. Legal hemp returned to America at the same time when scientists continued to learn more about the benefits of cannabidiol, or CBD, one of more than 100 nonintoxicating cannabinoids found in hemp.
The food, supplement and cosmetic industries quickly embraced access to hemp and flooded the market with products. However, the Food and Drug Administration quickly responded with a clear message — CBD and tetrahydrocannabinol, or THC, are not permissible additives to these products because both these cannabinoids are the active ingredients in approved prescription drugs (THC in Marinol and CBD in Epidiolex).
However, a hemp extract that contains CBD is different than purified and crystalized CBD. In fact, extracts derived from the full hemp plant contain a rich array of compounds, including cannabinoids, terpenes, flavonoids, vitamins, chlorophyll and fatty acids. More importantly, FDA recently conceded that hemp extracts differ from the approved pharmaceutical drugs and initiated a process to clarify the pathway by which products, containing cannabis or cannabis-derived compounds, may be approved for market.
According to New Frontier Data’s Hemp Business Journal, CBD led the 2018 hemp market categories with a $390 million market. By 2022, it predicts that number to more than triple to $1.3 billion. Currently, retail sales only make up $1 million for the category. By 2022, New Frontier Data estimates the mass-market CBD will be worth $430 million. The future flexibility of admissible CBD products, as determined by FDA, will influence the future CBD market environment.
Even with all the potential products, there’s still room for the pharmaceutical pathways. The Hemp Business Journal sees the market for Epidiolex in the United States and the European Union reaching $625 million within three years. The price tag exceeds $30,000 per year, but that is what it takes to get a pharmaceutical through the drug development pipeline and approved. These incentives must remain in place to encourage future development of additional cannabinoid-based medicines.
A shifting legal landscape, a patchwork of state regulations and evolving public opinion fuels growth in the cannabis industries. The emerging markets are leaps and bounds ahead of regulators. Lack of regulatory clarity and oversight creates blurred lines between cannabis-derived drugs, food, supplements and recreational products. Companies marketing isolated CBD in drinks and gummies could be viewed as culpable of adding an active pharmaceutical ingredient to the food supply.
Three distinct cannabis industries exist: the pharmaceutical, the hemp-based foods and supplements, and the state-based recreational marijuana. From the same plant, each of these industries create different products with different intended uses under different regulatory frameworks. A product being developed as a pharmaceutical has different expectations than a product used to supplement the diet, or a product used to get stoned. It is appropriate that a pharmaceutical product has rigorous manufacturing controls, minimal variability in composition, and rigorous clinical trials to prove benefits for a specific disease. Different regulatory frameworks are appropriate for different intended uses.
Retailers are a critical stakeholder in ensuring that the food, supplement and cosmetic cannabis industries are sustainable and successful. To realize the potential of CBD, we need three distinct categories of cannabis products. Retailers should ensure the products sold stay in their lane.
Retailers who take basic steps to ensure the sale of compliant CBD products do their part in securing long-term success for all.
Douglas “Duffy” McKay is senior vice president of scientific and regulatory affairs for CV Sciences.
The food, supplement and cosmetic industries quickly embraced access to hemp and flooded the market with products. However, the Food and Drug Administration quickly responded with a clear message — CBD and tetrahydrocannabinol, or THC, are not permissible additives to these products because both these cannabinoids are the active ingredients in approved prescription drugs (THC in Marinol and CBD in Epidiolex).
However, a hemp extract that contains CBD is different than purified and crystalized CBD. In fact, extracts derived from the full hemp plant contain a rich array of compounds, including cannabinoids, terpenes, flavonoids, vitamins, chlorophyll and fatty acids. More importantly, FDA recently conceded that hemp extracts differ from the approved pharmaceutical drugs and initiated a process to clarify the pathway by which products, containing cannabis or cannabis-derived compounds, may be approved for market.
According to New Frontier Data’s Hemp Business Journal, CBD led the 2018 hemp market categories with a $390 million market. By 2022, it predicts that number to more than triple to $1.3 billion. Currently, retail sales only make up $1 million for the category. By 2022, New Frontier Data estimates the mass-market CBD will be worth $430 million. The future flexibility of admissible CBD products, as determined by FDA, will influence the future CBD market environment.
Even with all the potential products, there’s still room for the pharmaceutical pathways. The Hemp Business Journal sees the market for Epidiolex in the United States and the European Union reaching $625 million within three years. The price tag exceeds $30,000 per year, but that is what it takes to get a pharmaceutical through the drug development pipeline and approved. These incentives must remain in place to encourage future development of additional cannabinoid-based medicines.
A shifting legal landscape, a patchwork of state regulations and evolving public opinion fuels growth in the cannabis industries. The emerging markets are leaps and bounds ahead of regulators. Lack of regulatory clarity and oversight creates blurred lines between cannabis-derived drugs, food, supplements and recreational products. Companies marketing isolated CBD in drinks and gummies could be viewed as culpable of adding an active pharmaceutical ingredient to the food supply.
Three distinct cannabis industries exist: the pharmaceutical, the hemp-based foods and supplements, and the state-based recreational marijuana. From the same plant, each of these industries create different products with different intended uses under different regulatory frameworks. A product being developed as a pharmaceutical has different expectations than a product used to supplement the diet, or a product used to get stoned. It is appropriate that a pharmaceutical product has rigorous manufacturing controls, minimal variability in composition, and rigorous clinical trials to prove benefits for a specific disease. Different regulatory frameworks are appropriate for different intended uses.
Retailers are a critical stakeholder in ensuring that the food, supplement and cosmetic cannabis industries are sustainable and successful. To realize the potential of CBD, we need three distinct categories of cannabis products. Retailers should ensure the products sold stay in their lane.
Retailers who take basic steps to ensure the sale of compliant CBD products do their part in securing long-term success for all.
Douglas “Duffy” McKay is senior vice president of scientific and regulatory affairs for CV Sciences.