THIS MONTH’S CBD EXPERT: Douglas “Duffy” MacKay, ND, is the senior vice president of scientific and regulatory affairs at CV Sciences. MacKay oversees the company’s scientific and regulatory affairs department, ensuring CV Sciences continues to pioneer the development of hemp-based cannabidiol (CBD) products driven by rigorous science, innovation and regulatory compliance.
THIS MONTH’S QUESTION: Is it legal to use a CBD isolate, or must a CBD product always be a full-spectrum industrial hemp extract?
FDA’s public position is that isolated CBD ingredients are prohibited from being added to dietary supplements or conventional food because isolated CBD has already been investigated as a drug. This is not a new FDA policy. Not allowing drug ingredients in supplements or food is a long-standing FDA policy that is intended to protect drug research investments. From FDA’s perspective, there is no gray area–a product that contains isolated CBD is an unapproved drug and is in violation of the Food, Drug and Cosmetic Act. However, some companies choose to make products that contain isolated CBD and strongly believe they are not doing anything illegal. CV Sciences believes that avoiding isolated CBD in its products is the best choice.
That said, the hemp and CBD market continues to grow and products with isolated CBD are skyrocketing. Stakeholders, along with Congress and the media, have noted the CBD product explosion and the disconnect with FDA’s public position on CBD. Marketers of isolated CBD products may be on the verge of learning how FDA responds when risk-averse companies try to avoid FDA drug regulations. For example, the compounding pharmacy industry experienced a significant regulatory change when irresponsible compounding pharmacies acted as drug manufacturers, producing thousands of doses in a single manufacturing run to avoid rigorous FDA drug manufacturing requirements. The Drug Quality and Security Act (DQSA), passed by Congress in 2013, requires large-scale compounders to register with FDA as outsourcing facilities subject to FDA oversight and inspection. When FDA acts, it means business.