CBD: Food Ingredient, Dietary Supplement, or Drug?
By Eric Edmunds
The basic definition of CBD is fairly clear: As the abbreviation for cannabidiol, CBD is a naturally occurring, non-psychoactive cannabinoid of the cannabis plant. As opposed to tetrahydrocannabinol (THC), CBD does not a “high.” In fact, according to the World Health Organization, “CBD is generally well tolerated with a good safety profile…. To date, there is no evidence of recreational use of CBD or any public health related problems associated with the use of pure CBD.”
However, the legal definition is not quite as clear, with a key differentiator being whether the CBD is derived from hemp or from marijuana. With the passage of the 2018 Farm Bill, CBD derived from hemp became federally legal. But …
it is still subject to a number of federal regulations, including those of FDA for its use in food, drugs, and dietary supplements.
it is still subject to various state regulations.
Federally, FDA announced that it intends to hold a public meeting in April, which will hopefully begin to provide some clarity and start to align state regulatory expectations. The USDA is also holding some meetings/listening sessions regarding industrial hemp programs that are starting to be developed under the 2018 Farm Bill.
As to state regulations, in the states that have made cannabis legal for medicinal and recreational use, CBD products are typically legal under state law, although there are some restrictions on whether or not the product can be sold in general commerce, or solely through state licensed cannabis dispensaries In states with no specific marijuana product laws, hemp-derived CBD is legal to use due to the provisions of the 2018 Farm Bill, but there is still some confusion around the regulatory framework. In some states (e.g. Idaho, Nebraska and South Dakota) that have not legalized cannabis in any form, even hemp and hemp-derived CBD products may be subject to criminal penalties.
State regulations vary not only in legality vs. illegality, but also in CBD’s distinction as a food, dietary supplement or drug. States are approaching the issue very differently. For example, among the high-profile states which have been taking some regulatory initiative: New York has leaned towards dietary supplement, California is following FDA’s lead and treating it as an active drug ingredient, and Maine is only allowing it through state cannabis programs.
To revert back to our original question, is CBD a food ingredient, dietary supplement, or drug? The only answer that can be given at this point is: It depends! State pilot programs developed under the 2014 Farm Bill and the 2018 Farm Bill provide some security, but this still tends to be a gray area from state to state, and it is best to tread lightly, particularly when it comes to interstate marketing and sales.
So, until we get more clarity from FDA and USDA, or unless your state has specific laws in this area, HashTAG’s recommendation is to avoid using CBD isolates that have concentrated the CBD to above naturally occurring levels. And — be especially careful about making any health or structure/function claims.
Led by Dr. David Acheson, HashTAG is part of The Acheson Group (TAG), a food safety consulting group that provides guidance and expertise worldwide for companies throughout the food supply chain. With a focus on the Cannabis Edibles Industry, the HashTAG team brings in-depth industry knowledge combined with real-world experience to help companies more effectively mitigate risk, improve operational efficiencies, and ensure regulatory and standards compliance. To learn more about HashTAG services and expertise, please visit: www.HashTAG.global