The FDA’s upcoming decision on CBD
CBD sales of hemp-CBD have been increasing at a furious pace – CBD can be found just about everywhere, from gas stations to grocery stores. But this has not been endorsed by the FDA, so sales remain in a grey area under current Federal law. The only FDA-approved CBD product on the market is GW Pharma’s Epidiolex, which received FDA approval for limited use cases (related to seizures and epilepsy in children). Outside these limited use-cases, CBD remains a Federally-unregulated substance. The FDA position (up to this point) remains:
– FDA-approved drugs can’t be used in nutraceuticals, food, pet food or animal feed/products
– The FDA has published bulletins and issued fines against those advertising health-benefit claims for CBD
The FDA held a public hearing on CBD in May, and may issue a decision this month. We have no idea what the FDA will decide, but here are some possible outcomes, and what it means to both the hemp-CBD industry and to cannabis retailers:
1. CBD gets approved as a nutraceutical: If the FDA green lights CBD as a nutraceutical, the CBD industry will continue as a mainstream CPG product…and “big business” will come in. Household name companies, from the beverage world, food products industry, and others who have been sitting on the sidelines, will get involved in CBD products. They may not only launch products, but acquire existing brands (as happened in the craft beer market). We may see acquisitions of companies that have developed (and patented ) different CBD delivery systems, such as water-soluble, high bio-availability, or fast-acting formulations.
2. CBD requires clinical trials for FDA drug approvals : If the FDA requires clinical trials for specific use cases (such as anxiety, PTSD, inflammation, etc), there are very few hemp-CBD companies with the experience to execute clinical trials, in our opinion, although some might have resources to do so. CBD may become a Big Pharma scramble. Currently, the US National Institute of Health’s website ClinicalTrials.gov lists 71 clinical trials in various stages using CBD or Epidiolex. (LINK)
3. CBD moves “offline” : Except for the cosmetics industry, where CBD does not require FDA approval, the widely available hemp-CBD products will disappear if clinical trials and FDA-approvals are needed. The demand for CBD will be met within each state, regulated under today’s state cannabis laws. The market for CBD could shift to cannabis retail. Washington State has become the latest state to ban the use of hemp-CBD in food. (LINK) Companies are not allowed to sell or produce CBD food products in Washington State, except those licensed within the state-cannabis industry.
Although we can’t predict the future, these are some of the possible outcomes of the FDA’s ruling. With any of the above, there really is no downside ahead for state-legal cannabis businesses, even if CBD is mainstreamed as a nutraceutical. Increased acceptance and growing awareness of the benefits of CBD will increase demand for CBD/THC and whole plant products, as the market matures from the focus on a single compound alone.
EXO CBD offers white label tinctures, vape pens, gummy, pet care, beverages, coffee, skincare and for sales inquiries please contact email@example.com or call 833-339-6223