On May 31, 2019, the Food and Drug Administration held its first public hearing on the regulation of cannabis-derived compounds with acting FDA commissioner Ned Sharpless leading the conversation. CBD, or cannabidiol, has been a hot topic since it hails from cannabis plants and is sold to the general public as a wellness supplement.
There is much confusion surrounding CBD. Low quality and dangerous products are hitting the market, financial regulations are unclear, and farmers lack guidance on how to proceed. The hearing was a chance for consumers, farmers, and researchers to push for clarification on the legal status of products in a growing industry that shows no signs of slowing down.
Despite the legalization of hemp as an agricultural crop with the 2018 Farm Bill, CBD still faces challenges since the compound is used in one FDA-approved drug, Epidiolex. Because of this, the FDA has prohibited the sale of any food products that have been infused with CBD.
Still, CBD edibles are widely available to the general public. Sold online and in stores, the manufacturing of these products is not standardized in any way. This is one of many factors that contributes to the murky legal landscape in the CBD market, along with state-by-state variations in the legal status of CBD products.
Gummies, as they’re called, were also cited by researchers as a risk to consumers because of the difficulty in dosing with a mechanism that every individual metabolizes differently.
With the widely unregulated CBD market, there are many concerns about the safety of hemp derived products. With some low quality CBD oils testing positive for harmful chemicals like pesticides, heavy metals, or higher concentrations of THC, speakers at the hearing pushed for compliance standards. Researchers cited synthetic cannabinoids as a danger and unintended psychoactive effects as a potential of bad CBD products.
In prepared remarks, the leader of the FDA said the agency would eventually take “an appropriate, well-informed, and science-based approach to the regulation of cannabis and cannabis derivatives, including CBD.” The question on everyone’s mind was: When?
With the rate at which CBD is growing in popularity, there is not nearly as much scientific research to back up the anecdotal evidence that touts the therapeutic value of this compound. Up to now, personal experiences and limited clinical trials have paved the way for CBD to become a trendy wellness supplement, but there’s a lot of questions that we still need answers to.
For instance, how much CBD is too much? Can CBD interact with other medications? What are the long-term effects? And are these products safe for children?
Following the FDA hearing, it became clear that CBD is not as close to reaching fully legal status as some people might have hoped. Because of this, the future potential of the hemp industry may seem somewhat less promising for those interested in capitalizing on the CBD boom. How the agency will regulate CBD, or if it will at all, has added a layer of confusion to the space as a whole. For now, it seems as though we won’t get any clarity on CBD regulations until the FDA has had time to collect more information and issue an official decision.
While the bulk of the hearing has ended, the FDA will continue to accept comments on their public docket through July 2, 2019. You can also expect there to be some follow-up to this hearing as more conversations take place about the appropriate steps in moving forward with the oversight of CBD products.
The FDA recognizes the need for regulation, but they also say they want to go about it in the right way—which will take time.
If the FDA does allow CBD to be sold in food products or as a dietary supplement, they will have to issue a regulation that makes an exception specifically for CBD, which has never been previously done for any substance. There will then be questions about the 100+ other cannabinoids extracted from cannabis, which leads one to think this process could take years.
That said, this first hearing is a big step forward for the CBD industry. What was once a niche market on the fringe of natural health is now a mainstream news issue. All parties involved think clarity needs to come quickly.
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