FDA to Provide Much-Needed Guidance on CBD this Week
May 28th, 2019
The U.S. Food and Drug Administration (FDA) will hold its first public hearing on how it will regulate cannabidiol (CBD) products this week. On May 31, the agency could provide much-needed guidance into the legal status of the cannabinoid and potentially introduce limits on how much of the substance can be included in foods and drugs.
“While the availability of CBD products in particular has increased dramatically in recent years, open questions remain regarding the safety considerations raised by their widespread use,” said then-FDA Commissioner Scott Gottlieb. “It’s critical that we address these unanswered questions about CBD and other cannabis and cannabis-derived products to help inform the FDA’s regulatory oversight of these products.”
Many companies introduced CBD-infused products to the public, ranging from CVS Health’s creams and lotions to Carl’s Jr.’s CBD-infused burger. With little enforcement of the FDA’s existing (and ambiguous) rules, companies seem willing to take on the risk of enforcement to gain early market share in a category that could be worth billions.
According to Piper Jaffray, the CBD market could be worth as much as $15 billion within the next five years, driven by increasing consumer awareness of the potential wellness benefits. The removal of hemp from the DEA’s Controlled Substances list also made it much easier for a wider range of companies to produce hemp-derived CBD without the need for cannabis cultivation licenses or extraction equipment.
The FDA has expressed concern about the substance being included in foods, beverages, and supplements, but has limited its warning letters and penalties to companies that have been making unsubstantiated claims about CBD’s effectiveness in treating conditions like cancer and Alzheimer’s diseases.
Many experts believe that the agency will permit low levels of CBD in consumer products, such as foods and beverages, but reserve higher levels of CBD for clinical research. When there’s more robust research in place, these regulations could be revised.
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