WASHINGTON — Retailers might soon begin to receive some much-needed clarity on the legality of cannabidiol (CBD) from the U.S. Food and Drug Administration (FDA). The agency will take public questions and comments related to the substance on May 31. The hearing will be the first regulatory discussion of the ingredient since the 2018 Farm Bill made growing industrial hemp, a key source for CBD, legal.
The goal of the hearing is to gather information on the safety and challenges of working with products containing cannabis and cannabis-derived compounds, such as CBD, a nonpsychoactive component of the plant said to have medicinal qualities. The FDA is seeking stakeholders’ input on how the items should be regulated.
Earlier this week, FDA Commissioner Scott Gottlieb, who is set to exit the organization, announced the formation of a “high-level internal agency” to explore CBD’s path to legality.
Gottlieb appointed Amy Abernethy, principal deputy commissioner, and Lowell Schiller, principal associate commissioner for policy, to co-chair the FDA working group on the topic. The group will likely begin sharing its findings this summer, Gottlieb said in a statement.
“This is a complicated topic, and we expect that it could take some time to resolve fully,” Gottlieb said. “Nevertheless, we're deeply focused on this issue and committed to continuing to engage relevant stakeholders as we consider potential paths forward.”
The FDA also announced that it sent warning letters for unsubstantiated claims to PotNetwork Holdings Inc., Advanced Spine and Pain LLC (dba Relievus) and Nutra Pure LLC. Some of the manufacturers’ claims included the ability to treat cancer, neurodegenerative conditions, autoimmune diseases, opioid abuse and other serious and life-threatening conditions.
“Selling unapproved products with unsubstantiated therapeutic claims can put patients and consumers at risk,” Gottlieb said. “These products have not been shown to be safe or effective, and deceptive marketing of unproven treatments may keep some patients from accessing appropriate, recognized therapies to treat serious and even fatal diseases. Additionally, because they are not evaluated by the FDA, there may be other ingredients that are not disclosed, which may be harmful.”
The FDA also updated its website with more information about CBD.
President Trump legalized hemp for processing and distribution when he signed the Farm Bill in December 2018. Hemp is a classification of cannabis with less than o.03% tetrahydrocannabinol (THC) levels. When consumed, it does not have the same intoxicating effect as marijuana. Although the FDA issued a statement emphasizing that Congress preserved the agency’s authority over products containing cannabis and cannabis derivatives, since then, retailers have been preparing for a CBD boom. Convenience stores such as Alimentation Couche-Tard, Laval, Quebec, have begun investing in cannabis and CBD.
C-stores are not the only retailers planning to sell CBD. CVS Health Corp. rolled out CBD in stores in eight states. Days later, Walgreens announced it would sell the products in nine states.
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