Last month, the U.S. Food and Drug Administration (FDA) released a statement regarding the legal status of cannabidiol (CBD) products, focusing on the agency’s desire to protect public health and provide clarity in a fast-growing market.
“We have seen many CBD products being marketed with claims of therapeutic benefit, without having gone through the drug approval process,” the statement read. “The proliferation of such products may deter consumers from seeking proven, safe medical therapies for serious illnesses—potentially endangering their health or life.”
“We also have serious concerns about products that put the public at risk in other ways,” it continued. “For example, we are aware of the risks posed by product contaminants such as heavy metals, THC (tetrahydrocannabinol) or other potentially harmful substances.”
“We also have significant concerns about products marketed with false claims or statements such as omitted ingredients, incorrect statements about the amount of CBD, products marketed for use by vulnerable populations like children or infants, and products that otherwise put the public health at risk.”
The agency also cited how little is known about potential side effects or the effect of continued regular CBD usage. “This does not mean that we know CBD is unsafe to these populations or under these circumstances,” the statement said. “But given the gaps in our current knowledge, and the known risks that have been identified, we also are not at a point where we can conclude that unapproved CBD products are safe for use.”
Educational efforts will be expanded, with the statement specifically noting updates to the FDA’s online resources and the continued sharing of information with Congress, industry stakeholders, researchers and other regulatory partners.
Leaders in the grocery and CBD industry were quick to express frustration with the FDA’s latest statement, as first reported by Whole Foods magazine.
“This is more of the same from FDA: all words and no action,” Daniel Fabricant, president and CEO of the Natural Products Association, said in a press release. “Setting a safe level of consumption for CBD products is the best way to move forward with this promising new product while protecting consumers.”
“Today’s report amounts to more bureaucratic can kicking, and Congress should recognize it as such and take action now to declare CBD a lawful dietary ingredient,” said Steve Mister, president and CEO of the Council for Responsible Nutrition. “Every day, more CBD products come to market, some from responsible manufacturers and some from less reputable companies. By not enforcing the full range of dietary supplement regulations on this category, the FDA is essentially an absentee regulator, and the public is at risk.”
“As several recent risk assessments have demonstrated, the safety of CBD as an ingredient itself is no longer an issue,” Mister’s statement continued. “However, as long as the FDA ‘actively’ continues to drag its feet, the public is at risk from CBD products that may be poorly manufactured or illegally marketed. The best way to protect public health and promote market clarity is to give industry a clear pathway to market.”
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