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As the U.S. Food and Drug Administration (FDA) is being flooded with requests to allow CBD in food and supplements, marijuana advocacy groups are eager for federal regulators to monitor the marketplace to help establish some semblance of order.
“The FDA needs to move quickly or Congress should step in and legislate quickly because there’s just so much confusion in the marketplace right now, it’s not sustainable,” Andrew Kline, director of public policy at the National Cannabis Industry Association, told FDA Health News. “The biggest elephant in the room right now is timing because no one knows what they can do and what they can’t do.”
Though CBD – the common term for cannabidiol – is extracted from cannabis plants, by itself it does not have the effect that marijuana does. Since the 2018 Farm Act declassified hemp, a strain of the cannabis plant, as a controlled substance, CBD proprietors and consumers have grown exponentially.
Many health organizations have lauded CBD as effective treatment for all types of pain, anxiety, sleep disorders and other conditions. The FDA already regulates CBD at the prescription level, which Kline agrees should remain constant.
NORML Deputy Director Paul Armentano
The confusion arises in what he calls the other two lanes of the marketplace.
“We think the FDA should retain authority over other CBD products that shouldn’t require prescriptions – those would be ingestible like dietary supplements and foods," Kline said. "And then separately, for topicals like lotions, they should regulate those like they regulate any other cosmetic you can buy on Amazon.”
Such concerns have multiplied in recent weeks since the FDA has requested data and held a public hearing on pending CBD regulation. Comments have numbered in the thousands.
“I’m not surprised because there is so much interest in CBD products right now, and the hemp industry in general,” said Kline, whose organization is among those that presented evidence to the FDA.
Paul Armentano, the deputy director of the National Organization for the Reform of Marijuana Laws, said the CBD marketplace is challenging to rein in. Despite a growing consensus among experts about the beneficial properties of CBD, the purity and potency of many products is open to question.
“The consumer would prefer a marketplace that is not buyer-beware,” Armentano told FDA Health News. “Are all products pure? Do we know they are not adulterated with metals or other substances? We can’t say that of all of them.”
Armentano, whose group also responded to the FDA’s request for CBD data, said federal regulators are in a difficult position in having to try and govern it.
“This is a market that largely operates in a gray area, there is very little, if any, regulation addressing it,” Armentano said. “There needs to be regulations put in place, mandating a level of standardization. There are mixed messages by the industry itself. There are some manufacturers — some legit, some not — that continue to profit from a continuation of that gray area.”
