A trade association representing the food industry has fired back against the Food and Drug Administration for its warning regarding the increased presence of CBD products for sale – and called on Congress to step in.
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Steve Mister, the president and CEO of the Council for Responsible Nutrition, said the FDA's own actions – or lack thereof – in response to the rapid growth of the CBD industry "facilitate an unregulated marketplace," which he added was "bad for consumers and bad for business," according to a late Tuesday press release.
"The FDA's continued failure to take this action, while raising consumer alarm over the entire market, requires that Congress get involved to direct the regulator to open the supplement lane to CBD and to police these products," he said.
Mister was referring to an FDA's Monday warning about risks associated with CBD and the announcement that it had sent warnings to more than a dozen companies that were allegedly selling illegitimate forms of CBD products.
"[T]hese particular companies are using product webpages, online stores and social media to market CBD products in interstate commerce in ways that violate the federal [Food, Drug, and Cosmetic Act], including marketing CBD products to treat diseases or for other therapeutic uses for humans and/or animals," according to an FDA release, which also provided a list of the 15 companies. "Other violations include marketing CBD products as dietary supplements and adding CBD to human and animal foods."
The FDA has only approved one CBD drug product, Epidiolex, which is produced by GW Pharmaceuticals and is used to treat certain forms of epilepsy.
"We remain concerned that some people wrongly think that the myriad of CBD products on the market, many of which are illegal, have been evaluated by the FDA and determined to be safe, or that trying CBD 'can’t hurt,'" the administration’s principal deputy commissioner Amy Abernethy said in the release.
CBD, or cannabidiol, is derived from the cannabis plant and, unlike THC, does not cause any known psychoactive effects.
The FDA also issued a stark warning about the risks associated with using unapproved products.
"CBD has the potential to harm you, and harm can happen even before you become aware of it," states its consumer update, which was also released Monday.
Mister acknowledged the FDA "raises legitimate questions about the safety of CBD."
"But the agency's actions to date have not advanced that cause," he said.
Mister said the FDA has neglected to take its own instructions to treat CBD as it would other ingredients. He also noted that the agency "does not distinguish between the high doses delivered in the approved prescription drug, and supplement levels."
Despite the FDA's acknowledgment that certain CBD products do, in fact, violate regulations, such as those that contain THC, the psychoactive derivative in cannabis, or other toxic ingredients, and those that actually contain little or no CBD, the agency has not taken strong enough action, he said.
"FDA has the authority to mandate recalls, to begin seizures of potentially harmful products, and to issue injunctions," he said, "but instead, the agency is choosing to issue tepid warning letters about CBD while the market of poorly made products continues to explode."
The Associated Press contributed to this report.