A batch of 15 warning letters last month from FDA highlighted a sobering reality for the hemp industry: Marketers of hemp-based CBD products continue to make disease claims even though their products haven’t been approved by FDA and are often labeled as dietary supplements.
The trend, industry sources suggested, undermines the efforts of responsible companies to establish credibility with consumers, lawmakers and regulators. It also has caught the attention of plaintiff’s class action lawyers.
Making unsubstantiated health claims casts “a dark shadow" over companies aiming to follow the rules, suggested Jason Mitchell, co-founder and president of HempFusion, a hemp-based CBD company in Denver.
Mitchell said he was “100% in favor” of FDA taking action against companies that make unsubstantiated disease claims. Such claims, he said in an interview, provide “false hope to customers [who] are truly looking for hope.”
Jonathan Miller, general counsel to the U.S. Hemp Roundtable, a coalition of hemp companies, shared a message for companies making disease claims—“please cut it out.”
“We’re a new industry,” he said in an interview. “We’ve got to demonstrate, particularly to FDA and the Congress, that we’re going to hold ourselves to high standards and hold ourselves to ultimate integrity, and when companies break those standards, it’s a blot on the industry.”
The “disease claim issue,” food and drug attorney Will Woodlee said, is “so obvious and so easy for marketers to avoid.”
And yet regulators continue to identify claims tying CBD products to the treatment of such diseases as autism, cancer, diabetes and schizophrenia. FDA has only approved one CBD product—Epidiolex, a medicine manufactured by GW Pharmaceuticals plc to treat severe and rare forms of epilepsy.
In November, FDA sent 15 warning letters to marketers of CBD-containing products. Woodlee, a partner in Washington with Kleinfeld, Kaplan & Becker LLP, closely reviewed the letters.
“Every single one of them contains” inappropriate claims for any dietary supplement, topical/cosmetic or conventional food product, the lawyer said. “That continues to be the consistent thread for FDA to take enforcement action, or more precisely, to take administrative action in the form of issuance of a warning letter.”
In a Q&A on cannabis-derived products, FDA expressed continuing concerns over “the proliferation of products asserting to contain CBD that are marketed for therapeutic or medical uses although they have not been approved by FDA.”
“Selling unapproved products with unsubstantiated therapeutic claims is not only a violation of the law, but also can put patients at risk, as these products have not been proven to be safe or effective,” the agency explained. “This deceptive marketing of unproven treatments also raises significant public health concerns, because patients and other consumers may be influenced not to use approved therapies to treat serious and even fatal diseases.”
Commenting on claims that CBD products treat cancer, Mitchell of HempFusion said: “If you’ve ever known anybody … fighting cancer, they’re looking for any and every hope they can. And when people give false hope without substantiation, and even if they did have substantiation, if they’re doing it willfully, it’s just wrong.”
The warning letters, Miller said, highlight the fact that companies making disease claims will be cited by FDA.
“[W]e don’t view the FDA or even plaintiff’s lawyers as our worst enemy,” he added. “We view our worst enemy to be those companies who are engaged in inappropriate conduct—whether it be making disease claims or it’s putting out products that aren’t safe, that don’t meet good manufacturing practices, [or] that have high levels of heavy metals in them.”