The U.S. Food and Drug Administration (FDA) is cracking down on a number of companies selling cannabidiol (CBD) products accompanied by unsubstantiated health claims. The latest target is a company called Curaleaf, which sells CBD products that it claims can treat everything from cancer and Alzheimer's, to anxiety and inflammation in dogs.
Alongside the booming new recreational marijuana market in some American states has been a rapidly growing industry in products containing marijuana-derived compounds. CBD in particular has become a source of great attention in the medical research community, showing promise as a therapeutic agent that can reduce epileptic seizures in children, treat insomnia, or even potentially function as a topical antibiotic.
The only legally approved therapeutic use of CBD currently is for the treatment of a rare form of epilepsy, under the brand name Epidiolex. And, while researchers are certainly exploring whether CBD is effective in treating a number of other conditions, some companies are taking advantage of this interstitial moment in time where the drug is somewhat unregulated.
The latest target of the FDA's ire is Curaleaf Inc. The FDA's recently-issued warning letter to the company cites a number of instances where products were sold with grand and scientifically unsupported claims. Some of the blatantly unfounded claims cited in the FDA warning include statements from Curaleaf suggesting, "CBD has been demonstrated to have properties that counteract the growth of [and/or] spread of cancer," and, "CBD has been linked to the effective treatment of Alzheimer's disease …"
"As we examine potential regulatory pathways for the lawful marketing of products containing cannabis and cannabis-derived compounds like CBD, protecting and promoting public health remains our top priority," says Acting FDA Commissioner Ned Sharpless in a statement. "Selling unapproved products with unsubstantiated therapeutic claims – such as claims that CBD products can treat serious diseases and conditions – can put patients and consumers at risk by leading them to put off important medical care."
Curaleaf is by no means the first company to market CBD products accompanied by unfounded medical claims. Over the past few years the FDA has sent a large number of warning letters to companies jumping on the CBD bandwagon. The fragmented legal status of marijuana across the United States has undeniably created a significant gray area allowing new companies to capitalize on the booming public attention surrounding the possible therapeutic uses of marijuana-derived compounds.
The FDA is largely playing catch up at the moment, suggesting it is, "expediting work to evaluate regulatory policies related to cannabis and cannabis-derived ingredients like CBD." The FDA Principal Deputy Commissioner Amy Abernethy, hopes to report some kind of progress toward a regulatory mechanism regarding CBD later this year.
"The agency has a well-established pathway for drug development and drug approvals, and we remain committed to evaluating the agency's regulatory policies related to other types of CBD products," says Abernethy. "We plan to report our progress by early this fall as we expedite our work to address the many questions about CBD. The step-wise, science-based approach we're taking protects patients and the public health, fosters innovation for safe and appropriate products, and promotes consumer confidence."
Since receiving the FDA warning letter, Curaleaf has removed a number of statements from its website and social media posts. The company has also deleted its blog, and advised the FDA that several of the products questioned in the warning letter have been discontinued.
"Our industry needs, wants and appreciates the work the FDA is doing to ensure there is regulation and compliance in the CBD marketplace," says Joseph Lusardi, CEO of Curaleaf, in a recent statement. "We care deeply about our customers and making a difference in our industry. Curaleaf is committed to being an ethical and responsible company and working with the FDA to be a leader in our industry, setting the standards and guidelines to best service our customers and the communities we serve."
Source: FDA