At the end of last month, leading medical and wellness cannabis operator Curaleaf Holdings Inc. was given a warning by the Food and Drug Administration (FDA) for making false health claims about the CBD-containing products for sale on its website.
Curaleaf serves over 150,000 registered medical cannabis patients across 14 U.S. states. Headquartered in Wakefield, Massachusetts, the company has allegedly been promising consumers that their products can help cure cancer, Alzheimer’s disease and other debilitating conditions, thus potentially delaying them from receiving professional medical care.
“[Curaleaf] is illegally selling unapproved products containing cannabidiol (CBD) online with unsubstantiated claims that the products treat cancer, Alzheimer’s disease, opioid withdrawal, pain, and pet anxiety, among other conditions or diseases,” wrote the FDA in an official statement last month.
Following the announcement, cannabis stocks took a nosedive; particularly Curaleaf. The company specializes in the sale of CBD products extracted from over 150 different strains of cannabis. CBD, a non-psychoactive cannabinoid that can be derived from both cannabis and hemp plants.
“Consumers should beware of purchasing or using any such products,” says FDA Commissioner
Norman “Ned” Sharples is the man who made this statement. Sharples, who also is the director for the National Cancer Institute (NCI), demanded a response from Curaleaf within 15 working days.
“Failure to correct these violations promptly may result in legal action, including product seizure and injunction,” read the letter, to which Curaleaf responded and addressed the violations by retracting CBD health claims from its website and social media accounts.
Other businesses in the cannabis space have also been on the receiving end of letters from the FDA, which is honing in on CBD regulation throughout the United States. However, Curaleaf’s warning was the first to be served upon a multistate cannabis operator.
Following a public hearing that was recently held by the FDA, a report is expected to be issued by the agency this fall. The report will outline the agency’s strategy for regulatory compliance. The public hearing received almost 4,500 comments.
Curaleaf’s letter from the FDA serves as a warning for other companies in the cannabis space to hold off on developing and launching CBD-focused product lines until the FDA releases an official set of rules.
FDA previously advised CBD companies not to make unproven claims
The predicament faced by Curaleaf could have been avoided, what with the FDA previously informing companies that they are forbidden to add CBD to ingestible products, such as food and drinks. Interestingly, adding CBD to topical products, such as lotions, balms, and salves, is not in violation of the rules. Despite this, companies must not make health claims regarding the non-psychotropic cannabinoid.
“We can reaffirm that nothing in the letter raises any issues concerning the safety of any Curaleaf product,” explained a spokesperson for the FDA, adding that, “Curaleaf products are all derived from hemp and meet the requirements of the Farm bill.”
More research into the plant’s medical benefits will surface once federal restrictions on research are lifted. Cannabis could be legalized at the governmental level by 2020, according to industry analysts.
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