Curaleaf, a Massachusetts-based marijuana producer and retailer, is accused of more than a dozen unfounded claims regarding its products containing cannabidiol.
The Food and Drug Administration (FDA) issued a warning letter to Curaleaf Inc. for allegedly illegally selling unapproved products containing cannabidiol (CBD) online with “unsubstantiated claims.” In turn, the company has 15 business days to respond with how the violations will be corrected.
The Massachusetts-based marijuana producer and retailer claimed that its products can treat several illnesses, including cancer, Alzheimer’s disease and Parkinson’s disease, as well as help fight opioid withdrawal, anxiety, depression and pain for both humans and pets.
“Today’s action demonstrates that the agency stands firm in its commitment to continue monitoring the marketplace and protecting the public health by taking action as needed against companies that deceive consumers and put them at risk by illegally selling products marketed for therapeutic uses for which they are not approved, such as those claiming to treat cancer or Alzheimer’s disease,” Dr. Ned Sharpless, who is the acting FDA commissioner, said in a press release. “Consumers should beware of purchasing or using any such products.”
Curaleaf made more than a dozen unfounded claims about different CBD products on its website and social media accounts, according to the FDA. Examples of such include “CBD has been demonstrated to have properties that counteract the growth of [and/or] spread of cancer” and “CBD was effective in killing human breast cancer cells.” In addition, Curaleaf claimed “CBD is being adopted more and more as a natural alternative to pharmaceutical-grade treatments for depression and anxiety.”
Only one product derived from CBD has been given the green light by the FDA. Last June, Epidiolex (cannabidiol) was approved to treat rare, severe forms of epilepsy in patients 2 years of age and older. In December, Congress legalized CBD, which is a nonintoxicating cannabinoid found in cannabis and hemp.
These types of products are marketed to consumers as creams, oil drops, capsules, syrups and teas, and they can be found in stores and online. However, unlike drugs approved by the FDA, these products have not been subject to FDA review, explained the press release.
“Unsubstantiated claims associated with CBD products may lead consumers to put off getting important medical care, such as proper diagnosis, treatment and supportive care,” stated the press release. “For that reason, it’s important that consumers talk to a health care professional about the best way to treat diseases or conditions with existing, approved treatment options.”
Consumers are asked to report any side effects from CBD-associated products with the FDA’s MedWatch program.
“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,” Sharpless said. “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. Additionally, there are many unanswered questions about the science, safety, effectiveness and quality of unapproved products containing CBD.”
Curaleaf, which was founded in 2010, became the world's largest cannabis company by revenue and the largest in the United States following two acquisitions of the Select and Grassroots brands, in May and June, respectively. After the deals, Curaleaf will have 68 open dispensaries, 20 cultivation sites and 26 processing facilities. Last year, the company reached $77.1 million in revenue.