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FDA issues warning to CBD company Curaleaf

pharmafile | July 29, 2019 | News story | Sales and Marketing CBD, FDA, cannabidiol, curaleaf, pharma, regulation 

The FDA has issued a warning to Massachusetts-based CBD company Curaleaf over the firm’s use of unsubstantiated claims about the health benefits of cannabidiol (CBD).

The US regulator on 23 July, sent a warning letter to Curaleaf over claims it made that CBD could be used to treat among other conditions, cancer, Alzheimer’s disease, opioid withdrawal, pain and pet anxiety.

The warning comes amid a crackdown on companies making dubious claims about the positive health effects of CBD.

FDA commissioner Ned Sharpless commented: “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.”

“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,” he added.

Currently, GW Pharma’s Epidiolex is the only CBD product licensed in the United States for medicinal use. Epidiolex was approved by the FDA in June 2018. The warning comes after three other CBD companies received FDA warnings over the use of unsubstantiated claims, at the end of March 2019. The FDA has sent tens of warnings to CBD companies since 2015

Louis Goss

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