Regulation

FDA Warns Curaleaf About Unproven CBD Health Claims 

FDA Warns Curaleaf About Unproven Health Claims

The Food and Drug Administration (FDA) has written a letter to Curaleaf regarding its alleged illegal selling of CBD products and its use of “unsubstantiated claims” about CBD being able to treat a range of ailments like cancer, Alzheimer’s disease, pain, pet anxiety and even withdrawal from opioids.

CNBC reports that shares in Curaleaf, which is one of the most popular companies selling CBD in the country, dropped 6 percent on the news.

In December of 2018, Congress legalized CBD, which is a non-psychoactive cannabidiol that comes from hemp. It does have some medicinal uses: Last year, the FDA approved a drug made from CBD called Epidiolex, which treats advanced cases of childhood epilepsy. There are so far no other official FDA-approved health benefits.

There have been some small steps toward creating new ways for people to get CBD, such as in food or dietary supplements, but the FDA said it will continue to battle with companies that make “egregious” statements about the benefits of the product.

“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,” acting FDA Commissioner Norman “Ned” Sharpless said 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.”

The FDA said it has sent out around 24 letters to companies that reportedly make false claims about the product. It claims that Curaleaf has “unfounded claims about more than a dozen different CBD products” on all of its channels. One of the claims said that “CBD has been demonstrated to have properties that counteract the growth of [and/or] spread of cancer,” and another claimed that “CBD has been linked to the effective treatment of Alzheimer’s disease ….”

Sharpless reiterated the importance of the agency’s job.

“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.”

A Curaleaf spokesperson said the company is reviewing the letter and figuring out how to respond within the 15-day timeframe.

“We intend to work collaboratively with the FDA to address the issues in the letter,” the spokeswoman said. “Curaleaf is fully committed to complying with FDA requirements for all of the products it markets.”

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