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FDA Again Warns CBD Product Manufacturer

Cannabis Law Blog

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FDA Again Warns CBD Product Manufacturer

On July 22, 2019 the FDA sent a warning letter to Curaleaf, Inc. warning it about the labeling and marketing of its CBD products including lotion, patches, tinctures, disposable vape pen, and pet products. FDA concluded that Curaleaf’s websites, social media and other marketing material made unsupported health claims about its products, in violation of FDA regulations. 

FDA concluded that the products were new drugs because the claims made by Curaleaf stated the products could cure or prevent diseases such as cancer, Parkinson’s and Alzheimer’s disease. This also included a conclusion under the statues related to unapproved new animal drugs relating to the claims Curaleaf was making about its product’s affect on dogs.

Specifically, some of the claims to which FDA objected included:

  • “CBD was effective in killing human breast cancer cells.”
  • “CBD has also been shown to be effective in Parkinson’s disease.”
  • “CBD has been linked to the effective treatment of Alzheimer’s disease...”
  • “CBD is being adopted more and more as a natural alternative to pharmaceutical-great treatments for depression and anxiety.”
  • “CBD can also be used in conjunction with opioid medications, and on a number of studies have demonstrated that CBD can in fact reduce the severity of obioid-related withdrawal and lessens the build-up of tolerance.”

FDA also continues to state that CBD cannot be a dietary supplement because it has been approved for use in epidiolex, a new drug. Unfounded claims without scientific support will lead to FDA scrutiny and possible product withdrawal. Curaleaf has 15 days to respond to FDA with support for its claims or remedial action to cure the cited violations.