The Food and Drug Administration (FDA) has issued a warning letter to Curalef Inc. of Wakefield, Massachusetts for illegally selling unapproved cannabidiol (CBD) products online with unsubstantiated health claims.

The warning letter describes how Curaleaf falsely marketed their CBD products on social media websites, online stores and webpages with unproven therapeutic claims. Additionally, some of the products were in violation of the Federal Food, Drug and Cosmetic Act because they were marketed as dietary supplements. The following are a few examples of the claims made by Curaleaf:

  • “CBD was effective in killing human breast cancer cells”
  • “CBD has also been shown to be effective in treating Parkinson’s disease”
  • “CBD has been linked to the effective treatment of Alzheimer’s disease …”
  • “[V]ets will prescribe puppy Xanax to pet owners which can help in certain instances but is not necessarily a desirable medication to give your dog continually. Whereas CBD oil is natural and offers similar results without the use of chemicals”
  • “CBD can also be used in conjunction with opioid medications, and a number of studies have demonstrated that CBD can in fact reduce the severity of opioid-related withdrawal and lessen the buildup of tolerance”

According to the FDA, the Company will have 15 working days to correct the violations listed in the warning letter, including an explanation on how to prevent its recurrence. Failure to correct the violations may result in legal action without further notice, including product seizure and injunction.

“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. Consumers should beware of purchasing or using any such products,” said Acting FDA Commissioner Ned Sharpless, MD. 

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With the growing interest in products containing cannabis or cannabis-derived compounds, the FDA has established a high-level internal working group to specifically address the regulation and lawful marketing of various types of CBD products. The Agency held a public hearing in May 2019 to obtain scientific data and information regarding the safety, manufacturing, product quality, marketing, labeling and sale of CBD products.

Adverse events related to Curaleaf Inc. products should be reported to the FDA’s MedWatch Adverse Event Reporting program.

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