Reed Smith Client Alerts

FDA continues to bring enforcement actions against CBD manufacturers selling products that claim to be effective against diseases such as cancer or Alzheimer’s. Such enforcement actions indicate that FDA is keeping a close eye on the CBD market.
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Yesterday, July 23, 2019, FDA issued a warning letter to Curaleaf, Inc. (one of the nation’s largest CBD (Cannabidiol) product companies) for unlawfully marketing CBD products online with claims that violate the Food, Drug, and Cosmetic Act (FDCA). This marks the fourth CBD-related warning letter publicly issued in 2019. FDA determined that the company’s “CBD Lotion,” “CBD Pain-Relief Patch,” “CBD Tincture,” and “CBD Disposable Vape Pen” products are misbranded and unapproved new drugs, in addition to determining that the company’s “Bido CBD for Pets” products are adulterated and unapproved new animal drugs that are unsafe for the products’ intended use. FDA’s warning letter largely focused on Curaleaf’s inclusion of certain claims in its marketing materials and social media presence.

Some of the claims with which FDA took issue included: 

  • “CBD has been demonstrated to have properties that counteract the growth of [and/or] spread of cancer.”
  • “CBD has been linked to the effective treatment of Alzheimer’s disease.”
  • “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.”
  • “For dogs experiencing pain, spasms, anxiety, nausea or inflammation often associated with cancer treatments, CBD (aka cannabidiol) may be a source of much-needed relief.”