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.”
Unsurprisingly, and continuing its stance from prior warning letters, FDA took issue with claims that, in its view, pose a greater risk for patients’ health than other claims, such as claims regarding cancer, Alzheimer’s disease, and opioid addiction. Given that FDA tends to prioritize enforcement actions based on the risk posed to consumers/patients, it is not surprising that FDA noted the above claims in its warning letter. Importantly, however, FDA also took issue with far less express claims made on both the product itself and also on the company’s webpages and social media (Twitter and Facebook) feeds.
Some of the less express claims with which FDA took issue included:
- “[F]or chronic pain.”
- “CBD is known for its anti-anxiety properties that can promote relaxation and stress relief. It can also help to restore focus and ability to concentrate on specific tasks, as well as reduce impulsivity.”
- “A 2018 study showed that CBD offers quick relief of depression and anxiety symptoms and that the residual effects can last up to seven days.”
- “It’s natural, safe and will allow your dog to play, eat, and do other things dogs enjoy without the symptoms of anxiety.”
FDA believes that the above claims render the products unapproved new drugs because the intended uses of the products fall outside of what has been recognized as generally safe and effective (i.e., via FDA’s new drug approval process). Additionally, FDA believes that the products are misbranded because they fail to bear adequate directions for use, as required by the FDCA.
This is a significant development because FDA has targeted one of the larger companies in the market to make its point. Curaleaf’s stock dropped with the publication of this warning letter, demonstrating the business implications of such an enforcement action. The warning letter indicates that FDA remains concerned about the use and marketing of CBD products, particularly when the product claims to be effective against diseases such as cancer or Alzheimer’s, and that the agency is unlikely to discontinue its enforcement actions until it establishes a framework for regulation. FDA commissioner Ned Sharpless stated that “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.”
We expect to see FDA remain active in its regulation and enforcement of the CBD industry as it works to develop a regulatory framework. Manufacturers and retailers alike should understand that there is FDA (and state) enforcement risk if any CBD product manufactured, distributed, or sold contains disease claims. The more egregious the claims, the greater the risk of enforcement. We will continue to monitor developments and provide updates. In the meantime, should you have any questions or concerns, please do not hesitate to reach out to the authors of this post or any member of Reed Smith's Cannabis Law Team.
Client Alert 2019-185
