Cannabusiness Advisory

FDA Warning Letter to Curaleaf Inc.

August 1, 2019


The Food and Drug Administration (FDA), following up on its public concerns about the science, safety, effectiveness and quality of unapproved products containing cannabidiol (CBD), recently issued a warning letter to Curaleaf Inc., of Wakefield, Massachusetts, for illegally selling unapproved products containing CBD online with unsubstantiated claims that the products treat cancer, Alzheimer’s disease, opioid withdrawal, pain and pet anxiety, among other conditions or diseases.

Acting FDA Commissioner Ned Sharpless, M.D., commenting on the warning letter,  indicated that “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.” He further stated that “there are many unanswered questions about the science, safety, effectiveness and quality of unapproved products containing CBD and 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.”

The agency has established an internal working group to explore potential regulatory pathways for various types of CBD products to be lawfully marketed, which held a public hearing in May. The acting Commissioner further noted that the “FDA will continue to work to protect the health and safety of American consumers from products that are being marketed in violation of the law,” through actions like the warning letter that was issued to Curaleaf. While the FDA stated that they recognize the potential opportunities and significant interest in drug and other consumer products containing CBD, the agency has a well-established pathway for drug development and drug approvals, and they remain committed to evaluating the agency’s regulatory policies related to other types of CBD products.

Now that products such as CBD have entered into the mainstream of commerce and increasing acceptance by society, greater regulatory oversight from federal and state agencies is now part of the industry. Advertising and promotional activities will need to comply with the well-established federal regulatory framework and health claims will need to be supported in order to market and distribute these products. It is clear that the FDA expects these products to comport to the federal regulations and therefore a regulatory strategy that includes scientific support along with quality of the products produced is a necessary component for product development in this emerging industry. Further guidance from the FDA is forthcoming; in the meantime it would be prudent for companies in this space to understand the agency’s current thinking in this matter set forth in this issued warning letter.


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