Seeking Authenticity The FDA is targeting health claims about CBD products

Although many consumers utilize cannabis for its purported health benefits, and although Washington State regulates cannabis not just for adult use, but for medicinal purposes, companies must be very careful about the health-related statements they make about their cannabis products. These statements are regulated not just by the Washington State Liquor and Cannabis Board (LCB), but also by the United States Food and Drug Administration (FDA) pursuant to the United States Federal Food, Drug and Cosmetic Act (FDCA).

The FDCA gave the FDA broad regulatory power over legal drugs as well as regulatory power over food. While there is nothing cannabis companies can do to make their products legal under federal law, there are certain precautions they can take in order to avoid scrutiny and enforcement by the FDA. Most importantly, companies should not make health claims about their products. Regarding a cannabidiol (CBD) product (prior to the approval of Epidiolex, a CBD-based drug intended for the treatment of epilepsy and categorized as a Schedule V drug under the Controlled Substances Act), the FDA published a news release that stated the following: “The FDA has grown increasingly concerned at the proliferation of products claiming to treat or cure serious diseases like cancer. In this case, the illegally sold products allegedly contain cannabidiol, a component of the marijuana plant that is not FDA approved in any drug product for any indication.”

Additionally, FDA Commissioner Scott Gottlieb also said stated that the organization is actively searching to remove CBD products that are not proven to work. “Substances that contain components of marijuana will be treated like any other products that make unproven claims to shrink cancer tumors. We don’t let companies market products that deliberately prey on sick people with baseless claims that their substance can shrink or cure cancer and we’re not going to look the other way on enforcing these principles when it comes to marijuana-containing products.”

The FDA has issued warning letters, which are the first step in its enforcement of federal law, to a number of CBD companies in particular. Some of the health claims the FDA has taken issue with include:

 

  • “Combats tumor and cancer cells”
  • “CBD makes cancer cells commit ‘suicide’ without killing other cells”
  • “CBD … [has] anti-proliferative properties that inhibit cell division and growth in certain types of cancer, not allowing the tumor to grow”
  • “Non-psychoactive cannabinoids like CBD (cannabidiol) may be effective in treating tumors from cancer – including breast cancer”

 

Claims along the lines of those cited above suggest that the products can cure, mitigate or prevent cancer and are thus considered, and treated as, drugs by the FDA. These products were not subject to FDA review pursuant to the drug approval process, and only the FDA may determine whether a drug can be labeled as safe and effective in the treatment of a particular disease.

In addition to the risk of FDA enforcement for making health claims, cannabis companies must also be cognizant of the state regulations governing labeling and advertising. For example, WAC 314-55-105 provides that “labels of usable marijuana and marijuana products sold at retail in the state of Washington must not contain any statement, depiction, or illustration that: (A) is false or misleading; (B) promotes over consumption; [or] (C) represents the use of marijuana has curative or therapeutic effects . . . ”

These restrictions on what can and can’t be said about the health benefits of cannabis serve to protect consumers in a market where, due in large part to its federal illegality, cannabis has not undergone the research needed to provide consumers with adequate information about its medicinal properties. Preventing health claims based on anecdotal evidence is one of the FDA’s most important functions. Cannabis businesses must therefore be diligent in complying both with applicable state labeling and advertising laws and with FDA regulations.

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