Taking a carrot and stick approach, the United States Food and Drug Administration (FDA) issued a consumer update entitled “What You Need to Know (And What We’re Working to Find Out) About Products Containing Cannabis or Cannabis-derived Compounds, Including CBD” on November 25, 2019, the same date that the FDA issued 15 warning letters to companies for illegally selling products containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act.
The 15 warning letters expanded the FDA’s previous set of warning letters from warnings mostly focused on issues arising from CBD companies selling CBD products in interstate commerce that claimed to prevent, diagnose, mitigate, treat or cure serious diseases, such as cancer, to also encompass warnings arising from CBD companies selling CBD products for use as human or animal food.
Similarly, the update details a broad set of the FDA’s concerns about the safety of CBD products, largely based on the lack of scientific information supporting the safety of CBD, especially in food. The key takeaways, with the italicized sentences being taken directly from the Update, are as follows:
- The FDA has approved only one CBD product, a prescription drug product to treat two rare, severe forms of epilepsy. The Update makes it clear that FDA continues to believe the drug approval process represents the best way to ensure that safe and effective new medicines, including any drugs derived from cannabis such as CBD, are available to patients in need of appropriate medical therapy.
- It is currently illegal to market CBD by adding it to a food or labeling it as a dietary supplement. In no uncertain terms, the FDA makes it clear it is illegal under federal law to market CBD as a food additive or dietary supplement. The FDA also included no discussion whatsoever of CBD’s potential positive health benefits. However, the Update is potentially not all bad news for the hemp-derived CBD industry. While the Update and the press release issued in conjunction with the 15 warning letters both state that the FDA cannot conclude that CBD is generally recognized as safe (GRAS) for its use in human or animal food, the fact that the Update addresses food safety and dietary supplements seems to indicate that the FDA is at least exploring ways for CBD to be legally allowed for use as a food additive. Further to support for this new avenue of FDA inquiry is that some of the 15 warning letters, e.g.: include commentary stating that the inclusion of CBD in food would require a food additive petition (which would need to be approved under a food additive regulation, which does not currently exist to the extent that it might authorize the use of CBD in food). Given its discussion of potential legislation, it does not seem unreasonable to view the Update as the FDA’s attempt to encourage Congress to act ahead of the FDA’s rulemaking on the topic in order to enact a regulatory framework to address cannabis-derived products that are intended for non-drug uses, including whether and/or how the FDA might consider updating its regulations. This seeming policy shift is important, as many industry insiders had expressed concern that the FDA would take the position that because a product containing CBD was approved as a drug (and substantial clinical trials studying CBD as a new drug were made public prior to the marketing of any food or dietary supplements containing CBD), dietary supplements or food would therefore be entirely precluded from containing CBD.
- The FDA has seen only limited data about CBD safety and these data point to real risks that need to be considered before taking CBD for any reason. In the Update, the FDA reiterates its statements that (a) CBD has the potential to harm consumers, and harm can happen even before consumers become aware of it, (b) CBD may have unnoticed side effects, including liver damage, gastrointestinal distress and changes in mood or alertness, and (c) there are many important aspects of CBD that are not yet know, including the effects of CBD on the brain, on the male reproductive system, on newborns, and in the interaction with other drugs being taken at the same time as CBD.
- Some CBD products are being marketed with unproven medical claims and are of unknown quality. The Update continues to make clear that the FDA’s top priority is to protect the public health. This priority includes making sure consumers know about products that put their health and safety at greatest risk, such as those claiming to prevent, diagnose, treat, mitigate, or cure serious diseases. As discussed above, the FDA has warned companies to stop selling CBD products they claim are intended to prevent, diagnose, treat, mitigate, or cure serious diseases such as cancer, Alzheimer’s disease, psychiatric disorders and diabetes.
- The FDA will continue to update the public as it learns more about CBD. While the FDA has now issued releases focusing on false medical claims with regard to CBD as well as CBD as a food additive, the FDA makes clear that it will continue to monitor the marketplace for any product that poses a risk to public health, including those with dangerous contaminants, those marketed to vulnerable populations, and products that otherwise put the public health at risk.
In summary, the Update and the warning letters make clear that the FDA is monitoring companies that make inappropriate healthcare claims as well as food or dietary supplement products as a matter of the protection of public health. However, these items also indicate that the FDA will continue to explore potential pathways for various types of CBD products to be lawfully marketed, hopefully as both a food additive/dietary supplement and as a pharmaceutical ingredient.