As you may be aware, over four years after the federal government signed the 2018 Farm Bill into law, last week, on January 26, 2023, the FDA announced that it will not engage in any rulemaking processes related to CBD or other similar cannabis-derived compounds because it is unable to safely regulate such compounds under its existing regulatory processes. Additionally, the FDA asserted that Congress would need to create and adopt an entirely new regulatory pathway before the FDA can regulate CBD and similar cannabis-derived compounds.
Per the FDA, a new regulatory pathway is necessary to balance individuals’ desire for access to CBD products with the need for regulatory oversight for risk management purposes. Some of the risk management tools the FDA referred to in its January 26th announcement are those we already see in the California commercial cannabis industry including those related to:
- labeling concerns; prevention of contaminants;
- CBD content limits; and
- measures to mitigate risk of consumption by underage persons (age limitations).
Though the FDA is prepared to work with Congress so that Congress can put safeguards in place and come up with proper risk management tools to allow for the regulation of CBD products, it is unclear how long it will take Congress to act. With that in mind, Rogoway is available for creative problem-solving for our existing clients or new clients operating in the CBD marketplace. We believe that looking to the regulated commercial cannabis industry regulations in California is helpful guidance on ways to proceed to, at least, mitigate risk of enforcement, noting that the FDA pointed out its intentions to continue with enforcement actions “when appropriate” (see below).
When rationalizing its decision not to move forward with the regulation of CBD and other similar compounds, the FDA pointed to studies and conclusions that raised “various safety concerns” associated with the long term or general use of such compounds, including potential liver harm, negative medication interactions, potential harm to the male reproductive system, potential harm to vulnerable populations (e.g. children or pregnant persons), and even potential harm to animals. The FDA stated that, under the law, any substance including CBD, must meet specific safety standards to be lawfully marketed as a dietary supplement or food additive and that the existing tools the FDA has access to are too limited to manage the risks associated with CBD. While the FDA stated that it does not intend to pursue rulemaking about CBD, another important aspect of the FDA’s January 26th announcement is that the FDA stated explicitly that it will “continue to take action against CBD and other cannabis-derived* products to protect the public, in coordination with state regulatory partners, when appropriate.”
At Rogoway Law, we understand that many of our clients operate in challenging regulatory areas with evolving legal landscapes and evolving legal risks. We also understand that this news is difficult to hear when so many operators have been waiting for clarity on this issue. We are therefore available to help our clients navigate emerging market developments and mitigate the associated risks and liabilities as much as possible and with a lens towards looking at existing regulations, mitigating activities, and policy concerns. For more information about how the FDA’s January 26th announcement may impact your business, contact Rogoway Law today.