Chapter 1 – The Double-Edged Nature of the FDA Approval Process

2018 proved to be a very busy (and frankly dizzying) year for the cannabis industry as three more states, including Missouri, passed laws legalizing some form of cannabis use, bringing the total number of such states and U.S. territories to well over thirty, despite the fact that cannabis, and its use, remains unlawful, under federal law that is. Today, there are thirty-three states that allow for medical use of cannabis, while ten states have legalized the recreational use of cannabis.  What is more, several state governments and governors are expected to prioritize new cannabis-related policies in 2019. As more states decide to permit various uses of cannabis, one issue that remains generally unanswered lies at the intersection of these emerging state laws and U.S. patent law, which falls within the exclusive purview of the federal government, both statutorily and in enforcement of patent rights.

Continue Reading Unique Issues with Cannabis-related Patents and Their Enforcement

As many in the marijuana and hemp industry are aware, the Food and Drug Administration (FDA) has recently turned its focus on cannabidiol (CBD). In 2015 alone, the FDA has sent 7 warning letters to companies that are currently marketing CBD in various forms as a dietary supplement. While some in the hemp CBD market claim that the FDA’s letters only apply to CBD derived from marijuana, this is simply not the case as set forth in the FDA Q&A question number 12. Many of these warning letters were sent to sellers of hemp oil products marketed as high CBD without regard for the CBD was derived from marijuana or hemp.

The FDA has also granted GW Pharma fast-track approval for studies of potential drugs that include CBD as a main active ingredient, and the studies are well underway. This classification significantly impacts to CBD industry as it effectively shuts the door on CBD being classified and marketed as a dietary supplement.

This is due to the fact that FDA rules prohibit a substance from being defined as a dietary supplement after investigations for that substance as a pharmaceutical have been authorized and initiated. The FDA has the power to regulate products claiming health benefits under the commerce clause of the United States Constitution, and indeed they have cited interstate commerce in their warning letters to CBD marketers.

While companies generally cannot specifically market their CBD products as having health benefits or as a dietary supplement, hemp products or hemp oils are still being marketed as containing CBD as an ingredient. Have these companies taken appropriate steps to comply with the FDA’s position regarding CBD?