Last Friday, May 31, the U.S. Food and Drug Administration (“FDA”) held their first public hearing regarding cannabis and cannabis-derived products. Influenced by the recent market boom of hemp and cannabidiol (“CBD”) products, the FDA’s hearing presented an opportunity for industry participants and stakeholders to weigh in on the safety of CBD as state and federal authorities work through the effects of the Agriculture Improvement Act of 2018 ( the “Farm Bill”).
Acting Commissioner of Food and Drugs, Norman “Ned” Sharpless, opened the hearing by noting the lack of established rules for products laced with CBD despite its newfound popularity, stating, “There are important reasons to generally prohibit putting drugs in the food supply.”1
Sharpless’ introduction was followed by nearly ten hours of testimony from FDA-selected speakers representing various aspects of the hemp and CBD industry. Of more than 400 applicants, The Rodman Law Group’s Founder and Managing Partner, Dave Rodman was one of the few selected to testify.
“It was a decidedly unique experience, and that’s coming from someone whose entire career has been made up of unique experiences!” Mr. Rodman said.
“You spend all this time prepping for the hearing, drafting a written comment, preparing oral comments, realizing that you aren’t going to even get close to enough time to say everything you want to say, agonizing over what to cut, and then you finally get to the hearing and you finally get to the podium… and the whole thing is over in the blink of an eye! I know I was speaking ridiculously fast and I didn’t even get to discuss my third suggestion. It was intense!”
When asked what some of the important takeaways from the hearing were. Mr. Rodman paused for a moment before responding:
There were a few. First, the sheer number of people at the hearing who were hugely uninformed, or misinformed, on some of the basics of the topic was incredibly surprising to me. This included some of the presenters, a good chunk of the audience and even members of the panel. To me this means that, as an industry, we need to work on our public education efforts! Second, I was stunned to see the testing results one presenter shared about CBD products from the Midwest and the Southeast. Out of 25 products tested, only one contained exactly what it said it contained and several products contained dangerous synthetic cannabinoids and one contained DXM, which is the active ingredient in many cough medications and also a powerful hallucinogen at higher dosages!”
Explaining his observations, Mr. Rodman continued,
I believe these things surprised me so much because I live in Colorado. Even though my firm has clients in this space around the world, I think it’s impossible to discount the fact that I live in an area that has access to the best source material in the country and produces some of the best products available and has a population that is highly educated on these matters. It is painfully obvious that people from states that have been less progressive than Colorado are the victims of archaic misinformation campaigns that have existed since the Regan era. The DEA’s Schedule I classification under the Controlled Substances Act has caused unbelievable damage over the years and this lingering confusion, and in some cases outright hostility to CBD, because of the decades old campaign against cannabis is a perfect example of the long-term effects of this incredibly anti-science legislation. For that matter, Schedule I is the reason the FDA finds itself in this incredibly unique situation with CBD, it is the reason CBD is now moving through the system backwards so to speak. There is no precedent here. To my knowledge no compound has ever been removed from Schedule I, and I can say with certainty that no compound has gone from this most restrictive classification, a classification that virtually forbids substantive research into the compounds within its purview, to mass adoption practically overnight. When individual states broke Schedule I’s stranglehold on cannabis and by extension CBD, massive strides were made in short order. Anecdotal experiences and limited studies seem to indicate that many people are leading fuller, happier, and healthier lives, but widespread clinical trials were skipped, DSHEA was sidestepped, and now FDA is faced with attempting to regulate a billion-dollar industry that shows no signs of slowing.”
While other opinions represented at the hearing varied, many urged a timely response by the FDA, as the lack of legal certainty regarding CBD has created immense legal and consumer uncertainty. The CBD market potential and interest has surged in the few months since the 2018 Farm Bill, despite the many legal caveats and pending new guidelines from state and federal enforcement agencies. States do not agree on the legality of ingestible CBD, as some states have banned their sale, while others have ensured that associated products and businesses have a measure of state-level protection. This year, Vitamin Shoppe and Carl’s Jr. have notably tested enforcement actions on consumable CBD, yet, the United States Patent and Trademark Office (“USPTO”) recently announced the refusal of mark applications using CBD as an additive to food, drinks, supplements, or pet supplies. For the long-term success and efficiency of the industry, the FDA will need to take quick action and revise its guidelines to appropriately consider CBD.
Upon the agency’s review and analysis of the hearing’s findings, further FDA regulatory instruction and guidance is expected. Until then, electronic and written public comments are currently being accepted by the FDA until July 2, 2019.
To watch a recording of the hearing, click here. Mr. Rodman’s comments begin around the 1:15 mark.
For more information and instructions on submitting public comment to the FDA, click here.
- Wan, William. “Many Unanswered Questions, Concerns about CBD Products, Says FDA Acting Chief at First Public Hearing.” The Washington Post. May 31, 2019. Accessed June 03, 2019. https://www.washingtonpost.com/business/2019/05/31/amid-flood-cbd-products-fda-holds-first-public-hearing-cannabis-extract/?noredirect=on&utm_term=.c0059f825dd3.