It is with great pride that we announce that our Founder and Managing Partner, Dave Rodman has been selected by the U.S. Food and Drug Administration (“FDA”) to give oral testimony regarding the safety of products containing cannabis-derived compounds, specifically cannabidiol (“CBD”), at the public hearing scheduled to take place on May 31, 2019, Mr. Rodman was one of the few individuals selected to advocate for practical solutions to allow common sense regulation of the burgeoning cannabinoid industry at the FDA’s Scientific Data and Information about Products Containing Cannabis or Cannabis-Derived Compounds Public Hearing.
When asked about being one of a handful of people selected to present at the hearing Mr. Rodman said,
“I cannot put into words how honored I am to have been given the opportunity to help proactively change the regulatory landscape of this industry so that my clients can operate with full governmental approval and so that all Americans can safely access reliable, standardized cannabinoid products. While I am a huge believer in the promise of cannabinoids and what appear to be their incredible benefits to human health, I have been warning my clients, and just about anyone else who would listen, about the legal risks of operating in this space since 2015. The Agriculture Improvement Act of 2018 was a large step in the right direction, but we have seen too many businesses interpret that legislation as the government’s full approval for CBD products intended for human and animal use, and that simply isn’t the case. The current regulatory framework does not permit the use of CBD in any consumable product other than the drug Epidiolex.”
When asked to expound upon what practical regulation of cannabinoids would mean for the industry he responded,
“First and foremost it will pave the way for larger and more definitive human studies to be conducted so that we can conclusively establish the actual, verifiable health benefits and the safety of these compounds, which for the record I believe to be quite safe given the anecdotal evidence, but as a lawyer and a person who understands the bell curve of human reaction to substances, I know that to be able to conclusively establish what health benefits each cannabinoid provides—if any, to confirm that those benefits are duplicable across at least the majority of the population, and to ensure the greatest safety for the greatest number of people, that the industry and its regulators need far more scientific and medical data than currently exists. Second, it will give producers a definitive answer as to how they can market and label their products. Right now, it’s more of an art than a science in interpreting what FDA labeling requirements are applicable to what products when according to the law none of them really are. Third, the normalization of the industry will remove the current “gray market taint” that leads to massive, and largely unfair, operational headaches. It will allow companies to access normalized banking and merchant processing, be able to advertise without consulting their attorneys on every action they take, and will make insurance costs more reasonable. The last big one is that practical regulation will create standards for the industry and the bad actors who are slinging snake oil that contains little to no actual cannabinoids will be easier to identify and remove from the market.”
The firm has carefully monitored enforcement actions and updates from the FDA following the ratification of the Agriculture Improvement Act of 2018 (“2018 Farm Bill”). In the months since its passing, the hemp industry has seen an incredible boom in market interest and value, with cannabidiol (“CBD”) market estimates projecting a potential value of $16 billion by 2025.1 The popularity of hemp and CBD products has, however, run into considerable regulatory challenges in the months following the 2018 Farm Bill from both state and federal agencies. Citing elements of the Controlled Substances Act (“CSA”) and the Federal Food, Drug, and Cosmetic Act (“FD&C”), the FDA has maintained that consumable products containing CBD are not currently permitted under its regulations, and it has emphasized the need for revised federal guidelines.
Consumable CBD, in particular, has generated significant public confusion. Some states prohibit the sale of food and drink with CBD additives on grounds of FDA health and safety concerns, while other states have not – Colorado granted state-level protection for CBD in 2018 with the adoption of House Bill 1295. Topical ointments, vaporizers, and products containing hemp seed or hemp seed oil may encounter fewer regulatory obstacles from agencies such as the U.S. Alcohol and Tobacco Tax and Trade Bureau (“TTB“) or United States Patent and Trademark Office (“USPTO”), however, the FDA has not yet presented a clear ruling on the legal sale, transportation, and usage of hemp following is removal from the list of federally controlled substances. We hope, and Mr. Rodman is actively working to ensure, that the hearing will provide the FDA the confidence it needs to enact common-sense regulations for CBD without the need to involve the legislative process.
The hearing will run from 8 am to 6 pm (EDT) at the FDA’s White Oak Campus and, following the hearing’s conclusion, a recorded webcast of the hearing will be uploaded to the agency’s website here. The FDA has also announced that they will be accepting electronic or written public comment submissions until July 2, 2019.
You can read Mr. Rodman’s written comment here.
For more information on the FDA’s hearing, please click here.
Additional information on submitting FDA public comment can be found here.
- Dorbian, Iris. “CBD Market Could Pull In $16 Billion By 2025, Says Study.” Forbes. March 12, 2019. Accessed May 22, 2019. https://www.forbes.com/sites/irisdorbian/2019/03/12/cbd-market-could-pull-in-16-bln-by-2025-says-study/#3bd497953efd.