FDA Public Hearing and Comments on Cannabis
This post was written by Kamran Aryah, an attorney with the Kight on Cannabis law firm.
The FDA issued another statement on April 2 concerning hemp and CBD. This may very well be the final statement issued by Scott Gottlieb before his resignation. As has been typical of prior statements from the FDA Commissioner, the April 2 Statement again said a lot, without substantively changing FDA policy. The FDA Act still prohibits the addition of CBD isolate to ingestible products, and health claims cannot be made about non-FDA approved articles.
The FDA is however finally allowing the public to weigh in, with the announcement of a Public Hearing to take place on May 31, 2019. What’s more, is that the Agency is allowing submission of public comment until July 2, 2019 and seems to earnestly want feedback from the hemp industry. This may signal the first step toward a full “notice and comment rulemaking process”. Notice and Comment Rulemaking is the way in which some federal regulatory agencies pass formal rules. The process is actually codified in the Administrative Procedures Act (APA) 5 U.S.C. Chapter 5. The Agency will release a “Notice of Proposed Rulemaking” (NPRM), and then allow for public comment.
In this largely unregulated market, this first public comment action seems to be a genuine effort to allow the hemp industry to weigh in, so that the FDA would even have the necessary information to issue an NPRM. The FDA published a Guidance Document in the Federal Register, outlining the topics regarding cannabis that they would like public comment on. The FDA invites the public to comment on things like:
FDA is interested in information about how products containing cannabis or cannabis-derived compounds, other than drug products approved by FDA for human or animal use, are marketed, labeled, and sold.
Please provide data and information on how products containing cannabis or cannabis-derived compounds (other than those marketed as drugs in compliance with the FD&C Act) are currently manufactured, including information about methods for ensuring product quality and consistency.
Are there any currently used standardized definitions for the ingredients in cannabis products (e.g., “hemp oil”)? If standardized definitions would be helpful, what terms should be defined and what should the definition(s) be?
This doesn’t sound like an agency that wants to shut down hemp and CBD production; it sounds like an agency desperate for industry guidance, and genuinely seeking the advice and information of industry professionals as far as what steps are needed to ensure quality and safety of hemp products.
It is refreshing when a Federal Agency demonstrates willingness to work with the hemp industry toward a common goal. Hemp industry professionals want, (and more importantly consumers deserve) accountability, and a standard set of protocols that they can follow to ensure that hemp and CBD products are safe, and contain CBD in concentrations that match their labels. While this is a positive development, it doesn’t represent a guarantee of a change in FDA policy. It represents that at the very least, the FDA is open to hearing from individuals who are directly involved in cultivating hemp, and manufacturing hemp and CBD products.
At the same time, the FDA indicated the renewal of its warning letter campaign against improper health claims. Remember, that an improper health claim is a claim about the capacity of an article to diagnose, treat, mitigate, cure or prevent a disease. Three warning letters have already been issued in 2019 to purveyors of hemp and CBD products, addressing both improper health claims, and inaccurate labeling for CBD content. The most cautious approach now, and the best way to avoid becoming the subject of a warning letter is to remove all references to named diseases, period. No more “inhibits cancer cell growth”, no more “helps prevent memory loss in Alzheimer patients”; no specific or general claims even mentioning a disease.
The variables still at play in forecasting the future of FDA regulation are Commissioner Gottlieb’s replacement, as well as the FDA’s response to the open comment period. This is a crucial opportunity for the industry to speak up! Individuals willing to participate, or present materials at the public comment session on May 31, can submit such requests up until May 10, 2019. The FDA has opened a docket on this subject, and public comment in response to the content of the hearing can be submitted until the docket closes on July 2, 2019. The Comment Portal is currently open, and instructions for submissions can be found at www.regulations.gov.
April 20, 2019
This post was written by Kight on Cannabis attorney Kamran Aryah. Kamran works closely with clients in the hemp and CBD industry to develop compliance strategies. Kight on Cannabis is a law firm founded by attorney Rod Kight that represents legal cannabis businesses. You can contact us by clicking here.