FDA Schedules Hearing on CBD, Issues New Press Release and Warning Letters
By Associate Attorney Lauren Mendelsohn
April 8, 2019
Last week, the Commissioner of the United States Food and Drug Administration (FDA), Scott Gottlieb, M.D., issued a press release regarding the FDA’s current standpoint with regards to cannabinoids including CBD. In the press release, the FDA states that interest in products containing cannabis derivatives such as CBD increased after U.S. Congress passed the Agriculture Improvement Act of 2018 (also known as the “2018 Farm Bill”) last December. The 2018 Farm Bill created a new definition for “hemp;” specifically, that the term now refers to cannabis and cannabis derivatives with no more than 0.3% THC on a dry-weight basis, and removed hemp from the Controlled Substances Act, though cannabis containing a THC content higher than 0.3% remains a Schedule I drug. We previously discussed the 2018 Farm Bill in detail here.
Despite this reclassification of hemp, the 2018 Farm Bill left intact the FDA’s authority to regulate products containing cannabis or cannabis-derived compounds under the Federal Food, Drug, and Cosmetic Act (“FD&C Act”) and section 351 of the Public Health Service Act. Thus, the FDA still plays an active role in ensuring the public’s health with regard to products derived from hemp or cannabis, as well as in crafting new regulatory pathways so these products can safely be brought to market.
In particular, the FDA is mainly concerned with companies selling cannabis-derived products (including hemp-CBD products) that claim to prevent, diagnose, treat, or cure any disease, since those cannabis-derived products have not been specifically approved as a medicine by the FDA. In addition, the FDA is concerned with food (including animal food or feed) that is sold in interstate commerce which contains CBD or THC, since neither have been approved as a food additive by the FDA, as well as products containing THC or CBD that are marketed as “dietary supplements” since neither meet the definition of a dietary supplement under the FD&C Act.
The FDA Commissioner’s recent press release revealed the following key information:
- A public hearing will be held on May 31 for stakeholders to provide comments regarding FDA’s regulatory strategy for products containing cannabis and cannabis-derived compounds, including CBD.
- The FDA is in the process of assembling a high-level interagency working group to “explore potential pathways for dietary supplements and/or conventional foods containing CBD to be lawfully marketed.”
- The FDA’s “Frequently Asked Questions” regarding cannabis and cannabis-derived products have recently been updated to include information about the 2018 Farm Bill and some new responses regarding products containing CBD.
- The FDA, in conjunction with the Federal Trade Commission (FTC), has sent out a new round of warning letters to companies selling products containing CBD that were making unsubstantiated health-related claims: Advanced Spine and Pain LLC (d/b/a Relievus); Nutra Pure LLC; and PotNetwork Holdings, Inc.
On April 3, 2019, a day after Commissioner Gottlieb’s press release, the FDA published a Notice of Public Hearing and Request for Comments in the Federal Register. The public hearing will be on May 31 from 8:00am to 6:00pm (EST) at the FDA’s White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993. The FDA is interested in receiving feedback from the public regarding the following areas related to products containing CBD:
- Health and Safety Risks
- Manufacturing and Product Quality
- Marketing / Labeling / Sales
The exact questions they are seeking input on can be found in the Notice of Public Hearing. Anyone interested in making an oral presentation or comment at the public hearing must submit a request to do so by May 10, 2019. Additionally, electronic or written comments will be accepted until July 2, 2019. All comment submissions must include the Docket No. FDA-2019-N-1482 for “Scientific Data and Information about Products Containing Cannabis or Cannabis-Derived Compounds; Public Hearing; Request for Comments.” Comments may be submitted via the Federal Rulemaking Portal or via regular mail to the following address:
Dockets Management Staff (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
So, what does all of this mean to companies interested in jumping on the CBD bandwagon? For one, this public hearing presents a rare opportunity to make an oral presentation and educate federal regulators presumed to be in listening mode. Certainly, thoughtful presentations by CBD entrepreneurs showcasing their efforts to manufacture high-quality products, mitigate health and safety risks, and conduct responsible marketing, labeling, and sales campaigns, would receive a warm reception at the hearing.
Entrepreneurs should keep in mind that the 2018 Farm Bill didn’t legalize industrial hemp or products derived from it outright — there is still a regulatory system in place which the FDA is actively overseeing. Additionally, how and where a particular product is marketed is critical in terms of what level of FDA and/or law enforcement scrutiny would be triggered. It is advised that any company operating or considering operating in the hemp/CBD space, consult with knowledgeable legal counsel.
This is a rapidly-evolving area of the law, so stay tuned for more updates on this topic!
The above information is provided as a public service and is not intended as legal advice. For more information about the 2018 Farm Bill, the FDA’s position regarding CBD and other cannabis-derived products, or other questions related to hemp or cannabis, please contact the Law Offices of Omar Figueroa at (707) 829-0215 or info@omarfigueroa.com to schedule a confidential legal consultation.