FDA Hearing Recap on Cannabis and Cannabis-Derived Products
Miller & Martin PLLC Alerts | June 04, 2019
Author: Stephanie Savage
The Food and Drug Administration (“FDA”) held its first public hearing on Friday, May 31, 2019, regarding cannabis and cannabis-derived products. The purpose of this hearing was for the FDA to “obtain scientific data and information about the safety, manufacturing, product quality, marketing, labeling, and the sale of products containing cannabis or cannabis derived compounds.” The hearing follows the enactment of the 2018 Federal Farm Bill which explicitly preserved the FDA’s authority to regulate hemp or hemp-derived products. Over the last several months, the FDA has released statements and issued several warning letters to companies marketing products in violation of the Food Drug and Cosmetic Act. The FDA is aware of the growing interest that the 2018 Farm Bill has had on the development and market expansion for these products.
With respect to such products, among others, the FDA encouraged comments on health and safety risks, manufacturing and product quality, marketing, labeling and sales. During the hearing, the panel from the FDA, among others, heard comments by industry leaders including, academics, agriculture, consumers, health professionals, manufacturers, patients, public safety and retailers. Overall, commenters highlighted concerns and issues experienced by local governments, consumers, manufacturers, among many others. Concerns and issues that were highlight among presenters included product labeling, marketing, manufacturing standards, terminology and access to product research. Dr. Amy Abernethy, principal deputy commissioner for the FDA, shared on Twitter (@DrAbernethyFDA) some takeaways from the hearing:
- “First, there is a need to further clarify the regulatory framework to reduce confusion in in the market. The product questions apply to people and animals.”
- “Given the rapid expansion of the market, timely clarification of the path forward is critical, but it’s [the FDA’s] responsibility to ensure that the regulatory path is scientifically sound and in the interest of public health.”
- “Key questions about product safety need to be addressed. Data are needed to determine safety thresholds for CBD; datasets/information should be objective, of adequate quality and available for transparent review. Lab testing and data analyses need to be replicable.”
- “There are both positive supporters of cannabis-cannabis derived products including CBD and also concerned citizens worried that widely available products can be harmful.”
- “Consumers need consistent information and labeling. State/government entities need support in knowing what to do. And we really need to understand the implications for children when they take CBD-containing products at different dosage ranges.”
The FDA will continue to allow public comments on the topic through its docket for public comments, FDA-2019-N-1482. The FDA will accept comments electronically through the Regulations.gov filing system, or by mailing written comments to Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. The deadline to submit electronic comments is 11:59 PM Eastern Time on July 2, 2019. If comments are mailed or hand delivered, comments will be accepted if they are postmarked or delivery service receipt on or before July 2, 2019. No late filed comments will be considered.
For more information, contact Miller & Martin Attorney Stephanie Savage.