Greenspoon Marder Clients to Testify at FDA Hearing or Submit Written Comments to
Inform FDA on Key Issues for Establishing CBD Regulations
FDA has been moving, since the December 20, 2018 passage of the
2018 Farm Bill, toward the full legal recognition of hemp-derived CBD as a food
additive and dietary supplement and recently announced that it will be holding
a public hearing on products, such as hemp derived CBD, on
2019, from 8 a.m. to 6 p.m. FDA is currently accepting requests for
presentations during the public hearing and is accepting written comments
through July 2, 2019.
This is a critical opportunity to inform FDA before it issues
regulations or moves forward to regulate CBD. The hearing will be a major
gathering of CBD companies in the Washington DC area to testify for a full day
at FDA headquarters before a panel of high-level FDA officials.
The public hearing will give stakeholders an opportunity to
provide the agency with additional input relevant to its regulatory strategy
related to existing products, as well as the lawful pathways by which products
can be marketed, and how FDA can make these legal pathways more predictable and
This hearing and comment period provide you the opportunity to
present information and explain why FDA should move forward to allow CBD
products to exist in the marketplace as food and supplements alongside CBD
drugs such as Epidiolex. FDA must be
convinced that responsible manufacturers are ready to work with FDA to allow
this innovative industry to flourish while producing a safe product.
FDA has requested information relating to the safety, manufacture,
and marketing/labeling of product including hemp-derived CBD:
How are such products manufactured; and are
standards, processes, validation and testing needed to address safety and
quality issues involved in manufacturing and processing such products? Are there standardized definitions used for
ingredients in such products and would standardized definitions be
helpful? What are the functional purposes of adding hemp-derived
compounds, such as CBD, to foods (e.g., nutritive value; technical effect) both
in terms of manufacturer intent and consumer perceptions? What risks should consumers be informed about,
and how should consumers be informed of such risks? What other information should FDA consider in
the labeling of specific product categories?
For further information or to discuss your comments or testimony,
contact Jessica Wasserman at
or your Greenspoon Marder attorney.