FDA Issues Long-Awaited CBD Update in Report to Congress and Public Statement
By Shawn Hauser, Partner
Mar 12, 2020
On March 5, the FDA issued its first report to Congress required under the Further Consolidated Appropriations Act 2020, along with a public update regarding its progress in evaluating lawful pathways for the marketing of CBD products and considering a risk-based enforcement policy.
The report made no immediate change to FDA’s regulatory approach and did not contain any specifics as to the timing or substance of any enforcement policy, while the public update reiterated FDA’s current position governing CBD and specifies the various factors the FDA continues to consider in its evaluation, along with its commitment to obtain relevant data. The agency stated that “[a]ny enforcement policy would need to further the goals of protecting the public and providing more clarity to industry and the public regarding the FDA’s enforcement priorities while we take potential steps to establish a clear regulatory pathway.”
Notably, FDA announced additional steps it is taking to receive relevant data relating to CBD and CBD-containing products including the indefinite re-opening of its public docket for “Products Containing Cannabis or Cannabis-Derived Compounds,” coordination with federal, state, and international regulatory agencies and stakeholders, sampling/evaluation of the current marketplace, and efforts to establish a process by which proprietary information submitted to the agency can be protected.
The FDA announced that it continues to seek reliable and high-quality data on numerous factors to inform its regulatory approach, including:
- Sedative effects of CBD
- Impacts of long-term sustained or cumulative exposure to CBD
- Transdermal penetration and pharmacokinetics of CBD
- Effect of different routes of CBD administration (e.g., oral, topical, inhaled) on its safety profile
- Safety of CBD for use in pets and food-producing animals
- Processes by which “full spectrum” and “broad spectrum” hemp extracts are derived, what the content of such extracts are, and how these products may compare to CBD isolate products
The update also states that the FDA will continue to take action against unlawful CBD products that pose a risk of harm to the public; including, but not limited to:
- Products marketed with claims of therapeutic benefits
- Products marketed with false statements (such as omitted ingredients and incorrect statements about CBD content)
- Products with contaminants (such as heavy metals or high levels of THC)
- Products marketed to vulnerable populations (such as children and infants) or that otherwise put the public at risk.
If you would like to submit any comments or data now that the public comment period has been indefinitely reopened, please contact our hemp team.