The FDA sets first public hearing date on food and drinks containing CBD as agency considers legalizing compound

Apr 8, 2019

On May 31, the Food and Drug Administration will hold its first public hearing on legalizing cannabidiol in food and drinks.

The agency is calling for data on CBD’s safety in food products as well as suggestions on how the FDA might regulate manufacturing, marketing, and labeling CBD-infused products.

In a statement released on April 2, the FDA commissioner stated that the agency is responding to the growing interest in the development of medical therapies and consumer products that derive from cannabis and its components, including CBD.

[As CEO, CannAmerica’s Dan Anglin wants a piece of the hemp and CBD market. As a Marine, he wants veterans to have access to cannabis too.]

“We’ve seen, or heard of interest in, products containing cannabis or cannabis derivatives that are marketed as human drugs, dietary supplements, conventional foods, animal foods and drugs, and cosmetics, among other things,” Gottlieb said in the statement.

“We also recognize that stakeholders are looking to the FDA for clarity on how our authorities apply to such products, what pathways are available to market such products lawfully under these authorities, and how the FDA is carrying out its responsibility to protect public health and safety with respect to such products,” Gottlieb concluded.

Gottlieb has appointed Principal Deputy Commissioner Amy Abernathy and Principal Associate Commissioner for Policy Lowell Schiller to co-chair a high-level working group to investigate, evaluate, and report on the issue.

“It’s critical that we address these unanswered questions about CBD and other cannabis and cannabis-derived products to help inform the FDA’s regulatory oversight of these products⸺especially as the agency considers whether it could be appropriate to exercise its authority to allow the use of CBD in dietary supplements and other foods,” Gottlieb stated.

What do the Farm Bill, the FDA, and CBD all have in common?

Gottlieb cited the passage of the Agriculture Improvement Act of 2018, also known as the 2018 Farm Bill, last December as interest in products that included hemp increased.

The Farm Bill established a new category of cannabis classified as hemp. Hemp must have an extremely low concentration of the psychoactive compound delta-9-tetrahydrocannabinol, no more than 0.3 percent on a dry weight basis.

The 2018 Farm Bill removed this type of hemp from the Controlled Substances Act, making hemp a non-controlled substance under federal law. Simultaneously, the bill preserved the FDA’s authority to regulate products containing cannabis or cannabis-derived compounds under the Public Health Service Act.

This meant that in spite of an increase in demand for hemp products, the FDA’s role in reviewing and regulating the addition of CBD into food, drinks, and cosmetic products meant that many organizations had to halt hemp inclusion in potential new products and wait for the FDA’s input.

[USDA and FDA issue statements on farm bill implementation, suggest process could run into 2020]

In response to this, Gottieb maintained that the agency must respond by inspecting those items which fall under their regulatory purview and establishing regulations for developers.

“Congress recognized the agency’s important public health role with respect to all the products it regulates. This allows the FDA to continue enforcing the law to protect patients and the public while also providing potential regulatory pathways, to the extent permitted by law, for products containing cannabis and cannabis-derived compounds,” Gottlieb said.

Gottlieb stated that the FDA would work on a solution to this issue.

“This is a complicated topic and we expect that it could take some time to resolve fully. Nevertheless, we’re deeply focused on this issue and committed to continuing to engage relevant stakeholders as we consider potential paths forward,” Gottlieb stated.

Part of this path forward has included updating the FDA Webpage with a handy FAQ section and the issuance of warning letters to companies that peddle CBD products with unfounded claims in their marketing campaign.

Additionally, the FDA will be holding a public hearing on May 31, as well as allowing for a broader public comment period, to ensure that stakeholders are able to share their experiences and challenges with CBD products.

The Public Hearing

On May 31, the FDA will take to the public its efforts to regulate hemp products, by holding a meeting near its headquarters in Washington, D.C. Additionally, the high-level working group is scheduled to share its findings later this summer.

[CBD has hit store shelves at America’s largest drugstore chain, CVS]

“The public hearing will give stakeholders an opportunity to provide the FDA with additional input relevant to the agency’s regulatory strategy related to existing products, as well as the lawful pathways by which appropriate products containing cannabis or cannabis-derived compounds can be marketed and how we can make these legal pathways more predictable and efficient,” Gottlieb stated. “We hope to gain additional information and data for the FDA to consider with respect to products containing cannabis and cannabis-derived compounds, including CBD.”

Stakeholders interested in providing information must submit requests to make oral presentations and/or comments at the public hearing by May 10. If pot politicos are interested in making a comment, but won’t be in the D.C. area on May 31, they can submit their comments up until July 2.

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