FDA asserts it has regulatory role over CBD products in USA

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The United States Food and Drug Administration (FDA) has asserted its authority to regulate products derived from cannabis, including hemp. FDA Commissioner Scott Gottlieb said CBD products, including those derived from hemp, would be subject to FDA oversight.

The declaration came recently in the wake of December’s signing of the U.S. Farm Bill that expanded the legal bounds for hemp

Gottlieb said in a press release that while the Farm Bill removed hemp from the Controlled Substances Act, the agency still has a regulatory responsibility.

“Congress explicitly preserved the agency’s current 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,” Gottlieb said. “In doing so, Congress recognized the agency’s important public health role with respect to all the products it regulates.”

Economic impact

Gottlieb said the agency is aware of the economic ramifications of the legalization of hemp.

“We recognize the potential opportunities that cannabis or cannabis-derived compounds could offer and acknowledge the significant interest in these possibilities,” Gottlieb said. “We’re committed to pursuing an efficient regulatory framework for allowing product developers that meet the requirements under our authorities to lawfully market these types of products.”

“We’re aware of the growing public interest in cannabis and cannabis-derived products, including cannabidiol (CBD),” Gottlieb continued. “This increasing public interest in these products makes it even more important with the passage of this law for the FDA to clarify its regulatory authority over these products. In short, we treat products containing cannabis or cannabis-derived compounds as we do any other FDA-regulated products — meaning they’re subject to the same authorities and requirements as FDA-regulated products containing any other substance. This is true regardless of the source of the substance, including whether the substance is derived from a plant that is classified as hemp.”

Path for Product Approval

Gottlieb said that the agency recognized the investment that was being put into the development of cannabis products including CBD and that an avenue for product development and approval would be implemented.

“While products containing cannabis and cannabis-derived compounds remain subject to the FDA’s authorities and requirements, there are pathways available for those who seek to lawfully introduce these products into interstate commerce,” said Gottlieb. “The FDA will continue to take steps to make the pathways for the lawful marketing of these products more efficient.”

Beware health claims

Gottlieb said the FDA would not allow products the agency deemed unsafe or that made unsubstantiated health claims.

“We’ll take enforcement action needed to protect public health against companies illegally selling cannabis and cannabis-derived products that can put consumers at risk and are being marketed in violation of the FDA’s authorities,” he said.

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