Know How: Alert


CBD Industry Must Prepare For FDA Regulation



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On May 31, 2019, the Food & Drug Administration (“FDA”) held its first public hearing on regulating the processing, dispensing, and ingesting of Cannabidiol (“CBD”). 

The FDA’s Deputy Commissioner, Dr. Amy Abernethy, noted FDA’s five key takeaways from the hearing:

There is a Serious Need for Regulatory Clarity
The 2018 Farm Bill explicitly removed hemp from the list of substances that are federally banned under the Controlled Substances Act. 

While hemp is no longer prohibited under federal law, the 2018 Farm Bill stipulated that the FDA shall regulate CBD under the FDCA and Section 351 of the Public Health Service Act.  Pursuant to this authority, the FDA has sent warning letters to certain businesses for making “egregious” and “unsubstantiated” claims related to the treatment of serious illnesses with CBD and the unlawful use of CBD in food, beverages and dietary supplements.

Thus, a regulatory vacuum exists: the Controlled Substances Act no longer prohibits the growing, processing, dispensing, and ingesting of hemp-derived CBD products, while the FDA has the authority to penalize businesses for unlawfully engaging in these activities.

Consumer Safety is Paramount
The FDA has never officially studied the effects of CBD on the human body and intends to collect scientific data on CBD. Observers can anticipate extensive analysis in the coming months focused on determining the manner in which CBD may be safely ingested. The FDA is gravely concerned with the childhood ingestion of CBD and possible negative health effects.

Nationwide Labeling Requirements Are Coming
The lack of regulation and lucrative profit margins in the CBD industry has led to the presence of bad actors.  As CBD is not currently regulated by the FDA, there is no guarantee that the products consumers are currently purchasing are safe or otherwise include the ingredients as found on the product’s label.

Dosing Guidelines Are Necessary
Currently there are no dosing guidelines for the ingestion of CBD.  The FDA intends to determine the “safety threshold” for CBD ingestion and establish dosing guidelines for the same.

Time is of the Essence
The FDA recognizes that it has to move quickly on this issue. The agency has requested additional public comments on its proposed regulation of CBD through July 2, 2019. 

Leadership at the Commission set the stage for significant regulation of the budding industry.  In his opening remarks, acting FDA Commissioner Ned Sharpless bluntly stated that “there are real risks [with CBD]” and that “critical questions remain about the safety of [THC and CBD] in foods and dietary supplements.”

Derived from hemp, CBD and CBD-infused products have exploded in popularity throughout the United States.  A recent study estimates that that the national CBD market could reach a value of $16 billion by 2025.  Despite widespread growth and ubiquitous consumption, CBD is essentially unregulated at this time.      

If you have questions about CBD and its treatment under federal law or how the FDA’s proposed regulation of CBD could impact you, please contact one of the authors of this Cannabis Counsel alert.


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