Regulatory Guidance

FDA hearing on CBD raises more questions than answers

Jun 03, 2019

On Friday, the FDA listened to testimonies from over 100 stakeholders in the growing market for CBD, a non-psychoactive compound found in marijuana.

Under the 2018 Farm Bill passed in December, CBD was legalized when it’s derived from hemp that meets strict growing requirements based on THC concentrations. But even before the easing of regulations, the market for CBD had exploded with a wide range of dietary supplements flooding the market, especially in states where marijuana has been legalized. 

CBD receptors are thought to target all systems in the body, creating a wide range of therapeutic benefits, but most Americans take the supplement for pain, sleep or anxiety. However, studies have shown that many of the CBD products on the market don’t contain the exact dosing that their labels promise, leading to quality control concerns. 

The FDA hearing was created as an important step in providing regulatory clarity around CBD, which fell under the agency’s purview as part of the Farm Bill. The presenters included representatives from academia and manufacturing as well as patients who lobbied for the compound’s safety and efficacy. But several speakers also spoke out on the dangers of marijuana and a lack of clinical trials on CBD dosing and safety. 

Ultimately the widespread hope in the industry is that the FDA will quickly get a handle on the rapidly evolving market for CBD and create concrete regulations about whether or not it should be classified as a drug or dietary supplement. So far, the agency has not set a timeline for any regulatory decisions. 

Read the CNN report.

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