Industry updateUS FDA unveils plan to gather ‘real-world’ data to fill CBD research gaps

After two years of delaying regulations, the agency looks to improve data-gathering methods on CBD product safety
Jared Gnam Jared GnamJanuary 11, 20219 min

The U.S. Food and Drug Administration has unveiled a plan to fill research gaps on the safety and efficacy of CBD with “real world” data in the coming months.

In a statement Friday, the agency said that despite a rapid increase in interest and availability of CBD products in the last two years, a lack of knowledge remains on long-term use of the compound. Potential dangers in people and animals include liver injury and adverse reactions with other medications.

The FDA has been seeking long-term data on CBD safety since hemp and its derivatives were legalized under the 2018 Farm Bill. In order to develop regulations for products, the agency has been consulting stakeholders since May 2019. Industry experts say a wild west market for CBD products is leaving consumers unprotected.

The agency named four primary challenges it’s faced in gathering information including: minimal studies on the long-term impacts of CBD consumption, limited data sources on adverse reactions to products, a poor understanding of CBD use rates and a lack of specific codes that precisely identify products.

To address those issues, Commissioner Stephen Hahn and Principal Deputy Commissioner Amy Abernethy said the agency plans to enhance data collection in the new year.

“We see an important public health opportunity in using novel sources of data and rigorous analytical methods to build a more robust base of scientific evidence on the safety profile and use of CBD products,” the agency wrote in the statement.

Read more: Global CBD report underscores need for low-dose clinical trials

Read more: Low does of CBD doesn’t impair driving, landmark study shows

CBD: US FDA unveils plan to gather ‘real-world data' to fill CBD research gaps
About 3,000 CBD brands are sold in the U.S., with Charlottes Web Holdings, Inc. leading in terms of market share. Press photo

The FDA says it will take steps to improve CBD product identification, help develop an open registry of CBD consumers, increase product sampling in line with reports of adverse effects, look at market research data as well as evaluate its strategies for safety and quality monitoring for different types of CBD products.

In the coming months, the FDA intends to target new research projects that will improve data gathering methods on CBD product safety. The agency will take greater advantage of existing sources such as poison control databases and electronic health records. It will evaluate market-research data and the value of combining various research projects, and also develop an open registry for CBD users.

The agency says it’s conducting a two-phase marketplace sampling and testing study. In the first phase, it published findings that showed fewer than half of 200 tested products contained CBD concentrations with 20 per cent of their claimed amount, while some products contained the psychoactive ingredient THC.

Last September, the FDA introduced new draft guidance to speed up drug approvals for oral CBD medications. Two months earlier, the agency unveiled new draft guidelines to encourage clinical research for compounds derived from cannabis and hemp.

Last July, the FDA also re-opened an online public hearing docket to collect more data from industry stakeholders and medical experts, after it was first launched in May 2019.

Large U.S. CBD sellers like Charlotte’s Web Holdings, Inc. and Canopy Growth Corp. have been funding studies on the long-term safety of CBD to submit to the FDA.

Read more: Charlotte’s Web backs study on health outcomes of CBD

Read more: Worm study shows CBD may extend life

Read more: FDA’s new draft guidelines could speed up CBD drug approvals

Top image via Deposit Photos

 

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