FDA progress report on CBD ‘nothing more than an end-of-Administration desk-clearing exercise,’ says CRN

In a statement ​released Friday, FDA commissioner Dr Stephen Hahn and principal deputy commissioner Dr Amy Abernethy noted that while CBD is now widely available, we “still have a limited understanding of the safety profile of CBD and many other cannabis-derived compounds​.”

Specifically, they added: “We still don’t have clear answers to important questions such as what adverse reactions may be associated with CBD products and what risks are associated with the long-term use of CBD products. Better data in these areas are needed for the FDA and other public health agencies to make informed, science-based decisions that impact public health.”

‘Outstanding knowledge gaps’

Existing efforts generally “are not adequate to fill the outstanding knowledge gaps,”​ they claimed, noting that longitudinal studies, which provide data about the health of subjects over an extended period of time, are needed to understand long-term health effects of CBD use.

Meanwhile, they added, “observational studies that are too small or that do not include techniques to ensure data quality or methodological rigor are of limited use for public health decision making.”

Rates of CBD use, and rates of use of specific CBD products, are also poorly understood, they said: “What is the denominator of risk for adverse events in the population taking CBD? What specific populations have the highest CBD exposures and what specific products are frequently used?  What other products, such as over-the-counter or prescription drugs, are used alongside CBD products? Are there risks associated with interactions between CBD products and other products, beyond those that have already been identified and communicated by the FDA?”

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