June 4, 2019

First Public Hearing for Cannabidiol (CBD) Products

The FDA recently held their very first public hearing on the regulation of cannabidiol (CBD) products, focused on obtaining scientific data and information about the safety, manufacturing, product quality, marketing, labeling, and sale of products containing cannabis or cannabis-derived compounds.

With medical marijuana legal in 33 states and the District of Columbia, there is much diversity in the regulation of marijuana products, and there has been much contention in the regulation of CBD products. While FDA-approved medications like Epidiolex have clear indications and usage guidelines, CBD products are not FDA approved.

CBD products are, in theory, supposed to lack THC, the compound responsible for the euphoric effects of marijuana, although depending on sourcing and quality, this may not in actuality be the case. Regardless, the belief that CBD products are not euphoric has led members of the public to believe these products are safer, despite a lack of clinical evidence.

Particularly relevant to workers’ comp, CBD products are often marketed to help relieve symptoms of all kinds, including muscle spasms, anxiety, depression, sleeplessness, and pain, meaning injured worker claimants could be using these products. And while initial research does indicate that CBD can offer certain clinical benefits for particular medical conditions, there has been an explosion of CBD products available on the market, and not only in smoke shops, but in health food stores and corner markets. These products are available in a myriad of formulations and marketed for a wide range of conditions.

CBD is available in oils, capsules and pills, gummies and other candies, edibles, topicals, sublingual picks, vape pens, bath bombs, pet treats, coffee, ice cream, energy drinks, beers and protein bars, vaginal suppositories, and much more. Furthermore, CBD is frequently advertised to benefit conditions such as post-traumatic stress disorder (PTSD), opioid addiction, brain injury, cancer, epilepsy, workout fatigue, high blood sugar, arthritis pain, anxiety, pain from menstrual cramps, insomnia, psychosis, and to slow the onset of Alzheimer’s or dementia.

And CBD products aren’t just available in smoke shops or alternative health stores; earlier this year CVS Pharmacies announced that they would carry CBD creams, sprays, lotions and salves in 800 stores across eight states. Shortly after that announcement, Walgreens announced that they would sell CBD creams, sprays and patches to 1,500 stores in nine states.

The FDA's public hearing involved testimony from stakeholders across academia, agriculture, consumers, health professionals, manufacturers, patients, and more. According to the opening statement from Acting FDA Commissioner Norman Sharpless, M. D., CBD products are being illegally marketed as drugs with intended therapeutic effects despite a lack of FDA approval or clinical testing, and as dietary supplements that have not been proven to be a safe food additive.

This trend is a cause for concern, as more clinical research is necessary to fully understand the impact CBD products can have on patients, especially if consumers combine multiple formulations, such as lotions with beverages or candy, oils, etc. Furthermore, as CBD can impact how the body breaks down other medications, there are potential drug-drug interactions to consider, along with other clinical uncertainties surrounding pregnancy and other conditions.

Though the FDA does not currently have a policy of enforcement discretion with respect to any CBD products, they have sent warning letters to various companies selling unapproved CBD products inappropriately, and the FDA has formed an internal working group to address existing data gaps.

While it will be some time before any definitive action is taken, the prevalence of CBD products has the potential to impact healthcare on a large scale, as patients may be mixing CBD products with various other medications. The scope of how prevalent CBD products are within injured workers populations remains to be seen, but considering these products’ popularity, it would be dubious to assume they have little-to-no impact on claimant populations.

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