ADventures in Law

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<img class="alignright wp-image-5295" src="https://adttorneys.bakerhostetlerblogs.com/wp-content/uploads/sites/33/2019/04/herbal-drop-natural-iStock-878414550_1200x630.jpg" alt="" width="438" height="230" />On May 31, the Food and Drug Administration (FDA) held a hearing at its headquarters in Silver Spring, Maryland, to hear from the public about cannabidiol (CBD). The popularity of CBD was reflected in participation at the meeting, which took place in a jam-packed conference room and involved 120 speakers, selected from more than 400 applicants. CBD is a cannabinoid found in the cannabis plant and now also found in coffee shops, pharmacies and, of course, online. It’s sold in oils, pills, gummies, lollipops, coffee, shampoo, pain cream and dog treats, to name just a few items. Companies claim that these products treat a wide range of ailments, including stress, sleeplessness and pain. But despite its seeming ubiquity, CBD’s legal status is a work in progress. By way of background, CBD was prohibited by federal law until the 2018 Farm Bill removed hemp from the definition of marijuana. That action created a veritable gold rush as companies raced into the sector. But some states still prohibit the substance, and the FDA prohibits unsubstantiated claims related to CBD, as it does for anything else within its regulatory ambit. Additionally, because CBD was approved for use in a drug before being used in conventional foods or supplements, the FDA prohibits its use in those products without additional rulemaking. The hearing was an opportunity for the FDA to hear about these issues and more. 

As such, it was largely “regulatory pageantry,” as I overheard an attendee sitting near me say, but there were still some valuable takeaways. For one, it was an opportunity to hear from acting Commissioner Ned Sharpless on the issue. He repeated much of this background and also expressed some concerns, which were echoed by other stakeholders during the meeting. He summarized these concerns in a series of questions, including “How much is too much? How will it interact with other drugs the person might be taking? What if she’s pregnant? What if children access CBD products like gummy edibles?” Along those lines the acting Commissioner reminded attendees that “While we don’t generally require foods to be approved by FDA before coming to market, we do require that a new food additive be approved as safe by FDA before being put in the food supply, unless the substance is generally recognized as safe, or GRAS. This requirement applies to cannabis-derived ingredients, just as it does to any other substance. Americans deserve to know that substances being added to their foods are safe, regardless of the source.”   Despite its prevalence, scientific testing of CBD is still limited, and it appears the FDA will proceed cautiously while a body of evidence develops.

Several stakeholders urged the FDA to not take their time, because the burgeoning industry needs clarity in order to succeed. They were also concerned that the status quo could lead to a “race to the bottom.” To this point, multiple speakers presented evidence in which they tested CBD products and found they had significantly less of the substance than claimed – or none at all. Some of these presentations also discussed incidents of adulterated CBD products that led to serious illness. This evidence and the general lack of studies on CBD, such as how it interacts with other drugs, might suggest the FDA will proceed cautiously. There were just as many voices, however, speaking out about the substance’s medical benefits. These speakers pointed to the significant harm in restricting CBD and making it inaccessible to those who need it. Almost all agreed that they would benefit from the FDA providing more clarity on CBD’s regulatory status. How the FDA might do so is still unclear, as the hearing shed little light on that issue, but we’ll keep you updated here on any developments.

Takeaways from FDA Hearing on CBD