New Study Points to Risks From Mislabeled Unregulated Cannabidiol ProductsGrowing consumer demand for cannabis-related products purported to have medicinal benefits has created an environment where people are using mislabeled cannabidiol (CBD) products sold online. While medicinal marijuana is legal in several states and the District of Columbia, it remains illegal under federal law. Therefore, it and related products such as CBD do not receive quality assurance oversight from the FDA. As a result, the oils, tinctures, and vaporization liquids offered online have varying levels of CBD, and listings of ingredients on the labels are unreliable. A new study from the University of Pennsylvania Perelman School of Medicine authored by Marcel Bonn-Miller, PhD, and coauthored by RTI International's Brian F. Thomas, PhD, and others, published in JAMA, found labeling inaccuracies in nearly 70% of CBD products obtained online. The study notes a continued need for federal and state regulatory agencies to take steps to ensure label accuracy. "The results of our study are consistent with observations made by the FDA in 2015, 2016, and again in November 2017, and speak to the need for increased regulatory guidance and specifications for cannabinoid-related products," says Thomas, principal scientist in analytical chemistry and pharmaceutics at RTI International. "Some of those products could be useful, but only after safety and efficacy have been established." The study purchased and analyzed 84 CBD products available online from 31 companies. Laboratory analysis showed 43% of products contained more CBD than indicated on the label, 26% contained less, and 31% were accurately labeled (within 10%). This degree of mislabeling poses safety and efficacy issues for consumers, particularly given the fact that these unapproved CBD formulations are often used to treat children with intractable epilepsy. Source: RTI International |