FDA’s Enforcement Discretion on CBD Creates Confusion for Consumers
[Thursday, June 20, 2019] FDA has maintained officially that cannabidiol (CBD) is regulated as drug and hence it is illegal to add CBD to food and dietary supplement while at the same time letting thousands of CBD containing food and supplement products sells openly. CBD is the active ingredient of one FDA-approved drug, Epidiolex, but is available in thousands of products such as CBD oils, creams, ointments, gummy bears, and many other formulations sold freely online on popular sites such as Amazon, Walmart, and many others. Last month FDA held a public hearing to collect opinions about regulating CBD. The meeting highlighted the diversity of opinions about CBD products. However, with FDA taking a back seat and claiming that it is in the “listening and learning” phase. The FDA’s blog following the meeting presented contradictory statements. On one hand it claimed that “it is currently illegal to put into interstate commerce a food to which CBD has been added, or to market CBD as, or in, a dietary supplement.” At the same time, it stated that FDA has the authority to create an exception in the regulation to allow CBD in dietary supplements and food although it has not yet done it. By making such confusing and vague announcements, FDA is aiding the spread of CBD products claiming a variety of benefits. FDA’s so-called enforcement discretion is a less understood and opaque practice that creates confusion and mistrust in the Agency’s ability to reign in unregulated products. FDA did the same for electronic cigarettes where the long delay in a clear policy led to the popularization of e-cigarettes making it hard to enforce the laws. Slow and unclear enforcement will likely lead to same situation with CBD products as well. |
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