November 27, 2019

FDA Issues New Warnings and Raises Questions About Use of CBD

Holland & Knight Healthcare Blog
Sara M. Klock | Michael J. Werner

On November 25, 2019, the U.S. Food and Drug Administration (FDA) announced that it issued warning letters to several companies for illegally selling products containing cannabidiol (CBD). The FDA also published a revised Consumer Update outlining more generally its safety concerns about CBD products.

As it has in the past, the FDA issued warning letters to companies it said were making medical claims about CBD products – for humans and pets – and therefore violating the Food Drug and Cosmetic Act by selling unapproved drugs. The warning letters outline that the companies use online stores and social media to market CBD products with unsubstantiated claims that the products treat cancer, Alzheimer’s disease, opioid withdrawal, pain and pet anxiety, among other conditions or diseases. In addition, the FDA reiterated its view that no human or animal product containing CBD can be lawfully marketed as a dietary supplement or food since CBD is an active ingredient in an already approved drug.

The FDA’s Consumer Update more generally identifies many safety risks with CBD and warns consumers about using CBD products. For example, it notes that the FDA "has seen only limited data about CBD safety and these data point to real risks that need to be considered before taking CBD for any reason.” It also says that “CBD has the potential to harm you, and harm can happen even before you become aware of it."

The FDA’s statement reiterates that the agency is working through how to properly regulate CBD products. The FDA acknowledges that CBD is being marketed in many different ways, including as an ingredient in a prescription drug, but in the Consumer Update, the FDA stresses that "there is very limited available information about CBD, including about its effects on the body."

Over the past several weeks, there has been pressure building on the FDA to articulate its views on CBD products. For example, the Senate legislation to fund the FDA for FY 2020 contained language calling on the agency to issue an "enforcement discretion policy" on CBD derived from hemp CBD within 120 days that would remain in place until the agency finalizes a permanent legal pathway for the products. In addition, the Consumer Healthcare Products Association filed a citizens petition earlier this month calling on the FDA to quickly establish a regulatory pathway to allow dietary supplements containing hemp-derived cannabidiol (CBD) to be legally marketed while urging the FDA to take enforcement action against unscrupulous companies. Moreover, it has become imperative for  the FDA to develop a regulatory approach since the U.S. Department of Agriculture (USDA) issued an Interim Final Rule, which outlined the regulations relating to the growing of industry hemp.

The FDA said it is still gathering information about CBD and will be making recommendations for a regulatory framework for the lawful marketing of CBD products soon. However, the warning letters indicate that the FDA will crack down on companies it believes are acting unlawfully and putting consumers at risk. In addition, the statements in the Consumer Update suggest that the agency remains skeptical of the safety of CBD products. This potentially puts the FDA at cross purposes with the USDA and Congress that have taken steps to expand a hemp-derived CBD market. In the meantime, companies involved in developing and marketing CBD products should take care to stay within existing regulatory parameters while continuing to monitor future FDA public statements.

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