FDA Reiterates Potential Safety Risks Of Using CBD Products

Jackson Lewis P.C.
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The U.S. Food and Drug Administration repeated its warning to the public about the potential risks of using CBD products in a statement released on March 5, 2020, FDA Advances Work Related to Cannabidiol Products with Focus on Protecting Public Health, Providing Market Clarity.

The FDA has been evaluating the safety of CBD products for the last year. There are many CBD products on the market such as oil drops, capsules, syrups, food products (such as chocolate bars and teas), cosmetics and other topical lotions and creams, as well as products marketed for pets and other animals. However, the FDA remains concerned that some people wrongly think that the myriad of CBD products on the market have been evaluated by the FDA and determined to be safe, or that using CBD “can’t hurt.” Aside from one prescription drug approved to treat two rare forms of epilepsy, no other CBD products have been evaluated or approved by the FDA.

In particular, the agency recently updated the public on concerns about potential harm from CBD products, including potential liver injury, interactions with other drugs and male reproductive toxicity, as well as side effects such as drowsiness. In addition, little is known about the potential effects of sustained and/or cumulative use of CBD, co-administration with other medicines, or the risks to vulnerable populations like children, pregnant and lactating women, the elderly, unborn children and certain animal populations. The FDA stated that it is “not at a point where we can conclude that unapproved CBD products are safe for use. We encourage Americans to consult with their health care providers before using CBD products.”

The FDA seeks reliable and high-quality scientific research and data regarding CBD and has re-opened its public docket established last year for submission of such research and data.

Another issue that was not addressed by the FDA but which should be noted by users of CBD products is that due to the unregulated nature of these products, they may contain THC – the psychoactive component of marijuana. THC is what causes a positive drug test result for marijuana. A CBD user may test positive for THC on a drug test, even if the user believes that the CBD product has little or no THC in it.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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