The FDA Issues Its 49th Warning Letter to CBD Company

Uncategorized Jul 25, 2019 Denver, CO

By: Stuart Knight, Esq. and Nabil Rodriguez, Esq.

On July 23, 2019, the United States Food and Drug Administration (the “FDA”) announced that it had issued a warning letter to Curaleaf Inc., a Massachusetts based online retailer of CBD products, for marketing its products with unsubstantiated curative claims. This is the 4^th such warning letter issued by the FDA to companies selling CBD products since the signing of the 2018 Farm Bill, and the 49th warning letter overall. Some examples of the unsubstantiated claims made by Curaleaf included:

“CBD has been demonstrated to have properties that counteract the growth of [and/or] spread of cancer.”
“CBD has also been shown to be effective in treating Parkinson’s disease.”
“CBD can also be used in conjunction with opioid medications, and a number of studies have demonstrated that CBD can in fact reduce the severity of opioid-related withdrawal and lessen the buildup of tolerance.”
“[V]ets will prescribe puppy Xanax to pet owners which can help in certain instances but is not necessarily a desirable medication to give your dog continually. Whereas CBD oil is natural and offers similar results without the use of chemicals.”

The FDA has been issuing similar warning letters since 2015 and has provided copies of prior FDA warning letters to companies selling CBD products, which can be found here. The warning letters issued in 2019 demonstrate that the FDA has not changed its approach to CBD products despite the 2018 Farm Bill. For example, the FDA issued a similar warning letter to a company called “That’s Natural! Marketing & Consulting” in 2017 for therapeutic and curative statements such as:

“Scientific research by doctors have shown it actually kills cancer cells and provides a protective coating around our brain cells.”
“CBD makes cancer cells commit ‘suicide’ without killing other cells”
“Non-psychoactive cannabinoids (like CBD) may have therapeutic effects for the human body, through the Endocannabinoid System (ECS). This includes treating tumors and cancer-related pain.”

The acting FDA commissioner, Dr. Ned Sharpless, has stated that the FDA’s top priority remains protecting and promoting the public health. Specifically, Dr. Sharpless stated “[s]elling unapproved products with unsubstantiated therapeutic claims… can put patients and consumers at risk by leading them to put off important medical care.” Dr. Sharpless further reiterated that the FDA is “committed to continue monitoring the marketplace and protecting the public health by taking action as needed against companies that deceive consumers and put them at risk by illegally selling products marketed for therapeutic uses for which they are not approved.”

Until the FDA updates its guidance and provides regulatory pathways for the lawful marketing of products containing CBD, companies engaged in the sale of CBD products should tread cautiously before making any claims regarding their products.

For more information on the FDA’s approach to CBD generally, see this statement from Dr. Amy Abernethy, Principal Deputy Commissioner, and Lowell Schiller, Principal Associate Commissioner for Policy. The FDA has also provided an update for consumers here.

If you have questions regarding how to market your CBD products to avoid enforcement action by the FDA or local regulatory agencies, contact Greenspoon Marder at (303) 665-0860.

About Greenspoon Marder

Greenspoon Marder LLP is a full-service law firm with over 240 attorneys and more than 20 office locations across the United States. With operations from Miami to New York and from Denver to Los Angeles, our firm attracts some of the nation’s top talent in key markets and innovation hubs. Our core practice areas include Real Estate, Litigation, and Transactional Services, complemented by the capabilities of a full-service firm. Greenspoon Marder has upheld a spot on The American Lawyer’s Am Law 200 as one of the top law firms in the U.S. since 2015, and our goal is to provide exceptional client service by developing a thorough understanding of each client’s business needs and objectives in order to provide strategic, cost-effective solutions.

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