FDA Issues Warning Letter To Four CBD Companies Including Stanley Brothers

The Food and Drug Administration has issued warnings letters to four CBD (cannabidiol)  companies for touting unsubstantiated therapeutic claims. The companies named in today’s press release were Greenroads Health, Natural Alchemist, That’s Natural Marketing and Consulting and Stanley Brothers Social Enterprises.

CBD products have become a huge part of the cannabis industry. Matt Karnes of Greenwave Advisors estimated that the growth of the CBD market recently saying, “In terms of the CBD market size, I estimate an almost $3 billion market by 2021.”

The FDA cited 25 products spanning multiple websites that make unfounded claims about the products ability to treat or cure cancer and other serious diseases. The FDA noted that these were some of the claims:

“Combats tumor and cancer cells;”

“CBD makes cancer cells commit ‘suicide’ without killing other cells;”

“CBD … [has] anti-proliferative properties that inhibit cell division and growth in certain types of cancer, not allowing the tumor to grow;” and

“Non-psychoactive cannabinoids like CBD (cannabidiol) may be effective in treating tumors from cancer – including breast cancer.”

“Substances that contain components of marijuana will be treated like any other products that make unproven claims to shrink cancer tumors. We don’t let companies market products that deliberately prey on sick people with baseless claims that their substance can shrink or cure cancer and we’re not going to look the other way on enforcing these principles when it comes to marijuana-containing products,” said FDA Commissioner Scott Gottlieb, M.D. “There are a growing number of effective therapies for many cancers. When people are allowed to illegally market agents that deliver no established benefit they may steer patients away from products that have proven, anti-tumor effects that could extend lives.”

The CBD products have not been approved by the FDA and the manufacture of them also also not been subjected to FDA review. The FDA has asked for responses from the companies on how they plan to correct the violations saying, “Failure to correct the violations promptly may result in legal action, including product seizure and injunction.”

The statement today said, “This latest action builds on the more than 90 warning letters issued in the past 10 years, including more than a dozen this year, to companies marketing hundreds of fraudulent products making cancer claims on websites, social media and in stores. Additionally, the FDA recently took decisive action to prevent the use of a potentially dangerous and unproven treatment used in ‘stem cell’ centers targeting vulnerable cancer patients. The FDA encourages healthcare professionals and consumers to report adverse reactions associated with these or similar products to the agency’s MedWatch program.”

“We have an obligation to provide caregivers and patients with the confidence that drugs making cancer treatment claims have been carefully evaluated for safety, efficacy, and quality, and are monitored by the FDA once they’re on the market,” Commissioner Gottlieb added. “We recognize that there’s interest in developing therapies from marijuana and its components, but the safest way for this to occur is through the drug approval process – not through unsubstantiated claims made on a website. We support sound, scientifically-based research using components derived from marijuana, and we’ll continue to work with product developers who are interested in bringing safe, effective, and quality products to market.”

Debra Borchardt

Debra Borchardt is the Co-Founder, and Executive Editor of GMR. She has covered the cannabis industry for several years at Forbes, Seeking Alpha and TheStreet. Prior to becoming a financial journalist, Debra was a Vice President at Bear Stearns where she held a Series 7 and Registered Investment Advisor license. Debra has a Master's degree in Business Journalism from New York University.

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