FDA sent warning letters dated March 28 to three companies marketing CBD products with what FDA describes as “egregious and unfounded claims that are aimed at vulnerable populations.” The companies which received warning letters sell hemp oil, CBD soft gels, CBD crystal isolate and other related products.
The unsubstantiated claims related to more than a dozen different products and span multiple product website pages, online stores and social media websites. Examples of the claims FDA warned against included:
- “C.B.D. successfully stopped cancer cells in multiple different cervical cancer varieties.”
- “C.B.D. also decreased human glioma cell growth and invasion, thus suggesting a possible role C.B.D. as an anti-tumor agent.”
- “For Alzheimer patients, C.B.D. his one treatment option that is slowing the progression of that disease.”
- “Fibromyalgia is conceived as a central sensitization state with secondary hyperalgesia. B.D. demonstrated the ability to block spinal, peripheral and gastrointestinal mechanisms responsible for the pain associated with migraines, fibromyalgia, IBS and other related disorders.”
- “Cannabidiol may be effective for treating substance use disorders.”
- “C.B.D. reduces the rewarding effects of morphine and reduced drugs seeking of heroin.”
The warning letter recipients must respond to the warning letters and provide substantiation for the claims or the FDA will take further action, including suspending sales and/or fines. This action is consistent with FDA’s latest statement of its intent to crack down on cannabis and cannabis-derived product health claims.