FDA issues three warning letters to companies dealing with cannabis related products

In a statement from the US FDA commissioner, the FDA on Tuesday said it has issued warning letters, in collaboration with the Federal Trade Commission, to three companies – Advanced Spine and Pain LLC (d/b/a Relievus), Nutra Pure LLC and PotNetwork Holdings Inc. – in response to their making unsubstantiated claims related to more than a dozen different products and spanning multiple product webpages, online stores and social media websites.

According to FDA’s press release, the companies used these online platforms to make unfounded, egregious claims about their products’ ability to limit, treat or cure cancer, neurodegenerative conditions, autoimmune diseases, opioid use disorder, and other serious diseases, without sufficient evidence and the legally required FDA approval.

Examples of claims made by these companies include:

• “CBD successfully stopped cancer cells in multiple different cervical cancer varieties.”
• “CBD also decreased human glioma cell growth and invasion, thus suggesting a possible role of CBD as an antitumor agent.”
• “For Alzheimer’s patients, CBD is one treatment option that is slowing the progression of that disease.”
• “Fibromyalgia is conceived as a central sensitization state with secondary hyperalgesia. CBD has 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.”
• “CBD reduced the rewarding effects of morphine and reduced drug seeking of heroin.”
• “CBD may be used to avoid or reduce withdrawal symptoms.”

FDA Commissioner Scott Gottlieb, said he believes these are egregious, over-the-line claims and that the FDA won’t tolerate this kind of deceptive marketing to vulnerable patients.

The press release was issued on new steps to advance agency’s continued evaluation of potential regulatory pathways for cannabis-containing and cannabis-derived products.