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Vendors that sell cannabidiol (CBD), a marijuana derivative, are on notice by the Food and Drug Administration for making claims the product can cure cancer, Alzheimer’s, and treat mental health conditions. The FDA issued a warning to CuraLeaf for promoting the oil as a pharmaceutical despite the product not having approval to treat any known illnesses.
According to a press release by the FDA, CuraLeaf is misleading consumers by claiming their product can treat multiple diseases. The step by the agency is a signal that they will be clamping down on the billion-dollar cannabis industry for their advertising and marketing tactics.
Additionally, the FDA says that promoting the CBD in misleading ways will prevent patients from seeking medical care for their conditions.
“As we examine potential regulatory pathways for the lawful marketing of products containing cannabis and cannabis-derived compounds like CBD, protecting and promoting public health remains our top priority. Selling unapproved products with unsubstantiated therapeutic claims — such as claims that CBD products can treat serious diseases and conditions — can put patients and consumers at risk by leading them to put off important medical care.”
“Additionally, there are many unanswered questions about the science, safety, effectiveness and quality of unapproved products containing CBD,” said Acting FDA Commissioner Ned Sharpless, M.D. “Consumers should beware of purchasing or using any such products.”
The FDA is serious about the risk to public health due to unknown dangers of the products sold as CBD. Additionally, the FDA established a working group in May to discuss the numerous issues within the hemp and marijuana industry.
“As part of that work, the FDA held a public hearing in May, and opened a docket for written comments, to obtain scientific data and information about the safety, manufacturing, product quality, marketing, labeling and sale of products containing cannabis or cannabis-derived compounds.”
According to the FDA, vendors like CuraLeaf make unsubstantiated claims about their products. Additionally, the CBD bottles do not provide dosing information which can lead to overdoses.
Examples of the outlandish claims made by CuraLeaf included,
- “CBD has been demonstrated to have properties that counteract the growth of [and/or] spread of cancer.”
- “CBD was effective in killing human breast cancer cells.” • “CBD has also been shown to be effective in treating Parkinson’s disease.”
- “has been linked to the effective treatment of Alzheimer’s disease ….”
- ” is being adopted more and more as a natural alternative to pharmaceutical-grade treatments for depression and anxiety.”
- “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.”
- “CBD oil is becoming a popular, all-natural source of relief used to address the symptoms of many common conditions, such as chronic pain, anxiety … ADHD.”
- “What are the benefits of CBD oil? …. Some of the most researched and well-supported hemp oil uses include …. Anxiety, depression, post-traumatic stress disorders, and even schizophrenia …. Chronic pain from fibromyalgia, slipped spinal discs . . . Eating disorders and addiction . . ..”
The FDA says that customers are lead to believe they can bypass medical advice from a doctor. Additionally, the products may contain dangerous or harmful additives. The FDA says they approved only once form of CBD to treat a rare type of epilepsy. However, the CBD sold online is not the same composition as the pharmaceutical form.
Also, the FDA is concerned that the CBD could cause unknown adverse reactions in customers. Rather than purchasing the products online, they urge consumers to work with their health care professional. There is no testing that shows CBD is safe for pets. Due to the lack of testing on pets, they urge people not to use these products on their furry friends.
According to the FDA, CuraLeaf has 15 days to respond to the warning letter.
Finally, Read the full letter here.