FDA is warning two companies for illegally selling cannabidiol (CBD) products that they claim can help treat diseases and opioid addiction.
The agency warned BIOTA Biosciences for distributing injectable CBD products and an injectable curcumin product, which are marketed for serious diseases and as an alternative to opioids.
“VISION: OPIOID-FREE FUTURE . . . Our goal is to supply the world with pharmaceutical grade, all natural products containing cannabidiol and other natural compounds. We believe strongly that pharmaceutical grade hemp oil will drastically reduce the need for opioid-based pain relief and eliminate the global opioid epidemic by providing a safe and natural alternative,” BIOTA said on its web site, FDA said in a press release.
Similarly, Homero Corp DBA Natures CBD Oil Distribution includes claims such as “Natures Pure CBD has had success in alleviating severe withdrawal symptoms associated with opiate dependency,” on its web site. Homero is an own label distributor for CBD products as well as a retailer for Green Roads CBD products.
“The opioid crisis continues to be a serious problem in the US, and we will continue to crack down on companies that attempt to benefit from selling products with unfounded treatment claims,” said FDA Principal Deputy Commissioner Amy Abernethy, MD, PhD.
“CBD has not been shown to treat opioid addiction. Opioid addiction is a real problem in our country, and those who are addicted need to seek out proper treatment from a health care provider,” Abernethy added. “There are many unanswered questions about the science, safety, effectiveness and quality of unapproved products containing CBD, and we will continue to work to protect the health and safety of American consumers from products that are being marketed in violation of the law.”
FDA has not approved any CBD products other than one prescription human drug product to treat rare, severe forms of epilepsy.
“Unlike drugs approved by the FDA, there has been no FDA evaluation of whether these unapproved products are effective for their intended use, what the proper dosage might be, how they could interact with FDA-approved drugs, or whether they have dangerous side effects or other safety concerns,” the agency said.
The agency continues to be concerned that some people wrongly think that the myriad of CBD products on the market have been evaluated by the FDA and determined to be safe, or that using CBD “can’t hurt,” FDA said. “The FDA remains focused on educating the public about the number of questions that remain regarding CBD’s safety. There may be risks that need to be considered before using CBD products outside of the monitored setting of a prescription from your health care provider.”
In March, FDA provided updates on its work related to CBD products with a focus on protecting public health and providing market clarity.
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