The U.S. Food and Drug Administration issued warnings to two companies Friday for selling CBD products as a cure for opioid addiction.
The letters, sent to BIOTA Biosciences, LLC of Washington State, and Homero Corp DBA Natures CBD Oil Distribution of New Hampshire, warned the companies they violated the Federal Food, Drug, and Cosmetic Act against claiming their products were a treatment for any medical condition.
BIOTA markets and distributes injectable and other forms of CBD products and an injectable curcumin product, both marketed as treatments of serious diseases and as an alternative to opioids. Natures Oil markets its CBD products as a treatment for opioid addiction and other serious diseases, the FDA said.
“The opioid crisis continues to be a serious problem in the United States, 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. “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. 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.”
Under the FD&C Act, no product can claim it has an intended effect on a disease or condition unless the FDA approves it. The FDA said it had not approved any CBD products, except for one prescription human drug product to treat rare forms of epilepsy.
The FDA said there had been no FDA evaluation of these products’ effectiveness, what the proper dosage might be, how they could interact with other drugs, or whether or not they have any side effects. Additionally, the agency said it had not reviewed the production process.
According to the FDA, updates on its work with CBD in March showed that there was no definitive approval for CBD products yet. The agency said it continues to be concerned about consumer confusion over its effectiveness, and the potential for it to be harmful.
“In particular, the agency recently updated the public on concerns about potential harm from CBD products, including potential liver injury, interactions with other drugs and male reproductive toxicity, as well as side effects such as drowsiness. In addition, there is still much we do not know about other potential risks,” the agency said in a press release. “For example, other than the approved prescription drug, we know little about the potential effects of sustained and/or cumulative use of CBD, co-administration with other medicines, or the risks to vulnerable populations like children, pregnant and lactating women, the elderly, unborn children and certain animal populations. This does not mean that we know CBD is unsafe to these populations or under these circumstances, but given the gaps in our current knowledge, and the known risks that have been identified, we also are not at a point where we can conclude that unapproved CBD products are safe for use. We encourage Americans to consult with their health care providers before using CBD products.”
The companies have 15 days to respond to the agency or face possible prosecution.