(RxWiki News) The US Food and Drug Administration (FDA) has issued warning letters to two companies for marketing unapproved CBD products that claim to treat serious medical conditions.
The two companies are BIOTA Biosciences, LLC, of Washington state, and Homero Corp DBA Natures CBD Oil Distribution, of New Hampshire.
Both companies are marketing and selling products that include injectables, beverages, bulk CBD extracts and water-soluble CBD, among other formulations. BIOTA Biosciences is also selling an injectable curcumin product.
The problem? These products are being marketed to treat serious medical conditions like opioid addiction. These products are being positioned as an alternative to opioids.
“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 Dr. Amy Abernethy in a press release. “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."
These products violate laws set by the FDA under the Federal Food, Drug and Cosmetic Act. The violations include marketing CBD products to treat or cure diseases. According to the FDA, any product that claims to cure a disease and is intended to affect the structure or function of the body is considered a drug. However, except for one prescription medication used to treat epilepsy, CBD products have not been approved by the FDA.
There has been no evaluation as to whether these unapproved products work for the listed uses or how they interact with prescription medications, the FDA noted. These products have not been evaluated for dosage, dangerous side effects or other safety concerns.
Plus, if consumers turn to these products that claim to treat serious medical conditions, this can result in delayed appropriate medical care or stopping of appropriate care. Delaying the right care or stopping appropriate treatment can place people at serious and life-threatening risk.
The FDA also noted its continued concerns that consumers may believe that CBD products on the market have been reviewed and found to be safe by the FDA. Another concern is consumers may think CBD “can’t hurt.”
Speak with your health care provider if you have any questions.