Another CBD company has issued a voluntary product recall after the U.S. Food and Drug Administration flagged it for making unsubstantiated claims.
Biota Biosciences, a Seattle-based CBD manufacturer, is recalling lots from three injectable products sold by distributors to consumers that were being marketed without FDA approval:
- Cannabidiol (CBD) Complex, marketed to suppress pain and aid detoxification as a promising therapeutic for medical disorders such as epilepsy.
- Curcurmin Complex, marketed as an anti-inflammatory and antioxidant that could help with symptoms of depression and arthritis.
- Cannabidiol + Curcurmin, marketed as a more-efficient therapeutic effect.
Prior to the recall, the FDA had notified Biota Biosciences that the marketing material on its website that made unapproved product claims made its products unapproved new drugs sold in violation of the federal Food, Drug and Cosmetic Act.
The agency has sent dozens of warning letters to CBD companies, giving them 15 days to demonstrate how they’ll correct the actions or risk legal action, including product seizure and injunction.
Biota Biosciences noted in a recall notice that was published on the FDA website last week that in addition to the unapproved marketing claims, the products are misbranded because the labeling fails to bear adequate directions for use.
If injected into the bloodstream, the unapproved products “could pose a serious risk of harm to users because they bypass many of the body’s natural defenses against toxic ingredients, toxins, or dangerous organisms that can lead to serious and life-threatening conditions such as septicemia or sepsis,” the company stated. It added that it has not received any reports of adverse events related to the products.
Biota Biosciences is notifying distributors and customers by email to arrange return of all recalled products.