The United States Food and Drug Administration (FDA) has issued warning letters to two cannabidiol (CBD) companies for illegally marketing products.
Last week, the FDA revealed that it had sent letters to Honest Globe Inc. and Biolyte Laboratories regarding significant violations of Current Good Manufacturing Practices (CGMP).
The letters address specific CGMP violations regarding finished pharmaceuticals and misbranding regulation violations for dietary supplements from both companies.
According to the letters, CBD has known pharmacological effects on humans, with demonstrated risks.
The FDA says that companies cannot legally market CBD as an inactive ingredient in over-the-counter drug products that it has not reviewed and approved.
The letters also address substandard manufacturing processes.
“The FDA continues to alert the public to potential safety and efficacy concerns with unapproved CBD products sold online and in stores across the country,” says FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D. “It’s important that consumers understand that the FDA has only approved one drug containing CBD as an ingredient. These other, unapproved, CBD products may have dangerous health impacts and side effects.”
Currently, G.W. Pharmaceuticals’ Epidiolex formulation is the only FDA-approved product that contains CBD.
The FDA says that the products listed in the letters have not gone through the Administration’s evaluation process and are considered unapproved drugs.
According to the FDA, it has not evaluated the manufacturers’ efficacy claims, appropriate doses, possible side effects, or how the products might interact with FDA-approved drugs or other products.
Without FDA approval, companies cannot legally claim their products prevent, diagnose, mitigate, treat, or cure diseases, regardless of whether CBD is an active or inactive ingredient.
Previously, the FDA has issued letters to other CBD manufacturers for producing and selling illegal CBD products in violation of the FD&C Act.
“We remain focused on exploring potential pathways for CBD products to be lawfully marketed while also educating the public about these outstanding questions of CBD’s safety,” says Abernethy. “Meanwhile, we will continue to monitor and take action, as needed, against companies that unlawfully market their products—prioritizing those that pose a risk to public health.”
The FDA requested responses from the companies within 15 working days stating how they plan to address the violations or provide arguments and information as to why they are not in violation of the law.
According to the FDA, failure to comply may result in legal action, including product seizure and injunction.
