OR WAIT null SECS
FDA explained in its warning letters to the firms that even if CBD in the product was labeled as an inactive ingredient, the product cannot be legally marketed without an approved new drug application.
The U.S. Food and Drug Administration (FDA) recently issued warning letters to two companies selling products containing cannabidiol (CBD) that were marketed to relieve pain. The products in question, sold by Honest Globe Inc. and Biolyte Laboratories, were topical pain relief products that the agency said violated the Federal Food, Drug, and Cosmetic Act (FD&C Act). As such, said FDA, they were unapproved drugs. FDA explained in its warning letters to the firms that even if CBD in the product was labeled as an inactive ingredient, the product cannot be legally marketed without an approved new drug application.
“To date, no CBD-containing drug has met applicable FDA requirements to be legally marketed for nonprescription use. As explained below, nonprescription drug products that include CBD as an active ingredient are not generally recognized as safe and effective (GRASE) and are new drugs which require an approved application to be legally marketed.
“Furthermore, even if CBD could be considered an inactive ingredient in a nonprescription drug product, that product would still need an approved new drug application to be legally marketed, because the product would not meet the general requirements for nonprescription drug products under section 505G of the FD&C Act,” explained FDA in its letter to Honest Globe.
“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,” said FDA principal deputy commissioner Amy Abernethy, MD, PhD, in a press release. “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. 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. 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 companies have 15 working days to provide a written response to FDA explain how they will address the violations, or provide their reasoning and supporting information as to why they believe their products are not in violation of the law.