BioLyte Laboratories and Honest Globe have 15 days to rectify the violations from their CBD products.
The FDA has recently sent warning letters to Honest Globe Inc and BioLyte Laboratories LLC for selling products labeled as containing CBD in ways that violate federal law, according to the news release.1
Only 1 drug containing CBD has been approved by the FDA; therefore, the products from the 2 companies do not meet the requirements to be legally marketed without an approved new drug application (NDA). The agency cited that CBD has “known pharmacological effects on humans, with demonstrated risks.”
CBD cannot be legally marketed without an NDA regardless of whether the CBD is an active ingredient or inactive ingredient, according to current FDA requirements.
“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 Amy Abernethy, MD, PhD, FDA principal deputy commissioner in a news 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,” Abernethy said.
Following an FDA inspection in January of BioLyte facilities, the agency reported myriad violations. For one, BioLyte’s OTC topical drug products were being shipped out without “adequate control testing,” according to the FDA investigator. “For example, identity and potency testing is not performed for the active ingredient in your Topical Pain Relief drug product (Menthol 4%) before release,” the letter to BioLyte asserted. Other violations include failing to conduct at least 1 test to verify the components of its drug product and failing to establish a written testing program to assess the stability and appropriate storage conditions for its product. 2
BioLyte has 15 days to submit a sizeable collection of information to the FDA, including, but not limited to, the following:
The FDA letter to Honest Globe stated3 “significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals.”
FDA investigators found these violations, among others:
Honest Globe must also mitigate these violations within 15 days of the letter by preparing detailed records, analyses, summaries, and data for its pain relief products.
“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,” Abernethy said. “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.”