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:

• A list of chemical and microbiological specifications, including test methods, that will be used to analyze each batch of the product before being sold
• Microbiological testing methods that are capable of recovering bioburden in the product and determining whether any microorganisms are objectionable in relation to the product’s intended use, route of administration, and patient population
• A commitment to testing each batch of product using certified methods
• A summary of all results from each batch of product testing
• A comprehensive review of the company’s material system to confirm that all suppliers of components, containers, and closures are qualified, and the materials have appropriate expiration dates
• A comprehensive assessment, corrective and preventative action plan to ensure that the program is adequate

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:

• Failure to establish an adequate quality control unit, where the responsibilities and procedures for the quality control unit are not in writing and not fully followed
• Failure to prepare batch production and control records that clearly document each major step in the manufacture, processing, packing, or holding of the batch, for each batch of products
• Failure to create written procedures for production and process control in a way that assures that the products have the identity, strength, quality, and purity they are represented to have.

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.”

References

1. FDA Warns Companies Illegally Selling Over-the-Counter CBD Products for Pain Relief. News Release. FDA; March 22, 2021. Accessed March 23, 2021. https://www.fda.gov/news-events/press-announcements/fda-warns-companies-illegally-selling-over-counter-cbd-products-pain-relief.
2. Division of Pharmaceutical Quality Operations III. Warning Letter. FDA; March 18, 2021. Accessed March 23, 2021. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/biolyte-laboratories-llc-603584-03182021.
3. Division of Pharmaceutical Quality Operations IV. Warning Letter. FDA; March 15, 2021. Accessed March 23, 2021. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/honest-globe-inc-597177-03152021