CBD New Roundup: CBD Doesn’t Induce Liver Toxicity, Per Trial Results

Here’s the latest CBD news:

• Preliminary findings from a seven-month-long trial assessing the effects of CBD on the human liver show no evidence of CBD-induced damage.
• Two companies selling over-the-counter topical drugs containing CBD have been warned by the FDA. 
• Dr. Amy Abernethy, head of an FDA task force dedicated to collecting data for CBD regulation, has resigned.

CBD Doesn’t Induce Liver Toxicity, Per Trial Results

The preliminary results of a clinical study assessing the safety profile of CBD—specifically, as it relates to the compound’s potential to induce liver toxicity in humans—were just released this Monday (3/22).

Co-investigators Dr. Jeff Lombardo and Dr. Keith Aqua claimed that, when compared to a “population with a similar incidence of medical conditions,” the 839 study participants who took oral CBD for 60 or more days showed no signs of liver toxicity. 

The trial was implemented during the pandemic (August 2020 – February 2021) using a virtual research platform, Validcare, LLC, and supported by a dozen prominent CBD brands (such as CBDistillery), who provided products, product support, participants, and more resources.

As we reported in September of last year, when the “real world experience” observational study was first being developed and funded, this trial was specifically designed to accommodate the FDA’s continued requests for science-backed information, a central requirement for the eventual regulation of supplements and/or medications containing cannabidiol.

In addition to providing this much needed precedent in hopes of accelerating the already long-winded CBD regulation process, this study also served to debunk claims from a 2019 study by the University of Arkansas that concluded the CBD-based (and FDA-approved) medication Epidiolex caused liver damage in mice.

As we reported then, the researchers in the older study made an error when appropriating CBD doses for mice, exceeding the human maximum by more than a hundred times (2,460mg/kg) in some cases.

Authors of the more recent investigation intend to share their data directly with the FDA as soon as the study is fully completed. 

FDA Warns Two Companies Marketing Over-the-Counter CBD Topicals 

Mere days after the Federal Trade Commission (FTC) delivered its “decisions and orders” (including heavy fines) to six CBD brands accused by the agency of making healthcare-related claims in the marketing of their products, the U.S. Food and Drug Administration (FDA) sent warning letters to two companies “illegally selling over-the-counter CBD products for pain relief.”

The allegation was part of the title of the FDA’s news release published this Monday (3/22), in which they announced their sending of warning letters to Honest Globe Inc and Biolyte Laboratories LLC, two companies that have developed and marketed over-the-counter, topical pain-relief products containing CBD. 

Both companies in mention are accused by the FDA of violating the Federal Food, Drug, and Cosmetic Act (FD&C) act, which prohibits the marketing of unapproved drugs containing CBD; this is the main reason why CBD brands are not allowed to call their products drugs or make healthcare-related claims in reference to said products. 

In addition to the principal issue of marketing drugs containing CBD, both Honest Globe Inc and Biolyte Laboratories were warned by the FDA in their respective warning letters that their facilities and processes do not conform to current good manufacturing practice (cGMP) standards.

The FDA then listed in their warning letters all of the “unapproved new drugs charges” and other infractions they learned of in their onsite facility inspections as well as their review of each company’s website and marketing materials, concluding that the brands need to correct all of these issues (and any others they find on their own) soon or face legal action. 

FDA Chief Information Officer and CBD Working Group Leader Dr. Amy Abernethy Resigns

Dr. Amy Abernethy, the Food and Drug Administration’s (FDA) Principal Deputy Commissioner and Acting Chief Information Officer, has announced her resignation from the agency, and will officially leave her post sometime in April.

This Tuesday (3/23), Dr. Abernethy posted several tweets thanking her mentors and colleagues and calling for them to “rethink US digital health infrastructure” as the pandemic and technological advances usher in new ways of accessing and caring for patients across the country.

In addition to streamlining the digital dissemination of healthcare support services during the pandemic, advancing technologies to update the FDA’s data collection processes, and many more accomplishments, Dr. Abernethy also spearheaded the FDA’s CBD working group, a team dedicated solely to informing the public about CBD and clearing the way for eventual regulation.

As such, her resignation is sure to be seen as a hurdle for CBD and cannabis supporters, but as acting FDA Commissioner Janet Woodcock stated in her FDA-wide memo announcing Dr. Abernethy’s resignation, the agency will act swiftly to “ensure a deliberate, well-planned transition of Amy’s many responsibilities.”