The US FDA has come under scrutiny for its allegedly one-sided representation of the potential issues associated with cannabidiol (CBD) consumption.
Advocacy group U.S. Hemp Roundtable contend the FDA is unfairly focusing on high-dose CBD formulations while disregarding the substantial body of evidence attesting to the safety of CBD in lower dosages.
In a letter sent to key congressional leaders, the organisation says the agency’s misguided use of incomplete safety data is the basis for its continued refusal to regulate CBD as a dietary supplement or food additive.
It argues that the FDA’s information has overlooked a number of toxicity studies from 2020 to 2023, showing the safety of CBD in smaller amounts. The first law of toxicology is the dose makes the poison – even essential nutrients like Vitamin D can have both beneficial and toxic effects depending on the dosage.
Between 2020 and 2023, there have been multiple published studies demonstrating the safety of CBD at lower doses. These studies, coupled with the low number of adverse events associated with CBD products and observational data, present a different view of CBD safety than the FDA suggests.
Among these studies – referenced in the letter – three focused on different types of hemp extract, all of which affirmed the safety of CBD at typical retail serving sizes. A fourth study on CBD isolate reported positive safety findings in 2023. A fifth study, also from 2023, established safe intake levels for male and female reproductive toxicity, filling a key data gap identified by the FDA.
Moreover, confidential studies presented to the FDA expected to be published in 2023-2024 have also reported positive safety findings. Another study, submitted with a Citizen Petition, provided additional safety data on another CBD-containing hemp extract.
US Hemp Roundtable have also pointed out the regulation of CBD seems to be held to a higher standard than other dietary supplements. It argues the existing regulatory framework for dietary supplements provides the necessary risk management tools, contrary to the FDA’s claim that it has “limited tools for managing many of the risks associated with CBD products.”
U.S. Hemp Roundtable General Counsel, Jonathan Miller states:
“As Congress develops plans to ensure the regulation of hemp extracts such as CBD, it should focus its attention on how these products are typically used, and not be distracted by studies that imagine their gross over-consumption which is not a realistic concern.”