House Committee on Oversight and Accountability Chairman James Comer is making good on a commitment to investigate the Food and Drug Administration’s (FDA’s) failure to regulate hemp-derived cannabidiol (CBD) products as dietary supplements.
In January this year, Chairman Comer said the FDA commissioner would be brought before the U.S. House Oversight Committee for questioning over the agency’s lack of action on regulation. That was soon followed by a statement from the FDA indicating it did not have the tools to regulate CBD as a dietary supplement and a new regulatory pathway is needed.
A letter has now been sent to the Commissioner of Food and Drugs at the FDA, Dr. Robert M. Califf, containing the Chairman’s concerns and requesting documents and information. In additional commentary, Chairman Comer says the FDA’s claim of a lack of a regulatory pathway is not only an “insufficient rationale” for inaction, but is also impacting the welfare of Americans.
“Without allowing for therapeutic CBD products to be regulated as dietary supplements such as melatonin or fish oils, the good faith actors in the industry are unable to enter the market and provide people with helpful products because they are currently not distinguished under the FDA from the intoxicating products containing Delta-8,” he said. “It is imperative that the FDA engages in this regulation quickly, safely, and efficiently to provide proper guidance to the American people about the safety of CBD products.”
What has been requested from the FDA:
- All documents, communications and drafts related to the FDA’s announcement back in January that it concluded existing regulatory frameworks for food and supplements aren’t appropriate for cannabidiol.
- All documents and communications relating to the FDA’s assessment of the existing regulatory framework at issue regarding CBD.
- All scientific data, reports, and research the FDA is in possession of relating to the safety of CBD products for consumption.
The FDA has been requested to supply this information no later than May 1.
A copy of the letter from Chairman Comer to Dr. Robert M. Califf can be viewed here.
General Counsel of the US Hemp Roundtable Jonathan Miller welcomed this latest action.
“The Chairman has been a steadfast supporter of our industry, and we look forward to working in a bi-partisan manner to ensure that hemp extracts like CBD are appropriately regulated,” he said.