In a meeting Wednesday with FDA Commissioner nominee, Stephen Hahn, Sen. Majority Leader Mitch McConnell (R-Kentucky) discussed the positive impact of hemp legalization as well as the need for a regulatory framework over CBD, according to a news release issued by his office.
Hemp, CBD and the youth vaping crisis were among the issues that McConnell discussed with Hahn, the chief medical executive at the University of Texas MD Anderson Cancer Center in Houston. On Nov. 5, President Trump tapped Hahn to lead FDA.
“Like many Kentuckians who are taking advantage of hemp’s legalization, I am eager for FDA’s plans to create certainty for CBD products,” McConnell said in a statement.
Hahn Testimony
Hahn also appeared Wednesday before the Senate Committee on Health, Education, Labor & Pensions (HELP) for his confirmation hearing. Lamar Alexander, a Republican from Tennessee who chairs the committee, described Hahn as “a strong choice to lead FDA.”
"There are many issues that will likely come before the Commissioner that are perplexing and engender honest disagreement," Hahn, a medical doctor and scientist, said in his prepared statement before the HELP Committee. "When that occurs, I pledge to listen, study and assess all viewpoints."
In response to comments from Sen. Pat Roberts (R-Kansas) about hemp and CBD, Hahn pointed out many Americans are using the products.
"And a significant proportion of Americans … using the products think they’re already judged to be safe and effective by FDA when they’re not," he said.
Hahn cited "unanswered questions" that data, research and science must fill in.
"I also know that there are signals that CBD, for example ... can be an effective medical product," he added. “I think we have to have a clear and transparent framework for assessing them—certainly on the medical product side.”
Earlier in the hearing in response to a question from Sen. Jackie Rosen (D-Nevada) about the challenges facing researchers seeking to study cannabis, Hahn discussed the potential for CBD to be used for cancer and in palliative care.
But he also suggested researchers must answer such important questions as the health effects of CBD's long-term use and the appropriate dosage for a specific indication.
Hahn also highlighted a problem that FDA officials have identified: marketing claims that unapproved CBD products treat diseases.
"I think unsubstantiated claims like we see in the marketplace are of concern in terms of things like curing Alzheimer’s or cancer that need to be supported by data," he said.
Frustration
The hemp industry is hopeful that FDA's new leader will take action to create a legal pathway for hemp-derived CBD in dietary supplements and conventional food. FDA has asserted CBD is excluded from being marketed in supplements or added to food because, in short, it was first studied as a drug. FDA has authority to create an exception, but agency officials have stressed they are currently focused on gathering data to ensure CBD is safe.
"If we don’t think we’ll have the data to say that some level of CBD can be safely added to a food or dietary supplement, then we wouldn’t want to create an exception for CBD," Lowell Schiller, an FDA official, said during a recent conference hosted by the Council for Responsible Nutrition (CRN).
The supplement industry has become increasingly frustrated with FDA's inaction on CBD, and many trade groups have turned to Congress for a legislative solution. McConnell championed passage of the 2018 Farm Bill, which removed hemp from the Controlled Substances Act, and he is considered a pivotal figure in any movement on Capitol Hill to authorize CBD in supplements and food.
Written By: Josh Long