In a 72-18 Senate vote, Stephen Hahn, MD, FASTRO was confirmed as the new head of the U.S. Food and Drug Administration (FDA), taking charge at a regulatory agency that oversees products ranging from complex cancer drugs, to food, cosmetics, tobacco and CBD.
“We look forward to working with Dr. Hahn and his staff to address much-needed regulation for cannabidiol (CBD) products and enforcement for adulterated dietary supplements,” said Daniel Fabricant, PhD, president and CEO of the Natural Products Association (NPA). “Inaction to date in the CBD marketplace has created a scenario that may lead to CBD products being pulled from retail shelves and limiting access to CBD. With thousands of CBD products available in the marketplace and tens of thousands of Americans relying on CBD products, it’s time for FDA to set a safe level for daily CBD use. We hope they will look closely and follow the NPA-sponsored and House-passed legislative approach to CBD regulation pending in the Agriculture Appropriations Conference Committee, as it is the best pathway to protecting consumers and ensuring science-based rules for this promising ingredient.
“In addition to regulating CBD,” Fabricant continued, “action is needed in FDA’s new dietary ingredient (NDI) notification process. Adulterated ingredients that have not completed the NDI notification process are entering our country at an alarming rate, and it’s been roughly six years since the FDA provided dietary supplement import alerts to prevent this. This puts American consumers at risk and compliant U.S. supplement makers at a terrible disadvantage. It is our hope that with Dr. Hahn as its new commissioner, the FDA will take on these much-needed actions to protect American consumers.”
Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN), said he is looking forward to making progress on not only CBD, but also on other issues surrounding the dietary supplement industry.
“CRN recognizes the importance of having a confirmed FDA commissioner because the agency can drift during interim periods and important decisions are postponed,” Mister explained. “Dr. Hahn’s leadership will be critical to moving FDA forward, and CRN expects to maintain an open dialogue with him and his staff on the full range of issues CRN is working for its members. CRN looks forward to working with Commissioner Hahn on top industry priorities including CBD, mandatory product listing, third-party GMPs [good manufacturing practices], certificates of free sale, and other issues.”
Hahn takes over as the FDA commissioner when e-cigarettes and vaping products have killed about five dozen people in the United States and hospitalized more than 2,400. His predecessor Scott Gottlieb, MD, who stepped down in April, was well regarded by public health advocates and won bipartisan support for his efforts to curb youth use of flavored e-cigarettes.
The new commissioner is a radiation oncologist who has been with the MD Anderson Cancer Center in Houston since 2015 and experts had highlighted his status as an outsider likely played a role in his nomination by President Donald Trump.
Hahn passed over Ned Sharpless, MD, who served as acting FDA commissioner. Sharpless returned to his role as director of the National Cancer Institute in November.