In a show of bipartisan support, the US Senate confirmed Dr. Stephen Hahn as commissioner of the Food and Drug Administration on Thursday by a vote of 72-18.
With a national health crisis underway, Hahn’s first order of business will likely be tackling the vaping crisis, which has been linked to more than 2,400 hospitalizations and reported to CDC from all 50 states, the District of Columbia, and two US territories (Puerto Rico and US Virgin Islands).
Hahn will also have regulatory authority over prescription drugs, food safety, vitamin supplements, cosmetics, medical devices, pet products and treatments.
Trade associations react
Natural Products Association (NPA) President and CEO Daniel Fabricant, Ph.D., said the NPA looks forward to Dr. Hahn and his staff to addressing much-needed regulation for cannabidiol (CBD) products and enforcement for adulterated dietary supplements. Fabricant released the following statement:
“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, 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 US 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.”
Last month Hahn said he wanted to see more research to answer “open and unanswered questions” about CBD, adding that that CBD already has “a pathway for medical products.” However, he also has concerns about CBD products that haven’t undergone pharmaceutical review. The Texas doctor did not say how he would approach the agency’s CBD review, but did say that he’s a “huge supporter of getting research and clarity and transparency around the processes to allow us to get the medical products to patients.”
To date, the FDA has not approved a marketing application for cannabis for the treatment of any disease or condition. The agency has, however, approved one cannabis-derived and three cannabis-related drug products. These approved products are only available with a prescription from a licensed healthcare provider.
The last confirmed FDA commissioner, Scott Gottlieb, left his post in April. Since, the job has been carried out by two acting commissioners.
Steve Mister, president & CEO, Council for Responsible Nutrition, told NutraIngredients that he is pleased to have a permanent commissioner in place: “CRN recognizes the importance of having a confirmed FDA commissioner because the agency can drift during interim periods and important decisions are postponed. 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, certificates of free sale, and other issues.”
American Herbal Products Association President Michael McGuffin told NutraIngredients-USA that the trade association hopes that food and nutrition policy that promotes consumer safety will be of focus.
"AHPA congratulates Dr. Hahn on his confirmation and looks forward to supporting FDA efforts to enforce dietary supplement laws and regulations as intended by Congress. The supplement industry looks forward to working with Dr. Hahn to further FDA’s goals of safety, product integrity, and informed consumer decision-making. We are optimistic the industry will continue to work effectively with FDA under Dr. Hahn's leadership,” said McGuffin.
Hahn gets nod from medical community
Several physicians and research organizations have come out in support of the 59-year-old’s nomination, along with five former FDA commissioners.
The American Association for Cancer Research (AACR) applauded the Senate for confirming Hahn, who has been a AACR member since 1999.
"The AACR is looking forward to working closely with him and his extraordinary team at the FDA to help facilitate and expedite the development and approval of safe and effective treatments for cancer patients," Dr. Margaret Foti, chief executive officer of the AACR, said in a written statement.
While vaping is expected to remain a top concern, while opioids, drug pricing and generics will also be ongoing issues.