After being confirmed by the Senate in a 72-18 vote on December 12, 2019, the new Commissioner of the Food and Drug Administration (FDA) Dr. Stephen Hahn will be facing a number of critical issues on the immediate horizon when he assumes the office in the new year. Between the issues surrounding vaping/e-cigarettes, the investigation into the romaine lettuce outbreak, and resolving how to regulate cannabidiol (CBD)-infused food products, any actions he takes on these contentious issues will be closely scrutinized by Congress.
Key Issues
The primary reason Dr. Hahn received 18 "no" votes on his confirmation was concern from some Senators over what they felt were evasive responses on how to curtail e-cigarette use by children. Sen. Patty Murray (D-WA) noted that the Trump Administration promised to ban non-tobacco-flavored e-cigarette products but reversed course. However, when Dr. Hahn was asked about this issue during his confirmation hearing, Sen. Murray declared, "He refused to commit to follow through on the promising step President Trump decided to abandon." Given the lack of answers, Sen. Murray indicated that she would vote against Dr. Hahn's nomination.
The FDA and other federal and state health agencies are continuing to investigate an E. coli outbreak linked to romaine lettuce from the Salinas, California, region that has sickened over 100 people in 23 states. The agency has advised that consumers should not consume romaine lettuce harvested from the Salinas area and to ask restaurants where it was harvested before ordering. Some consumer groups have responded to this advisory by declaring that consumers should stop consuming all romaine lettuce to avoid any confusion.
Frustration in Congress over the lack of progress in the outbreak investigation became evident recently through the introduction of legislation that would allow the FDA to investigate so-called concentrated animal feeding operations adjacent to produce farms if its suspected of being the source of an outbreak. This proposal is highly unlikely to advance as any approach that suggests on-farm testing and monitoring are always fraught with political peril, but it demonstrates that this issue likely will receive additional attention in the new year.
With its recent declaration that it cannot conclude that CBD is generally recognized as safe, the FDA appears to be signaling that it will continue to very deliberate in its process in determining an appropriate regulatory approach towards CBD-infused food products. Meanwhile, these products continue to permeate the market, and the FDA continues to face intense political pressure from Members of Congress to act quickly to provide industry guidance and with it, certainty for the industry.
These are just a few high-profile issues that Dr. Hahn will be confronting as he takes office. It only will be a few months until Dr. Hahn is appearing before Congress again, as FDA Commissioners typically appear in the spring every year to testify on the agency's budget request.
