Dr. Heidi Overton is President Trump’s nominee for FDA Commissioner. Her Senate confirmation hearing was today. From her Q&A on C-SPAN (starting at 31:001:44:15), her priorities on e-cigarettes are:
- protect kids
- adults prefer flavors for cessation
- emphasize legal pathways [for authorization]
- and [emphasize] enforcement against illicit products
Sen. Susan Collins (R-Maine) "has concerns":
One is actions that the FDA recently took concerning flavored nicotine products. As I explained to you, Senator Dick Durbin and I have worked for years on smoking-related issues. When youth use e-cigarettes, nearly 90% are choosing flavored products. Yet in August, the FDA authorized several new flavored nicotine pouches and vapes, including flavors like blueberry, mango, and citrus and autumn spice, cappuccino, and cool mint. These new approvals, in my judgment, jeopardize the recent progress that’s been made in reducing the number of youth who use e-cigarettes and become addicted to nicotine. FDA justified these approvals by saying that these products give more options to adults. However, we know that the demographic really driving consumption of flavored vapes are young people. It’s 90% [who] are more likely to choose flavored products. The previous commissioner of the FDA strongly disagreed with this decision, but apparently was overruled. What is your position on the FDA’s approval of more flavored vaping products?
Heidi Overton:
Senator, thank you… Specific to your question on flavored vapes, I would first like to propose that there is a 100% agreement from this administration that we must protect kids from illegal substances and from vapes and from flavored vapes. We saw some of that progress. Career FDA staff recommended the authorizations because they met the statutory “appropriate for the protection of the public health” standard [and] “because so many adult smokers are using flavors preferentially.” ...“If that standard is not appropriate, we should work on statutes to fix that.”
Senator:
We need an FDA Center for Tobacco Products that is efficient, predictable, and able to meet its statutory timelines. Dr. Overton, what steps would you take to improve the FDA’s tobacco review process and provide manufacturers with more regulatory clarity?
Overton:
Illicit vapes is one of those problems that we need to solve… Number 1, we have to protect kids as the first step. There have been 48 products that were authorized for use, and I think having that robust legal framework is critical in order to get legal approved market products to the people that use them for smoking cessation. While having the strongest protections available to keep them out of the hands of kids, which we all agree on, and being able to do proper enforcement with the other law enforcement agencies—DOJ, DHS all have a critical role—and if I’m confirmed, I would work with them to make sure the enforcement is just as strong as we work to fix the backlog that we inherited from the previous administration.
Senator:
I want to go back to the topic of flavored vapes and youth tobacco use… This is why I was deeply concerned to learn earlier this year that the FDA approved 2 more of these popular vape flavors. Dr. Overton, are you aware that flavored vapes are very popular with teens?
Overton: Senator, thank you, and I agree that it is critical and a core priority for us to protect kids from these products.
Senator Chris Murphy (D-Conn.):
On Thursday, April 30, tobacco giant Reynolds donated [$8 million] to Trump… followed by a sit-down meeting… After phone calls from Trump to Makary and HHS Secretary Kennedy, the FDA approved four new vape flavors from manufacturer Glas. Not long after, Makary was out… That is the definition of political interference in FDA decision-making. [Do you see the connection between the donation and the approvals?]
Overton:
I reject the framing of that question. I think the president is aware that adults are using vapes to quit smoking, and that has been his direction to get the best outcome for the American people in every decision that is made. Senator, if I’m confirmed as commissioner of Food and Drugs, my job will be to uphold the law and to abide by the statutory standards for the appropriate protection of the public health that is required for all reviews regarding vapes. And in the case of flavored vapes, I will note it was the career officials who made a recommendation that those products that were authorized by the FDA met that standard.
c-span.org/program/senate-co…