FDA commissioner Robert Califf was called to answer for the agency’s mishandling of regulating tobacco products. Photo credit: FDA
The US House Committee on Oversight and Accountability held a hearing titled “Oversight of the US Food and Drug Administration.” At the hearing, lawmakers asked FDA commissioner Robert Califf about a pattern of issues within FDA to ensure FDA is completing its role of regulatory oversight of the food and drug industries, prioritizing safety and effectiveness, and incentivizing innovation.
During his opening remarks, committee chairman James Comer said FDA was “failing to consistently and effectively regulate tobacco products,” going on to highlight that FDA “delayed review of applications for products that can reduce harm for many Americans” and that its “failure to regulate has allowed unsafe and illicit products to proliferate.”
During the hearing, Comer said, ““I think it’s safe to say the current regulatory process at the CTP [Center for Tobacco Products] is not at all what Congress envisioned when it passed the Tobacco Control Act 15 years ago. From the Reagan-Udall report you commissioned and recent court rulings, I have to conclude that those seeking to play by the rules don’t even know what the rules are because FDA won’t tell them.”
“Given what I just described, do you even want a functional regulatory process for these products or is it the objective to target the US tobacco industry, even if it means allowing a flood of Chinese products containing God knows what into this country?”
Commissioner Califf responded by saying, “[…] What was not even present when the initial law was passed that you referred to was the presence of vaping or e-cigarettes. No one anticipated there would be twenty-six million plus applications of vaping products. That is a bit overwhelming. […]
“It bothers me as much it does you to see what’s on our shelves. I do want you to know that we’ve really picked up our enforcement. Over six-hundred warning letters to manufacturers, hundreds of civil money penalties now, and we’ve also now begun to do injunctions…”
Rep. Virginia Foxx (R-NC) noted that despite FDA doubling CTP’s staff, it has delayed approving pre-market tobacco product applications and that demand for these products has been filled by illicit products. Commissioner Califf responded that CTP received over 26 million applications, and that the agency had completed reviewing 99% of those applications. Foxx added, “But you know among those applications are very frivolous applications. And there’s like a couple of dozen in there that are coming from legitimate places. You all should have focused your attention on those. It’s hard to believe that an agency that’s doubled its staff over a decade to over twelve hundred, receives over 700 million dollars per year in funding, is still not meeting the deadline for these PMTAs, the serious ones again.”
Rep. Russell Fry (R-SC) asked, “Does CTP still believe in the continuum of risk of nicotine products and does FDA think it’s helpful for adult smokers who would otherwise continue smoking cigarettes to switch from combustible cigarettes to smoke free alternatives?” To which Califf answered, “There’s not a yes or no answer to that because for adults, the best thing to do is to stop using tobacco products altogether.”