FDA chief, at UK, says 'It's fair to be critical' of failure to control e-cigarettes; voices concern about life expectancy, misinformation

By Melissa Patrick
Kentucky Health News

U.S. Food and Drug Administration Commissioner Dr. Robert Califf said Friday at the University of Kentucky, "It's fair to be critical of the FDA" regarding the agency's struggle to regulate electronic cigarettes.

Asked in a news-media interview what the FDA is doing to crack down on e-cigarette companies that defy FDA rules and continue to sell their products, with reports that the FDA is not enforcing the law to shut them down, Califf replied that this is a "tough issue." 

Robert Califf, M.D.

Califf said that while federal law requires the companies to submit an application to the FDA to determine if they can stay on the market, it turns out that there are 6.7 million vape products, which "no one expected." He said there were already a million synthetic nicotine products on store shelves by the time Congress passed a law to cover them.

"It's been a lot more labor-intensive than was expected," he said. "We're doing a complete evaluation now that will be out in December and enforcement is a big part of that. And I would just say, it's fair to be critical of the FDA in this regard.

"But in order for FDA to have enforcement, like taking things off the shelves, that involves other branches of government also. And so we've got to figure out how to adapt to a much more creative industry than we expected in terms of all the products that are developing and the way they're dealing with it." 

As a guest speaker at UK Healthcare's 60th Anniversary Symposium, Califf touched on a number of health-related topics very relevant to Kentucky, including tobacco use, decreasing life expectancies and the role of health-related misinformation.

He said Kentucky still has work to do on tobacco use, since it still has one of the top rates in the country (21.4% of adults) and is likely to lose about 8,000 people this year to tobacco-related illnesses.

"So we've got to work together to help people stop using tobacco or reduce their use of tobacco . . . and underneath that, we've got vaping, which is rising while the use of tobacco is declining," Califf said in the interview. "Those things are right in the core mission of the FDA." 

The FDA is working on a proposal to remove menthol from tobacco products to discourage smoking. The move has been long in coming because menthol cigarettes are the choice of most Black smokers. 

"Get rid of that and you're pretty much left with tobacco-flavored tobacco," he said. "That's going to, I think, be a disincentive for people to continue to use it. . . . Law prohibits us from eliminating tobacco products, you can't take them completely off the market."  

Life expectancy: Califf voiced grave concern that life expectancy, the most basic measure of population health, has decreased in the U.S. during the pandemic and is five years shorter than the average of other high-income countries. He pointed out that life expectancy is lower in the Appalachian region and the Southeast. 

"We've got very significant work to do if we're going to turn this around," he said, adding later, "It's something that I believe is an emergency that we need to take seriously, and it's something that is not sustainable."  

One of the ways to improve life expectancy, he said, is to improve health outcomes, which include things that we already know how to treat like obesity, low physical activity, cigarette smoking, high blood pressure and diabetes -- all conditions that plague Kentuckians. He also noted the widening disparities in health outcomes in rural people, compared to urban ones. 

"These are things that are not foreign objects to us, we understand them reasonably well," he said. "We're just not doing a good job of executing on the things that we already know."

He later told reporters that experts say it will be important to fix the underlying social determinants that impact health if we are ever going to move the needle on health outcomes, including things like fundamental economic and income distribution and the education system. 

"The good news for our health is, poor people can have really good health because you are talking about blood pressure, cholesterol level, use of tobacco, simple screening things that aren't very expensive. The most important drugs now are generic . . . so this is why I keep gravitating back to having a primary-care system that works." 

The role of the FDA in all of this would be in the regulation of food and nutrition and tobacco and digital products that would enhance better health outcomes, he said. 

He touched briefly on the increasing number of deaths caused by substance-use disorders, but did say that there is a great need for a non-addictive treatment for pain, which we don't have yet. 

Misinformation: Califf spent a fair amount of time talking about health misinformation, which he defined as when well-intentioned people get health information wrong and then influence a lot of people by sharing that bad information. He said it is largely driven by the widespread use of social media and the internet.

"I can't find a single expert who can put credibly put forth a strategy that will turn around the fact that we're losing the battle on misinformation right now," he said. 

Califf called on state health institutions and health professionals to actively work to dispel misinformation, most recently as it relates to the Covid-19 vaccinations and boosters. 

"We know that the most effective way to counter misinformation is through human interpersonal interaction with someone that you trust," he said "If we don't build this in as an active part of our medical education, what our doctors and nurses and pharmacists to in day to day work, we're going to lose." 

As for the FDA's role, Califf said one of the agency's missions is to provide people with reliable information about products, and the FDA will continue to put out reliable information. 

"We have a responsibility to try to do something about it, but it's overwhelming," said Califf, who is serving in his role as FDA commissioner for the second time. "The government can't fix this because there's so much mistrust of government that we need the private sector to pitch in. And we need the press to pitch in and be aware of when it's promoting misinformation and things that will affect people's health in a negative way."