The agency said it has no idea if vaping is good or bad for public health, but will regulate it anyway.
The government's chief tobacco regulator told Congress today that e-cigarettes are almost certainly healthier than tobacco, that much more research needs to be done, but that it needs to regulate them now anyway.
"If we could get all of those people [who smoke] to completely switch all of their cigarettes to noncombustible cigarettes, it would be good for public health," Mitch Zeller, director of the Food and Drug Administration's Center for Tobacco Products said today at a hearing that could help determine the fate of e-cigarettes in the United States.
But that's not stopping the agency from asking Congress for the authority to restrict the products now—regardless of whether the health impact is positive or negative. The FDA official told the Senate Committee on Health, Education, Labor, and Pensions that it has "far more questions than answers" when it comes to the effects of e-cigs on the people who use them, but that its current existence outside the FDA's regulatory authority is unacceptable.
"We don't need to have the answers to those questions to have regulatory authority," Zeller said. The FDA is currently funding "dozens" of scientific studies to find out, he said. However it's basing regulatory decisions on a "guilty until proven innocent" mindset in the meantime.
Earlier this month, the FDA proposed new e-cigarette regulations that threaten to choke out the burgeoning vaping industry, which supporters say has helped thousands of people quit and has helped millions cut back on their cigarette smoking.
The proposed regulations would make e-cigarette makers get FDA approval for any new products, a move that could completely remove small vaping companies from the industry, leaving Big Tobacco's e-cig products to dominate the market.
Instead of exploring the potential health benefits of vaping over smoking tobacco, government groups such as the Centers for Disease Control and some lawmakers are pushing for complete abstinence, saying that e-cigs' flavored nicotine juices couldn't possibly be enjoyed by adults.
Among those opponents is Sen. Tom Harkin (D-Iowa), who recently put out a scathing report about e-cigarettes, and spent most of the hearing proving he knows little-to-nothing about the growing vaping movement.
At one point, Harkin picked up a mod (and its plug, which, shockingly, is the "electronic" part) and said, "They're buying these fancy things here. Look, it goes in the wall—it looks like a computer plug. I don't know what that costs, but these are all geared toward young people."
The CDC's Tim McAfee offered the common anti-vaping hardline stance, suggesting that, though e-cigarettes could potentially help adults stop smoking, it wasn't worth "experimenting" with the lives of the "millions of children" who look at vaping as sexy and could eventually become addicted to regular cigarettes.
"We don't think there's any necessity to spend 5-10 years waiting to see if a 13-year old progresses from e-cigarettes to regular ones … it's not something we need to or should fool around with," McAfee said. "This is a huge experiment, and it's not fair to ask kids to be the test subjects for some hypothetical benefit to adult smokers."
That's the kind of talk we've heard from federal officials before, and it jives with the sort of calls for complete nicotine abstinence that public health officials have made before.
But vapers had at least one clear voice on their side, Sen. Richard Burr (R-NC) said that it's far too early to ban e-cigarettes, and it's probably even too early to put stringent regulations on them, too. That comes in stark contrast to everything the FDA, CDC, and many other lawmakers, who are seeking regulation as soon as possible, have said.
"If we kill technology and innovation, which is, in essence, what some are attempting to do at the beginning, it's not going to play a role in reducing the amount of Americans who smoke," he said. "I can remember when opportunities for harm reduction were the goal, but the technology wasn't there … well now, the technology is there, and how quickly we've moved to the point where harm reduction is no longer a goal."
If there's a silver lining to vapers in any of this, it's that the FDA doesn't appear to agree with the CDC's hardline stance. In fact, the agency has proposed extending the 75-day public comment period past July to allow for more voices to jump into the conversation and study the products further.
The agency clearly believes there is room for e-cigarettes as a smoking cessation aid. Whether they think that vaping—and its culture of creating smokeless, flavored nicotine juice—should continue to flourish without strict regulation is another matter.
"We've been given an opportunity to make a serious dent in the death and disease toll, now that we can regulate these," Zeller said. "Let's not lose our focus on what the primary cause is for those 480,000 avoidable deaths each year—it's primarily burning, combusting cigarettes."
Zeller's comments were some of the first that suggest the FDA sees vaping as inherently less harmful than smoking. But the insistence that regulation is necessary despite conclusive medical evidence about the real effects of vaping is little change from a debate that has been filled with knee-jerk calls for new laws and new regulations restricting their use.