FDA Rule Seeks Broad Regulation Over E-Cigarettes Because They Might Make People Want Real Cigarettes
Zeller conceded that if a traditional pack-a-day smoker switched to e-cigarettes, “I think even with all the questions that we have, we would concede that that person is likely to be substantially reducing their risk.”
“The challenge for us as regulators is we’re responsible for enforcing a law that has a population-level health standard. And our job is to figure out, well, what are the net impacts at a population — population level of all the possible uses. Because there’s a much greater proportion of smokers who are concerned about their health and are interested in quitting,” he said.
“And what happens if instead of continuing down that pathway to quitting, especially using FDA-approved safe and effective medicinal products, they start engaging in what’s called dual-use. And they’re using e-cigarettes in situations where they can’t light up, and they wind up being less interested or motivated to quit.”
At that point, Zeller argued, “this putatively less harmful product actually increases harm because all it does is serve as a bridge for health-concerned smokers to get from their last cigarette to their next cigarette.”
“We don’t know what the patterns of use are. We’re funding massive studies to try to get a better handle on what the behaviors are, but it’s awfully complicated because it’s going to be an assessment of what is the impact on initiation; what is the impact on cessation. That’s mandated by law,” he added.
Zeller called the current rulemaking “sort of like walk before you run.”
“In order to be able to do a rulemaking on advertising, marketing and promotion, you have to have jurisdiction over the product. In order to have jurisdiction over the product, this rule has to go final and be in effect,” he said. “So that’s why we call this foundational. That’s why this is a historic day. There are these entire categories of products out there that many people think are safer than cigarettes, including unregulated combusting products that people think are safer than cigarettes.”
“And the whole point of being regulated under our statute is to bring a public-health based, evidence-based, regulatory approach to protecting consumers, protecting the public health.”
Sen. Richard Blumenthal (D-Conn.) criticized the FDA’s proposed rule as “too little, too late.”
“Instead of comprehensive, robust rules the FDA has offered a loophole-ridden skeleton– timid and tepid in restricting relentless marketing of smoking to children. For far too long the lack of effective regulation of tobacco products has been a gift to tobacco companies who continue to hook new generations of kids on tobacco products and create new addicts to make up for the hundreds of thousands who die each year from tobacco use,” the senator said in a statement.
“While FDA has finally taken preliminary action on the agency’s ability to regulate all tobacco products, the reality is that flavored cigars, nicotine candies, and e-cigarettes will all remain on the market as products that entice children and continue addiction until further action is taken,” Blumenthal added. “I will do all I can to help push for a final rule and additional regulatory action so that there will finally be meaningful regulation of all tobacco products.”