FDA Rule Seeks Broad Regulation Over E-Cigarettes Because They Might Make People Want Real Cigarettes
WASHINGTON -- Citing the need to take greater measures against "gateways" as too many Americans are still using tobacco products, the Food and Drug Administration issued a proposed rule Thursday broadening its authority to include vapor-based e-cigarettes, cigars, pipes and other cigarette alternatives.
Health and Human Services Secretary Kathleen Sebelius told reporters on a conference call that it's part of an initiative "to make this next generation tobacco-free."
"CDC has found, for example, that the use of e-cigarettes among middle and high-school students doubled between 2011 and 2012. I think that bears repeating: the use of these products doubled," she said of the devices that simulate smoking by producing vapor with or without nicotine.
"What we don't know yet is the full impact and ramification that these products have on our nation's health. We don't yet have a full understanding as to whether these products serve as a gateway to the use of regular cigarettes. And we don't know how they influence the behavior of current smokers," Sebelius said. "This proposed deeming rule would allows us to gain a more robust understanding, and, if necessary, an ability to take action to mitigate potential harms."
Currently, the FDA regulates cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless tobacco. Proposed newly “deemed” products would include electronic cigarettes, cigars, pipe tobacco, certain dissolvables that are not “smokeless tobacco,” gels, and waterpipe tobacco.
"Once the proposed rule becomes final, FDA will be able to use powerful regulatory tools, such as age restrictions and rigorous scientific review of new tobacco products and claims to reduce tobacco-related disease and death," the agency said.
Sebelius lamented that "for all the progress we've made since the first surgeon general's report 50 years ago, tobacco use remains the leading cause of preventable death and disease here in the United States and also around the world."
"Every day, every day, more than 3,200 children try their first cigarette. And each day, 2,100 of those kids and young adults become daily smokers," she said. "And if we fail to reverse those trends, 5.6 million American children who are alive today will die prematurely, due to smoking."
The International Premium Cigar & Pipe Retailers Association said it is reviewing the rule before issuing a formal response, but the association did assure members that the trade group "is working hard to protect your rights and interests as a retail tobacconist."
The public comment period on the rule is 75 days.
"To date, the agency has not been able to fully assess the public health impact of unregulated tobacco products including the alarming increase in youth use of certain unregulated tobacco products such as e-cigarettes and certain types of cigars. These facts highlight the need for regulation designed to prevent early tobacco use that may lead to a lifetime of nicotine addiction and a range of potential serious health problems," said FDA Commissioner Dr. Margaret Hamburg.
Mitch Zeller, director of the FDA's Center for Tobacco Products, said since they don't know much about the effects of e-cigarettes one warning label is sought: "an addiction warning, reminding users that the product is addictive because it contains nicotine, which is an addictive chemical."
Zeller acknowledged the therapeutic uses of nicotine, including "safe and effective" gum and lozenges that smokers use to quit.
"But when it comes to e-cigarettes, it's the wild, wild west. We have e-cigarettes that are exploding in car chargers and wall sockets. We have people purchasing liquid e-nicotine cartridges. And it's buyer beware. None of this is taking place in a regulated environment. And that's why we're proposing this rule," he said. Zeller later added that the FDA had no proof of its own on exploding e-cigarettes, but read about instances in newspapers.
The FDA officials said they don't have a timeline for finalization of the rule, but there is "a sense of urgency" to set it in stone.
"And we will take all of the input very seriously, but we are eager to see this process move forward towards the final deeming rule, so that those new requirements, restrictions and oversight mechanisms will fall into place, and also so that we can move to other regulatory activities that we think also are very, very essential to promote and protect the health of the public," Hamburg said.
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."