The Food and Drug Administration moves at the pace of a tortoise, but unlike Aesop’s character, the agency is proving that slow and unsteady loses the race.
You may have seen the balloons of vapor containing unknown chemicals and known nicotine blown into the air by users of electronic cigarettes, the newest addiction craze that has turned into a rapidly growing $2 billion a year industry beyond the reach of regulators. Sales are doubling each year.
Perhaps we should give the FDA one cheer for finally, though egregiously slowly, tackling the problem by proposing a few regulations, cautious and inadequate as they may be, that would restrict sales to minors, require health warnings on labels of the products, bar free samples, and list the chemicals in the vapors inhaled by users.
The regulations, if and when they go into effect, also would forbid manufacturers from claiming not only that their e-cigarettes are not harmful to users’ health but also that they can cure addiction to cigarettes and other tobacco products.
Treading ever so cautiously, the agency declines to consider eliminating online sales of the products or banning TV advertising. But here’s the killer: the FDA isn’t dealing with e-cigarette flavorings, such as grape, pina colada and watermelon, clearly aimed at luring kids.
According to FDA officials who unveiled the proposed rules on Thursday, there are more questions than answers about e-cigarettes, so only a first step is being taken. "For the first time, there will be a science-based, independent regulatory agency playing a vital gate-keeping function," said Mitch Zeller, director of the FDA’s Center for Tobacco Products at a briefing for reporters.
E-cigarettes are pen-shaped devices that don’t burn tobacco with its cancer-causing tar but use batteries to heat nicotine-based liquid. That creates a vapor that a user inhales, but also contaminates the air in the immediate vicinity. It’s another form of second-hand chemical pollution.
Like many federal agencies, even a snail could outpace the FDA. There’s a 10-week public comment period followed by two years for the manufacturers to seek approval of their e-cigarettes. During that time, the stuff remains on the market, legal to sell.
As the president of the Campaign for Tobacco-Free Kids told The Washington Post: "In the absence of any meaningful regulation, the e-cigarette manufacturers have acted as if it’s the wild, wild West, with no rules and no restraints."
According to Kenneth Warner, a professor of public health at the University of Michigan, "there’s such a huge debate over whether e-cigarettes are a good thing or a bad thing for public health. But we’re in a kind of factual vacuum. There are not many reliable studies, we really don’t know the right answer."
Tobacco-related smoking, still an $80 billion a year industry, kills close to 500,000 Americans each year, according to the Centers for Disease Control. Optimists and e-cigarette advocates suggest that the product may cause smokers to abandon tobacco in favor of a less-dangerous alternative.
A CDC official interviewed by NPR defended the FDA, saying the agency has to walk a fine line, careful not to overreach with its regulations in order to avoid court challenges by the manufacturers, who have hired teams of lobbyists to defend their products to members of Congress and federal officials.
Stanton Glantz, a professor of medicine at the University of California, San Francisco, views the FDA proposal as weak and pro-industry. "Right now we have a little fire and a little bucket of water," he told The New York Times. "They are saying, ‘Let’s just watch the fire for a few years, and if it turns into a big fire we’ll deal with it with this same little bucket.’ "
"It’s a step forward -- but it’s not a giant step," said Gary A. Giovino, a professor of health behavior at the State University of New York in Buffalo. "But remember, it’s a battleship they are moving here. It’s not a dingy."
The e-cigarette makers, now including some big tobacco players such as R.J. Reynolds, Lorillard and Philip Morris, contend that their product is much less harmful than cigarette smoke and should not be rigorously regulated.
A free society cannot, and probably should not, prevent people from abusing their bodies with vaporized nicotine, excessive alcohol and obesity-level food consumption in the privacy of their homes.
But major cities such as Boston, Chicago and Los Angeles have outlawed e-cigarettes in public places. Across Massachusetts, 40 communities have done the same, though none are in Berkshire County, to the best of our knowledge.
While the FDA dithers and dallies, Berkshire County’s city and town governments need to move ahead to protect the rest of us outside our homes from the ill winds of nicotine vapor in the air around us. It’s not blowing smoke to exercise an abundance of caution in order to avoid a public health menace.
To contact Clarence Fanto: