The Food and Drug Administration is enacting “historic” regulations aimed at e-cigarettes aimed at further reducing youth nicotine consumption but a top regulatory expert says the government is needlessly meddling and actually making Americans less healthy.
On Thursday, Health and Human Services Secretary Sylvia Burwell announced that e-cigarette makers would be subject to the same standards as traditional tobacco firms, including marketing bans, warning labels on packages and requiring purchasers to be 18 years or older.
But perhaps the most significant part of the rule is that any product brought to market since February 15, 2007, will be subject to rigorous clearance procedures by the government just to stay in business. Hand-rolled cigars, hookahs and pipe tobacco are also under the same rule, which stems from the Tobacco Control Act of 2009.
“It’s actually a lot worse than they make it sound,” said Jeff Stier, director of the Risk Analysis Division at the National Center for Public Policy Research. “They’re actually holding them to a dramatically higher standard.”
“What the FDA did is so troubling because it will have the effect of taking almost all of the products, e-cigarettes, off the market because it’s holding these products to a pre-marketing approval requirement that even the FDA acknowledges may cost up to a million dollars each and will hold it to a standard that is so far very hard to prove,” said Stier.
Stier finds that especially frustrating because he says research shows e-cigarettes are demonstrably healthier for smokers than standard cigarettes.
“The Royal College of Physicians just a week-and-a-half ago released its own historic report and recommended in England that doctors recommend that patients who smoke switch to e-cigarettes because they are so much less harmful. They call it nicotine without the smoke. It’s the smoke that’s dangerous,” said Stier.
So why the FDA dropping the hammer in e-cigarettes?
“Because it’s the government. Seriously, this is an opportunity that the FDA has to regulate a new product and they are basically drooling over it.” said Stier, who points out tobacco firms aren’t facing standards anywhere near as high as e-cigarette makers.
Stier says the Tobacco Control Act requires any product in this area to be proven safer than traditional tobacco products and also be safer for the general public. But he also says Congress can take an important step in making this new FDA rules less burdensome. There is an amendment to an upcoming appropriations bill that would essentially grandfather e-cigarettes into the marketplace by moving the deadline from 2007 to the present day.
“The clock is ticking and Congress needs to pass amendment through the entire appropriations bill now because otherwise cigarette smokers’ lives are at risk because the FDA will be taking awaya much less harmful alternative to smoking,” said Stier.
If you’re wondering why e-cigarettes are being regulated under the Tobacco Control Act when they contain no tobacco, Stier says it’s part of the Obama FDA’s legacy of redefining what words mean – from tobacco products to using 300 words to define what a menu is so calorie counts have to be published on every thing from ads to coupons.
“In the Obama administration regulatory world, the legacy is that reality is irrelevant and the rules that we make up will govern your lives. Unfortunately, they’re making our food more expensive and they’re making it harder for smokers to quit. That’s bad for public health,” said Stier.
