There is a famous saying when it comes to smoking: “Nicotine keeps you coming back, but the tar and smoke is what kills.” And, as we’ve known, at least since the landmark U.S. Surgeon General’s report was published in 1964, smoking does indeed kill. Great Britain’s Royal College of Physicians, one of the world’s leading advocates for unbiased public health information, had reached the same conclusion two years earlier.
A billion lives. That’s the number of people who will die from traditional tobacco cigarettes in the next 100 years, according to the American Cancer Society. Very simply, smoking is the planet’s single most lethal cause of preventable death. Which is why more and more former smokers have turned to vaping — or e-cigarettes.
Vaping delivers the sensation of smoking with 95 percent less harm to the human body, according to Great Britain’s Royal College of Physicians. A study by the U.S. Centers for Disease Control shows upwards of 9 million vapers in the U.S. alone. And about 20,000 taxpaying businesses, employing over 100,000 people, have opened to serve the vaping public.
The bad news: The federal Food and Drug Administration, citing the 2009 Tobacco Control Act, has opted to classify vaping chemicals as a “tobacco product” — even though they contain no traditional tobacco. It’s a one-size-fits-all approach to regulation that poorly serves the public.
Specifically, the FDA has imposed its regulations on all vapor products introduced into the market since 2007. Ten years of innovation will now be forced to undergo the strenuous and costly Pre-Market Tobacco Application (PMTA) process.
Reality: The FDA regulations that went into effect in August will decimate the industry, the vast majority of which is comprised of small businesses that will not be able to afford the PMTA process.
Based on the estimates the FDA has given us, the PMTA process for the company I am affiliated with would range from $300,000 to $3 million per product or variety — and we’ve got 275 of them already on the market. Even the low number would cost us $82.5 million, on up to $550 million at the high end. These fees are assessed concurrent with testing required before submission to the FDA, with no guarantee of approval.
Then there’s the time factor. By the FDA’s own estimate of 500 hours per application, my company’s 275 applications will take 137,500 hours or 15 years to approve, a time frame that makes it impossible to meet the 2018 deadline for compliance. Since the PMTA process kicked in, hundreds of applications have been submitted, but only one has been approved to date. This is bureaucracy run amok.
Let’s be completely honest, no one within the industry is claiming that vaping is 100 percent healthy. Nicotine is an addictive substance, and we acknowledge this. The real message that we are trying to get across is that harm elimination will never work; harm reduction will.
The FDA regulations are masked by the “do it for the children” mantra. While the regulations place a federal ban on sales to minors, which the industry supports, 48 out of 50 states already had sales-to-minors bans before the regulations kicked in. What the FDA fails to mention in all of their anti-vaping propaganda is the costs that will fall upon the small businesses to get their products approved.
The Right to Be Smoke Free coalition, comprised of multiple vapor trade organizations, manufacturers and retail businesses, has filed suit against the FDA’s regulatory overreach. We have also been working with Congress to pass HR 2058, which would move up the start date for regulation. That would allow vaping products developed before that date to be “grandfathered in” and stay on the market. Another measure we back is the Cole-Bishop Amendment to the Agriculture Appropriations bill, which would also move the start date forward.
While both of these congressional strategies would not guarantee survival of the vapor industry, they will buy time. With the help of our elected officials, we can inform and educate the public about the benefits of vapor products and reduce the staggering death toll from traditional tobacco.
With Louisiana facing huge deficits and job losses, we should not let Big Pharma and Big Tobacco monopolize life-saving vapor products, and, in the process, kick small Louisiana businesses to the curb. They are the lifeblood of our state’s economy.
We call on our elected representatives, at the federal state and local level, to listen to your constituents and fight for our concerns. The regulatory assault on vaping is a classic case of special-interest lobbying on behalf of giant corporations. If Big Pharma prevails, hundreds of retail employers in Louisiana alone will be driven out of business. More to the point: tobacco’s lethal toll will rise. A billion lives are on the line.
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