FDA Electronic Cigarettes and the Public Health: A Public Workshop
March 10, 2015
I presented the following testimony during the public comment period of FDA's e-cigarette workshop, where FDA invited more than two dozen DHHS funded FDA deeming regulation proponents, seven tobacco industry scientists, and only several tobacco harm reduction advocates to present about vapor products and public health.
William T Godshall, MPH
1926 Monongahela Avenue
Pittsburgh, PA 15218
I'm Bill Godshall, founder and executive director of Smokefree Pennsylvania. Since 1990, we've campaigned to reduce cigarette smoking.
In 2007, we convinced Sen. Mike Enzi to amend the Tobacco Control Act to require large graphic warnings on cigarette packs. But the FDA has not 'deemed' that Congressionally mandated public health regulation a priority.
In 2009, we urged then FDA Deputy Commissioner Josh Sharfstein to keep e-cigarettes legal. And in 2010 we filed an amicus brief with the DC Court of Appeals in support of NJOY's litigation challenging FDA's ban, which was struck down as unlawful.
Since 2011, we've opposed the FDA's proposed 'deeming' regulation because it would create a huge black market by banning >99.9% of vapor products now on the market, and because it would create an e-cig cartel controlled by Big Tobacco companies to market inferior and more expensive cigalike e-cigs.
For disclosure, neither Smokefree Pennsylvania nor I have ever received any funding from any tobacco, drug or vapor product company.
The scientific and empirical evidence consistently indicates that nicotine vapor products are 99% (+/-1%) less hazardous than cigarettes, have never been found to be associated with any disease, and pose no known risks to nonusers.
Nicotine vapor products have already replaced >3 Billion packs of cigarettes, and are nearly all consumed by smokers and by exsmokers who switched to vaping.
Two new surveys have found that 3 and 4 million US smokers respectively are no longer regular smokers thanks to vapor products, which are at least as effective for smoking cessation as FDA approved NRT products, which have a 95% failure rate.
There's no evidence vapor products have ever created daily dependence in any nonsmoker (youth or adult), and there's no evidence vapor products have served as a gateway to cigarette smoking for any daily smoker (anywhere in the world).
Adult and teen surveys have consistently found that smokers were at least 20 times more likely than nonsmokers to report vaping, while adult and teen smoking rates have declined to new record lows every year since vapor product sales began to skyrocket in 2008.
Public health benefits every time a smoker vapes instead of smoking a cigarette, and vapor products have similar risk/benefit profiles as childhood vaccines, water and sewage treatment, and condoms.
But since 2009, the FDA has made many false and misleading fear-mongering claims to confuse, scare and lobby to ban these lifesaving products under the deceitful guise of protecting children and public health. Many FDA funding recipients also have made false and misleading claims to lobby for bans on vapor products and vaping.
Vapers and smokers have a human right to truthful information about, and to legal and affordable access to vapor products.
Consistently, the FDA has an ethical duty to truthfully inform the public, and to ensure that vapor products remain legal and affordable.
The deeming regulation is public health malpractice of the worst kind because it protects cigarettes and threatens the lives of millions of vapers and smokers.
The FDA should rescind its proposed 'deeming' regulation, and begin to truthfully tell Americans that vapor products are far less hazardous than cigarettes, and have helped many smokers quit smoking.