One is a product that produces more than 10,000 chemicals, including more than 60 known human carcinogens, and kills more than 400,000 Americans each year. The other is an alternative, much safer product that produces minimal exposure to carcinogens and has been shown to reduce carcinogenic and respiratory health risks. The Food and Drug Administration (FDA) allows one of these products to be marketed without any mandatory review, but the other must be pulled off the market in two years unless the company making it submits a burdensome application that is prohibitive expensive for all but the largest of corporations.
If you think that the more stringently regulated product is cigarettes, you are wrong. Right now, the FDA regulates e-cigarettes much more stringently than real cigarettes, putting an almost insurmountable obstacle in front of the development and marketing of a potentially life-saving alternative to smoking. The current FDA regulations will decimate the electronic cigarette industry, removing 99 percent of vaping products from the market and eliminating much of the competition faced by cigarettes for the nicotine market. This is all to the advantage of real, maximum harm, tobacco cigarettes.
Fortunately, there are now two bills before Congress that would put an end to the lunacy going on with the nonsensical approach by which the FDA is regulating cigarettes and e-cigarettes. The FDA Deeming Authority Clarification Act of 2017, sponsored by Reps. Tom Cole (R-OK) and Sanford Bishop (R-GA), would grandfather in existing electronic cigarettes so that they, just like Marlboro, Camel, and Newport, can stay on the market. Unlike Marlboro, Camel, and Newport, however, they will not kill half of the consumers who use these products for many years.
The Cigarette Smoking Reduction and Electronic Vapor Alternatives Act of 2017, introduced this past Thursday by Rep. Duncan Hunter (R-CA), would set up a distinct regulatory framework for electronic cigarettes that acknowledges the relative safety of these products compared to real tobacco cigarettes. Unlike current regulations, which take a prohibitionist approach, this bill would establish safety standards for e-liquids and vaping devices, ensuring that these products remain available to help smokers who want a safer alternative to smoking while at the same time maximizing product safety.
Surprisingly, many health groups are opposing these bills, claiming that they will remove FDA oversight of electronic cigarettes. For example, the Campaign for Tobacco-Free Kids argues that the Cole-Bishop bill would "exempt them [e-cigarettes] from FDA review." The truth is that the Cole-Bishop bill does not exempt electronic cigarettes from FDA review. The agency is still free to promulgate any health and safety standards it believes are necessary to protect the public's health.
But the fact of the matter is that despite having had regulatory jurisdiction over electronic cigarettes for the past seven years, it has not established a single safety standard or marketing restriction for these products. It has watched scores of people being injured by exploding batteries and done nothing. Even worse, the agency has actually prohibited companies from repairing this defective battery problem because any such change would render the product a "new tobacco product," meaning that it could not be marketed without pre-approval – a process that would take years and is prohibitively expensive for all but the largest of companies.
Now, in one fell swoop, Representative Hunter and co-sponsors are stepping in establishing almost immediate safety standards (that go into effect in one year) that not only regulate battery safety, but also regulate all aspects of e-liquid manufacturing. This is something that the FDA could have and should have done years ago. But it has been too busy developing its prohibitory approach to e-cigarettes rather than actually working to protect the public's health by assuring the maximum safety of e-cigarettes being used by millions of Americans.
Both pieces of legislation – the Cole-Bishop bill and the Hunter bill – make sense from a public health policy perspective. Far from protecting Big Tobacco, they make it more difficult to market deadly tobacco cigarettes by ensuring that competition from much safer tobacco-free vapor products can continue. They are a great start to correcting the lunacy of today's federal regulation of electronic cigarettes.
Michael Siegel, a tobacco health and policy researcher, is a professor in the Department of Community Health Sciences at the Boston University School of Public Health.
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