Regulations Should Not Come Before Study Results

The FDA is spending $270 million on Facebook posts and puff count studies and 45 other research projects to determine the risks of e-cigarettes before millions of more people use them. The FDA wants the data, but the results are years away. Studies of e-cigarettes not funded by the FDA are also underway, and the agency can factor those results into any action it takes. However, the FDA chose these 48 projects because they address questions central to future regulations. Wells Fargo Securities estimates will make $2 Billion in global sales this year, says the FDA must wait for the results of the research before it issues regulations, or manufacturers risk being driven out of business by unproven fears about their products. Backed by the world’s biggest tobacco companies, the industry is aggressively expanding its marketing across the country.

The missing science includes questions such as what compounds are in the vapor produced by e-cigarettes. It also includes complicated ones such as whether flavors such as butterscotch and bubble gum entice children to vape, how e-cigarette displays in online stores affect teenagers’ desire to buy vaping liquid, and whether e-cigarettes will reduce the number of smokers or produce millions of new nicotine addicts. Research on e-cigarettes has moved more quickly, partly because scientists can draw on regular tobacco research to establish the biological effects of vaping. Other leading tobacco companies are making a big push for a share of the growing market. 

Another crucial question that researchers are trying to answer is whether e-cigarettes will be used mostly by nicotine newbies, including adolescents, by ex-smokers craving a nicotine hit without the carcinogens of tobacco, or by smokers trying to quit.

The FDA’s proposed e-cigarette rules would give it the power to regulate the ingredients in the vaping liquid, but they are silent on the plumes of vapor produced when the liquid is heated. “We want to know what’s in the emissions, not just the ingredients,” said VCU toxicologist Robert Balster, who is helping to oversee four FDA-funded projects.

“If it turns out that people are tinkering with the electronics to increase the voltage of e-cigarettes, and FDA regulations limit the maximum voltage, that’s useful to know,” Balster said. It might justify a requirement that the devices be tinker-proof.

The studies and their results are soon to come in the next years, the FDA is trying to push the tests as best as they can so they can get the results so then maybe they will figure out whether E-cigs are actually safe or not.