The Food and Drug Administration’s new electronic cigarette regulations may condemn countless animals to death, and might hurt humans too.
Under new rules issued by the FDA earlier this month, all e-cigarette and smokeless tobacco products will have to undergo extensive testing and earn FDA approval before they can enter or remain on the market. The new mandate is retroactive and covers all products released since 2008, a move that will add millions of dollars in compliance costs to the makers of e-cigarettes and could block 90 percent of existing products.
Gaining FDA approval for e-cigarette products will almost certainly require animal testing.
According to People for the Ethical Treatment of Animals, or PETA, the FDA is encouraging e-cigarette manufacturers to meet with its Center for Tobacco Products to discuss what, if any, animal testing the agency considers “appropriate” or whether non-animal tests may be acceptable.
“The CTP will expect manufacturers to conduct animal tests in support of marketing applications,” said Joseph Manuppello, senior research associate for PETA.
PETA fears that the number of animals suffering and dying in tobacco-related testing will rise dramatically. In the most common tests, rats are immobilized inside tubes and test substances are pumped directly into their noses for up to six hours each day, PETA said in a statement.
The FDA says testing and approval of e-cigarette equipment and the chemicals used in vaping is necessary to prevent misleading claims by tobacco product manufacturers, evaluate the ingredients of tobacco products and how they are made, as well as communicate their potential risks.
“It will help us catch up with changes in the marketplace, put into place rules that protect our kids and give adults information they need to make informed decisions,” said Sylvia Burwell, secretary of the Department of Health and Human Services, in a statement this month announcing the new regulations.
The FDA rules for e-cigarettes include a lengthy list of expensive changes, such as mandatory warning labels and limitations on advertising and sales similar to those already in place for tobacco products like cigarettes and cigars.
But besides potentially killing animals, the FDA’s new rules for electronic cigarettes could harm humans too.
Research shows that e-cigarettes have been an effective tool for people trying to quit smoking by providing a safer alternative to lighting up.
They’re not just marginally safer, either — a 2015 study from Public Health England found e-cigarettes to be 95 percent less dangerous to your health than traditional cigarettes. Opponents of regulations for e-cigarettes and other forms of smokeless tobacco say those products have saved lives by helping decrease smoking in favor of vaping.
The entire vaping industry faces an uncertain future, though.
Electronic cigarettes did not make their debut until 2009, but classifying them under the same requirements as cigarettes will make them subject to a 2007 law requiring FDA approval for all new tobacco products. Getting approval can cost more than $1 million per product, an amount that is simply unreasonable for many e-cigarette manufacturers.
Nicopure Labs, a maker of e-cigarette cartridges, is already suing the FDA over the regulations, and the Smoke-Free Alternatives Trade Association, an e-cigarette industry group fighting state-level regulations like Indiana’s ban on e-cigarettes, says the federal approval process might be cumbersome enough to wipe out 99 percent of all vaping products.