The U.S. Food and Drug Administration’s insistence on keeping its 2007 predicate date has drawn protests not only from vapor companies but also from animal lovers.
“Countless animals will suffer and die now that newer tobacco products, such as e-cigarettes, will be required to FDA approval in order to enter or remain on the market,” wrote the People for the Ethical Treatment of Animals (PETA) in response the new regulations.
To obtain FDA approval, tobacco manufacturers will be required to show that their products reduce the risk to current tobacco users and do not increase the risk to non-users. In a guidance document accompanying the rule, the FDA encourages manufacturers of electronic nicotine-delivery systems to meet with its Center for Tobacco Products (CTP) early in the development process to discuss what, if any, animal testing the agency considers “appropriate” or whether non-animal tests may be acceptable.
“The FDA has stated that animal tests will still be required for toxicological issues that it claims cannot be addressed by non-animal approaches—even though we know that the link between tobacco and lung cancer in humans was obscured for years because animal tests did not demonstrate this relationship,’ wrote PETA.
PETA fears that despite the existence of robust human-relevant animal-free tests, the number of animals suffering and dying in tobacco-related testing will rise dramatically. In the most common tests, it says, rats are immobilized inside tubes and test substances are pumped directly into their noses for up to six hours each day.
“The CTP will expect manufacturers to conduct animal tests in support of marketing applications, and CTP is funding dozens of its own animal studies at universities and the National Center for Toxicological Research,” says Joseph Manuppello, senior research associate for PETA. “However, history has shown us that animal tests will not result in safer tobacco products.”
According to PETA, animal tests for tobacco products have already been banned in Belgium, Estonia, Germany, Slovakia, and the United Kingdom.