The Dangers of FDA Warnings

Your home can be a dangerous place. Each year, poison control centers across the country field more than 2 million phone calls related to exposures to dangerous household substances. In their most recent report, the American Association of Poison Control Centers reports calls to poison control about young children exposed to dishwasher detergents totaled more than 15,000, while calls about young children exposed to dental care products approached 20,000. For the last several years, calls to poison control related to e-cigarette exposure have increased as the popularity of e-cigarettes has increased, but in 2014 the number of reported exposures didn’t reach 4,000. Nevertheless, the Food and Drug Administration is preparing to require warning labels and child-resistant packaging for liquid nicotine, the principal ingredient in e-cigarettes, purportedly to make children and adults safer from inadvertent exposure. As I recently detailed in a formal submission to the FDA, the problem is that the FDA’s well-intentioned effort could result in greater health risks for Americans.

Tobacco use in the United States is the lowest it has been since the 1940s, and the nation is healthier because of it. Cigarettes contain dozens of known carcinogens and cause heart disease and a host of other ailments. Like cigarettes, e-cigarettes contain nicotine, an addictive substance extracted from the tobacco leaf. Not present in e-cigarettes, however, are the known carcinogens that make traditional tobacco so dangerous. While all the health consequences of e-cigarettes are not fully known because of the newness of the products, there is no evidence that their risk is in any way comparable to tobacco.

In short, e-cigarettes, while not healthy per se, offer a much healthier alternative to cigarettes. And the FDA, in its pursuit of protecting people from accidental exposure to liquid nicotine, risks discouraging smokers from switching from cigarettes to e-cigarettes. Hampering the cessation or reduction of smoking has far more serious public health consequences than the few thousand reported exposures to liquid nicotine.

Three examples illustrate this point:

  1. In terms of direct risks to smokers, quitting smoking or the use of other tobacco leaf products reduces the risk of mouth, throat, esophagus, bladder, and lung cancer by half in five to ten years.
  1. Prolonged exposure to second-hand smoke can cause serious adverse health consequences including heart disease, lung cancer, and stroke. While exposure rates to second-hand smoke have declined significantly in the United States, the Centers for Disease Control reports that 58 million nonsmokers over the age of three were exposed to second-hand smoke during 2011-2012.
  1. According to the U.S. Fire Administration, there are 7,600 smoking-related fires in residential buildings annually, and these fires are responsible for 14% of fire deaths in residential buildings. Cigarettes cause more house fires than liquid nicotine causes phone calls to poison control centers by a factor of two.

Without question, an appropriate function of the FDA is to ensure the safety of the products it regulates, and there is a role for the FDA in ensuring that consumers are properly warned of the risks posed by various products. No manufactured ingestible product is riskless, and liquid nicotine is no exception. Consumers should be properly informed about these risks and, as with many products we keep in our homes, should be careful about how e-cigarettes and liquid nicotine are used and stored. But excessive warnings about risks associated with liquid nicotine may have the unintended consequence of discouraging smokers from switching from deadly tobacco products to safer e-cigarettes.

In its aggressive campaign against e-cigarettes, the FDA is not considering the potential benefits these products offer relative to traditional smoking. The FDA should balance any warnings about the risk of liquid nicotine exposure with additional information about the relative safety of these products compared to cigarettes. If not, their one-sided focus is liable to backfire, causing greater harm to the children the agency is bent on protecting.


Alex Brill is a research fellow at the American Enterprise Institute. Previously, he served as policy director and chief economist for the House Ways and Means Committee.

Morning Consult