The agency’s final rule leaves conventional cigarettes on the market while requiring much safer alternatives to meet prohibitive requirements.
Today the Food and Drug Administration (FDA) announced what amounts to a slow-motion ban on e-cigarettes, ignoring the pleas of harm reduction advocates who say it makes no sense to prevent smokers from switching to nicotine products that are indisputably much less hazardous than the ones they are using now. The FDA rule, a preliminary version of which was published two years ago, effectively requires e-cigarette manufacturers to get their products approved as “new tobacco products,” an expensive, arduous, and time-consuming process that will be prohibitive for most, if not all, of them.
Each application is expected to cost $1 million or more, and a separate application will be required for each version of a product—an impossible burden for small businesses that sell vaporizers along with dozens of custom-made fluids. Even large companies that can afford to apply for approval may be unable to persuade the FDA that “permitting such tobacco product to be marketed would be appropriate for the protection of the public health,” a requirement set by the Family Smoking Prevention and Tobacco Control Act. Such appropriateness “shall be determined with respect to the risks and benefits to the population as a whole, including users and nonusers of the tobacco product, and taking into account (A) the increased or decreased likelihood that existing users of tobacco products will stop using such products; and (B) the increased or decreased likelihood that those who do not use tobacco products will start using such products.”