FDA’s New Vaping Rules May Actually Encourage Smoking

 Tobacco is a difficult thing to defend. It is smelly, toxic, unhealthy, and generally terrible. Smoking is an expensive habit that leads to even more expensive health problems.

Nevertheless, the FDA's new "presumption" principle is a terrible mistake. By regulating various forms of tobacco—including "e-cigarettes" (vaping), cigars, and pipe tobacco—more strictly than cigarettes, the FDA is harming small businesses and actually ensuring continued smoking.

This is what Dr. Michael Siegel from Boston University’s School of Public Health says. He should know; he has worked with the CDC on smoking issues for many years.

“Sadly,” he wrote, “the presumption rule would be better described as the '2016 Smoking Promotion Regulation.' They regulate smokeless tobacco and e-cigarettes much more strictly than they do real tobacco cigarettes, which the agency knows kill over 400,000 Americans each year. And by essentially crippling the vaping industry, stifling innovation, and forcing dishonest marketing, the regulations prevent these safer products from competing with cigarettes—the most deadly consumer product on the market.”

The concept of “harm reduction” is an important part of public health. People make all sorts of bad decisions, but some decisions are worse than others. Vaping is potentially harmful—we don’t know the long-term consequences because it is so new. But we do know that smoking is deadly. Many smokers have turned to vaping as a way to quit smoking cigarettes. They get nicotine without the tar and all the harmful substances.

The FDA, however, is cracking down on vaping and taking away that option for smokers.

“The regulation requires almost every manufacturer of a vaping device and/or e-liquid to submit a cumbersome and expensive premarket tobacco application (PMTA) for each of its devices and products,” Dr. Siegel explains.

Each PMTA will cost $330,000, the FDA estimates (Dr. Siegel believes they are lowballing it). And a PMTA will be required for every variety of product.

“So if you are a manufacturer making 20 different e-liquid flavors and each has three nicotine strengths, you will have to submit 60 different PMTA applications, each demonstrating that using them, especially e-liquids with issues, will be beneficial to public health,” Dr. Siegel points out.

Remember, e-cigarettes do not contain tobacco.

Cigars and pipe tobacco do, however. But the risks associated with them are much lower than those associated with cigarettes.

As Jacob Grier of Reason magazine points out, the FDA’s statement is “extremely disappointing for cigar enthusiasts, who may see their enjoyment greatly diminished by these expensive government regulations.”

Pipe tobacco is also affected by the new regulations (which take effect in August). Even new tobacco blends—and many tobacco shops with expert blenders—are subject to the rules and must have a PMTA.

At no point did Congress intentionally give this power to the FDA. The FDA is just taking it.

Congress can still intervene and address this issue.