Tobacco is a tough thing to defend. It’s smelly, noxious, unhealthy and generally awful. Cigarettes are an expensive habit that leads to even more expensive health problems.
That said, the FDA’s new “deeming” rule is a terrible mistake. By regulating all forms of tobacco - including “e-cigarettes” (vaping), cigars and pipe tobacco - in even more stringently than it regulates cigarettes, the FDA is hurting small businesses and actually ensuring continued cigarette smoking.
That’s what Dr. Michael Siegel of Boston University’s School of Public Health says. And he should know; he worked with the CDC on smoking issues for years.
“Sadly, the ‘deeming regulations’ would better be called ‘The Cigarette Smoking Promotion Regulations of 2016,’” he writes. “They regulate tobacco-free and smoke-free electronic cigarettes much more stringently than real tobacco cigarettes, which the agency knows kills more than 400,000 Americans each year. And by essentially decimating the vaping industry, stifling innovation, and forcing dishonest marketing, the regulations prevent these much safer products from competing with cigarettes - the deadliest consumer product on the market.”
The concept of “harm reduction” is an important one in public health. People make all kinds of bad decisions, but some decisions are worse than others. Vaping is potentially harmful - we simply don’t know the long-term consequences because it’s so new. But we do know that cigarette smoking is deadly. Many smokers have turned to vaping as a way to quit cigarettes. They get the nicotine, without all the harmful substances like tar.
The FDA, though, is cracking down on vaping, and taking away that option for smokers.
“The regulations require virtually every manufacturer of a vaping device and/or e-liquid to submit a burdensome and costly pre-market tobacco application (PMTA) for each of its devices and products,” Dr. Siegel explains.
Each PMTA will cost about $330,000, the FDA estimates (Dr. Siegel thinks that’s lowballing it). And a PMTA will be required for each variety of product.
“Thus, if you are a manufacturer that makes 20 different e-liquid flavors and each comes in three nicotine strengths, you will have to submit 60 different PMTA applications, each one demonstrating that the particular e-liquid in question, when used in a variety of different vaping devices, will be beneficial for the public's health,” Dr. Siegel notes.
Remember, e-cigarettes contain no tobacco.
Cigars and pipe tobacco, on the other hand, do. But the risks associated with them are far lower than those associated with cigarettes.
As Reason magazine’s Jacob Grier points out, the FDA’s announcement is “extremely disappointing for cigar smokers, who will likely see a source of their enjoyment much diminished by expensive government regulations that accomplish very little.”
Pipe tobacco is also subject to the new regulations (they went into effect in August). Even new blends of tobacco - and many tobacco shops have an expert blender on staff - are subject to the rules and must have a PMTA.
At no time did Congress intentionally hand this kind of power to the FDA. The FDA simply took it.
Congress can still step in and fix this.