Debate Forum: 06/16

Forum Center: Butt out

FDA considers e-cig regulation

By Sarah Sidlow

Vapes are so hot right now.

Particularly popular among teenagers and young adults, these sweet-scented solo- smoke machines are creating a buzz because of their cleaner-than-tobacco profile, their purported smoking-cessation benefits, and because they’re just damn cool. The vapor pens, or e-cigarettes, often filled with flavored liquid, can also contain nicotine, depending on the smoker’s preference. Independent and artisan smoke shops have popped up all over the country, and fanatics spend hours and serious cash on personal and handmade “mods” for their vapes.

Individual states and private businesses throughout the nation have had to make judgment calls about allowing vaping in public places, restaurants, bars and outdoor spaces, often raising the question, should e-cigs be treated like traditional cigarettes?

Enter the Food and Drug Administration (FDA), which has proposed a plan for how it will treat (read: regulate) the emerging industry. Because the nicotine found in e-cigs is derived from tobacco, the FDA categorizes e-cigarettes as a “tobacco product.” The FDA’s plan, which would require FDA approval for any e-cig product made after 2007, is being hailed as another attempt by the Feds and, weirdly, big tobacco, to choke these small businesses and the vapor trail they’ve blazed.

But the real crux of the conversation hangs on everything we don’t know about vaping.

While many studies clearly show rates of vape use increasing as traditional cigarette smoking decreases, the big health-related questions remain unanswered. Does vaping carry with it the dangers of second-hand smoke? What’s really in those liquid pods? And should I be subjected to someone else’s plume of pumpkin spice smoke, just because it probably won’t kill me?

The major proponents of regulating e-cigs, like the Centers for Disease Control (CDC) and various American health organizations, claim it’s a no-brainer. Vaping is bad for you—the liquids contain chemicals the effects of which are largely unknown, and some vapes can get hot enough to release carcinogens straight into your lungs. Sound familiar?

Moreover, regulatory proponents claim, with sweet-sounding flavors and bright colors, the vaping trend is deliberately roping in a young demographic—something big tobacco has long been scolded for.

Yet there are many who claim the science is inaccurate—that the negative press around vaping comes from a longstanding tradition by the government and the public of taking an abstinence-only approach to smoking.

Ironically, opponents point out, FDA regulations on vapes would actually play into the hand of big tobacco. How? Almost every major cigarette company now has its own e-cig model, and big tobacco can afford the estimated $3-4 million fee for the research that would be required if the FDA proposal passes, a price tag that would send small vapor shops up in smoke.

This isn’t the first time the FDA has floated the idea of regulating the e-cig industry. The plan was first discussed in 2011, and has been bolstered by the FDA since then, primarily under the instruction of FDA Commissioner Margaret Hamburg, who stepped down from her post in early April. The final decision about whether or not the FDA will regulate this burgeoning industry is expected soon.

Reach DCP Editor Sarah Sidlow at


Debate Forum Question of the Week:

Should electronic cigarettes be regulated like tobacco?

Debate Left: Smokeless fire

Response By Ben Tomkins

The perceived need to have the FDA regulate and test the products and techniques of tobacco vaporization products seems to have very little to do with the unknown. With any object, there are always going to be questions as to what is in it and how it affects the human body, but a possibility doesn’t necessarily warrant a serious federally sponsored investigation.

To start with, virtually no one is questioning the actual components of the vaporizer itself. Although quality control varies greatly between the high-quality products produced by independent vape shops and, say, the crappy big tobacco version by Reynolds called Vuse, whether you’re using Vuse or something that looks like a steampunk trombone you’re going to get a coil that heats the vapor, a cotton wick, a battery and a tube to suck it through. 

None of those components needs any evaluation when it comes to food-grade standards, and given the fact that being health-conscious is one of the premier selling points of e-cigarettes, the industry is highly self-regulating as it is. Vapes fall squarely on the hippie, or at least hipster side of the argument. Despite being a vice in that they deliver nicotine—one of the greatest drugs of all time, according to my grandfather, but for being incredibly addictive and the fact that average delivery system is horrific—they appeal to the health-conscious at least for solving the second point. If someone in the vape industry discovered that using a coil made of a combination of mercury and uranium (I would be extraordinarily impressed by the infinite heating capacity and environmentally-friendly use of uranium instead of a battery, and uber-bong-like power of liquid metal) was bad for you, it would take about three seconds for that information to spread around every vape shop in the world.

Independent vaporizer makers are generally users of their own products, and as such they are also tinkerers. First and foremost, nobody who is creating a product for personal use is going to want anything but the highest standards they can afford and create. In fact, the only issue in question is the content of the e-juice itself, and everything about every chemical in those things is already well-known and heavily studied by the FDA.

The contents of your average e-juice charge are water, propylene glycol, nicotine if you want it, and flavor. Propylene glycol? You mean, antifreeze? Nope. That’s ethylene, not propylene. You consume propylene glycol all the time in iced tea, cake mixes, ice creams, alcoholic drinks, and a whole host of other food products. In fact, the FDA classifies it as “generally safe for consumption,” provided it’s in small doses, and the evidence for that is the science experiment you’ve been running on your own body every time you sucked down ten times the recommended dose of birthday cake.

Even the nicotine they contain has no harmful effect that is above and beyond what one would expect from smoking. The only concern I’ve heard regarding nicotine in personal vaporizers is that some of the mods have larger batteries that create enough coil heat to convert a small portion of the nicotine into formaldehyde. Well, that’s the least interesting piece of knowledge about nicotine there is. The active ingredient in gin is responsible for millions of deaths every year—many from second-hand exposure through the bumper of a car—and nobody’s acting like that’s different just because another sector of the industry produces vodka.

As a matter of fact, just like GMOs, the primary issue is not the product but the companies with which the product is associated. While people hate Monsanto because of its business practices, they don’t necessarily have an issue with corn as a food product. The same is true of big tobacco. 

The Tobacco Master Settlement of 1998 is the single most comprehensive analysis and censorship of an industry’s products and practices in the history of mankind. I’ve read the entirety of the portion that pertains to the actions and effects upon which the settlement is founded, and there’s every reason to hate tobacco companies like Reynolds. They actually knew definitively that tobacco smoke produced carcinogens long before the FDA did, and spent far more money on in-house research to boot. The reason for this, naturally, was so they could figure out all the horrible things that their products were doing so as to most efficiently lie, mischaracterize and obfuscate the issues from consumers. 

I suppose I can understand some concern about the second-hand issue of vapor. That may be worth studying as many people use them indoors where cigarettes are illegal. However, preliminary studies aren’t suggesting an issue.

Ultimately, requiring FDA regulations to vape products will cost far more money than is worthwhile on the incredibly off-chance that something bordering on alchemical is occurring when a tiny collection of well-understood products occur in the same area at once. Until doctors start noticing “vape lung” in millions of vape users, I could care less what people do. 

Ben Tomkins is a violinist, teacher, journalist and critically acclaimed composer currently living in Denver, Colorado. He hates stupidity and generally believes that the volume of one’s own voice is inversely proportional to one’s knowledge of an issue. Reach Ben Tomkins at

Debate Right: FDA needs a smoking gun for E-cigarettes

Response By Rob Scott

Most of us remember the days in Ohio when you would go to a restaurant and a question was asked by the hostess: “Smoking or nonsmoking section?” It really was not too long ago, and some places still allow folks to smoke inside, but they are rare and breaking the law.

With every decade it seems it is tougher for smokers to be able to smoke. Cigarette taxes are extremely high, public smoking is condemned essentially anywhere and smoking seems to have waned in popularity. However, smoking remains stubbornly common, especially among teens. According to the Centers for Disease Control, in 2012 an estimated 18.1 percent of the U.S. adults were smokers, as were 14 percent of high school students. Each year, over 480,000 Americans die of smoking-related diseases.

Like anything, whenever there is a problem, invention will be there to assist. Electronic cigarettes, also known as e-cigarettes, are battery-operated products designed to deliver nicotine, flavor and other chemicals. They turn chemicals, including highly addictive nicotine, into an aerosol that is inhaled by the user.

It is in this environment that the market for e-cigarettes has developed since they were first introduced in the U.S. less than 10 years ago. By 2013, more than 47 percent of smokers had tried e-cigarettes; and 4 percent were regular users. In 2013, more than 250,000 minors who had never smoked had used an e-cigarette.

Most e-cigarettes are manufactured to look like conventional cigarettes, cigars or pipes. Some resemble everyday items such as pens and USB memory sticks. According to the Federal Drug Administration, e-cigarettes have not been fully studied, so consumers currently don’t know the potential risks of e-cigarettes when used as intended, how much nicotine or other potentially harmful chemicals are being inhaled during use or whether there are any benefits associated with using these products. Additionally, it is not known whether e-cigarettes may lead young people to try other tobacco products, including conventional cigarettes, which are known to cause disease and lead to premature death.

Only e-cigarettes that are marketed for therapeutic purposes are currently regulated by the FDA Center for Drug Evaluation and Research (CDER). Currently, the FDA Center for Tobacco Products (CTP) regulates cigarettes, cigarette tobacco, roll-your-own tobacco and smokeless tobacco.

For regulating e-cigarettes, the FDA has issued a proposed rule that would extend the agency’s tobacco authority to cover additional products that meet the legal definition of a tobacco product, such as e-cigarettes. FDA’s Extending Authorities to Additional Tobacco Products webpage offers more information on the proposed rule.

The proposed regulations require disclosure of ingredients used in e-cigarette liquids, proof of safety of those ingredients and regulation of the devices used to vaporize and deliver the liquid. The FDA-proposed regulation would ban the sale of e-cigarettes with nicotine to any individual under 18 years of age.

The challenge for regulators is that the science is not yet settled. In its notice of proposed rulemaking, the FDA admitted that it did “not currently have sufficient data about these products to determine what effects e-cigarettes have on the public health.”

Adding to the regulatory challenge are the limitations imposed by the federal statutory scheme. In 2010 a federal appeals court ruled that the FDA could not act against adulterated e-cigarettes under the Food, Drug and Cosmetic Act; rather its authority was limited to that provided by the 2009 Tobacco Control Act (TCA). That act imposes regulations on specified tobacco products, such as cigarettes and smokeless tobacco, and all other tobacco products that the FDA “deems” to be subject to the act. It is this provision that the FDA will invoke if it promulgates the deeming regulations.

The FDA, however, believes that it does not have the statutory authority to pick and choose among the provisions of the TCA. In other words, if e-cigarettes are deemed to be tobacco products, a wide range of regulations will automatically come into effect. Most notable is the requirement that new products undergo pre-market review.

Four states have already applied some or all of their indoor smoking laws to e-cigarettes; as have almost 200 cities. Many local jurisdictions also ban youth sales. There have been several proposals in the Ohio General Assembly regarding e-cigarettes, but no bill has been signed into law.

Ultimately, the question is should e-cigarettes be regulated? Absolutely—due to their chemical nature and that individuals will be ingesting them into their bodies, and others could also inadvertently ingest it. Government’s purpose is for the protection of its people, and this is clearly in the realm.

Science has underlined the harmful effects of tobacco and smoking due to nicotine. E-cigarettes—I would bet the farm—are very similar in effect.

Rob Scott is a general practice attorney at Oldham & Deitering, LLC. Scott is a Kettering City Councilman, founder of the Dayton Tea Party, member of the Dayton Masonic Lodge and Kettering Rotary. He can be contacted at or

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Reach DCP editor Sarah Sidlow at

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