A humorous evaluation of the FDA press release regarding electronic cigarettes:
Update: Since “13 Guys Named Ed” use a one page type website and the referred story is now buried, here is the actual post:
Recent Studies Indicate That the FDA May Contain Trace Elements of Bos Taurus Egesta
By Jason Katzwinkel
An FDA News Release from July 22, 2009:
FDA and Public Health Experts Warn About Electronic Cigarettes
The U.S. Food and Drug Administration today announced that a laboratory analysis of electronic cigarette samples has found that they contain carcinogens and toxic chemicals such as diethylene glycol, an ingredient used in antifreeze.
Do you happen to have a beverage at your side? What is it? … Wait, what? Are you serious? O’m’gawd, your drink contains an ingredient used in antifreeze! Yeah, that’s right. Water. The term “…is an ingredient used in antifreeze” is the comestible, fear-mongering equivalent of “…then the terrorists win.”
I must concede that diethylene glycol is indeed toxic. That much is true. But how toxic is it? It possesses one-tenth the toxicity of household aspirin, not to mention one-fortieth the toxicity of nicotine, the primary component of e-cigaratte vapor which is administered in much higher doses. So why is the FDA focusing on diethylene glycol? Because if they told you that e-cigarettes contain trace amounts nicotine, you’d stare blankly, shrug your shoulders, and take another long satisfying drag off of your e-cigarette before blowing a bunch of vapor in their faces. But when somebody starts throwing around a term like ‘diethylene glycol,’ people pay attention. Nobody knows what the hell it means and it doesn’t sound like something you’d necessarily want a tall frosty mug of.
Or does it? Diethylene glycol is also an ingredient found in toothpaste, mouthwash, cough syrup, dog food, wine and cigars among plenty of other consumer products. Do you know what it is not an ingredient of? Antifreeze. Propylene glycol is used in antifreeze. Diethylene glycol is used in coolants. Let’s get our scare tactics straight, shall we?
I’m reminded of city officials in Aliso Veijo, California who nearly proposed a ban on polystyrene containers because they heard that Styrofoam cups may contain dihydrogen monoxide, a colorless odorless chemical that is the main ingredient of acid rain and is lethal when inhaled. What is dihydrogen monoxide? H2O.
Electronic cigarettes, also called “e-cigarettes,” are battery-operated devices that generally contain cartridges filled with nicotine, flavor and other chemicals. The electronic cigarette turns nicotine, which is highly addictive, and other chemicals into a vapor that is inhaled by the user.
These products are marketed and sold to young people and are readily available online and in shopping malls. In addition, these products do not contain any health warnings comparable to FDA-approved nicotine replacement products or conventional cigarettes. They are also available in different flavors, such as chocolate and mint, which may appeal to young people.
I have yet to see any marketing for these devices out in the wild, let alone marketing geared toward young people. My own searches bring up loads of marketing, but nothing even remotely geared toward teenagers. Every bit of e-cig marketing that I can find consists of either poorly constructed web pages that don’t appeal to anybody, or lots of heraldry, parchment and black satin. Perhaps teens are more sophisticated than I recall.
And c’mon, FDA. It’s like you’re not even trying. Chocolate and mint may appeal to young people? I guarantee that chocolate and mint appeal to young people. Chocolate and mint appeal to all people. That’s like saying scuba divers are preying on children because scuba diving places a major emphasis on breathing, an activity that many young people are known to participate in. What exactly would adult-centric flavors be? Liver & onions? Butterscotch hard candies? Dentu-Creme? What’s the flavor that appeals to twenty-four-year-olds and not sixteen-year-olds? It doesn’t exist.
Marketing aside, these things cost fifty to one-hundred-and-fifty dollars each, not including accessories and recharges. A pack of smokes? Ten bucks. The Senate has approved a number of tax increases on cigarettes with the specific logic that the higher the cost on cigarettes, the fewer the teens that will smoke them. If the FDA has anything to fear, its that tobacco cigarettes will act as a gateway to e-cigarettes.
Regardless of price, however, teens don’t start smoking for the flavor. “Boy, I sure could go for a mouthful of stink right about now.” Kids start smoking to be popular. To fit in. To be cool. To be bad ass. If some punk shows up on a street corner with an e-cigarette, it’ll be shoved up his ass within sixty seconds if he’s not laughed into oblivion.
Public health experts expressed concern that electronic cigarettes could increase nicotine addiction and tobacco use in young people. Jonathan Winickoff, M.D., chair of the American Academy of Pediatrics Tobacco Consortium and Jonathan Samet, M.D., director of the Institute for Global Health at the University of Southern California, joined Joshua Sharfstein, M.D., principal deputy commissioner of the FDA, and Matthew McKenna, M.D., director of the Office of Smoking and Health for the Centers for Disease Control and Prevention, to discuss the potential risks associated with the use of electronic cigarettes.
Do you see what they did there? Two unrelated sentences jammed together in a flurry of words to create the illusion that these specific public health experts are saying something that they never said. What that paragraph breaks down into is, “Some people have denounced e-cigarettes. The topic will later be discussed by these four other public health experts.”
“The FDA is concerned about the safety of these products and how they are marketed to the public,” said Margaret A. Hamburg, M.D., commissioner of food and drugs. Because these products have not been submitted to the FDA for evaluation or approval, at this time the agency has no way of knowing, except for the limited testing it has performed, the levels of nicotine or the amounts or kinds of other chemicals that the various brands of these products deliver to the user.
If the FDA has no way of knowing the amounts or kinds of other chemicals in e-cigarettes, how do they specifically mention diethylene glycol and other carcinogens? And, in the very next paragraph: “The FDA’S Division of Pharmaceutical Analysis analyzed the ingredients in a small sample of of cartridges from two leading brands of electronic cigarettes.” So this whole letter boils down to, “We’ve determined that e-cigarettes contain a number of chemicals, but we have no way of determining if there are any chemicals in these e-cigarettes because nobody has submitted these e-cigarettes we’ve been analyzing for analysis.”
The FDA’s Division of Pharmaceutical Analysis analyzed the ingredients in a small sample of cartridges from two leading brands of electronic cigarettes. In one sample, the FDA’s analyses detected diethylene glycol, a chemical used in antifreeze that is toxic to humans, and in several other samples, the FDA analyses detected carcinogens, including nitrosamines. These tests indicate that these products contained detectable levels of known carcinogens and toxic chemicals to which users could potentially be exposed.
Nitrosamines! Another ten dollar word. Scary stuff. It’s true that some nitrosamines might be carcinogenic; half of them have shown trends that indicate that they might be carcinogenic in humans. The risk is certainly there, but it’s not like the FDA has cared about it before, because anybody can find nitrosamines in many food products including beer, bacon, fish, pickles, and a variety of other meats and cheeses, as well as in party ballons and condoms. And, of course, in cigarettes.
The FDA has been examining and detaining shipments of e-cigarettes at the border and the products it has examined thus far meet the definition of a combination drug-device product under the Federal Food, Drug, and Cosmetic Act. The FDA has been challenged regarding its jurisdiction over certain e-cigarettes in a case currently pending in federal district court. The agency is also planning additional activities to address its concerns about these products.Health care professionals and consumers may report serious adverse events (side effects) or product quality problems with the use of e-cigarettes to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.
None of this is to say that I am pro- or anti-electronic cigarettes. Or that I am pro- or anti-smoking. I, myself, am an ex-smoker who can understand the benefits and detriments of smoking or not smoking tobacco or e-cigarettes. I’m not here to convince you one way or the other except to say that not smoking at all is probably the healthiest way to go, should you find yourself concerned about such things. My primary goal is to open the question: “What’s in it for the FDA?”
Why would the FDA put out a letter that is so obviously spun to demonize electronic cigarettes with virtually no evidence that they cause any more harm than the tobacco cigarettes that are perfectly legal today? I don’t know the answer to that, but I am curious to find out.