Last month, the FDA released a statement which made headlines across the country, which potentially placed the entire electronic cigarette industry at financial risk while operating in an already fragile economy. The press announcement made by the FDA was libelous in opposition of the entire electronic cigarette industry. The announcement regarding the health concern of electronic cigarettes was premature, based entirely on a lack of quantifiable scientific data, and was purely motivated by the FDA’s crusade for smoker prevention in the United States; which has been an ongoing campaign of the FDA for over a decade. Conveniently a couple weeks prior to the FDA’s press release, electronic cigarettes were also making headlines across the country as being the new innovation for smokers who are looking for a healthier alternative to smoking conventional cigarettes.
At the time, when electronic cigarettes were perceived in a positive light for smokers, the media most commonly explained the electronic cigarette as being something that looked, felt like, tasted like, but was not a cigarette. E-cigarettes do not produce smoke when used, but a water based nicotine vapor instead, which is inhaled by the smoker just as if it was smoke from a normal cigarette. When the vapor is inhaled the nicotine it contains is absorbed by the smoker’s lungs. While the e-cig was in the limelight the media also focused on the benefits that smokers would receive by switching from the conventional tobacco cigarette to an electronic cigarette. Such benefits included the elimination of carcinogens (cancer causing agents) and tar from the smoke of a traditional cigarette, the elimination of second hand smoke and its smell, and the ability to aid smokers to quit as the nicotine cartridges are available in different concentrations to wean the smoker off nicotine. The use of electronic cigarettes is also permitted everywhere that smoking is prohibited including airplanes.
The FDA’s vague press release, which did not contain a shred of quantifiable scientific evidence to support the notion that electronic cigarettes are dangerous, and pose harm to human users was libelous to the entire industry and should be repealed immediately. As the FDA stated in its press announcement on electronic cigarettes on July 22, 2009:
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.
The initial scientific findings of the, Division of Pharmaceutical Analysis, have been used to mislead the public by the FDA. This press release failed to include the concentration of the trace amounts of chemicals found, which “users could potentially be exposed to”, and whether any of the chemicals found are concentrated enough to ever do harm to humans if exposed. It is truly appalling that the FDA released its initial findings to evaluate the products of an entire industry based on a small sample of less than 20 cartridges from two companies.
Dr.Michael Siegel, MD, and Master of Public Health, who is a professor in the Department of Community Health Services at the Boston University School of Public Health, is one of many in the scientific community challenging the FDA’s statement that electronic cigarettes are not a healthy alternative to tobacco cigarettes. Dr.Michael Siegel has stated:
The FDA's laboratory findings actually indicate that electronic cigarettes are much, much safer than conventional cigarettes. The traces of carcinogens present are also present in nicotine replacement products. The FDA and the anti-smoking groups have fallen into a huge analytical trap as they have failed to ask the appropriate question. The question they are asking is: 'Are electronic cigarettes safe?' That is not the right question. The right question is: 'Are electronic cigarettes much safer than traditional ones?'
Members of the scientific community are not the only people challenging the FDA’s disapproval of electronic cigarettes on a scientific basis. Every member of the electronic cigarette industry is also rebutting the FDA’s claim. One among many of the Industry’s voices is, Thomas R. Kiklas of inLife LLC, who has stated:
The FDA cited the detectable presence of carcinogens and "toxic chemicals" in a "small sample" of electronic cigarette cartridges as reason for alarm, singling out nitrosamines as particularly toxic. What the FDA fails to inform the public is that detectable amounts of carcinogens are also present in nicotine replacement products such as NicoDerm CQ and Nicorette gum, both approved by the FDA, and nitrosamines that can be also found in food items such bacon and beer. This double standard and alarmist attitude has had the significant and unfortunate effect of inducing hysteria among the public, discouraging tobacco smokers from using a product which is thought to be a significantly safer alternative to traditional tobacco.
In fact, the FDA’s press announcement titled, FDA and Public Health Experts Warn About Electronic Cigarettes, which contained an insufficient amount of scientific evidence to support its claim that electronic cigarettes are not safe, was primarily focused on warning people who smoke cigarettes not to use the e-cig as an alternative to smoking tobacco cigarettes; as future use of this product may lead to a growth in people who smoke. As stated in the FDA’s news announcement on July 22, 2009:
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.
Public health experts expressed concern that electronic cigarettes could increase nicotine addiction and tobacco use in young people.
“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.
Stating that electronic cigarettes are marketed to young people is deceitful, as the product is solely marketed as a healthier alternative to tobacco cigarettes. Saying different flavors are offered to appeal to young people is a ridiculous argument as the e-cig industry is trying to do the same as any business would do by accommodating consumer preferences.
How will premature inconclusive findings such as these, effect the future of current and new companies just entering the electronic cigarette industry? What will come of new companies just trying to get their feet off the ground, operating as part of an industry whose products are perceived by the consumer as being more dangerous than the use of conventional cigarettes? The only electronic cigarettes which have been examined by the FDA have used plastic cartridges containing liquid nicotine. The FDA also concluded its test results based on a small sample of less than 20 cartridges (one of which reportedly leaked some of its contents) from two companies out of an entire industry.
What will happen to the new innovators just entering the electronic cigarette industry, which may be able to greatly improve upon the electronic cigarette currently available on the market through technological advances? The industry’s consumer base, smokers looking for an alternative to tobacco cigarettes, will be less inclined to purchase a product if they are under the FDA’s impression of a false pretense that electronic cigarettes are more dangerous than tobacco cigarettes.
Smokefree Innotec, Inc. is leading the way, as one of the new innovators just entering the electronic cigarette industry. Smokefree Innotec has completely revolutionized their electronic cigarette by implementing the use of a biodegradable cartridge, which is micro-infused with dry nicotine; as opposed to using plastic cartridges containing liquid nicotine of higher concentrations in current models on the market, which would eliminate the possibility of chemical leaks.
Please help inform the public that the FDA’s statement made on July 22, 2009 was biased and inaccurate, and that electronic cigarettes are truthfully a healthier alternative for smokers than tobacco cigarettes.
