The current litigation between two electronic cigarette suppliers and the FDA has everyone in a tailspin. It certainly did not help that the FDA openly misled the public into believing that the electronic cigarette is as (or more) dangerous than tobacco cigarettes. Many medical health professionals have weighed in on this noting the following:
* Dr. Elizabeth Whelan, president of the American Council on Science and Health, called the FDA statement “distorted, incomplete, and misleading. She also noted that “products of combustion cause cancers, cardiovascular disease and lung disease, and more.”
* Dr. Joel Nitzkin, MD, MPH, DPA, FACPM, Chair, Tobacco Control Task Force, American Association of Public Health Physicians stated that “We have every reason to believe the hazard posed by electronic cigarettes would be much lower than 1% of that posed by (tobacco) cigarettes. The testing guidelines in the current tobacco act (circulating through Congress) would represent a ban on electronic cigarettes, (yet) if we get all tobacco smokers to switch from regular cigarettes (to electronic cigarettes), we would eventually reduce the US death toll from more than 400,000 a year to less than 4,000, maybe as low as 400.”
* Michael Siegel, a physician, researcher and professor at the Boston University School of Public Health noted that “What the FDA and anti-smoking groups are doing is committing medical malpractice on a massive scale: on a population basis. They are essentially condemning 100,000-plus consumers to a return to the most deadly known consumer product. So many of these individuals have reported a tremendous improvement in their health since switching to electronic cigarettes.”
Just for the record, all of the above public health officials are anti-smoking advocates.
The FDA and many anti-smoking groups are calling for the electronic cigarette to be pulled from the market on the basis that it is not a proven quit smoking device. The Electronic Cigarette Association (ECA) President Matt Salmon, former US Congressman from Arizona, noted in a letter to Congress that the ECA “acknowledges the health risks of cigarette smoking and advocates that smokers quit. But we also recognize the struggles that many have in quitting and who are looking for a more convenient and better alternative to tobacco cigarettes. While some of our customers have reported using our devices to help them quit smoking by slowing reducing the nicotine delivery in our products, it is important to note that our member companies do not market their e-cigarettes as smoking cessation products nor make any such claims.”
What is most important is the idea of claims. The FDA was formally named in 1930, and the “FDA’s modern regulatory functions began with the passage of the 1906 Pure Food and Drugs Act, a law a quarter-century in the making that prohibited interstate commerce in adulterated and misbranded food and drugs.” The original act had huge issues mainly that “False therapeutic claims for patent medicines were basically unregulated, as the manufacturer had only to show that he personally believed that his remedy worked to avoid prosecution, and standards for food purity and content were nonexistent.”
In 1938, after the 1937 Elixir Sulfanilamide Incident, where the SE Massengil Company created an elixir containing diethylene glycol as the base ingredient was given to children with strep which led to painful deaths, the Federal Food, Drug and Cosmetic Act was put into place. Following, came several examples of “incidents” and “near incidents” that lead for further revision of the Act.
But the question that lies at the heart of this debate is the electronic cigarette liquid really a “new drug” and is the electronic cigarette hardware really a “medical device”? According to the FDA’s definition of “new drug”, they state that the definition of a drug includes “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals” To put this into comparison with other products on the market that do not require FDA approval, let us look at dietary supplements.
Currently, the FDA does not regulate dietary supplements. Those products do not have to be FDA approved for safety, however, they can be recalled by the FDA if there are enough complaints. The only responsibility the manufacturer holds is that “Manufacturers must make sure that product label information is truthful and not misleading.”
Keeping this idea in mind that products can be on the market without FDA regulation, lets look at nicotine. Currently, there is nothing contained within the FDA website referring to nicotine. However, there is a plant out there that has many of the same effects as nicotine and that is lobelia inflata which IS specifically mentioned on the FDA website. The FDA notes in Sec. 310.544 Drug products containing active ingredients offered over-the-counter (OTC) for use as a smoking deterrent, that “Any OTC drug product that is labeled, represented, or promoted as a smoking deterrent is regarded as a new drug within the meaning of section 201(p) of the Federal Food, Drug, and Cosmetic Act (the act), for which an approved application or abbreviated application under section 505 of the act and part 314 of this chapter is required for marketing.” But what happens if these claims are not to be made and the product clearly states that this product has not been evaluated by the FDA?
Now, let’s review what the FDA considers a “medical device”. The term “device”… means an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is–
(1) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them,
(2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
(3) intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.
For comparison purposes, we need to look at tobacco vaporizers. Tobacco vaporizers are currently not FDA regulated. Many of the vaporizers currently sold on the market today, carry the warning that the vaporizer is not approved for medical-therapeutic purposes. If the electronic cigarette is simply a vaporizer, which is it as it uses no combustion, and there are currently hundreds of other products on the market that vaporize tobacco to deliver nicotine into the body, and those are not classified as “medical devices”, then these smaller, more compact versions should fall into the same category as the larger versions, like the Volcano.
If the electronic cigarette liquid uses ingredients that are found in traditional tobacco cigarettes, all ingredients are FDA approved as generally safe for consumption, and the supplier placing the product on the market is not making any claims, then based on the above arguments, the electronic cigarette liquid is not a “new drug” and therefor does not need to be approved by the FDA. This would also lead to the conclusion that if the liquid itself is not a “new drug”, then the hardware itself is not a “medical delivery device”.
Instead stands firm that smokers should have the option to smoke something other than tobacco cigarettes. There should be regulations and those regulations should be put forth by a regulatory body who understands that tobacco harm reduction products have a place in the free market.
