FDA first intended to treat electronic cigarettes as a drug, but a court ruled that it cannot and should instead be treated as tobacco. This ruling was then thought to be a victory, but now that ecigs would soon be classified as tobacco, perhaps classifying it as medicine is a better idea.
Ecigs As Drug
Senior Fellow for Global Health, Economics, and Development Thomas Bollyky wrote that if electronic cigarettes are regulated as drug and drug device, the devices and their independent manufacturers could maintain the competitive advantages they now have over traditional cigarettes and over Big Tobacco companies selling them.
Manufacturers will have the motivation to invest on R&D innovations that will help smokers give up smoking. The ban on public vaping and on eliquid flavorings could also be reversed due to better health benefits evidences resulting from the research. Onerous sin taxes that lawmakers want to levy on them will be inapplicable. Ecigs could very well be part of Medicare and of insurance reimbursement. Ecig use would be extended especially among the low income users.
Bollyky, however, acknowledged that these benefits are still all or nothing. Consumers as well as restaurant and bar proprietors cannot be expected to look at and distinguish which brands were approved for public use and smoke cessation and which ones are not.
Furthermore, the cost of the regulatory change will definitely not be cheap. Electronic cigarette devices are new while refined nicotine is not. Obtaining regulatory approval as medical devices involves costs that are substantially lower than novel drugs, but they are still immense amounts of money that most companies might not be able to afford.
The US tobacco industry involves just three huge dominating companies, but the medical device industry in the country is comprised of over 6,500 medical device companies. Most of them are also small to medium—sized firms.
Most medical devices are not patented. They compete on frequent innovation cycles and they are also subject to lower taxes than cigarettes. Back in the 1980s, the FDA approved patches and gums, the first nicotine delivery devices. The moratorium for direct-to-consumer pharmaceutical advertising likewise existed and lasted for about 10 years.
Investment on improvements was held up and smokers’ uptake of patches and gums survived only at modest sales. This need not happen again because such ban is already over and ecigarettes are now ever popular; perhaps even more popular than the patches and gums.
Need For Congress To Take Action
Going back to the US court ruling in 2008, the FDA’s oversight of electronic cigarettes as drugs and devices was blocked. This ruling indicated that if Congress would like a different outcome to be produced, it need only pass a decree.
It was an invitation that Congress had long been ignoring. It is only timely that Congress takes it up. However, it should not decree to treat ecigarettes as tobacco or as medicines. The recently announced proposed ecig regulations of the FDA as part of treating the devices as tobacco are already ominous as they are.
Categorizing the products as medicine and medicinal devices somehow seem advantageous in a way, but there remain very critical holes where the industry could fall and become extinct. With electronic cigarettes treated in very inappropriate ways, it is not the regulators or the lawmakers who will suffer. The ones who will receive the impact of inappropriate regulations are the smokers and the people who value them.
Ecigarettes now serve as a helpful tool in stopping the addiction to cigarette smoking. Critics could throw every possible argument on ecigarette use, but smokers and vapers are the ones who personally experience the beneficial effects of vaping and the detrimental effects of the urge of imposing dictating regulations. Congress should come up with more specific regulations on ecigs that will promote freer use of the devices.
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