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This week, the EU Parliament chose to tighten regulations on cigarettes. Not only did it approve a plan to require “scare” warnings on 65% of tobacco packages, but it also banned flavored cigarettes, including menthol (though the ban does not take effect until 2022). However, Parliament chose not to regulate E-cigarettes as a medicine, choosing instead to restrict sales and advertising of E-cigarettes the same way it does traditional tobacco products. Noting that E-cigarettes may be a useful cessation tool, some voters argued that they never wanted it to be more onerous to get an E-cigarette than a traditional cigarette.
Some industry observers are suggesting that this sets the stage for a contentious debate in the United States. Currently, the American E-cigarette industry lacks any meaningful regulation, although the FDA has indicated that it plans to begin issuing regulations or guidance soon. Unfortunately, not much data exists as to the safety of E-cigarettes. So, since the trusty regulators at the FDA are currently furloughed, we invite JETLaw’s readership to propose their own framework for regulating E-cigarettes.
On one hand, anecdotal evidence exists that E-cigarettes are useful as a cessation tool; certain studies suggest that they can be effective in reducing cravings during quitting. Additionally, studies also show that the vapor inhaled from E-cigarettes, which operate by vaporizing a vial of liquid nicotine for the user’s inhalation, contain significantly lower levels of carcinogens [PDF] than traditional cigarette smoke. Many professionals say they are “infinitely” more healthy than regular cigarettes. Defenders of E-cigarettes point out that most of the negative studies use a variety of different brands (or unidentified brands), and that safety and quality control has improved as the industry has grown.
On the other hand, E-cigarettes still contain nicotine and have led to increased nicotine use among teenagers. Studies have found that E-cigarettes do damage the lungs and can expose users to elevated levels of glycerin or propelyene glycol – to concentrations that have never been studied in humans. Critics of E-cigarettes point out that few studies have shown that the products are safe; even fewer exist that were not funded by interested parties. It does not help matters that the major tobacco companies have purchased the major E-cigarette producers and are sometimes using the same researchers and techniques that obfuscated the truth about second-hand smoke for many decades.
Why does this matter? Because industry analysts believe that E-cigarettes will overtake traditional cigarettes within a decade. One member of the EU Parliament noted that E-cigarettes pose a risk because once they take hold, it will be tough to “put the genie back in the bottle.” Should the FDA begin treating E-cigarettes like tobacco, restricting sales and advertisements? Should they be more tightly regulated than cigarettes, considering that the risks are unknown and the products are being offered as cessation tools? Would FDA regulation risk putting a “stamp of approval” on a product that may pose more risks than we know? Would federal regulation be arbitrary and capricious at this stage? Does it matter that Blu E-cigarettes, the major US brand, does not contain propelyene glycol? Should the FDA rely on EPA standards for carcinogens or Threshold Limit Values [PDF] for workplace safety? Unfortunately, the FDA can’t help us this week, so you be the judge/regulator. Let us know your thoughts in the comments!
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