FDA and electronic cigarettes

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FDA intervention

The US Food and Drug Administration (FDA) do not like electronic cigarettes or the relative freedom with which they are currently marketed. The bureaucracy wants to be able to regulate e-cigarettes in the same way that conventional tobacco products are regulated, under the provisions of something called the Family Smoking Prevention and Tobacco Control Act. And this, despite the fact, of course, that electronic cigarettes contain no tobacco!

In the course of the FDA’s determination to bring the product under the same kind of control as tobacco, in April 2011 the US Court of Appeals in Washington, DC, ruled that although electronic cigarettes are not drugs or devices (unless marketed for therapeutic purposes), they can nevertheless be regulated as “tobacco products” if they are “made or derived from tobacco”. Paradoxically, for a product that contains no tobacco, the FDA is currently arguing that electronic cigarettes are “made or derived from tobacco” and, as a result therefore, it will be developing a strategy to bring them under the provisions of the Family Smoking Prevention and Tobacco Control Act.

The FDA’s objections

In its own words: “The FDA is concerned about the safety of these products and how they are marketed to the public”. Specifically, the FDA’s objections appear to focus on just three aspects:

  • electronic cigarettes can play a part in encouraging nicotine addiction in children and young people, claims the FDA, which adds that they might also lead children to try “other tobacco products, including conventional cigarettes”, which, it reminds us, are widely known for causing damage to the smoker’s health and premature death;
  • some smokeless cigarettes might also contain ingredients that have been shown to be poisonous to humans;
  • while electronic cigarettes remain beyond the FDA’s control, it says, the organization cannot insist on the submission to it of clinical case studies or research on the safety or operation of the devices. As a result, the FDA is in no position to inform consumers about the general safety of electronic cigarettes nor advise them on the concentrations of potentially harmful ingredients or what dose of nicotine is being released when they “smoke” them.

The counter arguments

In fact, the FDA’s objections can be addressed quite simply. In so far as the first of the above points is concerned, electronic cigarettes are already clearly marketed as “adult products” for use only by those aged over 18 years or older.

In respect of the FDA’s fears about other poisons being included in electronic cigarettes, you only need to look as far as the principal constituent of the fluid used in almost all e-cigarette cartridges: namely, propylene glycol. Yet this same chemical is already approved for human consumption and use by the FDA itself and is widely used in toothpastes, medicines and cosmetics. So much for the widespread use of “toxic chemicals”, in other words.

Since electronic cigarettes are not currently regulated under the provisions of the Family Smoking Prevention and Tobacco Control Act (they are not “smoked” and contain no tobacco), of course, it is not the FDA’s job to comment on their general safety, the composition of any particular ingredients, or the relative doses of nicotine administered through the cigarette’s atomized liquid. In this regard, the responsible manufacturers of e cigarettes already concentrate on the safety of their use and openly advise consumers about the relative doses of nicotine that it is possible to choose in the different cartridges on sale.

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One Review to “FDA and electronic cigarettes”

  1. D Holland says:

    It seems to me that the governments of several countries are looking to regulate e cigarettes for no other reason than to be able to tax them. They are currently losing tobacco tax every time someone makes the switch to an electronic device and as numbers grow the duty lost will become significant.
    It seems odd to us that the FDA want to regulate electronic devices while failing to ban tobacco products which are proven to be killers?!
    Does that make any sense to anyone?

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