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Conundrums in the Courts

Among all the ironies swirling around electronic cigarettes, perhaps the oddest is the prohibition against saying out loud what everyone believes the product to be.

A California man, Joseph Sheppard, is bringing a lawsuit against e-cig distributor Fumizer arguing that it "falsely claims its e-cigarette vaporizers could help users quit smoking, despite the lack of evidence of this in medical studies." He is said to be seeking "class action" status for the case, presumably meaning that he will request reparations for those willing to join him. It is still unclear whether anyone will join him because, like 'duh' – e-cigs do help you quit, except that their distributors aren't supposed to say so.

Of course a growing body of scientific literature shows that vaping does indeed help, but these studies are carefully ignored by Sheppard, by vaping opponents (who present manipulated data analysis purporting to show the opposite), and by hostile journalists looking for a story. It remains to be seen whether the judge, in the Los Angeles Superior Court where Sheppard has filed suit, will go along with such cherry picking, or will look at all the data.

This confusion is embedded in the set of legal restrictions imposed on the product by US courts in 2010. Just a few years after e-cigarettes entered US markets, when most of them were still being imported from China, the FDA attempted to refuse entry to a shipment brought in by a company called Smoking Everywhere, calling e-cigs a "combination drug-device product" requiring preapproval.

Smoking Everywhere sued the FDA, and were joined by Sottera (NJOY), claiming that electronic cigarettes were a tobacco product, simply "an alternative" to combustibles. Meanwhile, the Obama Administration enacted the Family Smoking Prevention and Tobacco Control Act, giving the FDA the authority to regulate the tobacco industry.

The US Court of Appeals in Washington DC ruled for Smoking Everywhere (which no longer exists) and NJOY, agreeing that e-cigs are not medicines. Thereafter, the FDA could only regulate e-cigarettes as "tobacco products" (even though they contain no tobacco), and not as medicines – unless therapeutic claims are made. This is the origin of the conundrum. If a company were to claim that vaping products aid in smoking cessation, they would have to go through a cumbersome certification process, applying for a license to market a therapeutic product. For the time being they could not even do that, since the FDA delayed in producing its "deeming regulations" and e-cigs were in a no man's land, pending definition as anything.

This was a decision, and a definition, made by judges and lawyers, not by scientists. It illustrates the hazards of letting amateurs make scientific decisions. Now that nicotine specialists and harm-reduction health scientists have gotten into the act, we know more. But are the legal types listening?

This was when, and why, vaping supplies distributors began the confusing practice of saying in one part of their literature that they are not a therapeutic product and have not been proven to aid smoking cessation, and in another portion of the publicity admitting the truth that, yes, they can help you, and have indeed helped many, quit smoking.

As indeed they can and do. The studies began coming in, supplying increasing proof of the product's smoking cessation efficacy. Opponents called the evidence "anecdotal" – even as the numbers of anecdotes grew to many thousands. Purported scientific studies produced tortured data analysis to argue that they are ineffective. Increasing numbers of vapers worldwide know that they are effective, and even nay-sayers will admit that smoking cessation is the identity of the product.

European regulators belatedly got into the act. Britain's Medical and Healthcare Products Regulatory Agency ruled that, yes, vaping products are a medicine, and can help you quit smoking, announcing plans to require extensive certification procedures. The European Union finally weighed in with a "Tobacco Products Directive" that initially tried to regulate e-cigs as medicines, but then had to pull back to a "tobacco products" definition, stating that therapeutic claims would have to be backed up by extensive certifications.

This is a sketch of the reasons why it is a 'no-no' to advertise vaping products explicitly as smoking cessation products. It is not perfectly clear what will happen if the California lawsuit is decided against Fumizer.

In any case, for the moment, nobody is allowed to say what everybody knows.

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