FDa’s View on E-Cigarettes Draws Some Scrutiny

This month the US Food and Drug Administration is expected to make a decision about whether to categorize the popular e-cigarettes with conventional cigarettes. Such a move could restrict the growing market in areas such as advertising, flavoring, and sales.

It”s also a move that many e-cigarette manufacturers are anticipating.

“We do anticipate becoming a regulated industry, so it is very possible the way in which we advertise will change,” said Andries Verleur, co-founder of e-cigarette maker VMR Products.

But just because manufacturers are readying themselves for FDA oversight doesn”t mean everyone is happy about the possibility.

Historical moves

In late September, US attorneys in 40 states petitioned the FDA to regulate the sale and advertising of electronic cigarettes immediately. It is to this that the FDA is expected to respond.

However, it would not be the first time the agency made an attempt to push back against the rising tide of e-cigarette sales. A few years ago the FDA tried to ban their sale by classifying them as an unapproved pharmaceutical product. This attempt was blocked by a federal judge and an appeals court; however, the courts confirm the agency”s jurisdiction to regulate them as tobacco products, stating the nicotine in electronic cigarettes is derived from tobacco, and thus e-cigarettes fall under the purview of the FDA.

Yet experts have been quick to point out that this really isn”t the case, because the nicotine in electronic cigarettes is delivered as a propylene glycol vapor and not from a burned tobacco leaf.

Other mistakes noted

In an attempt to head off the resistance posed by the FDA, experts have pointed out some flaws in the arguments against e-cigarettes being safer than traditional cigarettes.

A recent article in the New York Post disputed statements made by the Southern Nevada Health District”s Maria Azzarelli, who told the Las Vegas Sun that “no one can say right now whether e-cigarettes are a healthier alternative to cigarettes.”

The paper countered by asking, “Really? No one can say whether inhaling vapor containing nicotine, flavoring, and propylene glycol, which the FDA has approved as an ingredient in food and medicine, is safer than inhaling smoke?”

Others quote the US Centers for Disease Control and Prevention which stated that “e-cigarettes appear to have far fewer of the toxins found in smoke compared to traditional cigarettes,” or Boston University”s public health professor Michael Siegel who declared that “we actually have a much better idea what is in an electronic cigarette vapor that what is in tobacco smoke.”

Siegel also authored a paper with the University of California at Berkley”s Zachary Cahn that pointed out that only 5300 of the estimated 10,000 to 100,000 chemicals in smoke from traditional cigarettes have been identified.

Europe opts not to interfere

In early October the European Parliament rejected proposals that would have categorized electronic cigarettes as pharmaceuticals. Instead of pushing on classification issues, the European Union agreed to set 18 years of age as the minimum purchase age and instituted restrictions on advertising for the product, a move that was welcomed by manufacturers of e-cigarettes>.

“This is a fantastic result for public health and the millions of smokers around Europe who are switching to e-cigarettes,” said Charles Hamshaw-Thomas, corporate affairs director for E-Lites, the leading British e-cigarette brand. “Common sense has prevailed.”

Until the FDA makes its decision, electronic cigarette sales and marketing in the US will continue as they have been for years. For those in the industry, the only question that remains is: Will common sense prevail here as well, or will the product be subject to further scrutiny?