I recently asked FDA spokesman Jeffrey Ventura to answer some of the questions raised by the agency's plans to regulate electronic cigarettes as tobacco products. The most important point he confirms is that e-cigarettes will remain legal but unregulated, like cigars and pipe tobacco, until the FDA gets around to issuing new rules. That may take a while. "The timeline for proposing the rule and subsequent enactment of the proposed rules has not yet been determined," Ventura says.
Meanwhile, the FDA will take action against e-cigarettes only if they are marketed based on "therapeutic claims," which would render them unapproved pharmaceutical products subject to seizure. Exactly what counts as a therapeutic claim is unclear. Cautious e-cigarette companies obviously should avoid saying their products cure the common cold or relieve migraine headaches. But what if they promote e-cigarettes as a safer alternative to smoking or as an aid to quitting? Last week the FDA said it was "considering whether to issue a guidance and/or a regulation on 'therapeutic' claims," but Ventura says "there is no timeline currently set for the issuance of this guidance."
While the FDA has issued a "guidance" (PDF) regarding the Family Smoking Prevention and Tobacco Control Act's grandfather clause, it does not offer much, uh, guidance. Under the grandfather clause, which will be important after the agency starts regulating e-cigarettes, tobacco products that were "commercially marketed in the United States" as of February 15, 2007, and "substantially equivalent" products introduced after that date are not subject to premarket approval. The FDA says evidence that a product qualifies for the grandfather clause may include "dated copies of advertisements," "dated catalog pages," "dated promotional material," "dated trade publications," "dated manufacturing documents," "dated bills of lading," "dated freight bills," or "dated waybills." It does not mention websites, but it sounds like a foreign-based company could qualify by showing that it made online sales to Americans in 2006 or early 2007.
Most e-cigarette brands were not available in the U.S. that early, so the question for them is whether they are "substantially equivalent" to any that were. One could argue that all e-cigarettes are "substantially equivalent" to each other, using the same basic technology. But the FDA may decide to make finer distinctions, and we won't know until it starts responding to applications from companies, which won't happen until it issues the new regulations, which could be months or years from now. Likewise the question of whether e-cigarettes that don't qualify for the grandfather clause can pass muster as "new tobacco products" or "modified risk tobacco products," a label that applies to products marketed as safer than the competition. Regarding the latter issue, Ventura says:
In assessing these products, the Agency is charged with making several findings, including that the product will significantly reduce harm to individual users and benefit the health of the population as a whole. The FDA is currently assessing how best to implement these requirements.
At this point, no product has been determined by the Agency to be a safer alternative to conventional cigarettes. Furthermore, the harm potentially caused by inhaling the various chemical substances in e-cigarettes has not been adequately evaluated. Experts have also raised concerns that the marketing of products such as e-cigarettes can increase nicotine addiction among young people and may lead kids to try other tobacco products.
Those caveats suggest that approval of e-cigarettes would not be the slam-dunk it ought to be, given the enormous difference in risk between smoking and vaping, which does not involve tobacco (except as raw material to produce the nicotine) or combustion products. The "population as a whole" standard, as I've pointed out before, means the FDA can block the sale of a product even if it is indisputably safer than existing alternatives. So it looks like the more the FDA drags its feet, the better off consumers will be.