FDA Still Not Regulating E-Cigarettes

Daniels Tredennick Pharmaceutical and Mass Torts 0 Comments

Proponents of e-cigarettes commonly say the following: It's not that E-Cigarettes are safe; it's just that they are significantly safer than regular cigarettes.  Isn't that like saying knives are safer than  guns?

Did you know that it’s legal to sell E-Cigarettes to minors? The FDA has yet to step in.

Electronic cigarettes, battery-powered devices that convert a solution of nicotine and other chemicals into a vapor that can be inhaled, or “vaped,” have the potential to wean a vast number of smokers off cigarettes. No burned tobacco leaves, no cancer-causing tar: a seemingly public health revolution in waiting.

Right?  Um, not so fast.

There’s the inaccurate inaccurate labeling, shoddy counterfeits and poorly made e-cigarettes that emit toxins and cancer-causing chemicals in vapor. And to the frustration of smokers, public health experts and, yes, manufacturers, the Food and Drug Administration, which has not yet set up sensible regulations, is making the situation worse.

There’s no doubt that the initial public enthusiasm over e-cigarettes is waning, and rightfully so.

Quality concerns are likely to keep rising: This year Chinese manufacturers, the most frequent culprit in safety oversight, are expected to ship more than 300 million e-cigarettes to the United States and Europe.  Yet, we lack an effective regulatory regime to distinguish the good from the bad.

It’s not that the F.D.A. has been idle. Last year it proposed a “deeming rule” — in effect, a blueprint for a regulatory framework for e-cigarettes. But given the avalanche of public comments (more than 135,000) and the importance of getting it right, a regulatory pathway will not be cleared anytime soon.

Consider the complexity. The proposal has some useful provisions, such as a ban on sale to minors and a requirement to disclose ingredients. But the proposal would also push e-cigarettes into the hugely burdensome regulatory framework that Congress set up for any new tobacco product.

That would be a mistake. To appreciate the extent of the unnecessary burden, consider “pre-market review.” Companies would have to demonstrate not only that each specific product was beneficial to intended users (adult smokers), but they would also have to show the consequences to teens and nonsmokers. Gathering these data would be vastly time consuming and expensive: According to the agency’s own estimates, conducting the necessary scientific investigations and preparing a pre-market application would take on average more than 5,000 hours and cost more than $300,000.

Only the large tobacco producers would be able to shoulder these costs, driving many of the 450 or so small e-cigarette makers from the market. This would suppress the innovation that’s crucial to expanding, refining and enhancing the safety and appeal of e-cigarettes.

Pre-market review is commonly used to prove that very risky products, like drugs, medical devices, pesticides and aircraft engines, aren’t harmful. But the point of e-cigarettes is not that they are safe, but that they are significantly safer than cigarettes.

Instead of waiting years to develop burdensome regulations, the F.D.A. should act now by setting interim safety guidelines. These guidelines would not carry the force of law, but they could go far to bolster smokers’ confidence that a safer way to inhale nicotine exists.

The agency should start by focusing on a few basic steps. It should outline basic good-manufacturing practices for the devices and liquids, including limits on the amount of chemicals, like formaldehyde, and metals, like nickel, that can be present in the aerosols. It should disallow outright some contaminants in the nicotine solution and flavorings.

It should require manufacturers to ensure that all batches of chemicals are traceable and that all sources of hardware are known. The guidelines should also require makers to verify that e-cigarette batteries can be charged safely and that they will operate safely in the course of normal use. Interim guidelines should require manufacturers to use childproof packaging that carries a warning: “This product contains nicotine, which is addictive and is intended for adult smokers only.” Also, a mechanism for reporting adverse effects is needed.

Such minimal standards are overdue. The longer it takes the F.D.A. to set them, the longer smokers risk confusion about the virtues of switching — and keep inhaling deadly smoke.

Leave a Reply