Tuesday, March 01, 2016

IN MY VIEW: FDA Bears Responsibility for Increasing Number of Severe E-Cigarette-Related Injuries; Wasting Time with Product Applications was a Doomed Approach

The FDA bears responsibility for the growing number of severe injuries occurring as a result of exploding e-cigarette batteries because rather than acting quickly to regulate e-cigarette safety, the agency dragged its feet, wasting its time in creating a bureaucratic nightmare based on prohibitively expensive product applications that do nothing to directly protect the public's health.

The problem of exploding e-cigarette batteries appears to be a growing one, and these explosions are resulting in severe, often debilitating injuries. While most of the explosions have occurred while the batteries were charging, some have occurred when the batteries were simply being stored or carried. And while some explosions resulted from improper use of the devices, at least several have involved conditions of normal product use.

Fortunately, much is known about the cause of these explosions and about safety standards that can be imposed to greatly reduce the risk. It appears that lithium-ion batteries are somewhat prone to explosion due to the possibility of thermal runaway. To reduce this risk, there are a number of safety precautions, which include overcharge protection, circuit protection (the inclusion of an approved safety circuit), high quality materials, and manufacture only by approved battery pack assemblers. In addition, more prominent and specific warnings and instructions can be provided.

Once the FDA made the decision to assert regulatory jurisdiction over electronic cigarettes, it should have immediately promulgated battery standards to greatly reduce the risk of lithium ion battery explosion. Instead, it has wasted several years crafting an absolutely absurd system of bureaucratic fanagling that will divert much needed resources into reviewing thousands of thousand-page applications and away from actually protecting the health of the public.

Instead of creating a regulatory scheme based entirely on the review of expensive, complex, and burdensome applications that will tie up agency personnel for years, the FDA should instead have simply directly promulgated a set of safety standards for electronic cigarettes. This could have been done many months ago, and we could have put the problem of exploding batteries to rest. Instead, a significant number of vapers are suffering from severe burns from battery explosions that the agency regulating this product has done absolutely nothing to prevent. This is why the FDA bears some responsibility for this unacceptable safety problem.

Were I directing the agency, I would put forward standards for e-cigarette battery safety tomorrow. Standards for temperature regulation, limits on the levels of certain chemicals and flavorings in e-vapor, quality control procedures, and e-liquid manufacturing standards would quickly follow. There would be no bureaucratic requirements for every company to submit burdensome and expensive applications for each stock keeping unit (SKU); instead, they would simply have to document that they are in compliance with the promulgated safety standards. This could be done quickly, without controversy, and without tie-ups in the Office of Management and Budget because of severe adverse effects on small businesses.

Instead, the FDA has gone down the wrong path. It is committed to using the most wasteful and non-productive bureaucratic approach that has no relevance for non-tobacco products and is eschewing the only type of regulation that makes sense for consumer products that are not cigarettes: direct safety regulation.

As a result, significant numbers of vapers are suffering severe and sometimes debilitating injuries.

This has got to stop.

And there's only two entities that can stop it. First, the OMB, by rejecting the current regulations and telling the FDA to put forward some actual safety regulations. Second, the Congress, by creating a sensible statutory framework for the regulation of electronic cigarettes that forces the FDA to put forward some actual safety regulations.

The FDA is so committed to treating vaping products like deadly cigarettes rather than as a much safer consumer product that it is costing people a great deal of unnecessary suffering. No 17-year-old should have to suffer third-degree burns because the agency that claims to want to protect people from the potential hazards of e-cigarettes is so out of touch with reality that they are unable to recognize that regulating vaping products like deadly cigarettes makes absolutely no sense.

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