Thursday, December 15, 2016

D.C. District Court Should Issue an Immediate Injunction Against Enforcement of FDA Deeming Regulations

According to an ABC News story, a Connecticut man was injured when an electronic cigarette exploded in his mouth. The problem, according to the local Deputy Fire Marshal, is that "cheaply made aftermarket batteries can short circuit in milliseconds." The article reports that there have been at least 92 other documented explosions.

There seems to be a simple solution to the problem. The company that manufactured the defective e-cigarette used by this Connecticut man should find a different source of batteries, instead of using the cheap aftermarket batteries that can short circuit in milliseconds.

However, there is just one problem. The FDA deeming regulations do not allow that e-cigarette company, or any of the multiple others whose batteries have exploded, to replace the cheap aftermarket batteries with safer ones. If they did so, it would constitute a new "tobacco product," and could not be placed on the market until the company applied for and received a marketing authorization from the FDA, a process that would take years and millions of dollars. So effectively, the FDA has banned safety improvements such as replacing defective batteries.

Because of this, the FDA deeming regulations represent a clear and present danger to the health of the public. Accordingly, the D.C. District Court should issue an immediate injunction against the enforcement of the new tobacco product application provisions of the regulations, thus allowing companies to make critical safety improvements necessary to protect the health and lives of consumers.

The FDA justifies its regulations based on pure speculation about the hazards of vaping products, yet is taking no action to remedy the one documented adverse health effect of these products: the potential for exploding batteries. Not only is the FDA failing to take action about this problem, but it has made the problem much worse by prohibiting companies from fixing the problem.

In all my years in public health, I cannot think of another public health regulatory action that is so acutely threatening to the public's health.

An alternative to a federal court injunction would be an executive action by the new president directing the FDA to immediately halt enforcement of the pre-market tobacco application requirements of the deeming regulations.

The Rest of the Story

Regardless of how anti-tobacco groups feel about the use of e-cigarettes for harm reduction in tobacco control, all should agree that sensible regulations would not block critical safety improvements to these products. The deeming regulations are nonsensical, and they need to be voided and replaced. This is something I and many others will be working on in the new year.

Ironically, the approach being advocated by anti-tobacco groups to providing safeguards against potential hazards of electronic cigarettes is doing the exact opposite. In contrast, my recommended approach - trashing the new product application process and directly promulgating safety standards - would have taken care of the exploding battery problem years ago.

The rest of the story is that the desire to just get rid of these products has overshadowed the desire to actually regulate the safety of the products and to protect public health and safety. In other words, in the tobacco control movement, ideology has overtaken science.

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